PLA 3.

0
Software for Biostatistical Analysis

Version: PLA 3.0.3

Stegmann Systems GmbH, Raiffeisenstr. 2, Rodgau, Germany

www.bioassay.de
PLA 3.0
Dokumentation
PLA 3.0 - Dokumentation

COPYRIGHT
PLA 3.0
© 2006-2015 Stegmann Systems GmbH, Rodgau, Germany. All
rights reserved.

The Stegmann Systems products referred to in this document are

also copyrighted, and all rights are reserved by Stegmann Systems
and/or its licensors, if any. This manual may not, in whole or in part,
be copied, translated, or reduced to any electronic medium or ma-
chine-readable form without prior consent, in writing, from Steg-
mann Systems.

The information in this manual is subject to change without notice,

and Stegmann Systems assumes no responsibility for any errors that
may appear in this document. The references in this manual to
specific platforms supported are subject to change.

Java and all Java-based marks are trademarks or registered trade-

marks of Oracle, Inc. in the U.S. and other countries.

Any other trademarks or service marks contained herein are the

property of their respective owners. PLA 3.0 includes software de-
veloped by the Apache Software Foundation
(http://www.apache.org/, Copyright 1999-2014 The Apache Soft-
ware Foundation. All rights reserved.

PLA 3.0 uses libraries that are subject to the Lesser GNU Public Li-
cense (LGPL) Version 2.1 (the "License"); you may not use these files
except in compliance with the License. A copy of the License is dis-
tributed in the same folder as the respective file. Software distrib-
uted under the License is distributed on an "AS IS" basis, WITHOUT
WARRANTY OF ANY KIND, either express or implied. See the License
for the specific language governing rights and limitations under the
License. All rights reserved.

2
 Kontakt

KONTAKT
Stegmann Systems GmbH
Raiffeisenstr. 2 // C1, C2
63110 Rodgau
Germany

Telefon: +49 6106 770100

Fax: +49 6106 7701029

www.bioassay.de
[email protected]

3
PLA 3.0 - Dokumentation

INHALT
Copyright ............................................................................................ 2
Kontakt ............................................................................................... 3
Inhalt .................................................................................................. 4
Willkommen zu PLA 3.0 ..................................................................... 6
Biologische Assays .......................................................................... 7
Parallel-Logistic Assay ................................................................ 7
Parallel-Line Assay ...................................................................... 8
Slope-Ratio Assay ....................................................................... 9
Dichotomes Assay .................................................................... 10
Dokumentarten für Biologische Assays........................................ 10

Quantitative Response Assay ............................................. 10

Dichotomes Assay .............................................................. 10

Combination of Assay Results ............................................ 11

Control Chart ...................................................................... 11

Basic Bioassay Protocol ...................................................... 11

Equivalence Margin Development ..................................... 11

Dokumentarten zur Dokumentation von Messungen ................. 11

Gerät .................................................................................. 11

Operator ............................................................................. 12

Substanz .............................................................................. 12
Allgemeine Dokumentarten ......................................................... 12

4
 Inhalt

Aufgabe............................................................................. 12

Termin ................................................................................ 12

Kontakt............................................................................... 12

Notiz ................................................................................... 12
Weitere Dokumentarten .............................................................. 12
Neue Dokumente und Navigation in der Datenbank ................... 13
Weiterführende Informationen ................................................... 13
Vorlagen und Standardvorschriften (SOPs) ............................. 13
21 CFR Part 11 Compliance ...................................................... 13
Qualifizierung und Verifikation (IQ, OQ, PQ) ........................... 14
Support......................................................................................... 14
Über diese Dokumentation .............................................................. 15
Quick Start Guide ......................................................................... 15
Benutzerhandbuch ....................................................................... 15
Document Package Biological Assays (english) ............................ 15
Document Package Measurement Documentation (english) ...... 16
Document Package Generic Documents (english) ....................... 16
Administratorhandbuch ............................................................... 16
Installationshandbuch .................................................................. 16

5
PLA 3.0 - Dokumentation

WILLKOMMEN ZU PLA 3.0

Willkommen in PLA 3.0! PLA 3.0 ist eine erweiterbare Plattform zur
biostatistischen Analyse in GxP- und Nicht-GxP Umgebungen.

PLA 3.0 unterstützt mehrere Dokumentarten in einer Datenbank.

Dokumentarten dienen unterschiedlichen Aufgaben wie z.B. der
Dokumentation oder der Durchführung statistischer Berechnungen.
PLA 3.0 wird mit drei Dokumentartgruppen ausgeliefert. Weitere
Dokumentarten können in Ihrer Datenbank verfügbar sein.

Biologische Assays dienen der Bestimmung der Wirksamkeit eines

Wirkstoffs. PLA 3.0 unterstützt alle wesentlichen Arten biologischer
Assays gemäß European Pharmacopoeia Kapitel 5.3 und US Phar-
macopoeia Kapitel 1032, 1033 und 1034.

6
 Willkommen zu PLA 3.0

BIOLOGISCHE ASSAYS
PARALLEL-LOGISTIC A SSAY

3-, 4- und 5-Parameter Logistische Auswertung zur Analyse sigmoi-

daler Dosis-Wirkungsbeziehungen.

7
PLA 3.0 - Dokumentation

PARALLEL-LINE ASSAY

Lineares Auswertungsverfahren für den linearen Bereich der Dosis-

Wirkungsbeziehung.

8
 Willkommen zu PLA 3.0

SLOPE-RATIO ASSAY

Lineares Auswertungsverfahren insbesondere für kleinere Konzent-

rationen.

9
PLA 3.0 - Dokumentation

DICHOTOMES ASSAY

Auswertungsverfahren auf Basis der Probit- und Logit-Funktionen

zur Analyse binärer Daten.

DOKUMENTARTEN FÜR BIOLOGISCHE ASSAYS

QUANTITATIVE RESPONSE ASSAY
Diese Dokumentart repräsentiert ein einzelnes, unabhängiges bio-
logisches Assay. Als Auswertungsmethoden stehen das Parallel-Line
Assay, das Parallel-Logistic Assay und das Slope-Ratio Assay zur
Verfügung.

DICHOTOMES ASSAY
Diese Dokumentart repräsentiert ein unabhängiges, biologisches
Assay auf der Basis binärer Ergebnisse. Es wird auch Binäres Assay

10
 Willkommen zu PLA 3.0

oder Quantal Response Assay genannt. Die Auswertung erfolgt mit

Hilfe der Probit- oder Logit-Methode.

COMBINATION OF A SSAY RESULTS

Diese Dokumentart kombiniert die Ergebnisse unabhängiger biolo-
gischer Assays zu einem Berichtswert (reportable value). Die Kom-
bination kann auf Basis der verschiedenen Verfahren der European
Pharmacopoeia oder der US Pharmacopoeia erfolgen.

CONTROL CHART
Diese Dokumente dienen zur Trendüberwachung. Es können meh-
rere Werte gleichzeitig überwacht und mit mehreren Grenzwerten
ausgestattet werden.

BASIC BIOASSAY PROTOCOL

Dieses Dokument repräsentiert ein einfaches Protokoll, in dem
mehrere Assay-Replikate für ein definiertes Produkt angelegt wer-
den, die anschließend mit Hilfe einer Kombinationsrechnung zu
mindestens einem Berichtswert zusammengefasst werden.

EQUIVALENCE MARGIN DEVELOPMENT

Diese Dokumentart erlaubt die Aggregation verschiedener Quanti-
tative Response Assays zur Entwicklung möglicher Equivalence Mar-
gins.

DOKUMENTARTEN ZUR DOKUMENTATION VON MES-

SUNGEN

GERÄT
Das Gerät-Dokument kann optional zur Dokumentation der in einer
Messung verwendeten Geräte genutzt werden. Innerhalb des Do-
kuments können auch Logbücher, Wartungsinformationen etc.
abgelegt werden.

11
PLA 3.0 - Dokumentation

OPERATOR
Das Operator-Dokument repräsentiert eine Person, die an der Her-
stellung, Durchführung oder Analyse eines Datensatzes beteiligt ist.

SUBSTANZ
Das Substanz-Dokument erlaubt die Aufnahme allgemeiner Infor-
mationen zu einer verwendeten Substanz. Dies kann der Standard,
der Werkstoff oder ein verwendetes Reagenz sein.

ALLGEMEINE DOKUMENTARTEN

AUFGABE
Das Aufgabe-Dokument repräsentiert eine Aufgabe und hat einen
Status, ein Fälligkeitsdatum und einen Bearbeiter.

TERMIN
Das Termin-Dokument bildet einen Kalendereintrag ab.

KONTAKT
Ein Kontakt-Dokument kann die Kontaktinformationen für einen
Kontakt abbilden.

NOTIZ
Das Notiz-Dokument repräsentiert einen Notizzettel.

WEITERE DOKUMENTARTEN
PLA 3.0 kann um weitere Dokumentarten erweitert werden, die
entweder zum öffentlich zum Download zur Verfügung stehen oder
die für Ihre Umgebung explizit erstellt wurden.

12
 Willkommen zu PLA 3.0

NEUE DOKUMENTE UND NAVIGATION IN DER DATEN-

BANK
PLA 3.0 organisiert alle Daten als elektronische Dokumente. Sie
werden Ihnen in Ordnern gruppiert präsentiert und befinden sich in
einer Datenbank. Dokumente innerhalb von Ordnern unterliegen
Zugriffsrechten und ggf. weiteren Einschränkungen (z.B. Verwen-
dung vorgeschriebener Vorlagen).

PLA 3.0 verfügt über die neue ElasticForms Editoren-Technologie

von Stegmann Systems, die ein einheitliches Editieren aller Doku-
mentarten erlaubt.

Zur Dateneingabe verfügt PLA 3.0 über drei separate Editoren, die
unterschiedliche Perspektiven auf die Daten ermöglichen. Der Be-
obachtungen-Editor ist das universelle Instrument zur Dateneingabe
und immer verfügbar. Liegen Ihre Daten als Verdünnungsserien vor,
was bei den biologischen Assays gewöhnlich der Fall ist, können Sie
den Sequenz-Editor verwenden. Der Positions-Editor erlaubt das
Editieren im Layout z.B. von Mikrotiter-Platten.

Nach Abschluss der Dateneingabe können Sie das Assay berechnen

und die verfügbaren Berichte zur Datenausgabe nutzen.

WEITERFÜHRENDE INFORMATIONEN
VORLAGEN UND STANDARDVORSCHRIFTEN (SOPS)
Leistungsstarke Vorlagen erlauben Ihrem Administrator die Definiti-
on festgelegter Einstellungen, so dass die möglichen Eingaben und
damit natürlich auch Fehlerquellen, reduziert werden.

21 CFR PART 11 COMPLIANCE

PLA 3.0 verhindert jede ungewollte Manipulation von Daten und
zeichnet alle Änderungen im Ereignisprotokoll (Audit Trail) auf.

13
PLA 3.0 - Dokumentation

Elektronische Signaturen können Ihre Dokumente vor weiteren

Eingaben schützen.

QUALIFIZIERUNG UND VERIFIKATION (IQ, OQ, PQ)

PLA 3.0 unterstützt automatisierte Installationsqualifizierungen (IQ),
Funktionsqualifizierungen (OQ) und auch die Leistungsqualifikation
mit eigenen Daten (PQ).

SUPPORT
Haben Sie Fragen? Vermissen Sie Funktionen oder haben Sie Ideen
für neue Funktionen? Benötigen Sie zusätzliche Rechenverfahren
oder neue Vorlagen für Berichte? Wir freuen uns über Ihren Anruf
oder Ihre Mail!

Stegmann Systems GmbH

Raiffeisenstr. 2, 63110 Rodgau, Germany

Telefon: +49 6106 77010-0

Telefax: +49 6106 77010-29

[email protected]
www.bioassay.de

14
 Über diese Dokumentation

ÜBER DIESE DOKUMENTATION

Diese Dokumentation ist in mehrere einzelne Handbücher unter-
teilt, die auf die unterschiedlichen Rollen der Leser abgestimmt
sind.

QUICK START GUIDE

Steigen Sie sofort in die Arbeit mit PLA 3.0 ein. Erstellen Sie Ihre
erste Datenbank, definieren Sie Ihr erstes Assay und führen Sie eine
Berechnung durch.

Dieses Handbuch ist für jeden Benutzer von PLA 3.0 geeignet.

BENUTZERHANDBUCH
Lernen Sie die volle Funktionalität und Benutzung von PLA 3.0 ken-
nen. Dieses Handbuch erklärt die Arbeit mit PLA 3.0.

Dieses Handbuch ist für jeden Benutzer von PLA 3.0 geeignet.

This handbook is suited for every user of PLA 3.0.

DOCUMENT PACKAGE BIOLOGICAL ASSAYS (ENGLISH)

Reference documentation for biological assay document types:
Quantitative Response Assays, Dichotomous Assays, Basic Bioassay
Protocol, Equivalence Margin Development, Combination Calcula-
tions and Control Charts.

This handbook is intended for users and function administrators of

PLA 3.0

15
PLA 3.0 - Dokumentation

DOCUMENT PACKAGE MEASUREMENT DOCUMENTATION

(ENGLISH)
Reference documentation for measurement documentation docu-
ment types: Operator, Substance, Equipment.

This handbook is intended for users and function administrators of

PLA 3.0

DOCUMENT PACKAGE GENERIC DOCUMENTS (ENGLISH)

Reference documentation for generic documents: Appointment,
Contact, Note and Task.

This handbook is intended for users and function administrators of

PLA 3.0

ADMINISTRATORHANDBUCH
Erfahren Sie wie Sie Dokumentvorlagen, Benutzerkonten, Berechti-
gungen, Sicherheitskontexte und Datenbanken einrichten und ver-
walten.

Dieses Handbuch richtet sich vor allem an die PLA 3.0 Administrato-
ren (Funktionaler Administrator) und Systemadministratoren.

INSTALLATIONSHANDBUCH
In diesem Handbuch erfahren Sie alles über die unterschiedlichen
Installationsszenarios für PLA 3.0.

Dieses Handbuch richtet sich vor allem an die Systemadministrato-

ren.

16
PLA 3.0
Quick Start Guide
PLA 3.0 - Quick Start Guide

COPYRIGHT
©2015 by Stegmann Systems GmbH, Rodgau, Germany.
All rights reserved.

KONTAKT
Stegmann Systems GmbH
Raiffeisenstr. 2 // C1, C2
63110 Rodgau
Germany

Telefon: +49 6106 770100

Fax: +49 6106 7701029

www.bioassay.de
[email protected]

2
 Inhalt

INHALT
Copyright ............................................................................................ 2
Kontakt ........................................................................................... 2
Inhalt .................................................................................................. 3
Willkommen ....................................................................................... 4
PLA 3.0 Installieren............................................................................. 5
Inhalte ............................................................................................ 5
Systemanforderungen................................................................ 5
PLA 3.0 Einzelplatzinstallation oder -aktualisierung .................. 6
Hardware-Schlüssel Installation ................................................. 8
Erste Schritte .................................................................................... 10
Inhalte .......................................................................................... 10
Aufgaben ...................................................................................... 11
Eine Datenbank erstellen ......................................................... 11
Lizenzen eingeben .................................................................... 16
An der Datenbank anmelden ................................................... 19
Einen Ordner erstellen ............................................................. 22
Ein Dokument erstellen ............................................................ 23
Daten eingeben ........................................................................ 27
Ein Dokument berechnen ........................................................ 30
Ein Dokument signieren ........................................................... 33
Einen Bericht erstellen ............................................................. 37
PLA 3.0 beenden ...................................................................... 40

3
PLA 3.0 - Quick Start Guide

WILLKOMMEN
Willkommen zum PLA 3.0 Quick Start Guide. Dieses Handbuch ist für
jeden Benutzer von PLA 3.0 geeignet.

Mit dem PLA 3.0 Quick Start Guide steigen Sie sofort in die Arbeit
mit PLA 3.0 ein. Sie erstellen Ihre erste Datenbank, definieren Ihr
erstes Assay und führen eine Berechnung durch.

4
 PLA 3.0 Installieren

PLA 3.0 INSTALLIEREN

INHALTE
In diesem Kapitel wird beschrieben welche Voraussetzungen für die
Installation bestehen und wie Sie PLA 3.0 und einen Hardware-
Schlüssel für die Lizenzierung an einem Einzelarbeitsplatz installie-
ren.

Sie können PLA 3.0 parallel zu einer bestehenden PLA 2.x Installati-
on betreiben. Die Installation von PLA 3.0 hat keinen Einfluss auf
eine bestehende PLA 2.x Installation.

Weitere Informationen zur Installation finden Sie im Installations-

handbuch.

SYSTEMANFORDERUNGEN

5
PLA 3.0 - Quick Start Guide

PLA 3.0 benötigt ohne Zusatzmodule ca. 500 Megabyte freien Fest-
plattenspeicher.

Als Betriebssystem wird Microsoft Windows 7, Microsoft Windows

8, Microsoft Windows 8.1, Windows Server 2003, Windows Server
2008, Windows Server 2008R2, Windows Server 2012 und Windows
Server 2012R2 unterstützt.

Für die Generierung von Berichten und Zertifikaten wird der Adobe
Reader benötigt. Diese kostenfreie Software ist
ter http://www.adobe.com/de/products/reader.html verfügbar.

Außerdem benötigen Sie für die Installation von PLA 3.0 ein Micro-
soft Windows Benutzerkonto mit Administrator Rechten. Für die
Benutzung von PLA 3.0 reicht ein normales Microsoft Benutzerkon-
to aus.

PLA 3.0 EINZELPLATZINSTALLATION ODER -AKTUALISIERUNG

6
 PLA 3.0 Installieren

Nachdem Sie PLA 3.0 herunter geladen haben, können Sie die Instal-
lation durch einen Doppelklick auf das Installationsprogramm star-
ten.

Falls Sie PLA 3.0 auf einer CD vorliegen haben, starten Sie die Instal-
lation durch einen Doppelklick auf das auf der CD befindliche Instal-
lationsprogramm.

Microsoft Windows wird Sie unter Umständen mit einer Sicher-

heitswarnung für Dateien die aus dem Internet herunter geladen
wurden konfrontieren. Stellen Sie sicher, dass es sich wirklich um
die PLA 3.0 Installation vom Herausgeber Stegmann Systems GmbH
handelt, und klicken Sie anschließend auf Ausführen um die Installa-
tion zu starten. Folgen Sie nun den Anweisungen auf dem Bild-
schirm um PLA 3.0 auf Ihrem Computer zu installieren oder eine
bestehende PLA 3.0 Installation zu aktualisieren.

7
PLA 3.0 - Quick Start Guide

Falls Sie Ihre PLA 3.0 Installation mit einem Hardware-Schlüssel

lizenziert haben führen Sie bitte nach der Erstinstallation von PLA
3.0 die Installation des Hardware-Schlüssels wie im Kapitel Hard-
ware-Schlüssel Installation beschrieben durch.

HARDWARE-SCHLÜSSEL INSTALLATION
Falls Sie PLA 3.0 mit einem lokalen Hardware-Schlüssel lizenziert
haben werden die Treiber für den Hardware-Schlüssel bei der ers-
ten Verwendung installiert.

Um die Treiber für den Hardware-Schlüssel zu installieren stecken

Sie den Hardware-Schlüssel nach der Installation von PLA 3.0 in
einen freien USB Steckplatz ein.

Microsoft Windows wird mit der Installation der Gerätetreibersoft-

ware beginnen. Wenn Sie auf das Symbol in der Microsoft Windows
Startleiste klicken können Sie den Verlauf der Installation auf dem
Bildschirm verfolgen.

Microsoft Windows wird zuerst mit Hilfe des Windows Update nach
den aktuellsten Treibern für den Hardware-Schlüssel suchen.

Wenn die passenden Treiber gefunden wurden wird die Treiber-

software durch Microsoft Windows installiert.

8
 PLA 3.0 Installieren

Wenn die Bestandteile der Gerätetreibersoftware den Status Ver-

wendung jetzt möglich tragen ist Ihr Hardware-Schlüssel vollständig
installiert und kann für die Lizenzierung von PLA 3.0 verwendet
werden.

Falls Sie keine Einzelplatzinstallation durchführen möchten finden

Sie weitere Installationsszenarien im Installationshandbuch.

9
PLA 3.0 - Quick Start Guide

ERSTE SCHRITTE

INHALTE
In diesem Kapitel wird beschrieben wie Sie eine PLA 3.0 Einzel-
platzinstallation nach der Installation zum ersten Mal starten, eine
Datenbank mit Beispieldokumenten einrichten, Lizenzen eingeben
können und mit Ordnern und Dokumenten arbeiten.

Nach der Installation können Sie PLA 3.0 14 Tage lang kostenlos
testen. Die Funktionalitäten im Bereich der Systemqualifikation und
Berichtserstellung stehen Ihnen in der Testversion allerdings nicht
oder nur teilweise zur Verfügung. Wenn Sie einen Schutzschlüssel
installieren und die dazugehörigen Lizenzen eingeben, wird Ihre
Testversion zu einer vollwertigen PLA 3.0 Installation ohne Ein-
schränkungen. Für die Systemqualifikation benötigen Sie zusätzlich
zu der PLA 3.0 und der Aktivierungslizenz eine Validierungslizenz.

Im Laufe des Kapitels Aufgaben wird Ihnen erläutert wie Sie eine
lokale Datenbank einrichten und PLA 3.0 lizenzieren können. Au-
ßerdem wird Ihnen in einzelnen Schritten erklärt wie Sie ein Quanti-
tative Response Assay erstellen, mit Daten versehen, berechnen,
vor Änderungen schützen und auswerten können.

10
 Erste Schritte

AUFGABEN
EINE DATENBANK ERSTELLEN

Wenn Sie PLA 3.0 das erste Mal starten werden Sie vom Einrich-
tungsassistenten der Datenbankverwaltung durch die nötigen
Schritte zur Erstellung einer PLA 3.0 Datenbank geleitet. Der Ex-
pressmodus erlaubt es Ihnen eine neue, lokale SQLite Datenbank zu
erstellen. Diese lokale SQLite Datenbank kann nur von Ihnen ver-
wendet werden und wird im PLA 3.0 Verzeichnis in Ihrem Microsoft
Windows Benutzerverzeichnis erstellt. Ihr Benutzerverzeichnis be-
findet sich üblicher Weise unter C:\Users\BENUTZERNAME.

Bestätigen Sie den Dialog mit dem Weiter Knopf.

11
PLA 3.0 - Quick Start Guide

Im nächsten Fenster können sie eine Datenbankvorlage für Ihre

Datenbank auswählen, sowie einen Namen und die Anmeldedaten
für Ihr administratives Konto eingeben.

Wählen Sie die Vorlage Default Database with Demo Data aus um
eine Datenbank mit Beispieldokumenten zu erstellen.

12
 Erste Schritte

Geben Sie danach in das Kennwort und das Kennwort bestätigen

Feld ein Kennwort für den Administrator Benutzer der Datenbank
ein und bestätigen Sie den Dialog mit dem Weiter Knopf.

13
PLA 3.0 - Quick Start Guide

Sie bekommen eine Zusammenfassung Ihrer neuen Datenbank

angezeigt.

Beginnen Sie die Erstellung der Datenbank mit dem Fertigstellen

Knopf. Die Erstellung der Datenbank kann einige Minuten in An-
spruch nehmen.

14
 Erste Schritte

Wenn die Erstellung der Datenbank abgeschlossen ist werden Sie

durch einen Informationsdialog darauf hingewiesen.

Bestätigen Sie den Dialog mit OK.

Weitere Informationen zur Datenbankverwaltung erhalten Sie im

Benutzerhandbuch im Kapitel Datenbanken verwenden und im
Administratorhandbuch im Kapitel Datenbankeinstellungen verwal-
ten.

15
PLA 3.0 - Quick Start Guide

LIZENZEN EINGEBEN

Um Ihren Lizenzstatus anzusehen, Ihre Testperiode zu verlängern

oder PLA 3.0 zu lizenzieren, können Sie die Lizenzverwaltung aus
dem Anmeldebildschirm heraus mit Hilfe des Extras Menüs aufru-
fen.

Wenn Sie Ihre PLA 3.0 Lizenzen aktivieren und benutzen möchten,
stellen Sie sicher, dass Ihr Schutzschlüssel für Ihren Computer ver-
bunden ist. Informationen zu den unterschiedlichen Schutzschlüs-
seln finden Sie im Installationshandbuch.

16
 Erste Schritte

In der Lizenzverwaltung erhalten Sie einen Überblick über Ihren

Lizenzstatus und können mit Hilfe des Hinzufügen… oder Herunter-
laden Knopfes Ihre PLA 3.0 Aktivierung- und Lizenzschlüssel zu Ihrer
Installation hinzufügen. Der Herunterladen Knopf lädt die zu Ihrem
Schutzschlüssel gehörenden Lizenzen vom Stegmann Systems Li-
zenzserver herunter, dafür wird eine aktive Internetverbindung
benötigt.

17
PLA 3.0 - Quick Start Guide

Falls Sie Ihre Lizenzen verlegt haben können Sie Ihre Lizenznum-
mern auch mit Hilfe der Seriennummer Ihres Schutzschlüssels be-
stimmen. Geben Sie dafür die Seriennummer Ihres Schutzschlüssels
auf der Webseite http://www.bioassay.de/index.php?id=163 ein.

Wenn Sie eine PLA 3.0 Lizenz erwerben möchten oder Hilfe bei der
Lizenzierung benötigen, nutzen Sie den Kontaktieren Sie uns Link in
der Lizenzverwaltung oder die im Kapitel Kontakt angegebenen
Kontaktinformationen um mit dem Stegmann Systems Kunden-
dienst in Verbindung zu treten.

Sie haben zudem die Möglichkeit die Verlängerung Ihrer Testperio-

de mit Hilfe des Testperiode verlängern… Knopfes zu beantragen.

Nutzen Sie den Webanfrage stellen oder E-Mail senden Knopf um

aus PLA 3.0 heraus eine Anfrage zur Verlängerung Ihrer Testperiode
zu stellen. Ein Mitarbeiter des Kundendienstes wird Ihnen nach der
Prüfung Ihrer Anfrage einen Verlängerungsschlüssel zusenden den
Sie in das Eingabefeld für den Verlängerungsschlüssel einfügen
müssen. Wenn Sie den Verlängerungsschlüssel eingefügt haben

18
 Erste Schritte

können Sie den Verlängern Sie Ihre Testperiode Knopf benutzen um

Ihre Testperiode zu verlängern.

Weitere Informationen zur Lizenzverwaltung erhalten Sie im Instal-

lationshandbuch.

AN DER DATENBANK ANMELDEN

Um sich zum ersten Mal an Ihrer Datenbank anzumelden müssen

Sie im Anmeldebildschirm, der erscheint wenn Sie PLA 3.0 starten,
das Kennwort Ihres administrativen Kontos eingeben. Im oberen
Drop-Down können Sie sehen und auswählen an welcher Daten-
bank Sie sich anmelden.

Geben Sie das Kennwort des administrativen Benutzerkontos ein

und melden Sie sich mit dem Anmelden Knopf an Ihrer neu erstell-
ten Datenbank an.

19
PLA 3.0 - Quick Start Guide

Wenn Sie sich an Ihrer neu erstellten Datenbank anmelden erhalten

Sie im Navigator einen Überblick über die vorhandenen Ordner. Die
Beispieldokumente wurden durch die Datenbankvorlage Default
Database with Demo Data erzeugt.

Maximieren Sie den Navigator durch einen Doppelklick auf den

Navigator Reiter.

20
 Erste Schritte

Im oberen Teil des maximierten Navigators sehen Sie die auf der
Datenbank vorhandene Ordnerstruktur. Im unteren Teil des Naviga-
tors (Navigator Details) sehen Sie die Inhalte des im oberen Naviga-
tor Teil selektierten Ordners.

Im Bild sehen Sie in den Navigator Details den Inhalt des Ordners
Root Folder.

Weitere Informationen zur allgemeinen Benutzung von PLA 3.0

erhalten Sie im Benutzerhandbuch.

21
PLA 3.0 - Quick Start Guide

EINEN ORDNER ERSTELLEN

Führen Sie einen Rechtsklick auf einen Ordner im oberen oder unte-
ren Teil des Navigators durch um die Aktion Neuer Ordner im Kon-
textmenü auswählen zu können.

Sie haben so die Möglichkeit einen neuen Unterordner in dem Ord-

ner zu erstellen, der im oberen Navigator Teil selektiert ist.

22
 Erste Schritte

Weitere Informationen zur Verwaltung von Ordnern erhalten Sie im

Benutzerhandbuch im Kapitel Dokumente verwalten und im Admi-
nistratorhandbuch im Kapitel Berechtigungen verwalten.

EIN DOKUMENT ERSTELLEN

Um ein neues Dokument zu erstellen führen Sie einen Rechtsklick

auf einen Ordner im oberen oder unteren Teil des Navigators aus
um die Aktion Neu… im Kontextmenü auswählen zu können.

23
PLA 3.0 - Quick Start Guide

Die Aktion Neu… gibt Ihnen die Möglichkeit ein neues Dokument zu
erstellen. Durch einen Klick auf die vor den Ordnern angezeigten
Pfeile lässt sich die Ordnerstruktur aufklappen und Sie können die
enthaltenen Dokumenttypen und Vorlagen auswählen.

Wählen Sie Neues Quantitative Response Assay-Dokument aus und

bestätigen Sie den Dialog mit OK um ein neues Quantitative
Response Assay zu erstellen.

24
 Erste Schritte

Wenn Sie ein neues Dokument erstellen wird es im Dokument-

Editor geöffnet. Maximieren Sie den Dokument-Editor durch einen
Doppelklick auf den Reiter des Dokument-Editors.

25
PLA 3.0 - Quick Start Guide

In der Inhalt Ansicht des Dokuments, die Sie aufrufen können indem
Sie die Aktion Inhalt in der Editor-Aktionsleiste anklicken, können
Sie die Eigenschaften des Dokuments definieren. So können Sie z.B.
in der PreparationScheme Eigenschaft (befindet sich unter Setup)
die Anzahl der Sequenzschritte (Step Count) und die Anzahl der
Wiederholungen (Replicate Count) einstellen. Um den Wert einer
Eigenschaft zu ändern klicken Sie mit der linken Maustaste auf den
Wert und verlassen Sie nach der Eingabe das Feld durch das Betäti-
gen der Enter Taste. Wenn Sie das Feld durch das Betätigen der
Escape (esc) Taste verlassen wird der von Ihnen eingegebene Wert
nicht übernommen.

Ändern Sie den Step Count Ihres neuen Dokuments auf 8 und den
Replicate Count auf 1.

Weitere Informationen zur Einrichtung von Dokumenten erhalten

Sie im Benutzerhandbuch im Kapitel Dokumente bearbeiten.

26
 Erste Schritte

DATEN EINGEBEN

Die Beobachtungen Ansicht ist eine Möglichkeit für die Eingabe von
Daten in ein Dokument. Die Zuweisungen Aktion im Beobachtungen
Editor erlaubt es Ihnen, die in der Inhalt Ansicht konfigurierten
Eigenschaften des Dokuments zu benutzen, um beispielsweise die
Spalten Observation Group ID und Sequence Step nach den Vorga-
ben der Eigenschaften zu befüllen.

Rufen Sie die Beobachtungen Ansicht durch einen Linksklick auf die
Beobachtungen Aktion in der Editor Aktionsleiste auf und führen Sie
in der Beobachtungen Ansicht die Zuweisung Observation Group ID
-> Secuence Step durch.

27
PLA 3.0 - Quick Start Guide

Im Anschluss müssen Sie nur noch die zu den Sequenzschritten

gehörenden Response Werte in der Beobachtungen Ansicht einge-
ben. Die Eingabe von Werten funktioniert wie die Eingabe von Wer-
ten in der Inhalt Ansicht.

28
 Erste Schritte

Wählen Sie ein Feld mit der linken Maustaste aus und geben Sie
einen Wert ein. Wenn Sie das Feld durch das Betätigen der Enter
Taste verlassen werden Ihre Eingaben übernommen. Wenn Sie das
Feld durch das Betätigen der Escape (esc) Taste verlassen werden
Ihre Eingaben nicht übernommen.

Geben Sie für jeden Sequenzschritt des Standard und des Test
Samples einen Response Wert ein.

1
2
4
8
10
12
14
16
1
2
4
6
8
12
14
16

Falls Sie die Dokumentation im PDF Format an Ihrem Arbeitsplatz

lesen, können Sie die Response Werte auch via Copy und Paste aus
dieser Tabelle in die PLA 3.0 Tabelle übernehmen.

Weitere Informationen zur Eingabe von Daten erhalten Sie im Be-

nutzerhandbuch im Kapitel Dokumente bearbeiten.

29
PLA 3.0 - Quick Start Guide

EIN DOKUMENT BERECHNEN

Nachdem Sie Response Werte in Ihr Dokument eingetragen haben,

können Sie das Dokument berechnen. Dazu rufen Sie die Berechnen
Aktion in der Editor Aktionsleiste mit einem Linksklick auf.

30
 Erste Schritte

Wenn Sie die Berechnen Aktion aufrufen erscheint ein Statusdialog

der Ihnen Informationen zum Fortschritt und Ausgang der Berech-
nung anzeigt. Wenn die Berechnung abgeschlossen ist können Sie
den Dialog mit dem Schließen Knopf wieder verlassen.

31
PLA 3.0 - Quick Start Guide

Nachdem Sie Ihr Dokument erfolgreich berechnet haben können Sie

auf der Dashboard Ansicht eine grafische Zusammenfassung der
Ergebnisse der Berechnung sehen.

Weitere Informationen zum Berechnen von Dokumenten erhalten

Sie im Benutzerhandbuch im Kapitel Dokumente bearbeiten.

32
 Erste Schritte

EIN DOKUMENT SIGNIEREN

Wenn Sie die Arbeit an einem Assay abgeschlossen haben, können

Sie das Dokument signieren um weitere Änderungen am Dokument
zu verhindern. Zum Signieren eines Dokuments sind erweitere Be-
rechtigungen nötig (Siehe Administratorhandbuch Kapitel Berechti-
gungen verwalten).

Öffnen Sie den Dialog zum Signieren von Dokumenten indem Sie auf
die Signaturen… Aktion im Dokument-Editor klicken.

33
PLA 3.0 - Quick Start Guide

Im Dialog zum Signieren von Dokumenten können Sie eine Signatur

zum Dokument hinzufügen.

Fügen Sie mit Hilfe des Signieren Knopfes eine Signatur zum Doku-
ment hinzu.

Im Konfigurationsdialog für die Signatur müssen Sie einen Grund für

die Signatur angeben. Sie können aus einer Liste an Vorlagen für
Gründe einen passenden Grund auswählen oder selbst einen Grund
eingeben.

Wählen Sie einen Grund für die Signatur aus der Liste aus.

34
 Erste Schritte

Um das Dokument mit dem angegebenen Grund signieren zu kön-

nen müssen Sie Ihr Kennwort eingeben.

Geben Sie Ihr Kennwort ein und fügen Sie die Signatur mit dem
Übernehmen Knopf zu Ihrem neuen Dokument hinzu.

35
PLA 3.0 - Quick Start Guide

Im Dialog zur Verwaltung von elektronischen Signaturen wird jetzt

Ihre Signatur angezeigt.

Schließen Sie den Dialog mit dem Schließen Knopf.

Im Dokument-Editor können Sie nun sehen dass das Dokument

durch Ihre Signatur geschützt wird. Es können jetzt keine Änderun-
gen mehr am Dokument vorgenommen werden ohne dass Ihre

36
 Erste Schritte

Signatur durch einen Benutzer mit der Berechtigung zum Entfernen

von Signaturen wieder entfernt wird.

Weitere Informationen zum Thema Signaturen und Berechtigungen

finden Sie im Benutzerhandbuch im Kapitel Dokumente bearbeiten
und im Administratorhandbuch im Kapitel Berechtigungen verwal-
ten.

EINEN BERICHT ERSTELLEN

Wenn Sie die Bericht… Aktion der Editor Aktionsleiste mit einem
Linksklick aufrufen können Sie einen detaillierten Bericht über die
Inhalte des Dokuments und die Ergebnisse der Berechnung erstel-
len.

37
PLA 3.0 - Quick Start Guide

Sie können je nach Dokumenttyp aus unterschiedlichen Berichten

wählen. Im Aktion Menü können Sie auswählen was nach der Erstel-
lung des Berichts geschehen soll. Die Aktion Anzeige öffnet den
Bericht in Ihrem Standard PDF Programm (z.B. Adobe Reader).

38
 Erste Schritte

In dem mehrseitigen Bericht können Sie unter anderem die von

Ihnen in der Inhalt Ansicht konfigurierten Eigenschaften des Doku-
ments sehen, als auch die von Ihnen eingegebenen Daten.

39
PLA 3.0 - Quick Start Guide

Weitere Informationen zur Erstellung von Berichten erhalten Sie im

Benutzerhandbuch im Kapitel Berichte erstellen.

PLA 3.0 BEENDEN

Um PLA 3.0 zu beenden Rufen Sie die Beenden Aktion aus dem
Dateimenü auf.

Weitere Informationen zur Allgemeinen Verwendung von PLA 3.0

und der Abmelden oder Beenden Aktion erhalten Sie im Benutzer-
handbuch.

40
 PLA 3.0
Benutzerhandbuch
PLA 3.0 - Benutzerhandbuch

COPYRIGHT
©2015 by Stegmann Systems GmbH, Rodgau, Germany.
All rights reserved.

KONTAKT
Stegmann Systems GmbH
Raiffeisenstr. 2 // C1, C2
63110 Rodgau
Germany

Telefon: +49 6106 770100

Fax: +49 6106 7701029

www.bioassay.de
[email protected]

2
 Inhalt

INHALT
Copyright ............................................................................................ 2
Kontakt ........................................................................................... 2
Inhalt .................................................................................................. 3
Willkommen ..................................................................................... 12
Datenbanken verwenden ................................................................. 13
Konzepte ...................................................................................... 13
Datenbanken für unterschiedliche Zwecke.............................. 13
Datenbankvorlagen .............................................................. 13
SQLite Datenbank................................................................. 13
SQL-Server Datenbank ......................................................... 14
Datenbankverbindungsprofil ................................................... 14
Datenbankdatei........................................................................ 14
Aktionen ....................................................................................... 15
Anmeldung an Datenbank ....................................................... 16
Abmelden / PLA 3.0 Beenden .................................................. 16
Datenbankverbindung einrichten ............................................ 17
Expressmodus ...................................................................... 18
Standardmodus .................................................................... 23
Datenbankverbindung importieren ................................. 26
Mit bestehender Datenbank verbinden ........................... 26
SQLite ........................................................................... 27
Microsoft SQL Server.................................................... 30
Neue Datenbank erstellen ............................................... 34

3
PLA 3.0 - Benutzerhandbuch

Verbindungsprofil kopieren ............................................. 42

Verbindungsprofile verwalten ................................................. 45
Verbindungsprofil exportieren ............................................. 45
Verbindungsprofil importieren ............................................ 47
Demo-Datenbank anlegen ....................................................... 52
Datenbankvorlagen verwalten ................................................. 58
Datenbankvorlagen erstellen ............................................... 58
Datenbankvorlagen verwenden ........................................... 65
Standardmodus ................................................................ 65
Dokumente verwalten ..................................................................... 75
Konzepte ...................................................................................... 75
Dokumente und Ordner ........................................................... 75
Verwendung des Navigators .................................................... 76
Navigator-Baum ....................................................................... 77
Detailansicht ............................................................................ 78
Filter-Optionen ......................................................................... 79
Aktionen ....................................................................................... 81
Navigation ................................................................................ 81
Sortieren von Inhalten ......................................................... 82
Navigator Layout Optionen .................................................. 83
Dokumente verwalten ............................................................. 85
Anlegen ................................................................................ 85
Öffnen .................................................................................. 90
Löschen ................................................................................ 91

4
 Inhalt

Kopieren ............................................................................... 91
Verschieben.......................................................................... 98
Umbenennen .....................................................................105
Bearbeiten ..........................................................................109
Ordner verwalten ...................................................................109
Anlegen ..............................................................................109
Öffnen ................................................................................111
Löschen ..............................................................................111
Kopieren .............................................................................111
Verschieben........................................................................112
Umbenennen .....................................................................112
Anzeige filtern ........................................................................114
Dokumente exportieren .........................................................121
Dokumente importieren ........................................................128
Import einer PLA 3.0 Dokumentpaketdatei .......................130
Import von PLA 2.x Dokumenten .......................................136
Dokumente bearbeiten ..................................................................143
Konzepte ....................................................................................143
ElasticForms-Technologie ......................................................143
Dashboard ..............................................................................145
Dokumentstruktur .................................................................147
Editoren..................................................................................148
Beobachtungen-Editor .......................................................148
Referenzen-Editor ..............................................................148

5
PLA 3.0 - Benutzerhandbuch

Sequenz-Editor ...................................................................149
Positions-Editor ..................................................................150
Signaturen ..............................................................................151
Signaturbereich Dokument ................................................151
Signaturbereich Inhalt ........................................................152
Signaturbereich Daten .......................................................152
Ereignisprotokoll (Audit Trail) ................................................152
Aktionen .....................................................................................153
Dashboard ..............................................................................153
Dokument einrichten .............................................................155
Ansicht anpassen................................................................155
Pfadnavigation ...............................................................155
Struktur ..........................................................................155
Erstellbare Elemente ......................................................156
Zoom ..............................................................................157
Hervorheben ..................................................................158
Suchen und Filtern Dialog ..............................................160
Suchen nach ...............................................................160
Erweitern/Reduzieren ................................................160
Suchrichtung ..............................................................161
Optionen ....................................................................161
Groß-/Kleinschreibung .................................161
Gesamter Ausdruck ......................................161
Gesamter Begriff ..........................................161

6
 Inhalt

Reguläre Ausdrücke ......................................161

Suchen ........................................................................161
Markieren ...................................................................161
Filtern/Filter aufheben ...............................................161
Elemente anlegen ..............................................................161
Werte eingeben .................................................................165
Referenzen zwischen Elementen bearbeiten.....................166
Referenzen zwischen Dokumenten bearbeiten .................170
Daten eingeben ......................................................................175
Beobachtungen-Editor .......................................................175
Referenzen-Editor ..............................................................180
Aktualisierungs-modi .....................................................181
Auto All .......................................................................182
Auto Data ...................................................................182
Manual All ..................................................................182
Manual Data ...............................................................182
Referenz hinzufügen ......................................................183
Referenzen entfernen ....................................................184
Filtern der Dokumentmenge ..........................................185
Document Type ..........................................................186
Template Key..............................................................186
Folder Key...................................................................186
Allow Subfolder ..........................................................186
Generator Key ............................................................186

7
PLA 3.0 - Benutzerhandbuch

Document Property Filter ..........................................186

Sektion Property Filter ...............................................187
Filtern der aggregierten Sektionen ................................187
Sequenz-Editor ...................................................................187
Positions-Editor ..................................................................189
Editorunabhängige Bearbeitungsaktionen.........................191
Kopieren .........................................................................191
Ausschneiden .................................................................192
Einfügen .........................................................................193
Löschen ..........................................................................194
Extern öffnen..................................................................195
Anzeigeoptionen ............................................................195
Daten Akquirieren ..............................................................196
Geschützte Werte ..............................................................200
Ereignisprotokoll (Audit Trail) ................................................201
Ereignisprotokoll filtern .....................................................203
Ereignisprotokoll exportieren ............................................207
Hilfe/Fehler anzeigen .............................................................211
Operationen ausführen ..........................................................213
Dokument berechnen ........................................................213
Dokument aktualisieren .....................................................216
Signaturen anbringen .............................................................217
Bericht erstellen .....................................................................223
Berichte erstellen ...........................................................................224

8
 Inhalt

Konzepte ....................................................................................224
Dokumenttypspezifische Berichte .........................................224
Pakete ................................................................................224
Konfigurationsbericht ............................................................224
PDF-Viewer.............................................................................224
Aktionen .....................................................................................225
Dokumenttypspezifischen Bericht erstellen ..........................225
Mehrere Berichte gleichzeitig erstellen .............................230
Konfigurationsbericht erstellen .............................................233
Teilberichte ........................................................................238
Lizenzinformationen.......................................................238
Umgebung ......................................................................238
Datenbankrichtlinien ......................................................238
Komponentenpakete .....................................................238
Dokumentbeschränkungen ............................................238
Dokumentschlüsselformate ...........................................239
Sicherheitskontexte........................................................239
Pfadinformationen von Sicherheitskontexten ...............239
Benutzer .........................................................................239
Gruppen .........................................................................239
Effektive Berechtigungen von Benutzern und Gruppen 240
Globale Rollen ................................................................240
Dokumentrollen .............................................................240
Dokumentstatistik ..........................................................240

9
PLA 3.0 - Benutzerhandbuch

Benutzerkonten und Systemeinstellungen ....................................241

Konzepte ....................................................................................241
Benutzerabhängige Einstellungen ..........................................241
Datenbankeinstellungen ........................................................241
Aktionen .....................................................................................242
Allgemeine Einstellungen .......................................................242
Anwendungspfade .................................................................244
Suche nach Aktualisierungen .................................................245
Proxy Einstellungen ................................................................246
Navigator-Aktualisierung .......................................................246
Einstellungen für Aufgaben ....................................................247
Benutzerkonto bearbeiten .....................................................248
Kennwort ändern ...................................................................251
Oberfläche zurücksetzen ........................................................252
Systemqualifizierung ......................................................................254
Konzept ......................................................................................254
Installationsqualifizierung (IQ) ...............................................254
Funktionsqualifizierung (OQ) .................................................254
Leistungsqualifizierung (PQ) ..................................................255
Aufgaben ....................................................................................255
Installationsqualifizierung (IQ) ...............................................255
Installationsqualifizierung (IQ) durchführen ......................256
Bericht ............................................................................259
Zertifikat .........................................................................261

10
 Inhalt

Protokoll .........................................................................261
Funktionsqualifizierung (OQ) .................................................263
Funktionsqualifizierung (OQ) durchführen ........................264
Bericht ............................................................................266
Zertifikat .........................................................................266
Protokoll .........................................................................269
Leistungsqualifizierung (PQ) ..................................................271
PQ-Definitionen erstellen...................................................271
PQ-Definitionen exportieren ..............................................274
Leistungsqualifizierung (PQ) durchführen..........................276
Bericht ............................................................................282
Zertifikat .........................................................................282
Protokoll .........................................................................284
Qualifikation weiterer Systeme..........................................287

11
PLA 3.0 - Benutzerhandbuch

WILLKOMMEN
Willkommen zum PLA 3.0 Benutzerhandbuch. Dieses Handbuch ist
für jeden Benutzer von PLA 3.0 geeignet.

Das PLA 3.0 Benutzerhandbuch erklärt die Arbeit mit PLA 3.0. Sie
lernen die volle Funktionalität und Benutzung von PLA 3.0 kennen.

12
 Datenbanken verwenden

DATENBANKEN VERWENDEN

KONZEPTE
PLA 3.0 verwendet Datenbankverbindungsprofile in Verbindung mit
SQLite Datenbanken oder Microsoft SQL Servern um Inhalte abzu-
speichern und zu verwalten.

DATENBANKEN FÜR UNTERSCHIEDLICHE ZWECKE

Sie können in PLA 3.0 beliebig viele Datenbankverbindungen für
lokale Datenbanken oder Microsoft SQL Server erzeugen und auch
beliebig viele lokale SQLite Datenbanken für unterschiedlichste
Verwendungszwecke erstellen. So ist es Ihnen möglich eine Tren-
nung der Datenbanken und Datenbestände für unterschiedliche
Zwecke vorzunehmen.

D ATENBANKVORLAGEN
PLA 3.0 unterstützt die Verwendung von Datenbankvorlagen um
schnell und einfach Datenbanken mit vordefinierten Inhalten und
Einstellungen erzeugen zu können. Jede PLA 3.0 Datenbank kann
durch entsprechende Einstellungen als Datenbankvorlage verwen-
det werden.

SQL ITE D ATENBANK

In PLA 3.0 haben Sie die Möglichkeit beliebig viele SQLite Datenban-
ken zu erzeugen und zu verwenden. Eine SQLite Datenbank kann
entweder nur für den aktiven Benutzer oder alle Benutzer eines
Computers erzeugt werden. Es ist zudem möglich eine SQLite Da-
tenbank auf einem Server im Netzwerk abzulegen und die Benutzer
über das Firmennetzwerk auf diese SQLite Datenbank zugreifen zu
lassen. Eine SQLite Datenbank kann, da Sie nur aus einer einzelnen
Datei besteht, einfach gesichert oder bewegt werden. Eine SQLite

13
PLA 3.0 - Benutzerhandbuch

Datenbank eignet sich für kleine Datenbestände die nicht von mehr
als fünf Benutzern gleichzeitig verwendet werden.

SQL-S ERVER D ATENBANK

Zusätzlich zu der Möglichkeit SQLite Datenbanken zu erzeugen,
können Sie PLA 3.0 auch in Kombination mit einem Microsoft SQL
Server verwenden. Für große Datenbestände und Mehrbenut-
zerumgebungen wird ein Microsoft SQL Server für die Verwendung
von PLA 3.0 benötigt.

DATENBANKVERBINDUNGSPROFIL
Die Verbindungsinformationen für lokale SQLite Datenbanken und
Microsoft SQL Server Datenbanken werden von PLA 3.0 mit Hilfe
von Datenbankverbindungsprofilen verwaltet. Ein Datenbankver-
bindungsprofil ist unabhängig von der verwendeten Datenbank, die
Profildatei dient lediglich dazu PLA 3.0 den Ort, Namen und ggf. die
Anmeldedaten in verschlüsselter Form mitzuteilen.

DATENBANKDATEI
Wenn Sie PLA 3.0 mit einer lokalen SQLite Datenbank verwenden,
erzeugen Sie zusätzlich zum Datenbankverbindungsprofil auch eine
Datenbankdatei. Die Datenbankdatei enthält alle Inhalte wie z.B.
Dokumente, Ordner und Benutzerkonten Ihrer PLA 3.0 Installation.
Es wird empfohlen die Datenbankdateien in regelmäßigen Abstän-
den zu sichern um den Verlust Ihrer Daten zu verhindern.

14
 Datenbanken verwenden

AKTIONEN

Zum Verwalten von Datenbanken rufen Sie die Datenbankverwal-

tung mit Hilfe des Extras Menüs im Anmeldebildschirm von PLA 3.0
auf.

15
PLA 3.0 - Benutzerhandbuch

ANMELDUNG AN DATENBANK

Im Anmeldebildschirm von PLA 3.0 können Sie mit Hilfe des Drop
Down Menüs aus allen für Sie verfügbaren Verbindungsprofilen ein
Profil für die Anmeldung auswählen. Wenn Sie die gewünschte
Verbindung ausgewählt haben können Sie sich mit Hilfe des Anmel-
den Knopfes an der im Verbindungsprofil hinterlegten Datenbank
anmelden.

ABMELDEN / PLA 3.0 BEENDEN

Im Datei Menü von PLA finden Sie die Optionen Abmelden und
Beenden. Wenn Sie sich von PLA 3.0 abmelden oder die Anwendung
beenden, müssen Sie alle nicht gespeicherten Änderungen an Do-
kumenten speichern oder verwerfen. Geöffnete Dokumente ohne
ungespeicherte Änderungen werden automatisch für Sie geschlos-

16
 Datenbanken verwenden

sen bevor Sie von der Datenbank abgemeldet werden oder PLA 3.0
beendet wird.

DATENBANKVERBINDUNG EINRICHTEN

Zum Einrichten einer Datenbankverbindung müssen Sie die Daten-

bankverwaltung mit Hilfe des Extras Menüs im Anmeldebildschirm
von PLA 3.0 öffnen.

17
PLA 3.0 - Benutzerhandbuch

In der Datenbankverwaltung können Sie mit Hilfe des Hinzufügen…

Knopfes eine neue Datenbankverbindung einrichten.

E XPRESSMODUS

18
 Datenbanken verwenden

Der Expressmodus erlaubt es Ihnen eine neue, lokale SQLite Daten-

bank zu erstellen. Diese lokale SQLite Datenbank kann nur von
Ihnen verwendet werden und wird in Ihrem Benutzerverzeichnis
Ihres Betriebssystems erstellt.

Unter Microsoft Windows 7 wird die durch den Expressmodus er-

zeugte SQLite Datenbank im Verzeichnis
C:\Users\BENUTZERNAME\AppData\Local\Stegmann Systems\PLA
3.0\Databases abgelegt.

19
PLA 3.0 - Benutzerhandbuch

Im Dialog zur Erstellung eines Datenbankverbindungsprofils im

Expressmodus können Sie einen Namen für die Datenbank angeben
und eine Vorlage wählen, nach der die Datenbank erstellt werden
soll. Im Auslieferungszustand stehen die Vorlagen Standard Data-
base und Standard Database with Demo Data zur Verfügung.

Weitere Informationen zu Datenbankvorlagen finden Sie im Ab-

schnitt Datenbankvorlagen verwalten.

Außerdem müssen Sie ein administratives Benutzerkonto erstellen,

das benötigt wird um Ihre PLA 3.0 Datenbank einzurichten.

20
 Datenbanken verwenden

Verwahren Sie eine Kopie der Anmeldedaten an einem sicheren Ort.

Sie werden benötigt um Datenbankrichtlinien anzupassen und Be-
nutzerkonten zu erstellen.

Weitere Informationen zur Verwaltung von PLA 3.0 finden Sie im

Administrator Handbuch im Kapitel Datenbankeinstellungen verwal-
ten.

Wenn Sie den Dialog mit Weiter bestätigen können Sie Ihre Einstel-
lungen noch einmal prüfen bevor die Datenbank und das Daten-
bankverbindungsprofil erstellt werden. Alternativ können Sie den
Dialog auch mit Fertigstellen bestätigen um die Erstellung der Da-
tenbank und des Datenbankverbindungsprofils sofort zu starten.

21
PLA 3.0 - Benutzerhandbuch

Falls Sie den Dialog mit Weiter bestätigt haben können Sie nun,
bevor das Datenbankverbindungsprofil und die Datenbank erzeugt
werden, die Verbindungseinstellungen erneut überprüfen. Falls Sie
Fehler in der Konfiguration entdecken, können Sie mit dem Zurück
Knopf wieder zu den Einstellungen wechseln. Die benötigten Datei-
en werden erzeugt sobald Sie den Dialog mit Fertigstellen bestäti-
gen. Dieser Prozess kann einige Minuten in Anspruch nehmen. Sie
werden durch einen Erfolgsdialog benachrichtigt, wenn die Erstel-
lung Ihrer Datenbank abgeschlossen ist.

Wenn Sie den Erfolgsdialog bestätigen gelangen Sie zurück zur Da-
tenbankverwaltung.

22
 Datenbanken verwenden

Nach der Erstellung sehen Sie Ihre neue Datenbankverbindung in

der Übersicht der Datenbankverwaltung. Sie können den Dialog zur
Verwaltung von Datenbanken mit Hilfe des Verbinden oder Schlie-
ßen Knopfes verlassen.

S TANDARDMODUS

23
PLA 3.0 - Benutzerhandbuch

Der Standardmodus erlaubt Ihnen eine Vielzahl an Konfigurations-

möglichkeiten für Datenbankverbindungen.

24
 Datenbanken verwenden

Für alle Optionen im Standardmodus ist die Einstellung Datenbank-

profil ist für alle Benutzer an diesem Computer verfügbar ein- oder
ausschaltbar.

Wenn die Option aktiv ist wird das Datenbankverbindungsprofil im

Verzeichnis C:\ProgramData\Stegmann Systems\PLA
3.0\DBConnections abgelegt und kann von allen Benutzern des
Computers erreicht werden.

Wenn die Option inaktiv ist wird das Datenbankverbindungsprofil

im Verzeichnis C:\Users\BENUTZERNAME\AppData\Local\Stegmann
Systems\PLA 3.0\DBConnections abgelegt und kann nur vom aktuell

25
PLA 3.0 - Benutzerhandbuch

am Betriebssystem angemeldeten Benutzer des Computers erreicht

werden.

D ATENBANKVERBINDUNG IMPORTIEREN

Informationen zum Import von Verbindungsprofilen finden Sie im

Kapitel Verbindungsprofile verwalten.

M IT BESTEHENDER D ATENBANK VERBINDEN

Der Standardmodus erlaubt es Ihnen, sich mit einer bereits beste-
henden SQLite oder SQL Datenbank zu verbinden.

26
 Datenbanken verwenden

Wenn Sie die Einstellung Mit bestehender Datenbank verbinden

ausgewählt haben, können Sie im Auswahlmenü zwischen Microsoft
SQL Server und SQLite wählen.

SQLITE

27
PLA 3.0 - Benutzerhandbuch

Wenn Sie im Auswahlmenü für die Verbindung mit einer bestehen-

den Datenbank die Option SQLite ausgewählt haben, können Sie im
Einrichtungsassistent eine SQLite Datenbankdatei auswählen indem
Sie den … Knopf verwenden um den Dateiauswahldialog zu öffnen.

28
 Datenbanken verwenden

Im Dateiauswahldialog können Sie eine bestehende SQLite Daten-

bankdatei (s3db Datei) auswählen.

29
PLA 3.0 - Benutzerhandbuch

Wenn Sie eine bestehende SQLite Datenbankdatei ausgewählt ha-

ben können Sie im Einrichtungsassistent eine Beschreibung für die
Datenbankverbindung eingeben. Die Beschreibung wird als Name
für das Datenbankverbindungsprofil verwendet. Nachdem Sie die
Beschreibung eingegeben haben können Sie Ihre Konfiguration des
Verbindungsprofils mit dem Weiter Knopf erneut überprüfen oder
dem Fertigstellen Knopf abschließen.

MICROSOFT SQL SERVER

30
 Datenbanken verwenden

Wenn Sie im Auswahlmenü für die Verbindung mit einer bestehen-

den Datenbank die Option Microsoft SQL Server ausgewählt haben
können Sie im Einrichtungsassistent im Servername Auswahlmenü
einen Microsoft SQL Server auswählen oder alternativ, die IP-
Adresse oder den Namen des Servers mit der Tastatur eingeben.

31
PLA 3.0 - Benutzerhandbuch

Als Authentifizierungsmethoden für den SQL Server stehen Ihnen

Windows und SQL-Server zur Verfügung.

Die Auswahl Windows verwendet Ihre Microsoft Windows Anmel-

dedaten für die Authentifizierung am SQL Server.

Die Auswahl SQL-Server erlaubt es Ihnen einen Benutzernamen und

ein Kennwort für die Verbindung zum SQL Server anzugeben.

Wenn Sie einen Microsoft SQL Server ausgewählt und die korrekten
Anmeldedaten für den Server hinterlegt haben, können Sie im Aus-
wahlmenü Datenbankname eine auf dem Server verfügbare SQL
Datenbank auswählen.

32
 Datenbanken verwenden

Nachdem Sie einen Datenbanknamen ausgewählt haben wurde das

Beschreibungsfeld durch PLA 3.0 automatisch mit dem Serverna-
men und dem Datenbanknamen gefüllt. Sie können die Beschrei-
bung aber auch selbst anpassen und danach die Konfiguration des
Verbindungsprofils mit Weiter Knopf überprüfen oder dem Fertig-
stellen Knopf abschließen.

33
PLA 3.0 - Benutzerhandbuch

Falls Sie die Konfiguration des Verbindungsprofils mit dem Weiter

Knopf verlassen haben können Sie im Einrichtungsassistent Ihre
Einstellungen noch einmal überprüfen bevor Sie die Erstellung mit
Fertigstellen beenden. Falls Sie Fehler in Ihrer Konfiguration entde-
cken können Sie mit dem Zurück Knopf wieder zur Einrichtung des
Verbindungsprofils wechseln.

N EUE D ATENBANK ERSTELLEN

Der Standardmodus erlaubt es Ihnen eine neue SQLite Datenbank
zu erstellen.

34
 Datenbanken verwenden

Um eine neue S QLite Datenbank zu erstellen müssen Sie die Ein-

stellung Neue Datenbank erstellen auswählen.

35
PLA 3.0 - Benutzerhandbuch

Im Dialog zur Erstellung einer neuen SQLite Datenbank haben Sie

mit Hilfe des … Knopfes die Möglichkeit zu bestimmen wo die SQLi-
te Datenbank erstellt werden soll.

36
 Datenbanken verwenden

Im Auswahldialog können Sie einen Ort und einen Namen für die
SQLite Datenbankdatei angeben.

37
PLA 3.0 - Benutzerhandbuch

Zusätzlich zur Auswahl der Datenbankdatei haben Sie die Möglich-

keit eine Beschreibung für die Datenbankverbindung einzugeben.
PLA 3.0 füllt dieses Feld automatisch mit dem Namen der Daten-
bankdatei. Sie können die Beschreibung für die Datenbankverbin-
dung anpassen bevor Sie mit Hilfe des Weiter Knopfes fortfahren.

38
 Datenbanken verwenden

Nachdem Sie eine Datenbankdatei ausgewählt haben müssen Sie

eine Vorlage für die Initialisierung der Datenbank auswählen. PLA
3.0 wird mit 2 unterschiedlichen Datenbankvorlagen ausgeliefert:

Default Database (empty) initialisiert die Datenbank mit allen nöti-

gen Dokumenttypen, Rollen, Gruppen und Sicherheitskontexten die
Sie benötigen um mit PLA 3.0 arbeiten zu können.

Default Database with Demo Data initialisiert die Datenbank wie die
Default Database (empty) Vorlage, erstellt aber zusätzlich eine
Auswahl an Beispieldokumenten um einen Überblick über die Funk-
tionalität von PLA 3.0 Dokumenten zu gewähren.

39
PLA 3.0 - Benutzerhandbuch

Weiter führende Informationen zu diesen Themen finden Sie im

Administratorhandbuch.

Zusätzlich zu den Standard Vorlagen haben Sie in diesem Dialog

auch die Möglichkeit eine eigene Datenbankvorlage auszuwählen.

Weitere Informationen zu Datenbankvorlagen finden Sie im Ab-

schnitt Datenbankvorlagen verwalten.

40
 Datenbanken verwenden

Um eine neue SQLite Datenbank für PLA 3.0 einzurichten müssen

Sie ein administratives Benutzerkonto erstellen.

Verwahren Sie eine Kopie der Anmeldedaten an einem sicheren Ort.

Sie werden benötigt um Datenbankrichtlinien anzupassen und Be-
nutzerkonten zu erstellen.

Weitere Informationen zur Verwaltung von PLA 3.0 finden Sie im

Administrator Handbuch im Kapitel Datenbankeinstellungen verwal-
ten.

Wenn Sie den Dialog mit Weiter bestätigen können Sie Ihre Einstel-
lungen noch einmal überprüfen bevor Sie die Datenbankverbin-

41
PLA 3.0 - Benutzerhandbuch

dungsdatei erstellen. Wenn Sie den Dialog mit Fertigstellen bestäti-

gen wird die Datenbank und die Profildatei erstellt.

Wenn die Erstellung und Einrichtung der neuen SQLite Datenbank

abgeschlossen ist werden Sie durch einen Informationsdialog infor-
miert. Die Erstellung und Einrichtung einer neuen SQLite Datenbank
abhängig von der ausgewählten Datenbankvorlage einige Minuten
in Anspruch nehmen.

V ERBINDUNGSPROFIL KOPIEREN

42
 Datenbanken verwenden

Der Standardmodus der Datenbankverwaltung erlaubt es Ihnen ein

bestehendes Verbindungsprofil zu kopieren. Im Quelle Drop-Down
Menü können Sie das Verbindungsprofil wählen, das Sie kopieren
möchten. Wenn Sie den Dialog mit dem Weiter Knopf bestätigen
können Sie Ihre Einstellungen noch einmal überprüfen bevor das
Verbindungsprofil kopiert wird. Wenn Sie den Dialog mit Fertigstel-
len bestätigen wird eine Kopie des Verbindungsprofils erstellt.

43
PLA 3.0 - Benutzerhandbuch

Falls Sie die Konfiguration der Kopie eines Verbindungsprofils mit

dem Weiter Knopf verlassen haben können Sie im Einrichtungsassis-
tent Ihre Einstellungen noch einmal überprüfen bevor Sie die Erstel-
lung mit Fertigstellen beenden. Falls Sie Fehler in Ihrer Konfigurati-
on entdecken können Sie mit dem Zurück Knopf wieder zur Einrich-
tung des Verbindungsprofils wechseln.

44
 Datenbanken verwenden

Wenn die der Kopie des Verbindungsprofils abgeschlossen ist wer-

den Sie durch einen Informationsdialog informiert.

VERBINDUNGSPROFILE VERWALTEN

V ERBINDUNGSPROFIL EXPORTIEREN

45
PLA 3.0 - Benutzerhandbuch

In der Datenbankverwaltung haben Sie die Möglichkeit vorhandene

Datenbankverbindungsprofile mit Hilfe des Exportieren… Knopfes
zu exportieren.

Im Dialog zum Export von Datenbankverbindungsprofilen können

Sie mit Hilfe des … Knopfes einen Zielordner für den Export Ihres
Datenbankverbindungsprofils auswählen.

46
 Datenbanken verwenden

Außerdem können Sie im Feld Dateiname einen Namen für das

exportierte Datenbankverbindungsprofil angeben. Wenn Sie den
Dialog mit OK bestätigen wird die Datenbankverbindungsdatei mit
dem angegebenen Namen in den ausgewählten Ordner exportiert.

V ERBINDUNGSPROFIL IMPORTIEREN
In der Datenbankverwaltung haben Sie die Möglichkeit vorhandene
Datenbankverbindungsprofile zu importieren.

47
PLA 3.0 - Benutzerhandbuch

Zum Importieren eines bestehenden Datenbankverbindungsprofils

müssen Sie in der Datenbankverwaltung mit Hilfe des Hinzufügen…
Knopfes ein neues Datenbankverbindungsprofil hinzufügen.

Im Dialog zum Hinzufügen einer Datenbankverbindung wählen Sie

für den Import eines bestehenden Datenbankverbindungsprofils
den Standardmodus aus.

48
 Datenbanken verwenden

Der Standardmodus der Datenbankverwaltung erlaubt es Ihnen ein

bestehendes Verbindungsprofil zu importieren. Wählen Sie dazu die
Einstellung Datenbankverbindung importieren aus um mit Hilfe des
… Knopfes eine Datenbankprofildatei auszuwählen.

49
PLA 3.0 - Benutzerhandbuch

Im Dialog zur Auswahl einer Datenbankverbindungsprofildatei kön-

nen Sie eine von PLA 3.0 erzeugte .DBConnection Datei auswählen.

50
 Datenbanken verwenden

Falls Sie die Konfiguration des Imports eines Verbindungsprofils mit

dem Weiter Knopf verlassen haben können Sie im Einrichtungsassis-
tent Ihre Einstellungen noch einmal überprüfen bevor Sie den Im-
port mit Fertigstellen beenden. Falls Sie Fehler in Ihrer Konfigurati-
on entdecken können Sie mit dem Zurück Knopf wieder zur Einrich-
tung des Verbindungsprofils wechseln.

51
PLA 3.0 - Benutzerhandbuch

DEMO-DATENBANK ANLEGEN

Der Expressmodus erlaubt es Ihnen eine neue, lokale SQLite Daten-

bank zu erstellen. Diese lokale SQLite Datenbank kann nur von
Ihnen verwendet werden und wird in Ihrem Benutzerverzeichnis
Ihres Betriebssystems erstellt.

Unter Microsoft Windows 7 wird die durch den Expressmodus er-

zeugte SQLite Datenbank im Verzeichnis
C:\Users\BENUTZERNAME\AppData\Local\Stegmann Systems\PLA
3.0\Databases abgelegt.

52
 Datenbanken verwenden

Im Dialog zur Erstellung eines Datenbankverbindungsprofils im

Expressmodus können Sie einen Namen für die Datenbank angeben
und eine Vorlage wählen nach der die Datenbank erstellt werden
soll.

Um eine Demo Datenbank anzulegen wählen Sie bitte die Vorlage

Default Database with Demo Data aus.

Außerdem müssen Sie ein administratives Benutzerkonto erstellen,

das benötigt wird um Ihre PLA 3.0 Datenbank einzurichten.

53
PLA 3.0 - Benutzerhandbuch

Verwahren Sie eine Kopie der Anmeldedaten an einem sicheren Ort.

Sie benötigen diese Daten um sich an Ihrer neuen Demo Datenbank
anzumelden.

Wenn Sie den Dialog mit Weiter bestätigen können Sie Ihre Einstel-
lungen noch einmal prüfen bevor die Datenbank und das Daten-
bankverbindungsprofil erstellt werden. Alternativ können Sie den
Dialog auch mit Fertigstellen bestätigen um die Erstellung der Da-
tenbank und des Datenbankverbindungsprofils sofort zu starten.

Falls Sie den Dialog mit Weiter bestätigt haben können Sie nun,
bevor das Datenbankverbindungsprofil und die Datenbank erzeugt
werden, die Verbindungseinstellungen erneut überprüfen. Ihre

54
 Datenbanken verwenden

Demo Datenbank wird erzeugt sobald Sie den Dialog mit Fertigstel-
len bestätigen. Dieser Prozess kann einige Minuten in Anspruch
nehmen. Sie werden durch einen Erfolgsdialog benachrichtigt wenn
die Erstellung Ihrer Demo Datenbank abgeschlossen ist.

Wenn Sie den Dialog mit OK bestätigen gelangen Sie zurück zur
Datenbankverwaltung.

55
PLA 3.0 - Benutzerhandbuch

Dort können Sie Ihre neue Demo Datenbank aus allen verfügbaren
Datenbanken auswählen und mit dem Verbinden Knopf zum An-
meldedialog der Datenbank wechseln.

56
 Datenbanken verwenden

Der Anmeldedialog erlaubt es Ihnen sich mit dem für die Demo
Datenbank erstellten administrativen Konto an der Datenbank an-
zumelden. Falls Sie bei der Erstellung Ihrer Demo Datenbank ein
Kennwort für das administrative Konto gesetzt haben müssen Sie es
im Anmeldedialog im Kennwort Feld eingeben.

57
PLA 3.0 - Benutzerhandbuch

Nach der Anmeldung können Sie sofort damit beginnen Ihre neue
Demo Datenbank zu verwenden.

DATENBANKVORLAGEN VERWALTEN
PLA 3.0 erlaubt es Ihnen Datenbankvorlagen zu erstellen um daraus
vorkonfigurierte Datenbanken zu erzeugen.

D ATENBANKVORLAGEN ERSTELLEN

58
 Datenbanken verwenden

Um eine Datenbankvorlage anzulegen benötigen Sie eine initialisier-

te Datenbank. Im Kapitel Datenbankverbindung einrichten erfahren
Sie wie Sie eine PLA 3.0 Datenbank anlegen können.

59
PLA 3.0 - Benutzerhandbuch

Wenn Sie eine initialisierte Datenbank haben müssen Sie sich an der
Datenbank anmelden die Sie als Datenbankvorlage nutzen möchten.

60
 Datenbanken verwenden

Im Anschluss können Sie die Datenbank mit Benutzerkonten, Si-

cherheitskontexten, Ordnern und Dokumenten einrichten. Wenn
Ihre Datenbank fertig eingerichtet ist rufen Sie die Systemeinstel-
lung Datenbankrichtlinien auf um Ihre Datenbank als Datenbankvor-
lage zu markieren.

61
PLA 3.0 - Benutzerhandbuch

In den erweiterten Datenbankrichtlinien haben Sie die Möglichkeit

die Nutzung der Datenbank an der Sie gerade angemeldet als Da-
tenbankvorlage zu erlauben.

62
 Datenbanken verwenden

Zusätzlich haben Sie in der Systemeinstellung Datenbankeigenschaf-

ten weitere Anpassungen vorzunehmen.

63
PLA 3.0 - Benutzerhandbuch

So können Sie dort zum Beispiel das Label der Datenbank verändern
und eine Beschreibung zur Datenbank hinterlegen. Das Label und
die Beschreibung werden bei der Erstellung von Datenbanken aus
einer Datenbankvorlage angezeigt.

64
 Datenbanken verwenden

Sie können nun im Standardmodus die als Vorlage gekennzeichnete

Datenbank als benutzerdefinierte Vorlage auswählen.

Weitere Informationen zur Verwendung von Datenbankvorlagen

finden Sie im Kapitel Datenbankvorlagen verwenden.

D ATENBANKVORLAGEN VERWENDEN

S TANDARDMODUS

65
PLA 3.0 - Benutzerhandbuch

Im Standardmodus haben Sie die Möglichkeit eine neue Datenbank

aus einer Vorlage zu erzeugen.

66
 Datenbanken verwenden

Wählen Sie dazu im Einrichtungsassistent des Standardmodus die

Option Neue Datenbank erstellen aus und bestätigen Sie den Dialog
mit Weiter.

67
PLA 3.0 - Benutzerhandbuch

Wählen Sie wie im Kapitel Datenbankverbindung einrichten erläu-

tert eine Datenbankdatei aus und geben Sie eine Beschreibung für
Ihre neue Datenbank ein. Bestätigen Sie den Dialog anschließend
mit Weiter.

68
 Datenbanken verwenden

Im Dialog zur Auswahl einer Datenbankvorlage können Sie die Da-

tenbank aus der Liste der Standard Vorlagen auswählen wenn sich
die Vorlagendatei im Ordner C:\ProgramData\Stegmann Sys-
tems\PLA 3.0\Templates befindet.

69
PLA 3.0 - Benutzerhandbuch

Andernfalls müssen Sie die Option Benutzerdefinierte Vorlage ver-

wenden und mit Hilfe des Dateiauswahldialogs Ihre Datenbankvor-
lage auswählen.

70
 Datenbanken verwenden

Das beim Erstellen der Datenbankvorlage in der Systemeinstellung

Datenbankeinstellungen hinterlegte Label und die Beschreibung
werden in der Infobox zur Vorlage angezeigt. Wenn Sie Ihre Daten-
bankvorlage ausgewählt haben bestätigen Sie den Dialog mit Wei-
ter.

71
PLA 3.0 - Benutzerhandbuch

Bei der Initialisierung einer neuen Datenbank aus einer benutzerde-

finierten Vorlage müssen Sie wie auch bei der Initialisierung aus
einer Standardvorlage ein administratives Konto für die Datenbank
anlegen. Verwahren Sie eine Kopie des Benutzernamens und Kenn-
worts Ihres administrativen Benutzerkontos an einem sicheren Ort.
Sie benötigen Ihr administratives Konto um Datenbankrichtlinien
und Benutzerkonten zu verwalten. Nach der Eingabe des Benutzer-
namens und Kennworts für Ihr neues administratives Konto können
Sie den Dialog mit Weiter oder Fertigstellen bestätigen. Wenn Sie
den Dialog mit Weiter bestätigen erhalten Sie bevor Ihre Datenbank
erzeugt wird noch einmal eine Übersicht über die von Ihnen vorge-
nommenen Einstellungen. Wenn Sie den Dialog mit Fertigstellen

72
 Datenbanken verwenden

bestätigen wird Ihre neue Datenbank aus der gewählten Vorlage

erzeugt. Dieser Vorgang kann mehrere Minuten in Anspruch neh-
men. Sie werden durch eine Erfolgsmeldung informiert wenn die
Erstellung der Datenbank abgeschlossen ist.

Wenn die Erstellung der Datenbank abgeschlossen ist wird sie in der
Übersicht der Datenbankverbindungsprofile gelistet.

73
PLA 3.0 - Benutzerhandbuch

Wenn Sie sich an Ihrer aus der Vorlage erzeugten Datenbank an-
melden enthält Ihre neue Datenbank alle Ordner, Dokumente, Da-
tenbankrichtlinien, Sicherheitskontexte und Benutzerkonten der
Vorlage.

74
 Dokumente verwalten

DOKUMENTE VERWALTEN

KONZEPTE

DOKUMENTE UND ORDNER

Das System bietet Ihnen zahlreiche Möglichkeiten zur Verwaltung
Ihrer Inhalte. Die Inhalte werden im System durch Dokumente und
Ordner dargestellt.

75
PLA 3.0 - Benutzerhandbuch

Jedem Dokument und jedem Ordner wird bei seiner Erstellung ein
einzigartiger Dokument- bzw. Ordnerschlüssel zugewiesen, der
durch die Eigenschaften des übergeordneten Ordners vorgegeben
wird.

Dokumente können unterschiedlichen Dokumenttyps sein und

werden in Ordnern abgelegt. Ordner werden verwendet um Zu-
griffsberechtigungen auf Dokumente innerhalb des Systems durch-
zusetzen.

Weiter führende Informationen zum Thema Ordnereigenschaften

und Berechtigungen finden Sie im Administratorhandbuch.

VERWENDUNG DES NAVIGATORS

76
 Dokumente verwalten

Um Ihre Inhalte übersichtlich darzustellen und Ihnen den Zugriff auf

die vom System zur Darstellung Ihrer Inhalte verwendeten Doku-
mente und Ordner zu realisieren, bietet Ihnen das System den Navi-
gator.

Die Inhalte des Naviga-

tors können durch vielfäl-
tige Filter- und unter-
schiedliche Layout-
Optionen angepasst
werden.

NAVIGATOR-BAUM
Der Navigator-Baum zeigt Ihnen eine hierarchische Übersicht über
alle im System für Sie verfügbaren Ordner und erlaubt Ihnen bei
entsprechenden Berechtigungen vielfältige Aktionen zur Bearbei-
tung oder Verwaltung des Ordners und seiner Inhalte auszuführen.

77
PLA 3.0 - Benutzerhandbuch

Informationen zum Thema Berechtigungen finden Sie im Admi-

nistratorhandbuch im Kapitel Berechtigungen verwalten.

Oberhalb des Navigator Baums befindet sich ein interaktives

Breadcrumb-Menü das Ihnen die Position des Ordners innerhalb der
Hierarchie anzeigt und ebenfalls zur Navigation verwendet werden
kann.

DETAILANSICHT
Die Detailansicht des Navigators zeigt Ihnen die Inhalte des im Navi-
gator-Baum selektierten Ordners an und ermöglicht es Ihnen Aktio-
nen zur Bearbeitung oder Verwaltung von Dokumenten auszufüh-
ren. In der Detailansicht können Sie auf einen Blick den Titel (Na-
men), Dokumentschlüssel, Dokumenttyp und den Zeitpunkt der
letzten Änderung aller Inhalte eines im Navigator-Baum selektier-
ten Ordners sehen.

78
 Dokumente verwalten

Zudem werden Ihnen abhängig von Ihrer Selektion unterhalb der

Detailansicht weitere Informationen wie der Name und Dokument-
schlüssel des Dokuments, der Dokumenttyp des Dokuments und der
Sicherheitskontext des Ordners in dem sich das Dokument befindet,
angezeigt. Abhängig vom Status des Dokuments sehen Sie in der
unteren, rechten Ecke der Detailansicht Ikonen die anzeigen ob das
Dokument berechnet wurde (Tabellenikone) oder ob das Dokument
signiert ist (Siegelikone).

Informationen zu verfügbaren Aktionen finden Sie in diesem Kapitel

im Abschnitt Aktionen

FILTER-OPTIONEN
Die Anzeige von Inhalten im Navigator kann durch einen Volltextfil-
ter und eine Vielzahl vordefinierter Filteroptionen beeinflusst wer-
den.

79
PLA 3.0 - Benutzerhandbuch

Wenn Sie das Eingabefeld des Volltextfilters zum Einschränken der

Ansicht des Navigators nutzen, werden alle Inhalte aus dem Naviga-
tor-Baum entfernt, die kein Dokument enthalten, dass das im Ein-
gabefeld des Volltextfilters eingegebene Wort weder im Titel, noch
im Dokumentschlüssel enthalten.

80
 Dokumente verwalten

Sie können beliebige Filteroptionen miteinander kombinieren um

die Ansicht der Inhalte des Navigators auf Ihre Bedürfnisse anzupas-
sen. Eine Liste der verfügbaren Filteroptionen finden Sie in diesem
Kapitel im Abschnitt Aktionen.

AKTIONEN
NAVIGATION
Im Navigator-Baum kann durch einen Klick mit der linken Maustaste
ein einzelner Ordner selektiert werden. Dessen Unterordner kön-
nen, sofern vorhanden, durch einen Doppelklick auf den Ordner,
oder einen einzelnen Klick mit der linken Maustaste auf den neben
dem Ordner befindlichen Pfeil, angezeigt werden.

81
PLA 3.0 - Benutzerhandbuch

Die verfügbaren Aktionen zur Bearbeitung oder Verwaltung des

Ordners und seiner Inhalte können sie aus dem Kontextmenü her-
aus ausführen, dass Sie durch einen Rechtsklick auf den entspre-
chenden Ordner aufrufen können.

Alternativ stehen Ihnen die im Kontextmenü enthaltenen Aktionen

auch im Datei-Menü und in eingeschränktem Umfang auch in der
Tool Bar zur Verfügung.

S ORTIEREN VON I NHALTEN

Die Sortierung der Inhalte der Detailansicht können Sie beeinflussen
indem Sie einen Klick auf eine Spaltenüberschrift der Detailansicht
durchführen.

82
 Dokumente verwalten

Der erste Klick sortiert die Ergebnisliste aufsteigend nach der ge-
wählten Tabellenspalte, durch einen weiteren Klick auf die gleiche
Überschrift wird die Ergebnisliste absteigend nach der entspre-
chenden Tabellenspalte sortiert. Die Detailansicht unterstützt die
gängigen Methoden zur Mehrfachselektion von Dokumenten und
Ordnern, was es Ihnen erlaubt Aktionen auf mehrere Dokumente
und Ordner gleichzeitig ausführen. Die verfügbaren Aktionen zur
Bearbeitung oder Verwaltung der selektierten Inhalte können sie
aus dem Kontextmenü heraus ausführen, dass Sie durch einen
Rechtsklick auf den selektierten Inhalt aufrufen können.

Alternativ stehen Ihnen die im Kontextmenü enthaltenen Aktionen

auch im Datei-Menü und in eingeschränktem Umfang auch in der
Tool Bar zur Verfügung.

N AVIGATOR L AYOUT O PTIONEN

Der Navigator kann durch einen Doppelklick auf seinen Reiter ma-
ximiert werden, was die Verwaltung großer Mengen an Dokumen-
ten oder tiefer Ordnerhierarchien vereinfacht.

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PLA 3.0 - Benutzerhandbuch

Außerdem stehen für den Navigator zwei unterschiedliche Layout-

Optionen zur Verfügung, zwischen denen Sie durch einen einzelnen
Klick mit der linken Maustaste wechseln können.

In der Standardeinstellung zeigt der Navigator die Detailansicht

unter dem Navigator-Baum an.

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Als Alternative steht die Anzeige der Detailansicht neben dem Navi-
gator-Baum zur Auswahl.

DOKUMENTE VERWALTEN

A NLEGEN
Zum Anlegen eines neuen Dokuments stehen Ihren die folgenden
Möglichkeiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner in dem Sie ein neues Dokument erstellen möchten Zugriff auf
die Aktion Neu….

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PLA 3.0 - Benutzerhandbuch

In der Detailansicht haben Sie durch einen Rechtsklick ebenfalls

Zugriff auf die Aktion Neu…, das Dokument wird jedoch immer in
dem Ordner erstellt dessen Inhalt in der Detailansicht angezeigt
wird bzw. der im Navigator-Baum selektiert ist. Zusätzlich dazu
haben Sie über die Tool Bar und das Datei-Menü die Möglichkeit in
dem im Navigator-Baum selektierten Ordner ein neues Dokument
zu erstellen.

Im Dialog zur Erstellung eines neuen Dokuments können Sie an-

schließend den Dokumenttyp oder die Dokumentvorlage des neuen
Dokuments aus der Liste der in diesem Ordner verfügbaren Doku-
menttypen oder der Liste der kürzlich verwendeten Dokumenttypen
auswählen.

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Ob es sich um einen Dokumenttyp oder eine Dokumentvorlage

handelt erkennen Sie an den Einträgen in der Spalte Dokumentvor-
lage hinter dem Namen des Dokumenttyps. Wenn die Spalte anstatt
dem Wert <Keine Vorlage> den Dokumentschlüssel einer Vorlage
enthält handelt es sich um eine Dokumentvorlage, die entgegen
eines Dokumenttyps ohne Vorlage, weiterführende vorbereitende
Aktionen auf das neue Dokument anwenden oder die Editierbarkeit
der Inhalte des Dokuments einschränken kann.

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PLA 3.0 - Benutzerhandbuch

Der Dialog bietet Ihnen außerdem die aus den Navigator bekannte
Volltext Filter-Option.

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 Dokumente verwalten

Zusätzlich besteht die Möglichkeit Dokumenttypen als Favorit

(Stern) zu markieren und nur als Favorit markierte Dokumenttypen
und -vorlagen in der Liste der verfügbaren Dokumenttypen anzuzei-
gen.

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PLA 3.0 - Benutzerhandbuch

Wenn Sie einen Dokumenttyp oder eine Dokumentvorlage ausge-

wählt haben und den Dialog zur Erstellung eines neuen Dokuments
mit OK bestätigt haben, wird Ihr neues Dokument vom ausgewähl-
ten Dokumenttyp nach der ggf. ausgewählten Vorlage unter Be-
rücksichtigung der in den Ordnereigenschaften gesetzten Regeln
zum Dokumentschlüsselformat erstellt und im Dokument-Editor
geöffnet.

Ö FFNEN
Zum Öffnen eines Dokuments im Dokument-Editor stehen Ihren die
folgenden Möglichkeiten zur Verfügung:

In der Detailansicht des Navigators haben Sie durch einen Doppel-

klick auf ein Dokument die Möglichkeit ein Dokument im Doku-
ment-Editor zu öffnen. Zudem bietet ihnen das Kontextmenü bei
einem Rechtsklick auf ein Dokument oder eine Selektion mehrerer
Dokumente ebenfalls Zugriff auf die Aktion Öffnen.

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 Dokumente verwalten

Die Öffnen Aktion für ein oder mehrere in der Detailansicht selek-
tierte Dokumente steht auch über die Tool Bar oder das Datei-Menü
zur Verfügung.

L ÖSCHEN
Zum Löschen eines Dokuments stehen Ihren die folgenden Möglich-
keiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner den Sie inklusive seiner Inhalte entfernen möchten Zugriff auf
die Aktion Löschen.

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf ein Dokument oder eine Selektion mehrerer Dokumente
ebenfalls Zugriff die Aktion Löschen.

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit einen im Navigator-Baum selektierten Ordner und des-
sen Inhalte oder in der Detailansicht selektierte Dokumente zu lö-
schen.

Einmal gelöschte Dokumente oder Ordner können nicht wiederher-

gestellt werden.

K OPIEREN
Zum Kopieren eines Dokuments stehen Ihren die folgenden Mög-
lichkeiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner den Sie inklusive seiner Inhalte kopieren möchten Zugriff auf die
Aktion Kopieren.

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PLA 3.0 - Benutzerhandbuch

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf ein Dokument oder eine Selektion mehrerer Dokumente
ebenfalls Zugriff die Aktion Kopieren.

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit einen im Navigator-Baum selektierten Ordner oder in
der Detailansicht selektierte Dokumente zu kopieren.

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 Dokumente verwalten

Wenn Sie die Aktion zum Kopieren von Dokumenten und Ordnern
aufrufen haben Sie im Dialog zum Kopieren von Dokumenten und
Ordnern die Möglichkeit einen Zielordner für die Kopien anzugeben.

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PLA 3.0 - Benutzerhandbuch

Nach der Auswahl des Zielordners können Sie im Dialog zum

Kopieren von Dokumenten und Ordnern den Prozess Starten.

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 Dokumente verwalten

Im Statusdialog des Kopiervorgangs können Sie den Verlauf des

Kopiervorgangs betrachten.

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PLA 3.0 - Benutzerhandbuch

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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Dokumente verwalten

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PLA 3.0 - Benutzerhandbuch

Der Kopiervorgang erstellt im Zielordner unter Verwendung eines

neuen Dokumentschlüssels eine Kopie des Originaldokuments.

V ERSCHIEBEN
Zum Verschieben eines Dokuments stehen Ihren die folgenden
Möglichkeiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner den Sie inklusive seiner Inhalte verschieben möchten Zugriff auf
die Aktion Verschieben.

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 Dokumente verwalten

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf ein Dokument oder eine Selektion mehrerer Dokumente
ebenfalls Zugriff die Aktion Verschieben.

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit einen im Navigator-Baum selektierten Ordner inklusive
seiner Inhalte oder in der Detailansicht selektierte Dokumente zu
verschieben.

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PLA 3.0 - Benutzerhandbuch

Wenn Sie die Aktion zum Verschieben von Dokumenten und Ord-
nern aufrufen haben Sie im Dialog zum Verschieben von Dokumen-
ten und Ordnern die Möglichkeit einen Zielordner für die Dokumen-
te und/oder Ordner anzugeben.

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 Dokumente verwalten

Nach der Auswahl des Zielordners können Sie im Dialog zum

Verschieben von Dokumenten und Ordnern den Prozess Starten.

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PLA 3.0 - Benutzerhandbuch

Im Statusdialog des Verschiebevorgangs können Sie den Verlauf

betrachten.

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 Dokumente verwalten

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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PLA 3.0 - Benutzerhandbuch

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 Dokumente verwalten

Die Dokumente und/oder Ordner werden unter Beibehaltung ihrer

Dokumentschlüssel in den gewählten Zielordner verschoben.

U MBENENNEN
Zum Ändern des Namens eines Dokuments müssen Sie das Doku-
ment im Dokument-Editor öffnen.

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PLA 3.0 - Benutzerhandbuch

In der Inhalt-Ansicht des Dokuments können Sie den Wert des Ele-
ments Name verändern.

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 Dokumente verwalten

Die Änderung des Namens wird nach dem Speichern des Doku-
ments aktiv.

Zum Ändern des Dokumentschlüssels eines Dokuments stehen Ih-

ren die folgenden Möglichkeiten zur Verfügung:

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf ein Dokument Zugriff die Aktion Dokumentschlüssel än-
dern.

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit den Dokumentschlüssel eines in der Detailansicht selek-
tierten Dokuments zu ändern.

Wenn Sie die Aktion zum Ändern des Dokumentschlüssels von Do-
kumenten aufrufen haben Sie, abhängig von den Datenbankrichtli-
nien, die Möglichkeit einen neuen, automatisch generierten Doku-

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PLA 3.0 - Benutzerhandbuch

mentschlüssel oder einen benutzerdefinierten Dokumentschlüssel

zu vergeben.

Beide Optionen berücksichtigen alle in den Ordnereigenschaften

gesetzten Regeln zum Dokumentschlüsselformat.

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 Dokumente verwalten

Wenn Sie den Dialog zum Ändern des Dokumentschlüssels mit OK

bestätigen wird dem Dokument der neue Dokumentschlüssel zuge-
wiesen.

B EARBEITEN
Informationen zum Bearbeiten von Dokumenten finden Sie im Kapi-
tel Dokumente bearbeiten.

ORDNER VERWALTEN

A NLEGEN
Zum Anlegen eines neuen Ordners stehen Ihren die folgenden Mög-
lichkeiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner in dem Sie einen neuen Ordner erstellen möchten Zugriff auf die
Aktion Neuer Ordner.

In der Detailansicht haben Sie durch einen Rechtsklick ebenfalls

Zugriff auf die Aktion Neuer Ordner, der neue Ordner wird jedoch

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PLA 3.0 - Benutzerhandbuch

immer in dem Ordner erstellt dessen Inhalt in der Detailansicht

angezeigt wird bzw. der im Navigator-Baum selektiert ist.

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit in dem im Navigator-Baum selektierten Ordner einen
neuen Ordner zu erstellen.

Im Dialog zur Erstellung eines neuen Ordners haben Sie die Mög-
lichkeit dem Ordner einen benutzerdefinierten Namen zu geben.

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Wenn Sie den Dialog zur Erstellung eines neuen Ordners mit OK
bestätigt haben, wird Ihr neuer Ordner unter Berücksichtigung der
in den Ordnereigenschaften gesetzten Regeln zum Dokument-
schlüsselformat erstellt. Der neue Ordner erbt seine Sicherheitsein-
stellungen und Ordnereigenschaften vom übergeordneten Ordner.
Die Sicherheitseinstellungen und Ordnereigenschaften können mit
entsprechenden Berechtigungen für den neu erstellten Ordner
geändert werden.

Ö FFNEN
Ein Ordner kann durch einen Doppelklick im Navigator-Baum oder
der Detailansicht des Navigators geöffnet werden. Die Inhalte des
Ordners werden in der Detailansicht des Navigators angezeigt.

L Ö s CHEN
Siehe Löschen von Dokumenten.

K OPIE r EN

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PLA 3.0 - Benutzerhandbuch

Siehe Kopieren von Dokumenten.

V ERSCHIEBEN
Siehe Verschieben von Dokumenten.

U MBENENNEN
Zum Ändern des Namens eines Ordners müssen Sie mit entspre-
chenden Berechtigungen die Ordnereigenschaften öffnen.

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 Dokumente verwalten

Im Dialog der Ordnereigenschaften können Sie den vorhandenen

Namen des Ordners mit einem neuen Namen überschreiben.

Wenn Sie den Dialog der Ordnereigenschaften mit OK bestätigen

wird der Name des Ordners geändert.

Zum Aufrufen der Ordnereigenschaften stehen Ihren die folgenden

Möglichkeiten zur Verfügung:

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf einen Ordner Zugriff die Aktion Eigenschaften.

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PLA 3.0 - Benutzerhandbuch

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit die Eigenschaften eines in der Detailansicht selektierten
Ordners zu ändern.

ANZEIGE FILTERN
Wenn Sie das Eingabefeld des Volltextfilters zum Einschränken der
Ansicht des Navigators nutzen, werden alle Inhalte aus dem Naviga-
tor-Baum entfernt, die kein Dokument enthalten, dass das im Ein-
gabefeld des Volltextfilters eingegebene Wort weder im Titel, noch
im Dokumentschlüssel enthalten.

Durch einen einzelnen Klick auf das Symbol zum Zurücksetzen der
Filtereinstellungen oder durch das vollständige Entfernen aller In-
halte im Eingabefeld des Volltextfilters können Sie die Einschrän-
kung der Anzeige von Inhalten im Navigator wieder aufheben. Das
Symbol zum Zurücksetzen der Filtereinstellungen ist immer dann
aktiv wenn ein Filter auf die Navigator-Ansicht angewendet wird.

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Die vordefinierten Filteroptionen rufen Sie durch einen Klick auf das
Symbol der Filtereinstellungen auf. Sie können beliebige Filteropti-
onen miteinander kombinieren um die Ansicht der Inhalte des Navi-
gators auf Ihre Bedürfnisse anzupassen. Die folgenden Filteroptio-
nen sind verfügbar:

Signaturstatus: Das Filtern der Anzeige nach Signaturstatus erlaubt

es Dokumente anhand ihres Signaturstatus einzubeziehen oder
auszuschließen.

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PLA 3.0 - Benutzerhandbuch

Signierte Dokumente können durch die exklusive Auswahl von Sig-

niert in die Anzeige einbezogen oder durch die exklusive Auswahl
von Nicht signiert ausgeschlossen werden.

Ergebnis: Das Filtern der Anzeige nach Ergebnis erlaubt es Doku-

mente anhand ihres Ergebnisstatus in die Anzeige einzubeziehen
oder auszuschließen.

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 Dokumente verwalten

Dokumente die ein Ergebnis enthalten können durch die Auswahl

eines Ergebnisinhaltstyps einbezogen oder durch die Auswahl von
Kein Ergebnis ausgeschlossen werden.

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PLA 3.0 - Benutzerhandbuch

Die Mehrfachselektion von unterschiedlichen Ergebnisinhaltstypen

sowie die Kombination eines oder mehrerer Ergebnisinhaltstypen
mit der Auswahl Kein Ergebnis ist möglich.

Dokumenttyp: Das Filtern der Anzeige nach Dokumenttyp erlaubt es

Dokumente anhand ihres Dokumenttyps einzubeziehen oder auszu-
schließen.

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PLA 3.0 - Benutzerhandbuch

Sobald ein Dokumenttyp unterhalb der Dokumenttyp Filteroption

ausgewählt wurde werden alle nicht ausgewählten Dokumenttypen
automatisch ausgeschlossen.

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Die Mehrfachselektion von unterschiedlichen Dokumenttypen ist

möglich.

DOKUMENTE EXPORTIEREN
Zum Exportieren von Dokumenten stehen Ihren die folgenden Mög-
lichkeiten zur Verfügung:

Im Navigator-Baum haben Sie durch einen Rechtsklick auf einen

Ordner Zugriff auf die Aktion Exportieren… -> Dokument(e).

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PLA 3.0 - Benutzerhandbuch

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf ein oder mehrere selektierte Dokumente oder Ordner oder
den freien Bereich in der Detailansicht Zugriff die Aktion Exportie-
ren… -> Dokument(e).

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit einen im Navigator-Baum selektierten Ordner inklusive
seiner Inhalte oder in der Detailansicht selektierte Dokumente und
Ordner zu exportieren.

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 Dokumente verwalten

Wenn Sie die Aktion zum Exportieren von Dokumenten aufrufen

haben Sie im Dialog zum Exportieren von Dokumenten die Möglich-
keit eine Zieldatei auszuwählen und eine zum Exportvorgang gehö-
rende Beschreibung einzugeben.

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PLA 3.0 - Benutzerhandbuch

Nach der Auswahl einer Zieldatei können Sie den Exportprozess

starten.

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 Dokumente verwalten

Der Statusdialog informiert Sie über den Fortschritt des Exports.

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PLA 3.0 - Benutzerhandbuch

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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Dokumente verwalten

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PLA 3.0 - Benutzerhandbuch

Nach Abschluss des Exportvorgangs werden die ausgewählten Do-

kumente und Ordner mit der zum Exportvorgang gehörenden Be-
schreibung in einer PLA 3.0 Dokumentpaketdatei abgelegt.

DOKUMENTE IMPORTIEREN
Zum Importieren von Dokumenten stehen Ihren die folgenden Mög-
lichkeiten zur Verfügung:

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 Dokumente verwalten

Im Navigator-Baum haben Sie durch einen Rechtsklick auf den Ord-

ner Zugriff auf die Aktion Importieren….

In der Detailansicht des Navigators haben Sie durch einen Rechts-

klick auf einen Ordner oder einen Rechtsklick auf freien Bereich in
der Detailansicht Zugriff die Aktion Importieren….

Zusätzlich dazu haben Sie über die Tool Bar und das Datei-Menü die
Möglichkeit Dokumente in einen im Navigator-Baum oder in der
Detailansicht selektierten Ordner zu importieren.

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PLA 3.0 - Benutzerhandbuch

Wenn Sie die Aktion zum Importieren von Dokumenten aufrufen

haben Sie im Dialog zum Importieren von Dokumenten die Möglich-
keit aus einer Liste an verfügbaren Importformaten auszuwählen.

I MPORT EINER PLA 3.0 D OKUMENTPAKETDATEI

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 Dokumente verwalten

Wenn Sie die Aktion zum Importieren einer Dokumentpaketdatei

aufrufen, haben Sie im Dialog zum Importieren von Dokumenten
aus Dokumentpaketdateien die Möglichkeit eine Quelldatei auszu-
wählen.

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PLA 3.0 - Benutzerhandbuch

Nach der Auswahl der Quelldatei wird Ihnen die zum Dokumentpa-
ket gehörende Beschreibung angezeigt.

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 Dokumente verwalten

Die in dem Dokumentpaket enthaltenen Dokumente und Ordner

werden in den angegebenen Zielordner importiert.

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PLA 3.0 - Benutzerhandbuch

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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Dokumente verwalten

135
PLA 3.0 - Benutzerhandbuch

Die im Dokumentpaket enthaltenen Dokumente werden unter Ver-

wendung eines neuen Dokumentschlüssels abgespeichert, wobei
die im Dokumentpaket hinterlegte Ordnerhierarchie nachgebildet
wird.

I MPORT VON PLA 2. X D OKUMENTEN

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 Dokumente verwalten

Wenn Sie die Aktion zum Importieren von PLA 2.x Dokumenten
aufrufen haben Sie im Dialog zum Importieren von PLA 2.x Doku-
menten die Möglichkeit eine Quelldatei auszuwählen.

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PLA 3.0 - Benutzerhandbuch

Nach der Auswahl der Quelldatei können sie den Importvorgang

starten.

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 Dokumente verwalten

Die in dem Dokumentpaket enthaltenen Dokumente und Ordner

werden in den angegebenen Zielordner importiert.

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PLA 3.0 - Benutzerhandbuch

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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Dokumente verwalten

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PLA 3.0 - Benutzerhandbuch

Die Ordner und Dokumente werden unter Verwendung eines neuen

Dokumentschlüssels abgespeichert, wobei die im Dokumentpaket
hinterlegte Ordnerhierarchie nachgebildet wird.

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DOKUMENTE BEARBEITEN

KONZEPTE
ELASTICFORMS-TECHNOLOGIE
ElasticForms ist eine Editoren-Technologie von Stegmann Systems,
die eine extrem flexible und effiziente Möglichkeit zum Editieren
komplexer Datenstrukturen darstellt.

Im Gegensatz zu klassischen, formularbasierten Programmen ist es

nicht notwendig, den ElasticForms-Editor zu programmieren, um
Anpassungen für komplexe Editier-Situationen zu entwickeln.

Dokumente bestehen aus Elementen. Jedes Element hat einen Typ,

der die Art der Information bestimmt, die in diesem Element edi-
tiert werden darf. Ebenso verfügt jedes Element über eine Multipli-
zitätsangabe, die definiert, wie oft ein Element in einem Dokument
vorkommen darf. Jedes Element verfügt über eine minimale Angabe

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PLA 3.0 - Benutzerhandbuch

(typischerweise 0 oder 1) und eine maximale Angabe (typisch 1

oder unlimitiert) für die Multiplizität.

Elemente können andere Elemente inkludieren, was zu hierarchi-

schen Strukturen im Dokument führt. Die Regeln, wie die Elemente
angeordnet werden können, werden im Dokumenttyp definiert. Der
Dokumenttyp beschreibt die Sequenzen oder auch Alternativen für
Elemente.

Um das erste Mal mit ElasticForms zu arbeiten, fügen Sie doch ein-
fach ein Notiz- oder Kontakt-Element in Ihr Dokument ein.

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Testen Sie Elemente mit Hilfe der erstellbaren Elemente, die Sie
durch einen Doppelklick zu Ihrem Dokument hinzuzufügen können,
oder löschen Sie Elemente mit Hilfe des Kontextmenüs das er-
scheint, wenn sie ein Element mit der rechten Maustaste anklicken.
Sie werden die Vorteile dieser Technik bereits nach wenigen Minu-
ten erkennen.

DASHBOARD
Das interaktive Dashboard bietet Ihnen eine Übersicht der Inhalte
und Änderungen am Dokument.

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PLA 3.0 - Benutzerhandbuch

Die Inhalte des Dashboards sind abhängig vom Dokumenttyp und

Bearbeitungsstatus des Dokuments.

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Bei berechneten biologischen Assays bietet das Dashboard eine

aufbereitete Zusammenfassung der Ergebnisse.

Weitere Informationen finden Sie im Handbuch der Dokumentty-

pen.

DOKUMENTSTRUKTUR
Im Dokument-Editor bietet Ihnen der Struktur-Baum der Inhalt-
Ansicht die Möglichkeit auf einen Blick die Struktur des Dokuments
zu sehen und durch die Struktur des Dokuments zu navigieren.

Wenn Sie ein Element im Struktur-Baum selektieren, werden Ihnen

in der nebenstehenden Detailansicht je nach Anzeigeoption die
Unterelemente mit ihrem Datentyp und ihrem Wert angezeigt.
Weitere Informationen zu den Anzeigeoptionen finden Sie im Kapi-
tel Dokument einrichten.

Die Inhalt-Ansicht dient zur Definition aller Eigenschaften eines

Dokuments mit Ausnahme der Daten.

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PLA 3.0 - Benutzerhandbuch

EDITOREN
Datenpunkte können in mehreren Editoren verwaltet werden, die
unterschiedliche Perspektiven auf die Daten bieten. Der universelle
Dateneditor ist der Beobachtungs-Editor. Beinhalten die Daten
Positionsinformationen (z.B. Plattennummer, Reihe, Spalte), so
steht auch der Positions-Editor zur Verfügung. Beinhalten die Daten
Sequenzen (z.B. Verdünnungsserien), so können sie alternativ auch
im Sequenz-Editor betrachtet werden.

B EOBACHTUNGEN -E DITOR

Der Beobachtungen-Editor ist für Dokumente mit der Observation

Source User Input verfügbar und enthält die Daten einer Beobach-
tung pro Zeile. Die Eigenschaften einer Beobachtung befinden sich
in den verschiedenen Spalten. Dieser Editor ist der universelle Edi-
tor zur Dateneingabe.

R EFERENZEN -E DITOR

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Datenpunkte können in mehreren Editoren verwaltet werden, die

unterschiedliche Perspektiven auf die Daten bieten. Der Referen-
zen-Editor ist für Dokumente mit der Observation Source Aggrega-
tion verfügbar und benötigt ein Column: Document Reference Ele-
ment unterhalb des Observation Data Elements eines Dokuments.
Je nach Konfiguration des Observation Data Elements zeigt der
Referenzen-Editor die aggregierten Daten der durch die Observati-
on Data Konfiguration des Dokuments definierten Dokumente.

S EQUENZ -E DITOR

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PLA 3.0 - Benutzerhandbuch

Datenpunkte können in mehreren Editoren verwaltet werden, die

unterschiedliche Perspektiven auf die Daten bieten. Der Sequenz-
Editor zeigt die Daten einer Sequenz (z.B. Verdünnungsserie) pro
Zeile an. Die Faktor-Werte der Replikate sind in den einzelnen Spal-
ten sichtbar.

P OS i TIONS -E DITOR

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Datenpunkte können in mehreren Editoren verwaltet werden, die

unterschiedliche Perspektiven auf die Daten bieten. Der Positions-
Editor zeigt die Daten einer Positionsinformation (z.B. Position auf
einer Mikrotiterplatte) pro Zelle auf einer x*y Matrizen an. Der
Positions-Editor ermöglicht es auch die Daten der Positionsinforma-
tionen von z* x*y Matrizen (Positionen auf mehreren Mikrotiter-
platten) anzuzeigen und zu bearbeiten.

SIGNATUREN
Wenn Sie Änderungen an einem Dokument verhindern möchten,
können Sie das Dokument oder Teile des Dokuments (Inhalt oder
Daten) signieren. Zum Signieren sind erweitere Berechtigungen
nötig (Siehe Administratorhandbuch Kapitel Berechtigungen verwal-
ten).

S IGNATURBEREICH D OKUMENT
Wenn Sie den Dokument Bereich signieren wird das vollständige
Dokument schreibgeschützt.

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S IGNATURBEREICH I NHALT
Wenn Sie eine Signatur zum Inhalt Bereich hinzufügen, wird die
Dokumentstruktur schreibgeschützt. Weitere Informationen zur
Dokumentstruktur finden Sie im Kapitel Dokumentstruktur.

S IGNATURBEREICH D ATEN
Wenn Sie die Daten eines Dokuments signieren, werden die Daten-
Editoren des Dokuments schreibgeschützt. Weitere Informationen
zu den Daten-Editoren finden Sie im Kapitel Editoren.

EREIGNISPROTOKOLL (AUDIT TRAIL)

Im Ereignisprotokoll (Audit Trail) werden die Erstellung und alle
darauf folgenden Änderungen am Dokument protokolliert.

Zu jeder am Dokument durchgeführten Aktion wird ein Eintrag

erstellt, der Details zu jedem durch die Aktion veränderten Element
des Dokuments enthält. Die Details beinhalten den Name des Ele-
ments, die durchgeführte Aktion, den alten Wert und den neuen
Wert des Elements.

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AKTIONEN
DASHBOARD
Das Dashboard zeigt Inhalte abhängig vom Dokumenttyp und dem
Bearbeitungsstand des Dokuments an.

Durch einen einzelnen Linksklick auf die Pfeile der Überschriften im

Dashboard, lassen sich einzelne Inhalte ein- oder ausblenden.

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Bei berechneten biologischen Assays bietet das Dashboard zudem

eine aufbereitete Ansicht der Ergebnisse.

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Die Grafiken berechneter biologischer Assays lassen sich ebenfalls

durch einen einzelnen Linksklick vergrößern und wieder verkleinern.

DOKUMENT EINRICHTEN

A NSICHT ANPASSEN

Die Anzeigeoptionen der Inhalt-

Ansicht erlauben es Elemente
des Editors ein- oder auszublen-
den um die Oberfläche an Ihre
aktuelle Tätigkeit anzupassen.

P FADNAVIGATION

Die Anzeigeoption Pfadnavigation der Inhalt-Ansicht erlaubt es

Ihnen die über dem Struktur-Baum liegende Pfadnavigation ein-
oder auszublenden.

S TRUKTUR

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Die Anzeigeoption Struktur der Inhalt-Ansicht erlaubt es Ihnen den

links neben der Detailansicht liegenden Struktur-Baum ein- oder
auszublenden.

E RSTELLBARE E LEMENTE

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Die Anzeigeoption Erstellbare Elemente der Inhalt-Ansicht erlaubt

es Ihnen die rechts neben der Detailansicht liegende Liste Erstellba-
re Elemente ein- oder auszublenden.

Z OOM

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Die Anzeigeoption Zoom der Inhalt-Ansicht erlaubt es Ihnen das

Verhalten der Detailansicht bei Selektionen im Struktur-Baum zu
bestimmen. Bei Aktivierter Zoom Anzeigeoption, führt eine Selekti-
on eines Elements im Struktur-Baum zur Anzeige aller Unterelemen-
te des selektierten Elements in der Detailansicht. Die Aktivierung
der Anzeigeoption Zoom deaktiviert die Anzeigeoption Hervorhe-
ben.

H ERVORHEBEN

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Die Anzeigeoption Hervorheben der Inhalt-Ansicht erlaubt es Ihnen

das Verhalten der Detailansicht bei Selektionen im Struktur-Baum
zu bestimmen. Die Aktivierung der Hervorheben Anzeigeoption
bewirkt, dass eine Selektion eines Elements im Struktur-Baum
gleichzeitig das gleiche Element in der Detailansicht selektiert. Die
Aktivierung der Anzeigeoption Hervorheben deaktiviert die Anzei-
geoption Zoom.

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S UCHEN UND F ILTERN D IALOG

Der Suchen und Filtern Dialog erlaubt es, das Dokument sowohl zu
durchsuchen als auch zu filtern. Geöffnet werden kann er mit der
Tastenkombination STRG+F im Dokumenteditor.

SUCHEN NACH
Dieses Feld ist mit dem Begriff, nach dem zu suchen bzw. zu filtern
ist, zu füllen. Bereits benutzte Begriffe können mit dem Pfeil nach
unten ausgewählt werden.

ERWEITERN/REDUZIEREN
Erlaubt es zwischen einfacher und erweiterter Ansicht umzuschal-
ten.

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SUCHRICHTUNG
Legt die Suchrichtung nach Vorne oder nach Hinten fest. Zudem
kann man entscheiden, ob man nach der Durchsuchung wieder von
vorn beginnen möchte.

OPTIONEN
G ROß -/K LEINSCHREIBUNG
Legt fest, ob die Suche Groß- und Kleinschreibung berücksichtigen
soll.

G ESAMTER A USDRUCK
Sucht den exakten Wert in dem Dokument.

G ESAMTER B EGRIFF
Sucht nach ganzen Wörtern.

R EGULÄRE A USDRÜCKE
Erlaubt die Benutzung Regulärer Ausdrücke

SUCHEN
Wählt die nächste Übereinstimmung aus.

MARKIEREN
Markiert alle Übereinstimmungen in dem Dokument.

FILTERN/FILTER AUFHEBEN
Zeigt nur noch Übereistimmungen an bzw. hebt die Filterung wieder
auf.

E LEMENTE ANLEGEN
Wenn Sie ein neues Dokument bearbeiten, werden einige Elemente
bereits vordefinierte Werte enthalten. Beispielsweise sind in Biolo-
gischen Assay Dokumenten bereits Elemente für den Standard und
eine Probe enthalten. Falls Sie weitere Dokument-Elemente benöti-

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gen, bietet Ihnen die ElasticForms Technologie die Möglichkeit Ihr

Dokument zu erweitern.

Zum Hinzufügen eines Elements in Ihr Dokument stehen Ihren die

folgenden Möglichkeiten zur Verfügung:

Mit Hilfe der Erstellbare Elemente Liste können Sie durch einen
Doppelklick auf ein Element, dieses zu Ihrem Dokument hinzufügen.
Je nachdem welchen Elementtyp sie in der Inhalt-Ansicht selektiert
haben werden Ihnen unterschiedliche Dokument-Elemente zur
Auswahl angeboten.

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Das Kontextmenü, dass durch einen Rechtsklick auf ein Element in

der Inhalt-Ansicht geöffnet werden kann, bietet Ihnen ebenfalls
Zugriff auf die Aktion Element erstellen. Die angebotenen Elemente
sind abhängig vom Elementtyp auf den der Rechtsklick durchgeführt
wurde.

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Die Hinzufügen… Aktion in der Tool Bar der Inhalt-Ansicht erlaubt

Ihnen ebenfalls das Hinzufügen von Elementen. Die im Dialog zum
Hinzufügen von Elementen verfügbaren Elemente sind abhängig
von Ihrer Selektion in der Inhalt-Ansicht.

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Einige Elemente können unterschiedliche Ausprägungen haben (z.B.

Das Element Model, ein Unterelement des Elements Analytical
Model). Wenn ein Element unterschiedliche Ausprägungen haben
kann, befindet sich rechts neben dem Namen des Elements ein
Pfeilknopf, der die Auswahl einer Ausprägung erlaubt.

W ERTE EINGEBEN
In der Inhalt-Ansicht haben Sie die Möglichkeit den im Dokument
enthaltenen Elementen Werte zuzuweisen. Der eingegebene Wert
wird übernommen, wenn Sie das Eingabefeld durch das Betätigen
der Enter Taste oder einen Linksklick auf einen Bereich außerhalb
des Eingabefeldes verlassen. Wenn Sie das Eingabefeld durch das
Betätigen der Escape (esc) Taste verlassen, wird der eingegebene
Wert nicht übernommen.

Je nach Elementtyp stehen unterschiedliche Eingabemöglichkeiten

für Werte zur Verfügung:

Einzeiliges Textfeld (T): Erlaubt die freie Eingabe eines einzeiligen

Textes.

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Mehrzeiliges Textfeld (M): Erlaubt die freie Eingabe eines mehrzeili-

gen Textes.

Datumsfeld: Erlaubt die Auswahl eines Kalendertages oder die ma-

nuelle Eingabe eines der Vorgabe entsprechenden Datums.

Zeitfeld: Erlaubt das Ändern der eingetragenen Uhrzeit mit Hilfe der
am Feld befindlichen Pfeiltasten oder die manuelle Eingabe einer
der Vorgabe entsprechenden Uhrzeit.

Ganzzahlfeld (Z): Erlaubt das Eingeben eines ganzzahligen Wertes.

Listenfeld: Erlaubt die Auswahl eines Wertes aus einer Liste an vor-
gegebenen Werten. Die Liste kann durch das Anklicken des im Lis-
tenfeld befindlichen Pfeilknopfes angezeigt werden.

Element-Referenzfeld: Erlaubt das auswählen eines Elements.

Dokument-Referenzfeld: Erlaubt das auswählen eines Dokuments.

Farbfeld: Erlaubt die Auswahl einer Farbe aus einem Farbkatalog

oder die manuelle Eingabe von RGB Farbwerten entsprechend der
Vorgabe.

R EFERENZEN ZWISCHEN E LEMENTEN BEARBEITEN

Der Dokument-Editor unterstützt Referenzen zwischen Elementen
innerhalb eines Dokuments.

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So kann zum Beispiel ein Test Sample das verwendete Preparation

Scheme und Data Selection Scheme referenzieren. Das referenzierte
Element wird als Wert des referenzierenden Elements in Form eines
Hyperlinks dargestellt. Diese Art der Darstellung erlaubt es Ihnen
zum Ziel der Referenz zu navigieren indem Sie bei gedrückter Um-
schalttaste einen Linksklick auf den Hyperlink durchführen. Das
referenzierte Element wird daraufhin in der Inhalt-Ansicht ausge-
wählt und angezeigt.

Zum Bearbeiten einer Referenz zwischen Elementen innerhalb eines

Dokuments stehen Ihren die folgenden Möglichkeiten zur Verfü-
gung:

Durch einen Rechtsklick auf das referenzierende Element können

Sie im Kontextmenü die Aktionen Ziel auswählen und Ziel erstellen
aufrufen.

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Durch den Dialog zur Auswahl eines Referenzziels können Sie eine
Referenz auf ein bestehendes Element erstellen.

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Durch den Dialog zur Erstellung eines Referenzziels können sie ein
neues Element erstellen, das automatisch als Ziel für die Referenz
eingetragen wird.

Eine Referenz zwischen zwei Elementen innerhalb eines Dokuments

kann jedoch auch in umgekehrter Reihenfolge aufgebaut werden.

Durch einen Rechtsklick auf den Namen des zu referenzierenden

Elements können sie im Kontextmenü die Aktion Element zuweisen
auswählen.

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Zusätzlich können Sie über die Aktion Zeige Verweise auf dieses
Element eine Liste der Elemente ansehen die das ausgewählte Ele-
ment bereits referenzieren.

R EFERENZEN ZWISCHEN D OKUMENTEN BEARBEITEN

Der Dokument-Editor unterstützt neben Referenzen innerhalb eines
Dokuments auch Referenzen zwischen Dokumenten. Das referen-
zierte Dokument wird als Wert des referenzierenden Elements in
Form eines Hyperlinks dargestellt. Diese Art der Darstellung erlaubt
es Ihnen das Ziel der Referenz im Dokument-Editor zu öffnen.

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So kann zum Beispiel ein Kommentar-Element in einem Dokument

ein beliebiges anderes Dokument innerhalb der gleichen Datenbank
referenzieren.

Zum Bearbeiten einer Referenz zwischen zwei Dokumenten stehen

Ihren die folgenden Möglichkeiten zur Verfügung:

Durch einen Linksklick auf den Wert des referenzierenden Elements

können Sie durch einen Linksklick auf den zum Wertefeld gehören-
den … Knopf die Aktion zum Auswählen eines Referenzziels aufru-
fen.

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Mit Hilfe des Dialogs zur Auswahl eines Referenzziels können Sie
durch die in der Datenbank verfügbaren Ordner navigieren und ein
Dokument als Ziel für die Referenz auswählen.

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Falls das referenzierende Element so konfiguriert wurde dass es die

Erstellung von Referenzzielen erlaubt, können Sie durch einen
Linksklick auf den zum Wertefeld gehörenden * Knopf die Aktion
zum Erstellen eines Referenzziels aufrufen. Sie werden zum Spei-
chern des referenzierenden Dokuments aufgefordert, falls das Do-
kument noch nicht initial gespeichert wurde. Nach dem initialen
Speichern des referenzierenden Dokuments können Sie ein Ziel für
die Referenz erzeugen.

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Durch den Dialog zur Erstellung eines Referenzziels können sie ein
neues Dokument erstellen, das automatisch als Ziel für die Referenz
eingetragen wird.

Alternativ können Sie durch die Aktion Referenzen… in der Tool Bar
der Inhalt-Ansicht den Dialog zum Verwalten aller Dokumentrefe-
renzfelder aufrufen.

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Der Dialog zum Verwalten der Dokumentreferenzen erlaubt es

Ihnen abhängig von der Konfiguration des referenzierenden Ele-
ments ein Dokument als Referenzziel zu erstellen oder auszuwählen
sowie das referenzierende Element in der Inhalt-Ansicht anzuzei-
gen, das referenzierende Element zu Duplizieren oder das als Ziel
der Referenz hinterlegte Dokument in einem neuen Dokument-
Editor Fenster zu öffnen.

DATEN EINGEBEN

B EOBACHTUNGEN -E DITOR

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Im Beobachtungen-Editor haben Sie die Möglichkeit mit der Hinzu-

fügen Aktion einzelne leere Zeilen zu erstellen um diese für die
Eingabe Ihrer Response Daten vorzubereiten.

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Die Zuweisungen Aktion des Beobachtungen-Editors füllt basierend

auf der Konfiguration des Dokuments je nach Auswahl die Observa-
tion Group ID und die Sequence Step Spalten (Zuweisung der Se-
quenzen), oder die Positionsspalten(Zuweisung der Positionen) mit
den in der Inhalt-Ansicht konfigurierten Werten.

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Die Entfernen Aktion erlaubt es eine oder mehrere selektierte Spal-

ten aus dem Beobachtungen-Editor zu entfernen. Zur Umsortierung
der angezeigten Beobachtungen stehen Ihnen die Aktionen Nach
oben und Nach unten zur Verfügung.

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Durch einen einzelnen Klick auf die Nach oben Aktion werden alle
selektierten Spalten um eine Position nach oben verschoben.

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Wenn Sie mehrere nicht zusammenhängende Zeilen selektieren und

die Nach oben Aktion ausführen, werden die Zeilen zuerst unter der
obersten Zeile angeordnet und danach um eine Position nach oben
verschoben. Die Aktion Nach unten verhält sich entsprechend der
Nach oben Aktion, versetzt die selektierten Zeilen jedoch um eine
Position nach unten.

R EFERENZEN -E DITOR

Um den Referenz-Editor zu verwenden müssen Sie zuerst am Da-

tensatz die Observation Source auf Aggregation einstellen. Je nach
Dokumentart kann das Datensatz-Element unterschiedlich benannt
sein, Sie können es an der pro Dokument eindeutigen Ikone erken-
nen.

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Anschließend ist der Referenzen-Editor in der Editor-Auswahl ver-

fügbar.

A KTUALISIERUNGS - MODI
Es gibt vier unterschiedliche Modi um Referenzen zu aktualisieren.

Die Einstellungen zum Aktualisieren von Referenzen finden Sie im-

mer unter Column: Document Referenz  Update Mode unterhalb
des Datensatz-Elements.

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Grundsätzlich kann ein Dokument immer manuell aktualisiert wer-

den, außer wenn der Bereich oder das Dokument durch eine Signa-
tur geschützt ist.

AUTO ALL
Mit dieser Einstellung werden automatisch alle Dokumente in der
Datenbank als Referenz angelegt und die aggregierten Datenwerte
im Referenzen-Editor aktualisiert. Diese Aktualisierung wird beim
Öffnen des Dokuments vorgenommen insofern der Bereich oder das
Dokument nicht über eine Signatur geschützt ist. Wenn der Bereich
nach dem entfernen einer Signatur wieder editierbar ist, wird eben-
falls eine Aktualisierung vorgenommen. Es ist möglich die zu aggre-
gierenden Dokumente über Filter einzuschränken.

AUTO DATA
Mit dieser Einstellung werden automatisch die aggregierten Daten-
werte im Referenzen-Editor aktualisiert. Diese Aktualisierung wird
beim Öffnen des Dokuments vorgenommen insofern der Bereich
oder das Dokument nicht über eine Signatur geschützt ist. Wenn
der Bereich nach dem entfernen einer Signatur wieder editierbar
ist, wird ebenfalls eine Aktualisierung vorgenommen. Referenzen
müssen manuell über Referenz Hinzufügen angelegt werden.

MANUAL ALL
Mit dieser Einstellung werden nur bei manuellem Aktualisieren alle
Dokumente in der Datenbank als Referenz angelegt und die aggre-
gierten Datenwerte im Referenzen-Editor aktualisiert. Es ist möglich
die zu aggregierenden Dokumente über Filter einzuschränken.

MANUAL DATA
Mit dieser Einstellung werden nur bei manuellem Aktualisieren die
aggregierten Datenwerte im Referenzen-Editor aktualisiert. Refe-
renzen müssen manuell über Referenz Hinzufügen angelegt wer-
den.

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R EFERENZ HINZUFÜGEN
Die Aktion Referenz Hinzufügen ist nur dann verfügbar wenn Up-
date Mode entweder auf Auto Data oder Manual Data eingestellt
ist. Ansonsten wird das Hinzufügen von Referenzen automatisch
über die definierten Filter vorgenommen.

Zum manuellen Aggregieren von Daten aus Dokumenten, steht

Ihnen in der Referenzen-Editor Tool Bar die Aktion Referenz hinzu-
fügen zur Verfügung.

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Der Dialog zum Hinzufügen von Referenzen erlaubt es ein Doku-

ment zur Aggregation auszuwählen. Nach der Auswahl des Doku-
ments und der Bestätigung des Dialogs werden alle verfügbaren
Daten des ausgewählten Dokuments in den Referenzen-Editor
übernommen.

R EFERENZEN ENTFERNEN

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Die Aktion Referenzen entfernen kann genutzt werden um eine

oder mehrere selektierte Zeilen aus dem Referenzen-Editor zu ent-
fernen. Wenn eine Zeile gelöscht wird werden auch alle anderen
Zeilen gelöscht, die vom selben Dokument aggregiert wurden.

F ILTERN DER D OKUMENTMENGE

Es ist möglich die Auswahl der zu aggregierenden Dokumente mit
Filtern einzuschränken. So kann man zum Beispiel nur Dokumente
eines bestimmten Dokumenttyps in einem bestimmten Ordner zu
aggregieren.

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Filter werden als Elemente Column: Dokument Reference angelegt.

DOCUMENT TYPE
Nur Dokumente mit diesem Dokument-Typ können aggregiert wer-
den.

TEMPLATE KEY
Nur Dokumente, die mit dieser Vorlage erstellt wurden können
aggregiert werden.

FOLDER KEY
Nur Dokumente in diesem Ordner können aggregiert werden.

ALLOW SUBFOLDER
Wirkt nur in Verbindung mit Folder Key einschränkend. Es ist mög-
lich auch Dokumenten in Unterordnern des durch Folder Key defi-
nierten Ordners zu aggregieren.

GENERATOR KEY
Nur Dokumente die durch dieses generierende Dokument erstellt
wurden können aggregiert werden.

DOCUMENT PROPERTY FILTER

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Nur Dokumente bei denen die bestimmte Eigenschaft den in Term

spezifizierten Wert hat können aggregiert werden.

SEKTION PROPERTY FILTER

Nur Dokumente, die eine Sektion enthalten deren Titel dem Wert
von Section Key entspricht und in der es eine durch Property Key
spezifizierte Eigenschaft mit dem Wert Term gibt können aggregiert
werden. Wenn alle Sektionen überprüft werden sollen muss Section
Key den Wert $$$ANYSECTION$$$ haben.

F ILTERN DER AGGREGIERTEN S EKTIONEN

Es ist möglich zusätzlich zu Dokumentmengenfilter, die Dokumente
gänzlich ausschließen, nur bestimmte Sektionen der verbleibenden
Dokumente zu aggregieren. Hierfür werden Section Filter benötigt.

Sektion Filter werden unter Column:Section angelegt. Die Eingen-

schaft mit dem Schlüssel Property Key muss dem Wert Term ent-
sprechen, damit die Sektion aggregiert wird.

S EQUENZ -E DITOR

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Durch das einmalige Anklicken oder die Auswahl eines Elements mit
Hilfe des Sample Knopfes können Sie bestimmen welches Sample im
Sequenz-Editor angezeigt wird.

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Durch das einmalige Anklicken oder die Auswahl eines Elements mit
Hilfe des Faktor Knopfes können Sie bestimmen welcher Faktor im
Sequenz-Editor angezeigt wird. So können Sie durch die Kombinati-
on des Sample und des Faktor Knopfes alle Faktoren aller Sequenz-
schritte eines Samples ansehen oder bearbeiten.

P OSITIONS -E DITOR
Der Positions-Editor zeigt abhängig von der Anzahl und den Werten
der im Dokument konfigurierten Position Factor Elemente eine x*y
Matrix oder mehrere x*y Matrizen an.

Bei der Angabe von 2 Positionsfaktoren zeigt der Positions-Editor

eine x*y Matrix an, wobei x der Number of positions Wert des ers-
ten Positionsfaktors und y der Number of positions Wert des zwei-
ten Positionsfaktors ist.

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Bei der Angabe von 3 Positionsfaktoren haben Sie die Möglichkeit

den Wert des dritten Positionsfaktors zu Nutzen um die Anzahl der
verfügbaren Matrizen zu erhöhen. Bei einem dritten Positionsfaktor
mit einem Number of Positions Wert von 2 haben Sie die Möglich-
keit die Daten von 2 unabhängigen x*y Matrizen im Positions-Editor
anzuzeigen und zu bearbeiten(z.B. Die Daten von zwei Mikrotiter-
platten). Die Aktivierung des Number of positions Werts eines drit-
ten Position Factor Elements in der Inhalt-Ansicht schaltet im Posi-
tions-Editor die Aktion zum Wechseln der angezeigten x*y Matrix
frei.

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In der Positions-Ansicht können Sie dann durch das einmalige Ankli-

cken des Position Knopfes zwischen den verfügbaren x*y Matrizen
wechseln. Alternativ können Sie durch die Auswahl eines Elements
im Drop-Down Menü des Position Knopfes eine bestimmte x*y
Matrix im Positions-Editor anzeigen.

E DITORUNABHÄNGIGE B EARBEITUNGSAKTIONEN

K OPIEREN
Wenn Sie einzelne Werte, oder Werte einer oder mehreren Zellen,
Zeilen oder Spalten in ein anderes Dokument, einen anderen PLA
3.0 Editor oder ein externes Programm übernehmen möchten, be-
steht die Möglichkeit die im Editor selektierten Inhalte zu kopieren.

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PLA 3.0 - Benutzerhandbuch

Selektieren Sie die gewünschten Inhalte, rufen Sie über einen

Rechtsklick auf einen selektierten Inhalt das Kontextmenü des Edi-
tors auf und wählen Sie die Aktion Kopieren aus. Die so kopierten
Inhalte können Sie in jedem Programm das Einfüge Aktionen von
Textdaten erlaubt, einfügen.

A USSCHNEIDEN
Wenn Sie einzelne Werte, oder Werte einer oder mehreren Zellen,
Zeilen oder Spalten in ein anderes Dokument, einen anderen PLA
3.0 Editor oder ein externes Programm übernehmen möchten, be-
steht die Möglichkeit die im Editor selektierten Inhalte auszuschnei-
den.

Selektieren Sie die gewünschten Inhalte, rufen Sie über einen

Rechtsklick auf einen selektierten Inhalt das Kontextmenü des Edi-

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tors auf und wählen Sie die Aktion Ausschneiden aus. Die ausge-
schnittenen Inhalte werden aus dem Editor entfernt und können in
jedem Programm das Einfüge Aktionen von Textdaten erlaubt, ein-
gefügt werden.

E INFÜGEN
Wenn Sie einzelne kopierte oder ausgeschnittene Werte, oder Wer-
te aus einer oder mehreren Zellen, Zeilen oder Spalten aus einem
PLA 3.0 Editor oder einem externen Programm übernehmen möch-
ten, besteht die Möglichkeit Inhalte aus der Zwischenablage einzu-
fügen.

Selektieren Sie die Position an der Sie den oder die Inhalte einfügen
möchten im Editor und rufen Sie über einen Rechtsklick auf eine
selektierte Zelle das Kontextmenü des Editors auf. Im Kontextmenü
können Sie die Aktion Einfügen aufrufen, um die Inhalte aus der
Zwischenablage an der selektierten Position in den Editor einzufü-
gen.

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Die Aktion Einfügen ist nur verfügbar wenn sich Textdaten in Ihrer
Zwischenablage befinden.

L ÖSCHEN
Wenn Sie einzelne Werte, oder Werte einer oder mehreren Zellen,
Zeilen oder Spalten aus dem Editor entfernen möchten, besteht die
Möglichkeit die Werte der im Editor selektierten Zellen, Zeilen oder
Spalten zu löschen.

Selektieren Sie die gewünschten Zellen, Zeilen oder Spalten, rufen

Sie über einen Rechtsklick auf einen selektierten Wert das Kontext-
menü des Editors auf und wählen Sie die Aktion Löschen aus. Nur
die Inhalte editierbarer einzelner Zellen oder mehrzelliger Selektio-
nen, die ein Rechteck abbilden, können aus dem Editor gelöscht
werden.

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E XTERN ÖFFNEN
Durch die Aktion Extern öffnen der Daten-Editoren haben Sie die
Möglichkeit die angezeigten Daten in einem externen Programm
anzuzeigen.

Die Aktion öffnet das in Ihrem Betriebssystem als Standardpro-

gramm für .csv Dateien definierte Programm.

Bitte prüfen Sie nach dem Öffnen ob das als Standardprogramm für
.csv Dateien die übergebenen Werte mit der korrekten Formatie-
rung darstellt. Microsoft Excel wird z.B. das Verhältnis 1:50 automa-
tisch als Zeitangabe interpretieren und als 1:50:00 Uhr anzeigen.
Passen Sie ggf. die Werte nachträglich in Ihrem Standardprogramm
für .csv Dateien an.

A NZEIGEOPTIONEN
Die Anzeigeoptionen der Daten-Editoren erlauben es die Tabelle
einzufärben.

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Je heller der Farbwert ist, desto niedriger ist der zugehörige Wert.

D ATEN A KQUIRIEREN
PLA 3.0 bietet durch Importmodule die Möglichkeit Daten aus ex-
ternen Quellen (z.B. Programme von Drittherstellern) in Dokumente
zu importieren. Nach dem Import können diese Daten mit Hilfe der
Dateneditoren betrachtet oder bearbeitet werden. Weitere
Informationen zu den Dateneditoren finden Sie im Kapitel Editoren.

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Wenn Sie über ein installiertes Importmodul verfügen, können Sie

bei kompatiblen Dokumenten im Dokument-Editor die Aktion Daten
akquirieren aufrufen.

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PLA 3.0 - Benutzerhandbuch

Im Dialog zum Akquirieren von Daten können Sie aus den für Sie
durch installierte Importmodule verfügbaren Importformaten wäh-
len.

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Nach der Auswahl eines Importformates können Sie eine Quelldatei

und die Position an der die Daten eingefügt werden sollen auswäh-
len.

Zur Auswahl stehen:

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Anfang: Fügt die Daten auf Position 1 innerhalb des Dokuments ein.
Falls schon Daten im Dokument existieren werden diese durch die
importierten Daten ersetzt. Falls mehr Daten im Dokument vorhan-
den sind als durch den Import überschrieben werden, bleiben die
Daten auf den überschüssigen Positionen erhalten.

Anfügen: Fügt die Daten am Ende des Dokuments ein. Falls schon
Daten im Dokument existieren werden diese durch die importierten
Daten nicht ersetzt.

Position: Fügt die Daten auf der gewünschten Position innerhalb des
Dokuments ein. Falls schon auf dieser oder nachfolgenden Positio-
nen existieren, werden diese durch die importierten Daten ersetzt.
Falls mehr Daten im Dokument vorhanden sind als durch den Im-
port überschrieben werden, bleiben die Daten auf den überschüssi-
gen Positionen erhalten.

Nach Abschluss des Imports können Sie die Daten im Beobachtun-

gen-Editor betrachten.

Weitere Informationen zu Importmodulen finden Sie im Administra-

torhandbuch.

G ESCHÜTZTE W ERTE
Akquirierte Daten und der Technical Outlier Status werden als ge-
schützte Werte angesehen. Das Bearbeiten von geschützten Werten
mit dem Dateneditor kann es erforderlich machen, dass ein Ände-
rungsgrund oder eine zusätzliche Signatur angebracht werden muss.
Es ist außerdem möglich das Ändern von geschützten Werten voll-
ständig zu verbieten.

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Abhängig von den Datenbankrichtlinien werden Sie aufgefordert die

Änderungen an einem geschützten Wert durch eine Annotation zu
bestätigen. Falls Sie mehrere geschützte Werte auf einmal ändern,
können Sie die Option Für alle weiteren Änderungen übernehmen
des Annotationsdialoges verwenden, um alle Änderungen mit dem
angegebenen Grund, Benutzernamen und Kennwort zu bestätigen.

EREIGNISPROTOKOLL (AUDIT TRAIL)

Im Ereignisprotokoll (Audit Trail) werden die Erstellung und alle
darauf folgenden Änderungen am Dokument protokolliert.

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Durch einen Linksklick auf einen Protokolleintrag werden im Detail-

bereich die Details zu jedem durch die Aktion veränderten Element
des Dokuments angezeigt.

Die Details beinhalten den Name des Elements, die durchgeführte

Aktion, den alten Wert und den neuen Wert des Elements.

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E REIGNISPROTOKOLL FILTERN
Die angezeigten Einträge im Ereignisprotokoll können mit Hilfe der
Filterfunktion eingeschränkt werden.

Es stehen unterschiedliche Filteroptionen zur Verfügung:

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PLA 3.0 - Benutzerhandbuch

Der „…“ Button des Dialogs erlaubt es die Anzeige der Einträge auf
Aktionen eines bestimmten ausführenden Benutzers zu filtern.

Zum aktivieren/deaktivieren des Filters den Haken bei „Filter nach

Ausführenden“ setzen/entfernen. Im „<Filter eingeben>“ Feld ist es
möglich, die angezeigten Ausführenden einzuschränken. Anschlie-
ßend ist die Auswahl mit „OK“ zu bestätigen.

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Das Aktion Drop-Down Menü erlaubt es die Anzeige der Einträge

auf bestimmte, auf das Dokument angewendete Aktionen einzu-
schränken.

Verfügbare Aktionen:

Siehe Datenbanken überwachen im Administrators Guide.

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PLA 3.0 - Benutzerhandbuch

Zusätzlich bietet der Filtereinstellungen Dialog die Möglichkeit die

Anzeige der Einträge auf einen bestimmten Zeitraum einzuschrän-
ken.

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Wenn ein Filter auf dem Ereignisprotokoll aktiv ist wird die Aktion
zum Zurücksetzen des Filters aktiv. Durch das Anklicken der Aktion
Filter zurücksetzen werden alle aktiven Filter auf das Ereignisproto-
koll wieder entfernt.

E REIGNISPROTOKOLL EXPORTIEREN
Die angezeigten Einträge im Ereignisprotokoll können mit Hilfe der
Exportfunktion exportiert werden.

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Wenn Sie die Exportieren Aktion aufrufen öffnet sich der vorkonfi-
gurierte Exportdialog.

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Im Exportdialog können Sie den Ausgabepfad anpassen. Außerdem

weißt Sie der Dialog auf eventuell aktive Filtereinstellungen hin.
Abhängig von der Menge der Einträge im Ereignisprotokoll und den
gewählten Filtereinstellungen kann der Export mehrere Minuten in
Anspruch nehmen.

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Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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HILFE/FEHLER ANZEIGEN
Der Dokument-Editor führt während Sie ein Dokument bearbeiten
eine automatische Validierung der Inhalte durch und bietet Hilfe-
stellungen zu Ihrer aktuellen Selektion im Dokument an. Die Hilfe

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PLA 3.0 - Benutzerhandbuch

und Fehler-Details können durch einen Klick auf das entsprechende

Symbol in der unteren linken Ecke der Aktions-Bar des Editors ein-
und ausgeblendet werden.

Die Hilfe zum aktuell selektierten Element ist permanent verfügbar,

wohingegen die Fehler-Details nur verfügbar werden wenn Fehler
im Dokument vorhanden sind.

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Wenn die automatische Validierung einen Fehler im Dokument

findet, wird zudem das fehlerhafte Element im Dokument-Editor
mit dem Fehlersymbol kenntlich gemacht.

OPERATIONEN AUSFÜHREN

D OKUMENT BERECHNEN

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PLA 3.0 - Benutzerhandbuch

Nach der vollständigen Definition eines Biologischen Assays können

Sie die Berechnungsaktion aus dem Aktionen-Menü des Editors
starten. Das Assay wird berechnet und die Resultate werden nicht
sichtbar im Dokument gespeichert.

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Falls Sie keine aktuellen Resultate im Dokument haben, etwa weil

Sie nach einer Berechnung noch Eigenschaften des Dokuments
geändert haben, informiert Sie das System am oberen Rand des
Editors darüber.

Je nach Einstellungen und Komplexität des Dokuments können die

Rechenzeiten zwischen einer Sekunden und mehreren Minuten
variieren.

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PLA 3.0 - Benutzerhandbuch

Der Fortschrittsdialog informiert Sie über den Fortschritt der Be-

rechnung.

Aus dem Navigator heraus können Sie durch die Selektion mehrerer
vollständig definierter Dokumente mit Hilfe des Kontext-Menüs
oder der Tool Bar auch mehrere Berechnungen gleichzeitig starten.

D OKUMENT AKTUALISIEREN
Nach der vollständigen Definition eines Control Charts können Sie
die Aktualisieren Aktion aus dem Aktionen-Menü des Editors star-
ten. Das Assay wird aktualisiert und die Resultate werden nicht
sichtbar im Dokument gespeichert.

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 Dokumente bearbeiten

Falls Sie keine aktuellen Resultate im Dokument haben, etwa weil

Sie nach einer Aktualisierung noch Eigenschaften des Dokuments
geändert haben, informiert Sie das System am oberen Rand des
Editors darüber.

Je nach Einstellungen und Komplexität des Dokuments können die

Aktualisierungszeiten zwischen einer Sekunde und mehreren Minu-
ten variieren.

Aus dem Navigator heraus können Sie durch die Selektion mehrerer
vollständig definierter Dokumente mit Hilfe des Kontext-Menüs
oder der Tool Bar auch mehrere Aktualisierungen gleichzeitig star-
ten.

SIGNATUREN ANBRINGEN
Wenn Sie Änderungen an einem Dokument verhindern möchten,
können Sie das Dokument oder Teile des Dokuments (Inhalt oder
Daten) signieren. Weitere Informationen zu Signaturen finden Sie
im Unterkapitel Konzepte des Dokumente bearbeiten Kapitels.

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PLA 3.0 - Benutzerhandbuch

Den Dialog zum Verwalten von Signaturen können Sie mit Hilfe der
Signaturen… Aktion im Dokument-Editor öffnen.

Wenn Sie über entsprechende Berechtigungen verfügen, können Sie

mit dem Signieren Knopf im Dialog zum Signieren von Dokumenten
eine Signatur zum Dokument hinzufügen.

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 Dokumente bearbeiten

Im Konfigurationsdialog für die Signatur müssen Sie einen Grund für

die Signatur angeben. Sie können aus einer Liste an Vorlagen für
Gründe einen passenden Grund auswählen oder selbst einen Grund
eingeben. Zusätzlich können Sie den Bereich, für den die Signatur
gilt, festlegen.

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PLA 3.0 - Benutzerhandbuch

Um das Dokument mit dem angegebenen Grund signieren zu kön-

nen müssen Sie Ihr Kennwort eingeben.

220
 Dokumente bearbeiten

Im Dialog zur Verwaltung von elektronischen Signaturen wird jetzt

Ihre Signatur angezeigt.

Signaturen für Bereiche können auch im jeweiligen Editor ange-

bracht werden. Die Zahl in Klammern zeigt wie viele Signaturen für
diesen Bereich angebracht wurden.

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PLA 3.0 - Benutzerhandbuch

Im Dokument-Editor können Sie nun sehen dass das Dokument

durch Ihre Signatur geschützt wird. Es können jetzt keine Änderun-
gen mehr am Dokument vorgenommen werden ohne dass Ihre
Signatur durch einen Benutzer mit der Berechtigung zum Entfernen
von Signaturen wieder entfernt wird.

Die Berechtigungen zum Hinzufügen und Entfernen von Signaturen

können getrennt vergeben werden. Falls sich mehr als eine Signatur
auf dem Dokument befindet, müssen Sie die Signaturen von der
neuesten Signatur zur ältesten Signatur einzeln entfernen.

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Sie können eine Signatur nur entfernen nachdem Sie Ihr Kennwort
eingegeben haben.

Weitere Informationen zum Thema Signaturen und Berechtigungen

finden Sie im Administratorhandbuch im Kapitel Berechtigungen
verwalten.

BERICHT ERSTELLEN
Wie Sie einen Bericht erstellen erfahren Sie im Kapitel Berichte
erstellen.

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PLA 3.0 - Benutzerhandbuch

BERICHTE ERSTELLEN

KONZEPTE
PLA 3.0 erlaubt die Erstellung von Dokumenttypspezifischen Berich-
ten, die den Inhalt und das Ergebnis einer durchgeführten Berech-
nung wiedergeben. Ein Konfigurationsbericht, der die Konfiguration
der Datenbank zusammenfasst, ist ebenfalls verfügbar.

DOKUMENTTYPSPEZIFISCHE BERICHTE
Die Berichte in PLA 3.0 sind abhängig vom Dokumenttyp des Doku-
ments für den der Bericht erstellt wird.

P AKETE
Die Layouts der Berichte sind in Dokumentpaketen enthalten. Im
Paket Biologische Assays sind z.B. Layouts für die Berichte von
Quantitative Response Assay, Dichotomous Assay, Combination of
Assay Results, Equivalence Margin Development und Control Chart
Dokumente enthalten.

KONFIGURATIONSBERICHT
Der Konfigurationsbericht (Configuration Item List (CIL)) fasst die
Konfiguration der Datenbank zusammen und stellt sie als PDF-Datei
bereit.

PDF-VIEWER
Die Berichte werden als PDF Dateien erzeugt. Sie können die er-
zeugte PDF Datei mit dem in Ihrem Betriebssystem als Standardpro-
gramm für die Anzeige von PDF Dateien konfigurierten Programm
angesehen, auf dem in Ihrem Betriebssystem als Standarddrucker
definierten Drucker ausgedruckt oder auf Ihrer Festplatte abgespei-
chert werden.

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AKTIONEN
DOKUMENTTYPSPEZIFISCHEN BERICHT ERSTeLLEN

PLA 3.0 bietet die Möglichkeit Berichte über die Inhalte und Ergeb-
nisse von Dokumenten zu erstellen. Um einen Bericht für ein ein-
zelnes Dokument zu erstellen, öffnen Sie das Dokument und wählen
Sie die Aktion Bericht… aus um den Dialog zur Berichtserstellung zu
öffnen.

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PLA 3.0 - Benutzerhandbuch

Im Auswahldialog der Berichtserstellung können Sie eine Aktion

auswählen, die nach der Erzeugung des Berichts ausgeführt wird.

Anzeige: Der Bericht wird in Ihrem Standardprogramm für die An-

zeige von PDF Dateien geöffnet.

Drucken: Der Bericht wird auf Ihrem als Standard definierten Dru-
cker ausgedruckt.

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 Berichte erstellen

Speichern: Der Bericht wird im unter Zielordner angegebenen Ord-

ner abgespeichert.

Im Auswahldialog für Berichte können Sie außerdem aus den ver-

fügbaren Berichtslayouts des ausgewählten Dokumenttyps wählen.
Die Mehrfachselektion von Layouts ist möglich. Es wird dann jeweils
ein Bericht pro Layout für das ausgewählte Dokument erstellt.

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PLA 3.0 - Benutzerhandbuch

Wenn Sie die Berichtserstellung gestartet haben, informiert Sie der

Statusdialog über den Fortschritt der Erstellung.

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 Berichte erstellen

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

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PLA 3.0 - Benutzerhandbuch

M EHRERE B ERICHTE GLEICHZEITIG ERSTELLEN

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 Berichte erstellen

Das Kontextmenü, dass erscheint wenn Sie einen Rechtsklick auf ein
oder mehrere selektierte Dokumente machen, bietet Ihnen Zugriff
auf die Aktion Bericht erstellen. Dies erlaubt es Ihnen aus dem Na-
vigator heraus Berichte für mehrere Dokumente unterschiedlichen
Typs zu erstellen.

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PLA 3.0 - Benutzerhandbuch

Im Auswahldialog zur Berichtserstellung können Sie im Anschluss

das gewünschte Layout der Berichte pro Dokumenttyp auswählen.
Falls Ihre Selektion im Navigator Dokumente enthält für die kein
Layout verfügbar ist, wird das Dokument automatisch bei der Erstel-
lung der Berichte übersprungen.

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KONFIGURATIONSBERICHT ERSTELLEN
Der Konfigurationsbericht kann von jedem Benutzer erstellt wer-
den, der über die Berechtigung zum Bearbeiten der Datenbankricht-
linien verfügt. Im Administratorenhandbuch finden Sie Informatio-
nen zu den PLA 3.0 Berechtigungen. Der Konfigurationsbericht fasst
die Konfiguration der Datenbank aus Sicht des Berichterstellers
zusammen.

Der Dialog zur Erstellung von Konfigurationsberichten kann über das

System-Menü geöffnet werden, falls das Benutzerkonto über die
Berechtigung zum Bearbeiten der Datenbankrichtlinien verfügt.

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PLA 3.0 - Benutzerhandbuch

Im Dialog zur Erstellung von Konfigurationsberichten können Sie

einen Zielordner, in dem der Bericht erstellt wird, auswählen. Zu-
sätzlich haben Sie die Möglichkeit auszuwählen, welche Teilberichte
im Bericht enthalten sein sollen. Mehr Informationen zu den Teilbe-
richten finden Sie im Unterkapitel Teilberichte. Einige Standardin-
halte wie z.B. Informationen zum ausführenden Benutzer oder der
verwendeten Datenbank sind immer im Bericht enthalten.

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 Berichte erstellen

Nachdem Sie die gewünschten Teilberichte ausgewählt haben, star-

ten Sie die Erzeugung des Berichts mit Hilfe des Starten Knopfes.

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PLA 3.0 - Benutzerhandbuch

Der Statusdialog informiert Sie über den Fortschritt und aktuellen

Status der Berichterstellung. Abhängig von der Menge an Teilberich-
ten und der Größe der Datenbank kann die Erstellung des Konfigu-
rationsberichts einige Minuten in Anspruch nehmen.

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 Berichte erstellen

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern. Der Statusdialog erlaubt
es Ihnen auch den erzeugten Bericht direkt zu öffnen. Alternativ
können Sie die erstellte PDF Datei auch später ansehen und den
Dialog Schließen.

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PLA 3.0 - Benutzerhandbuch

T EILBERICHTE
Einige Teilberichte benötigen weitere Berechtigungen, wie z.B.
Konten verwalten oder Ordnereigenschaften ansehen.

L IZENZINFORMATIONEN
Keine weiteren Berechtigungen nötig.

Teilbericht: Informationen zu allen PLA 3 Lizenzen, die für den an-

gemeldeten Benutzer verfügbar sind.

U MGEBUNG
Keine weiteren Berechtigungen nötig.

Teilbericht: Systeminformationen, wie das PLA 3 Installationsver-

zeichnis und Microsoft Windows Umgebungsvariablen, die für den
angemeldeten Microsoft Windows Benutzer zugänglich sind.

D ATENBANKRICHTLINIEN
Benötigte Berechtigung: Datenbankrichtlinien bearbeiten

Teilbericht: Informationen über die Einstellungen der Datenbank-

richtlinien

K OMPONENTENPAKETE
Benötigte Berechtigung: Komponentenpakete ansehen

Teilbericht: Informationen über die in der Datenbank installierten

Komponentenpakete.

D OKUMENTBESCHRÄNKUNGEN
Benötigte Berechtigung: Ordnereigenschaften ansehen

Teilbericht: Informationen über die in den Ordnereigenschaften

hinterlegten Dokumentbeschränkungen. Nur Ordner, auf die der

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 Berichte erstellen

ausführende Benutzer die benötigten Berechtigungen hat, werden

im Bericht ausgegeben.

D OKUMENTSCHLÜSSELFORMATE
Benötige Berechtigung: Ordnereigenschaften ansehen

Teilbericht: Informationen über die in den Ordnereigenschaften

hinterlegten Dokumentschlüsselformate. Nur Ordner, auf die der
ausführende Benutzer die benötigten Berechtigungen hat, werden
im Bericht ausgegeben.

S ICHERHEITSKONTEXTE
Benötigte Berechtigung: Dokumente lesen oder Konten verwalten

Teilbericht: Informationen zu den Sicherheitskontexten, die über die

Ordnereigenschaften oder die Benutzerkontenverwaltung eingese-
hen werden können. Nur Ordner, auf die der ausführende Benutzer
die benötigten Berechtigungen hat, werden im Bericht ausgegeben.
Falls der Benutzer über die Berechtigung Konten verwalten verfügt,
werden alle Sicherheitskontexte ausgegeben.

P FADINFORMATIONEN VON S ICHERHEITSKONTEXTEN

Benötigte Berechtigung: Dokumente lesen oder Konten verwalten

Teilbericht: Fügt Pfadinformationen zum Teilbericht Sicherheitskon-

texte hinzu.

B ENUTZER
Benötigte Berechtigung: Konten verwalten

Teilbericht: Informationen zu allen Benutzern der Datenbank, in

Kombination mit den ihnen zugewiesenen Gruppen, Globalen Rol-
len und Dokumentrollen.

G RUPPEN

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PLA 3.0 - Benutzerhandbuch

Benötigte Berechtigung: Konten verwalten

Teilbericht: Informationen zu allen Gruppen der Datenbank, in

Kombination mit den ihnen zugewiesenen Mitgliedern, Globalen
Rollen und Dokumentrollen.

E FFEKTIVE B ERECHTIGUNGEN VON B ENUTZERN UND G RUPPEN

Benötigte Berechtigung: Konten verwalten

Teilbericht: Fügt die effektiven Berechtigungen zu den Globalen

Rollen und Dokumentrollen, die Benutzern oder Gruppen zugewie-
sen sind, hinzu.

G LOBALE R OLLEN
Benötigte Berechtigung: Konten verwalten

Teilbericht: Informationen zu allen verfügbaren Globalen Rollen der

Datenbank.

D OKUMENTROLLEN
Benötigte Berechtigung: Konten verwalten

Teilbericht: Informationen zu allen verfügbaren Dokumentrollen der

Datenbank.

D OKUMENTSTATISTIK
Benötigte Berechtigung: Dokumente lesen

Teilbericht: Eine Statistik über die in der Datenbank vorhandenen

Dokumente. Nur Dokumente auf die der ausführende Benutzer die
benötigten Berechtigungen hat werden in die Statistik aufgenom-
men.

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 Benutzerkonten und Systemeinstellungen

BENUTZERKONTEN UND SYSTEMEINSTELLUNGEN

KONZEPTE
In PLA 3.0 wird zwischen benutzerabhängigen und datenbankab-
hängigen Einstellungen unterschieden.

BENUTZERABHÄNGIGE EINSTELLUNGEN
Die unter dem Menüpunkt Einstellungen verfügbaren Optionen sind
abhängig von Ihrem Betriebssystem-Benutzerkonto. Es ist somit
möglich unterschiedliche PLA 3.0 Einstellungen auf einem PC vorzu-
nehmen, falls sich mehrere Benutzer mit unterschiedlichen Benut-
zerkonten am gleichen PC anmelden.

DATENBANKEINSTELLUNGEN
Die unter den Menüpunkten Datenbankrichtlinien, Datenbankein-
stellungen und Benutzerkontenverwaltung vorgenommenen Ein-
stellungen sind für alle Benutzerkonten einer Datenbank gültig.
Informationen zu den Datenbankeinstellungen finden Sie im Admi-
nistrator Handbuch.

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PLA 3.0 - Benutzerhandbuch

AKTIONEN
ALLGEMEINE EINSTELLUNGEN

Mit Hilfe der Aktion Einstellungen im System Menü können Sie die
Einstellungen Ihrer PLA 3.0 Installation anpassen.

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 Benutzerkonten und Systemeinstellungen

Die Einstellungen sind an Ihr Betriebssystem-Benutzerkonto gebun-

den.

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PLA 3.0 - Benutzerhandbuch

ANWENDUNGSPFADE

Die Standardpfade definieren welche Verzeichnisse bei Exportie-

renden und Importierenden Dialogen vorausgewählt werden. Mit
Hilfe der … Knöpfe können die Standardpfade für Importe, Exporte,
Ausgaben und Ressourcen geändert werden.

Der Standard Exportpfad definiert welches Verzeichnis als Stan-

dardverzeichnis für den Export von Daten genutzt werden soll. Dies
Betrifft unter Anderem die Vorauswahl des Verzeichnisses für den
Export von Dokumenten.

Der Standard Importpfad definiert welches Verzeichnis als Stan-

dardverzeichnis für den Import von Daten genutzt werden soll. Dies
Betrifft unter Anderem die Vorauswahl des Verzeichnisses für den
Import von Dokumenten oder das Akquirieren von Daten.

Der Standard Ausgabepfad definiert welches Verzeichnis als Stan-

dardverzeichnis für die Ausgabe von Daten genutzt werden soll.
Dies Betrifft unter Anderem die Vorauswahl des Verzeichnisses für
den Export des Ereignisprotokolls, oder das Speichern von Berich-
ten.

Der Standard Ressourcenpfad definiert welches Verzeichnis als

Standardverzeichnis für die von PLA 3.0 verwendeten Ressourcen
genutzt werden soll. Dies Betrifft unter Anderem die Vorauswahl
des Verzeichnisses für den Import von Benutzer-Avataren.

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SUCHE NACH AKTUALISIERUNGEN

Die Suche nach Aktualisierungen Einstellung erlaubt es Ihnen das

Abrufen von Neuigkeiten und Aktualisierungen von PLA 3.0 zu be-
stimmen.

Die Einstellung Deaktiviert verhindert das Prüfen auf Aktualisierun-

gen.

Die Einstellung Manuell erlaubt es aus dem PLA 3.0 Anmeldefenster

heraus eine Aktion zum Abrufen von Aktualisierungen auszuführen.

245
PLA 3.0 - Benutzerhandbuch

Die Einstellung Automatisch sorgt dafür dass beim Starten von PLA
3.0 auf Aktualisierungen geprüft wird.

PROXY EINSTELLUNGEN

PLA 3.0 erlaubt es einen Proxy Server für Verbindungen zum Inter-
net zu hinterlegen. Durch das Aktivieren der Checkbox aktivieren Sie
die Eingabefelder für die Adresse und den Port des Proxy Servers.
Der Test Knopf prüft ob eine Verbindung zum angegebenen Proxy
Server hergestellt werden kann.

NAVIGATOR-AKTUALISIERUNG

Die Einstellung für die Automatische Aktualisierung des Navigators

erlaubt es Ihnen das Aktualisierungsverhalten des Navigators zu
bestimmen. Sie können zwischen einem Aktualisierungsintervall von
10 Sekunden, 30 Sekunden, 1 Minute oder 5 Minuten wählen. Au-
ßerdem kann die automatische Aktualisierung vollständig deakti-
viert werden.

246
 Benutzerkonten und Systemeinstellungen

EINSTELLUNGEN FÜR AUFGABEN

PLA 3.0 erlaubt es das Verhalten von Aufgaben-Dialogen anzupas-

sen.

247
PLA 3.0 - Benutzerhandbuch

Die Option das Dialogfenster nach Beendigung der Aufgabe schlie-

ßen, schließt das Dialogfenster automatisch wenn die Aufgabe er-
folgreich durchgeführt wurde. Falls bei der Durchführung ein Fehler
auftritt wird das Dialogfenster nicht automatisch geschlossen.

BENUTZERKONTO BEARBEITEN

Mit Hilfe der Aktion Mein Benutzerkonto im System Menü, haben

Sie die Möglichkeit die zu Ihrem Benutzerkonto hinterlegten Infor-
mationen und Ihren Avatar anzupassen. Ihr Avatar wird unter Ande-
rem im Dashboard von Dokumenten neben von Ihnen durchgeführ-
ten Aktionen angezeigt.

248
 Benutzerkonten und Systemeinstellungen

Sie können Ihren Avatar durch das Betätigen des Ändern Knopfes
unterhalb des Avatar-Bildes ändern.

249
PLA 3.0 - Benutzerhandbuch

Im Auswahldialog für Avatare können Sie aus den von PLA 3.0 mit-
gelieferten Avataren wählen, oder durch das Betätigen des Impor-
tieren Knopfes ein eigenes Avatar Bild im JPEG oder PNG Format
hinzufügen und auswählen.

250
 Benutzerkonten und Systemeinstellungen

KENNWORT ÄNDERN

Die Kennwort ändern Aktion im System Menü von PLA 3.0 erlaubt
es Ihnen, Ihr Benutzerkennwort für die Anmeldung an der aktuell
verwendeten Datenbank zu ändern.

251
PLA 3.0 - Benutzerhandbuch

Im Dialog zur Änderung Ihres Benutzerkennwortes müssen Sie Ihr

aktuelles Kennwort und Ihr gewünschtes neues Kennwort eingeben.
Im Feld Kennwort bestätigen müssen Sie Ihr gewünschtes neues
Kennwort erneut eingeben. Das gewählte Kennwort muss allen für
die Datenbank geltenden Kennwortrichtlinien entsprechen. Falls Ihr
Kennwort nicht den Richtlinien entspricht werden Sie darauf hinge-
wiesen. Sobald Sie den Dialog mit OK bestätigen ist Ihr neues Kenn-
wort gültig.

OBERFLÄCHE ZURÜCKSETZEN

252
 Benutzerkonten und Systemeinstellungen

Falls Sie Probleme mit der PLA 3.0 Oberfläche feststellen, können
Sie die Oberfläche mit Hilfe der Benutzeroberfläche zurücksetzten
Aktion im Hilfe Menü zurück auf den Auslieferungsstand von PLA
3.0 setzen.

253
PLA 3.0 - Benutzerhandbuch

SYSTEMQUALIFIZIERUNG

KONZEPT
PLA 3.0 unterstützt automatisierte Installationsqualifizierungen (IQ),
Funktionsqualifizierungen (OQ) und auch die Qualifikation mit eige-
nen Daten (Leistungsqualifizierung (PQ)).

INSTALLATIONSQUALIFIZIERUNG (IQ)
PLA 3.0 verfügt über eine Funktion für die Installationsqualifizierung
(IQ). Der Prozess läuft vollautomatisch ab und erzeugt einen Bericht
über die Ausführung und, bei erfolgreicher Ausführung, ein Zertifi-
kat.

Mit Hilfe der einfach zu bedienende Funktion können Sie überprü-

fen, ob Ihr installiertes PLA 3.0 sich in einem konsistenten Zustand
befindet. Tritt bei der Überprüfung ein Fehler auf, werden Sie durch
die Installationsqualifizierung darauf hingewiesen.

FUNKTIONSQUALIFIZIERUNG (OQ)
PLA 3.0 verfügt über eine Funktion für die Funktionsqualifizierung
(OQ). Für die Funktionsqualifizierung wird die PLA 3.0 Validierungs-
lizenz benötigt.

Der Prozess läuft vollautomatisch ab und erzeugt einen Bericht über

die Ausführung und, bei erfolgreicher Ausführung, ein Zertifikat.

Mit Hilfe der automatisierten OQ können die von PLA 3.0 durchge-
führten Berechnungen unter Verwendung von durch die Hersteller-
seite verifizierten Assays an Ihrem Arbeitsplatz verifiziert werden.

254
 Systemqualifizierung

LEISTUNGSQUALIFIZIERUNG (PQ)
PLA 3.0 verfügt über eine Funktion für die Leistungsqualifizierung
(OQ). Für die Leistungsqualifizierung wird die PLA 3.0 Validierungsli-
zenz benötigt.

Die Leistungsqualifizierung kann mit eigenen Daten erstellt werden.

Der Prozess läuft vollautomatisch ab und erzeugt einen Bericht über
die Ausführung und, bei erfolgreicher Ausführung, ein Zertifikat.

Mit Hilfe der automatisierten PQ können Sie die vom PLA 3.0 durch-
geführten Berechnungen unter Verwendung Ihrer Assays an Ihrem
Arbeitsplatz verifizieren.

AUFGABEN
INSTALLATIONSQUALIFIZIERUNG (IQ)

Sie können die Installationsqualifizierung mit Hilfe des Validierung

Menüs von PLA 3.0 aufrufen.

255
PLA 3.0 - Benutzerhandbuch

I NSTALLATIONSQUALIFIZIERUNG (IQ) DURCHFÜHREN

Im Einstellungsdialog der Installationsqualifizierung können Sie mit

Hilfe des … Knopfes einen Pfad angeben an dem der nach Abschluss
der Installationsqualifizierung erzeugte Bericht abgelegt werden
soll. Wenn Sie den gewünschten Pfad gewählt haben beginnen Sie
die Installationsqualifizierung durch den Starten Knopf. Die Installa-
tionsqualifizierung wird mehrere Minuten in Anspruch nehmen.

256
 Systemqualifizierung

Der Statusdialog informiert Sie über den Fortschritt und aktuellen

Status der Installationsqualifizierung. Sie können die Installations-
qualifizierung jederzeit mit Hilfe des Abbrechen Knopfes beenden.
Die Installationsqualifizierung wird dann als nicht erfolgreich einge-
stuft.

257
PLA 3.0 - Benutzerhandbuch

Falls während der Installationsqualifizierungen Abweichungen vom

definierten Zustand Ihrer PLA 3.0 Installation festgestellt werden,
wird Ihre Installation als fehlerhaft eingestuft. Bei einer fehlgeschla-
genen Installationsqualifizierung wird ein Bericht, aber kein Zertifi-
kat erstellt.

258
 Systemqualifizierung

Der Statusdialog erlaubt es Ihnen den erzeugten Bericht direkt zu

öffnen. Alternativ können Sie die erstellte PDF Datei auch später
ansehen und den Dialog Schließen. Weitere Information zum Be-
richt finden Sie im Unterkapitel Bericht.

B ERICHT

259
PLA 3.0 - Benutzerhandbuch

Der Bericht einer fehlgeschlagenen Installationsqualifizierung weißt

Sie auf der ersten Seite auf das Ergebnis der Qualifizierung hin. Auf
den nachfolgenden Seiten können Sie im Detail sehen welche Da-
teien Ihrer Installation die Prüfung nicht bestanden haben.

260
 Systemqualifizierung

Z ERTIFIKAT
Bei einer erfolgreichen Installationsqualifizierung wird ein Zertifikat
erstellt. Das Zertifikat befindet sich auf Seite 1 des Berichts.

P ROTOKOLL

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern.

261
PLA 3.0 - Benutzerhandbuch

262
 Systemqualifizierung

FUNKTIONSQUALIFIZIERUNG (OQ)

Wenn Sie über eine Validierungslizenz verfügen, könne Sie die Funk-
tionsqualifizierung mit Hilfe des Validierung Menüs von PLA 3.0
aufrufen.

Weitere Informationen zur Lizenzierung von PLA 3.0 finden Sie im

Quick Start Guide oder im Installationshandbuch.

263
PLA 3.0 - Benutzerhandbuch

F UNKTIONSQUALIFIZIERUNG (OQ) DURCHFÜHREN

Im Einstellungsdialog der Funktionsqualifizierung können Sie aus

dem Drop-Down Menü eine OQ Quelldatei auswählen und mit Hilfe
des … Knopfes einen Pfad angeben an dem der nach Abschluss der
Funktionsqualifizierung erzeugte Bericht abgelegt werden soll.
Wenn Sie eine OQ Quelldatei ausgewählt und den gewünschten
Pfad gewählt haben beginnen Sie die Funktionsqualifizierung durch

264
 Systemqualifizierung

den Starten Knopf. Die Funktionsqualifizierung kann mehrere Minu-

ten in Anspruch nehmen.

Der Statusdialog informiert Sie über den Fortschritt und aktuellen

Status der Funktionsqualifizierung. Sie können die Funktionsqualifi-
zierung jederzeit mit Hilfe des Abbrechen Knopfes beenden.

265
PLA 3.0 - Benutzerhandbuch

Wenn der Vorgang abgeschlossen ist, können Sie mit dem Signatur
anzeigen Knopf das Zertifikat ansehen, das genutzt wurde um das
Dokument digital zu signieren.

B ERICHT
Für jede durchgeführte Funktionsqualifizierung wird ein Bericht
erstellt. Der Bericht befindet sich in dem während der Funktions-
qualifizierung angegebenen Ordner für die Protokolldatei.

Z ERTIFIKAT
Für jede durchgeführte Funktionsqualifizierung, die keine Abwei-
chungen feststellt, wird ein Zertifikat erstellt. Das Zertifikat befindet
sich auf Seite eins des durch die Funktionsqualifizierung erzeugten
Berichts.

266
Systemqualifizierung

267
PLA 3.0 - Benutzerhandbuch

Bei einer Funktionsqualifizierung, die Abweichungen feststellt, wird

ein Bericht, aber kein Zertifikat erstellt.

268
 Systemqualifizierung

P ROTOKOLL

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern. Der Statusdialog erlaubt
es Ihnen auch den erzeugten Bericht direkt zu öffnen. Alternativ
können Sie die erstellte PDF Datei auch später ansehen und den
Dialog Schließen.

269
PLA 3.0 - Benutzerhandbuch

270
 Systemqualifizierung

LEISTUNGSQUALIFIZIERUNG (PQ)

Wenn Sie über eine aktive Validierungslizenz verfügen, können Sie

die Leistungsqualifizierung mit Hilfe des Validierung Menüs von PLA
3.0 aufrufen.

Weitere Informationen zur Lizenzierung von PLA 3.0 finden Sie im

Quick Start Guide oder im Installationshandbuch.

PQ-D EFINITIONEN ERSTELLEN

271
PLA 3.0 - Benutzerhandbuch

Um eine PQ-Definition zu erstellen benötigen Sie ein PLA 3.0 Assay

mit von Ihnen verifizierten und von PLA 3.0 berechneten Inhalten.

Öffnen Sie das Assay im Editor von PLA 3.0 und wählen Sie im An-
schluss die Aktion Als PQ-Definition speichern im Validierung Menü
aus. Eine PQ-Definition des Dokuments wird erstellt, im gleichen
Ordner wie das Assay aus dem es erzeugt wurde abgespeichert und
im Editor geöffnet.

272
 Systemqualifizierung

Um die PQ-Definition exportieren und für die Leistungsqualifizie-

rung nutzen zu können, müssen Sie die PQ-Definition erneut mit
PLA 3.0 berechnen. Die Ergebnisse der Berechnung müssen mit den
Ergebnissen des ursprünglichen Assays übereinstimmen.

273
PLA 3.0 - Benutzerhandbuch

PQ-D EFINITIONEN EXPORTIEREN

Um eine oder mehrere PQ-Definitionen für eine Leistungsqualifizie-

rung zu exportieren müssen Sie den Ordner in dem sich die PQ-
Definitionen befinden im Navigator selektieren und danach im Vali-
dierung Menü die Aktion PQ-Definition exportieren auswählen.

274
 Systemqualifizierung

Im Exportdialog können Sie eine Zieldatei für den Export auswählen

und eine Beschreibung für das PQ-Paket hinterlegen.

275
PLA 3.0 - Benutzerhandbuch

Der Statusdialog des Exportdialoges informiert Sie über den Fort-

schritt des Exports.

L EISTUNGSQUALIFIZIERUNG (PQ) DURCHFÜHREN

276
 Systemqualifizierung

Um eine Leistungsqualifizierung (PQ) durchzuführen benötigen Sie

ein PQ-Paket. Wenn Sie über eine PQ-Paketdatei verfügen können
Sie die Leistungsqualifizierung durchführen indem Sie im Validie-
rung Menü die Aktion Leistungsqualifizierung (PQ) aufrufen.

Im Leistungsqualifizierungsdialog können Sie eine PQ-Paketdatei als

Quelldatei und einen Zielordner für die Protokolldatei auswählen.

277
PLA 3.0 - Benutzerhandbuch

Wählen Sie mit Hilfe des Auswahldialoges eine PQ-Paketdatei als

Quelldatei aus. Und passen Sie bei Bedarf den Zielordner und Na-
men für die Protokolldatei an.

278
 Systemqualifizierung

Wenn Sie eine Quelldatei ausgewählt haben, wird die zum PQ-Paket
gehörende Beschreibung im Dialog angezeigt und Sie können die
Leistungsqualifizierung mit dem Starten Knopf beginnen.

279
PLA 3.0 - Benutzerhandbuch

Der Statusdialog informiert Sie über den Fortschritt der Leistungs-

qualifizierung. Wenn die Leistungsqualifizierung abgeschlossen ist
können Sie den generierten Bericht mit dem Protokoll anzeigen
Knopf öffnen. Alternativ können Sie den Dialog auch schließen und
das erstellte Protokoll im PDF Format im ausgewählten Zielordner
öffnen. Der Signatur anzeigen Knopf ermöglicht es Ihnen, das Zerti-
fikat, welches für die digitale Signatur des Dokuments verwendet
wurde, anzusehen.

280
 Systemqualifizierung

Falls das PQ-Paket Dokumente eines veralteten Dokumenttyps ent-

hält, wird die Struktur des Dokuments aktualisiert, bevor die Leis-
tungsqualifizierung ausgeführt wird.

281
PLA 3.0 - Benutzerhandbuch

B ERICHT

Für jede durchgeführte Leistungsqualifizierung wird ein Bericht

erstellt. Der Bericht befindet sich in dem während der Leistungsqua-
lifizierung angegebenen Ordner für die Protokolldatei.

Z ERTIFIKAT
Für jede durchgeführte Leistungsqualifizierung, die keine Abwei-
chungen feststellt, wird ein Zertifikat erstellt. Das Zertifikat befindet

282
 Systemqualifizierung

sich auf Seite eins des durch die Funktionsqualifizierung erzeugten

Berichts.

283
PLA 3.0 - Benutzerhandbuch

Bei einer Leistungsqualifizierung, die Abweichungen feststellt, wird

ein Bericht, aber kein Zertifikat erstellt.

P ROTOKOLL

284
 Systemqualifizierung

Nach Abschluss des Vorgangs haben Sie die Möglichkeit sich ein
Protokoll, das alle Informationen aus dem Statusdialog enthält,
anzeigen zu lassen und dieses zu speichern. Der Statusdialog erlaubt
es Ihnen auch den erzeugten Bericht direkt zu öffnen. Alternativ
können Sie die erstellte PDF Datei auch später ansehen und den
Dialog Schließen.

285
PLA 3.0 - Benutzerhandbuch

286
 Systemqualifizierung

Q UALIFIKATION WEITERER S YSTEME

Wenn Sie bereits über PQ-Paketdateien verfügen können Sie die
PQ-Paketdateien auf andere Computer mit PLA 3.0 Installationen
kopieren und dort für die Leistungsqualifizierung der Installationen
verwenden.

Falls Sie noch nicht über PQ-Paketdateien verfügen müssen Sie

zuerst PQ-Definitionen erstellen, die PQ-Definitionen exportieren
und die so generierten PQ-Paketdateien auf andere Computer mit
PLA 3.0 Installationen kopieren.

287
DOCUMENT PACKAGE: BIOLOGICAL ASSAYS
Reference Manual for Biological Assay Package 18
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

OVERVIEW
The Biological Assay Document Package is the successor of the Biological Assay functionality
of the PLA 2.x system. The document package consists of several document types:

They can be divided in assay documents, advanced calculations and supporting document
types.

Assay Documents
Quantitative Response Assay This document type represents all types of inde-
pendent biological assays based on quantitative
response. These are parallel-line assays, parallel-
logistic assays (full curve fits), and slope-ratio as-
says.
Dichotomous Assays This document type represents dichotomous as-
says. They are also called binary assays or quantal
response assays. The result of this document type is
the calculated potency of the test sample based on
binary input value (e.g. a number of specimen
shows out of a total number shows a given re-
sponse).
Advanced Calculations
Combination of Assay Results The combination of assay results can be performed
in several ways. The Combination of Assay Results
document performs several kinds of combination
calculations.
Equivalence Margin Devel- The development of equivalence margins is a chal-
opment lenge. The Equivalence Margin Development docu-
ment calculates candidates for equivalence margins
from existing assays. The candidates can be used
for the test systems of the quantitative response
assay.
Supporting document types:
Basic Bioassay Protocol This document steers a standard calculation of re-
portable values from independent assays.
Control Chart The control chart document allows the trending of
different parameters.

UPDATES OF THE BIOLOGICAL ASSAY PACKAGE

Stegmann Systems is able to provide updates of the Biological Assay Package independent of
the platform PLA 3.0.3. It is recommended to check the Website www.bioassay.de periodi-
cally for updates and corrections to this package.

2
 Overview

HOW TO USE THIS MANUAL

This manual is a reference manual for a document package. The structure of this document
is as follows:

Description of the different document types

• Description of the document

• Literature References (optional)
• Document concepts (optional)
• Available Reports
• Available Tasks

Reference Information

• Document Outlines – describe the overall structure of the documents

• Document Structure – overall list of all document elements
• Element Reference – description of every field
• Aggregation Opportunities – which data could be aggregated from other documents
• Digests – data that can be used by other documents

3
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

TABLE OF CONTENTS
Overview ................................................................................................................................................................. 2
Updates of the Biological Assay Package ............................................................................................................ 2
How to use this Manual ...................................................................................................................................... 3
Table of Contents .................................................................................................................................................... 4
Welcome ................................................................................................................................................................. 8
Quantitative Response Assays ................................................................................................................................ 9
Description .......................................................................................................................................................... 9
Parallel-Line Assay ........................................................................................................................................... 9
Parallel-Logistic Assay ..................................................................................................................................... 9
Slope-Ratio Assay ............................................................................................................................................ 9
Assay Elements ............................................................................................................................................. 10
Calculation Overview .................................................................................................................................... 11
Response Adjustment ............................................................................................................................... 11
Data Transformation ................................................................................................................................. 11
Outlier Detection....................................................................................................................................... 11
Regression Analysis ................................................................................................................................... 12
Multiplex Assays .................................................................................................................................... 12
Include Control Line .............................................................................................................................. 12
Analysis of Variance ...................................................................................................................................... 12
Potency Calculation....................................................................................................................................... 12
Test System ................................................................................................................................................... 14
Test System Logic .................................................................................................................................. 14
Test Level........................................................................................................................................... 14
Test Severity ...................................................................................................................................... 14
Test Scope ......................................................................................................................................... 14
Test of Similarity (Equivalence Tests) .................................................................................................... 15
F-Tests ................................................................................................................................................... 15
Additional Tests ..................................................................................................................................... 15
Configuration Optimization........................................................................................................................... 15
Concepts............................................................................................................................................................ 16
Preparation Scheme ...................................................................................................................................... 16
Data Selection Schemes ................................................................................................................................ 17
Suitability Tests ............................................................................................................................................. 17
Observation Group ID ................................................................................................................................... 17
Literature .......................................................................................................................................................... 17
Reports .............................................................................................................................................................. 18

4
 Table of Contents

Tasks .................................................................................................................................................................. 18
Document Structure .......................................................................................................................................... 18
Document Outline ......................................................................................................................................... 18
Document Structure ...................................................................................................................................... 19
Document Element Reference ...................................................................................................................... 28
Aggregation Opportunities.......................................................................................................................... 149
Digest Results .............................................................................................................................................. 149
Dichotomous Assays ........................................................................................................................................... 155
Description ...................................................................................................................................................... 155
Assay Elements ........................................................................................................................................... 155
Calculation Overview .................................................................................................................................. 156
Regression Analysis ................................................................................................................................. 156
Multiplex Assays .................................................................................................................................. 156
Analysis of Variance .................................................................................................................................... 157
Potency Calculation..................................................................................................................................... 157
Test System ................................................................................................................................................. 158
Test System Logic ................................................................................................................................ 158
Test Level......................................................................................................................................... 158
Test Severity .................................................................................................................................... 158
Test Scope ....................................................................................................................................... 158
Chi-Square-Tests ................................................................................................................................. 159
Additional Tests ................................................................................................................................... 159
Concepts.......................................................................................................................................................... 159
Preparation Scheme .................................................................................................................................... 159
Suitability Tests ........................................................................................................................................... 160
Literature ........................................................................................................................................................ 160
Reports ............................................................................................................................................................ 160
Tasks ................................................................................................................................................................ 160
Document Structure ........................................................................................................................................ 160
Document Outline ....................................................................................................................................... 160
Document Structure .................................................................................................................................... 161
Document Element Reference .................................................................................................................... 166
Aggregation Opportunities.......................................................................................................................... 216
Digest Results .............................................................................................................................................. 216
Basic Bioassay Protocol ....................................................................................................................................... 222
Description ...................................................................................................................................................... 222
General Workflow ....................................................................................................................................... 222

5
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

Templates .................................................................................................................................................... 222

Execution Modes ......................................................................................................................................... 223
Specifying Combination Calculations .......................................................................................................... 224
Structure of the Protocol ............................................................................................................................ 225
Reports ............................................................................................................................................................ 226
Tasks ................................................................................................................................................................ 226
Document Structure ........................................................................................................................................ 226
Document Structure .................................................................................................................................... 226
Document Element Reference .................................................................................................................... 230
Aggregation Opportunities.......................................................................................................................... 266
Digest Results .............................................................................................................................................. 266
Equivalence Margin Development ...................................................................................................................... 267
Description ...................................................................................................................................................... 267
Literature ........................................................................................................................................................ 267
Reports ............................................................................................................................................................ 267
Tasks ................................................................................................................................................................ 267
Document Structure ........................................................................................................................................ 267
Document Structure .................................................................................................................................... 267
Document Element Reference .................................................................................................................... 269
Aggregation Opportunities.......................................................................................................................... 283
Digest Results .............................................................................................................................................. 283
Combination of Assay Results ............................................................................................................................. 284
Description ...................................................................................................................................................... 284
Data Source ................................................................................................................................................. 284
Setting up Data Aggregation ....................................................................................................................... 284
Test System ................................................................................................................................................. 285
Concepts.......................................................................................................................................................... 285
Combination Groups ................................................................................................................................... 285
Literature ........................................................................................................................................................ 286
Reports ............................................................................................................................................................ 286
Tasks ................................................................................................................................................................ 286
Document Structure ........................................................................................................................................ 286
Document Structure .................................................................................................................................... 286
Document Element Reference .................................................................................................................... 289
Aggregation Opportunities.......................................................................................................................... 317
Digest Results .............................................................................................................................................. 317
Control Chart ....................................................................................................................................................... 319

6
 Table of Contents

Description ...................................................................................................................................................... 319

Predefined Control Charts........................................................................................................................... 319
User Defined Control Charts ....................................................................................................................... 320
Create a new Control Chart (Without a Template) ................................................................................. 320
Define Observation Source ..................................................................................................................... 320
Define the Data Columns ............................................................................................................................ 321
Define the Charting Options ................................................................................................................... 322
Control Limit Definitions ......................................................................................................................... 322
Setting up Data Aggregation ....................................................................................................................... 322
Reports ............................................................................................................................................................ 323
Tasks ................................................................................................................................................................ 323
Document Structure ........................................................................................................................................ 323
Document Structure .................................................................................................................................... 323
Document Element Reference .................................................................................................................... 324
Aggregation Opportunities.......................................................................................................................... 331
Digest Results .............................................................................................................................................. 331

7
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

WELCOME
Welcome to the reference documentation for the biological assays document package. This handbook is in-
tended for users and functional administrators of PLA 3.0.

The reference documentation for biological assays describes all aspects of the document types Quantitative
Response Assay, Dichotomous Assay, Basic Bioassay Protocol, Equivalence Margin Development, Combination
of Assay Results and Control Chart.

8
 Quantitative Response Assays

QUANTITATIVE RESPONSE ASSAYS

DESCRIPTION
Purpose of the Quantitative Response Assay document type is the calculation of relative po-
tencies. If information about stock solution or the raw material is given, the document type
performs a backfit calculation for absolute potencies.

A Quantitative Response Assay is a dilution assay containing at least one reference and one
test or control sample to calculate the potency. An assay consists of different elements with
measurement data at different concentrations (or dilutions) of the active ingredient. De-
pending on the type of the assay, different formulas are used to calculate the relative poten-
cy of the test elements compared to the standard.

Supported assay types are:

• Parallel-Line Assay
• Parallel-Logistic Assay (Full Curve Fit)
• Slope-Ratio Assay

Note: Due to the different nature of the response values dichotomous assays (quantal re-
sponse assays, binary assays) are implemented separately.

PARALLEL-LINE ASSAY
Parallel-Line Assay is a robust method for calculating the relative potency of the test sample
compared to a standard sample based on the linear portion of the dose-response curve. The
dose axis of the assay is logarithmic. The relative potency can be calculated from the shift of
the lines. The system supports the selection and the automatic optimization of the linear
portion of the curve (configuration optimization).

PARALLEL-LOGISTIC A SSAY
Parallel-Logistic Assays or full curve fits focus the whole sigmoidal dose-response correlation
to calculate the relative potency. The typical method is the 4-parameter logistic fit function.
Its four parameters describe the lower and upper asymptote as well as the slope at the cen-
ter point (EC50). Variants are the five parameter fit function, which adds an asymmetry pa-
rameter g and the three parameter fit function which is structural identical to the 4-
parameter logistic function but fixes either the lower or the upper asymptote to a fixed val-
ue or to the mean of a control line.

SLOPE-RATIO ASSAY
Slope-Ratio Assays are carried out with an untransformed dose axis. The potency is calculat-
ed from the ratio of the slopes of the linear regressions. This assay type is usually carried out
with very small doses.

9
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

ASSAY ELEMENTS
Assay Elements are the building block for an assay.

The assay elements are

Standard Sample The reference standard of the assay. Relative potency is calculated
against this element. Each assay document has exactly one Standard
Sample. The Standard Sample is a series of measurements at different
dilution or concentration levels.

Exactly 1 Standard Element is required for each assay.

Test Sample The calculation of the potency of the test sample is the aim of the doc-
ument. The Test Sample is a series of measurements at different dilu-
tion or concentration levels.

The element is optional but at least one test sample or control sample
is required. Any number of elements is supported.

Control Sample A control sample is a “well-known” test sample. Usually it is used as

the basis of an assay acceptance test. The Control Sample is a series of
measurements at different dilution or concentration levels.

The element is optional but at least one test sample or control sample
is required. Any number of elements is supported.

Control Line A control line is an undiluted control value displayed usually as line in
the chart of an assay. It can be used for response adjustment (e.g.
blank deduction) or as the basis for restrictions of the asymptote in full
curve fits (3-parameter fit)

The element is optional. Any number of elements is supported.

10
 Quantitative Response Assays

CALCULATION OVERVIEW
The calculation is carried out following a number of steps.

The calculation can be started after the assay has been set up. As a result the assay docu-
ment will contain the results of the calculation.

R ESPONSE A DJUSTMENT
Response Adjustment is the first step. It is usually not required. The step allows the deduc-
tion of a specific value from the response values. The correction value can be entered manu-
ally or it can be derived from the mean of a selected control line.

D ATA T RANSFORMATION
Response Transformation is an optional step to address heteroscedascity issues. If the re-
sponse data is not homoscedastic and follows a trend either logarithmic, square or square
root transformations may be suitable to address this behavior.

O UTLIER D ETECTION
Detection of statistical outliers is fully optional. If activated the system supports four differ-
ent tests for statistical outliers:

• Treatment Based Outlier Detection

o Dixon Test for Data Outliers
o Grubb’s Test
o Standard Deviation Test
• Model Based Outlier Detection
o Studentized Residuals Test

All outlier tests can be executed iteratively and their sensitivity can be adjusted. Statistical
outliers are flagged and removed from further analysis. Some suitability tests are available to
ensure the validity of the results.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

R EGRESSION A NALYSIS
The regression analysis is carried out be running two regressions. In the full model all regres-
sion parameters are defined per assay element. The system is able to find the best fit for the
system. The restricted model restricts the regression model to describe only the difference
of the elements. The latter analysis is used to carry out the potency calculation. The full
model or the difference between the full and the restricted model is used to describe the
suitability of the system in the later step of suitability testing.

The following regression models are supported:

• Parallel-Line Assay (Linear Parallel Line)

• 4-Parameter Logistic Fit
• 5-Parameter Logistic Fit
• 3-Parameter Logistic Fit (fixed upper asymptote)
• 3-Parameter Logistic Fit (fixed lower asymptote)
• Slope Ratio Assay

M ULTIPLEX A SSAYS
As a standard all assay regressions are carried out one-by-one, which means that all regres-
sion is done pair-wise. In a multiplex assay all regressions are carried out at once in a single
model. This type of assay can be used to address incomplete data in single assay elements.

Note: In combination with the configuration optimizer multiplex assays create a huge num-
ber of configurations and your system may not be able to carry them out in a timely manner.

I NCLUDE C ONTROL L INE

Control Lines can be included into the regression model in 4-parameter fit functions and in
the slope ratio model. If the control line is included an additional semi-restricted regression
is carried out. This leads to an additional term in the analysis of variance.

ANALYSIS OF VARIANCE
The variance analysis describes the regression system. The influence of different compo-
nents is being used to get a good overall description of the system. The system supports two
different splitting of the components. In the residual error ANOVA the lack of fit of the sys-
tem is considered as part of the error term of the ANOVA. In the pure error ANOVA the lack
of fit is considered to be an independent part of the description. The pure error ANOVA can
only be carried out with at least two replicates per dose steps. The choice of the ANOVA
model has an influence on the width of the confidence intervals for multiple parameters.

POTENCY CALCULATION
The primary target of the method is the calculation of a relative potency between the test
sample and the standard sample. However, the system can carry out various backfit calcula-
tions if the absolute potencies of the stock solution and or the raw material are given. The
system calculates the relative potency and all additional absolute potencies.

12
 Quantitative Response Assays

The dilution model follows this path:

From a raw material the concentration of a stock solution can be calculated. From the stock
solution the concentration of the measurement doses can be calculated.

Since the definition of the stock solution and the raw material is optional the system can
carry out different types of backfit calculations depending on the definitions.

Defined Potency Infor- Calculated Potency Information

mation
Standard Test Relative Po-
S1 S2 T1 T2 tency Absolute Potency

X No
X
X (*)
Always
X X
calculated
X X Stock Solution
X (*)
X X
X X Raw Material
(*) When no stock solution potency of the test is given, it is assumed to be 1.

Note: For the correct calculation of the stock solution the Dilution Factors for all assay ele-
ments have to be defined.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

TEST SYSTEM
A major advantage of assay based on curve similarity is the option to prove the validity of
the calculation each time the calculation is performed.

As a rule of thumb at least one parallelism test or one test of common intercept should be
defined for a valid result.

T EST S YSTEM L OGIC

The test system of PLA 3.0 allows sophisticated test setups. Three different aspects are rele-
vant to setup the test system logic:

• Test Level
• Test Severity
• Test Scope

TEST LEVEL
The test system distinguishes assay suitability tests and sample suitability tests. If an assay
suitability test fails this has an impact on all assay elements. E.g. you can setup an assay suit-
ability test for a (well-known) control sample. If this test fails, all results for all assay ele-
ments will fail. A sample suitability test only fails the corresponding sample.

TEST SEVERITY
Three different severity levels allow flexible reactions of the system.

Highest Test Severity of a Impact on assay result when test fails

Failed Test
(No Test Failed) None.
Information None, but an information message is dis-
played
Warning FAILED, but potency will be calculat-
ed/reported
Reject FAILED, no potency is calculated/reported

TEST SCOPE
Test can have different scopes. The test scopes define whether a test is relevant in a specific
scenario.

Available Scopes:

• All Assay Elements: The test is performed for every element.

• Standard only: Test is performed only for standard elements. Note: Only tests for sin-
gle assay elements are being calculated (e.g. test for parallelism would be ignored).
• Tests Samples only: The test is performed with every test sample but not with other
elements.
• Control Samples only: The test is performed with every control sample but not with
other elements.

14
 Quantitative Response Assays

• Control Lines only: The test is performed with every control line but not with other
elements. Note: only tests available for control lines are being calculated. Others are
ignored.

T EST OF S IMILARITY (E QUIVALENCE T ESTS )

The system has a set of 22 different equivalence tests available. The tests can be grouped
into:

• Difference of parameter estimates

• Ratios of parameter estimates
• Scaled ratios of parameter estimates
• Single parameter estimates

F-T ESTS
Different F-Tests are available to the system:

• Significance of Regression
• Significance of Non-Parallelism
• Significance of Non-Linearity
• Significance of Non-Similarity (for slope-ratio model)
• Significance of the Slope
• Significance of Quadratic Coefficient

A DDITIONAL T ESTS
A range of additional tests is also available:

• Sum of Squares of the Non-Linearity

• Maximum number of outliers
• Response Value Range
• Relative Potency Value
• Relative Potency Confidence Interval
• Relative Potency Range (%)
• Minimal R²
• Weight W

CONFIGURATION OPTIMIZATION
The configuration optimizer allows an automatic detection of the linear portion of the dose
response curve. If activated PLA 3.0 calculates all possible configurations of dilution steps
according to the optimization settings.

Note: improper setup can lead to an extremely high number of configurations to be calculat-
ed. The system may not be able to calculate all configurations in a timely manner.

Note: The settings have changed since PLA 2.x. Several combinations available in PLA 2.1 are
now available only by splitting the assay in several assay documents.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

The following parameters define the configuration optimization:

Strategy can be set to maximum range or best range. Depending on this setting PLA 3.0 tries
to find the maximum range where all suitability tests pass or the best range based on the
regression R2 value.

Range defines whether the allocation considers all points or only a subset.

IdenticalRange: Only configurations with identical steps are selected.

IdenticalTreatmentNumber: Only configurations with identical treatment numbers are con-

sidered.

Include 50% Response: Only configurations with the 50% value included are considered.

Minimal number of steps: At least these step numbers are being considered.

Exact number of steps: Only configurations with this step number are considered.

All settings can be setup for every assay element.

CONCEPTS
A few technical concepts are required to understand the structure of a Quantitative Re-
sponse Document.

PREPARATION SCHEME
In most assays all or at least several assay elements are prepared in the same way. This
means the number of dilution steps, the number of replicates etc. is identical. The prepara-
tion schemes simplify identical definitions. Each assay element must be linked to a prepara-
tion scheme. At least one preparation scheme must exist in the document.

E.g. When you setup a 3x3 parallel line assay, all assay elements have 3 dose steps and 3
replicates. You can set up a named preparation scheme called “3x3 preparation scheme” to
define the number of replicates, dilution steps, the dilutions etc. Once finished select the
assay elements and select the “3x3 preparation scheme” from the dropdown box.

The preparation scheme contains the following information:

• Step Count
• Number of Replicates
• Absolute Potency Definition (Stock solution or raw material) [optional]
• Dilution Factors [optional]
• Definition of the dose steps
o Geometrical dose definition (default)
o Linear dose definition (for slope-ratio assays)
o Defined Dilution Sequence (direct input)

16
 Quantitative Response Assays

DATA SELECTION SCHEMES

Every assay must be connected to a data selection scheme in the same manner as the prepa-
ration schemes are connected. This scheme contains definitions which data points or dilu-
tion steps are included in the analysis. The default data selection scheme simply selects all
data points.

Other options to define:

• Statistical outlier testing (default: none)

• Range Selection (default: full range)
• Configuration Optimization Settings (default: off)

SUITABILITY TESTS
Suitability tests need to be added to the assay definition. When no tests are added a relative
potency can still be calculated, but its validity is not proven.

OBSERVATION GROUP ID
The observation data is linked to the assay elements by the use of the observation group id.

The observation group id is assigned to every assay element. In the data editor the observa-
tion group id is used as a reference to the assay element:

This concept allows to change the assignment of position e.g. on a plate by editing the ob-
servation group number of an assay element.

LITERATURE
• European Pharmacopoeia 6th Edition chapter 5.3
• US Pharmacopeia <111>, <1032>, <1033>, <1034>
• Finney, Biological Assay, 3rd Edition

17
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

• W. J. Dixon, 1953, Processing Data for Outliers, Biometrics, Vol. 9, S. 74-89

• David B. Rorabacher, 1991, Statistical Treatment for Rejection of Deviant Values: Crit-
ical Values of Dixon’s “Q” Parameter and Related Subrange Ratios at the 95% Confi-
dence Level, Analytical Chemistry, Vol 63, S. 139-146
• Frank E. Grubbs, 1969, Procedures for Detecting Outlying Observations in Samples,
Technometrics, Vol. 11 No. 1, S. 1-21

REPORTS
• Compact Report
The compact report contains the observation tables, suitability tests and potency re-
sults for each assay element on one page.
• Detail Report
The detail report contains all necessary information for the full documentation of the
assay.
• Advanced Detail Report (incl. additional information)
The advanced detail report contains all information of the detail report plus details of
the configuration optimization process.

TASKS
• Calculate – performs the calculation process
Note: If the calculation cannot be performed the reports contain more detailed error
information.

DOCUMENT STRUCTURE
DOCUMENT OUTLINE
The overall structure of the Quantitative Response Assay document is hierarchically orga-
nized. The main sections are the Setup section and the Analysis section. The Setup section
contains all data describing the observation data and the measurement incl. dilution steps,
response values etc. The Analysis section describes the flow of the statistical analysis of the
assay.

Quantitative Response Assay

• Setup Setup of the Assay System
o Assay Elements Container for all defined assay elements
 Named Assay Elements Every defined assay element is listed here
o Preparation Schemes Container Element for all defined prepara-
tion schemes
o Observation Data Definitions of the data table
• Analysis Setup of the Analytical Model
o Analytical Model Regression model and analytical proper-
ties
o Data Selection Schemes Data Selection Schemes
o Suitability Tests Container of the Suitability Tests

18
 Quantitative Response Assays

DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for a Quantitative Re-
sponse Assay document. It is indicated whether a field is required or optional. The number is
a reference to the following section with more reference data for every field.

Quantitative Response Assay required 001

. Name required 002
. Identification optional 003
. Date required 004
. Documentation optional 005
. . Assay Purpose optional 006
. . CHOICE required 007
. . . Substance Name optional 008
. . . Substance Reference optional 009
. . Substance Identification optional 010
. . Substance Batch/Lot number optional 011
. . Substance Sub-Batch/Sub-Lot number optional 012
. . Substance Variant optional 013
. . Substance Class optional 014
. . Substance Description optional 015
. . Operator optional 016
. . . CHOICE required 017
. . . . Operator Name required 018
. . . . Operator Reference required 019
. . . Role optional 020
. . Reagent optional 021
. . . CHOICE required 022
. . . . Reagent Name optional 023
. . . . Reagent Reference optional 024
. . . Reagent Identification optional 025
. . . Reagent Batch/Lot number optional 026
. . . Reagent Sub-Batch/Sub-Lot number optional 027
. . . Reagent Variant optional 028
. . . Reagent Class optional 029
. . . Reagent Description optional 030
. . . Amount optional 031
. . Equipment optional 032
. . . CHOICE required 033
. . . . Equipment Name required 034
. . . . Equipment Reference required 035
. . User Variable optional 036
. . . Key required 037
. . . Value optional 038
. . Data Source optional 039
. . . Filename optional 040
. . . Import Timestamp optional 041
. . . Import Modul Identification optional 042
. . . Import Comment optional 043
. Setup required 044
. . Assay Elements required 045

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Standard Sample required 046

. . . . Name required 047
. . . . Observation Group Id required 048
. . . . Preparation Scheme required 049
. . . . Data Selection Scheme required 050
. . . . Display Color required 051
. . . . User Variable optional 052
. . . . . Key required 053
. . . . . Value optional 054
. . . . CHOICE required 055
. . . . . Substance Name optional 056
. . . . . Substance Reference optional 057
. . . . Substance Identification optional 058
. . . . Substance Batch/Lot number optional 059
. . . . Substance Sub-Batch/Sub-Lot number optional 060
. . . . Substance Variant optional 061
. . . . Substance Class optional 062
. . . . Substance Description optional 063
. . . Test Sample optional 064
. . . . Name required 065
. . . . Observation Group Id required 066
. . . . Preparation Scheme required 067
. . . . Data Selection Scheme required 068
. . . . Display Color required 069
. . . . User Variable optional 070
. . . . . Key required 071
. . . . . Value optional 072
. . . . Group optional 073
. . . . CHOICE required 074
. . . . . Substance Name optional 075
. . . . . Substance Reference optional 076
. . . . Substance Identification optional 077
. . . . Substance Batch/Lot number optional 078
. . . . Substance Sub-Batch/Sub-Lot number optional 079
. . . . Substance Variant optional 080
. . . . Substance Class optional 081
. . . . Substance Description optional 082
. . . . Exclude from Analysis / Invalid Assay Element required 083
. . . Control Sample optional 084
. . . . Name required 085
. . . . CHOICE required 086
. . . . . Substance Name optional 087
. . . . . Substance Reference optional 088
. . . . Substance Identification optional 089
. . . . Substance Batch/Lot number optional 090
. . . . Substance Sub-Batch/Sub-Lot number optional 091
. . . . Substance Variant optional 092
. . . . Substance Class optional 093
. . . . Substance Description optional 094
. . . . Observation Group Id required 095
. . . . Preparation Scheme required 096
. . . . Data Selection Scheme required 097
. . . . Display Color required 098

20
 Quantitative Response Assays

. . . User Variable
. optional 099
. . . . Key
. required 100
. . . . Value
. optional 101
. . . Exclude from Analysis / Invalid Assay Element
. required 102
. . . Control Line optional 103
. . . . Name required 104
. . . . CHOICE required 105
. . . . . Substance Name optional 106
. . . . . Substance Reference optional 107
. . . . Substance Identification optional 108
. . . . Substance Batch/Lot number optional 109
. . . . Substance Sub-Batch/Sub-Lot number optional 110
. . . . Substance Variant optional 111
. . . . Substance Class optional 112
. . . . Substance Description optional 113
. . . . Observation Group Id required 114
. . . . Preparation Scheme required 115
. . . . Data Selection Scheme required 116
. . . . Display Color required 117
. . . . User Variable optional 118
. . . . . Key required 119
. . . . . Value optional 120
. . . . Exclude from Analysis / Invalid Assay Element required 121
. . Preparation Schemes required 122
. . . PreparationScheme required 123
. . . . Name required 124
. . . . Step Count required 125
. . . . Replicate Count required 126
. . . . CHOICE required 127
. . . . . Absolute Potency: not defined required 128
. . . . . Absolute Potency: defined by Raw Material required 129
. . . . . . Assigned/Assumed Potency (Summary) required 130
. . . . . . . Assigned/Assumed Potency required 131
. . . . . . . Assigned/Assumed Potency Units required 132
. . . . . . Amount (Summary) required 133
. . . . . . . Amount required 134
. . . . . . . Amount Units required 135
. . . . . . Solvent (Summary) required 136
. . . . . . . Solvent Volume required 137
. . . . . . . Solvent Volume Units required 138
. . . . . Absolute Potency: defined by Stock Solution required 139
. . . . . . Assigned/Assumed Potency required 140
. . . . . . Assigned/Assumed Potency Units required 141
. . . . Dilution Factors required 142
. . . . . Dilution Factor optional 143
. . . . CHOICE required 144
. . . . . N-Fold Geometrical Sequence required 145
. . . . . . First Dose required 146
. . . . . . Base required 147
. . . . . Linear Sequence required 148
. . . . . . First Dose required 149
. . . . . . Delta required 150
. . . . . Defined Sequence required 151

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . . . Dose Value
. required 152
. Observation Data
. required 153
. . Observation Source
. required 154
. . Column: Document Reference
. optional 155
. . Column: Section
. optional 156
. . Row Order
. optional 157
. . Column: Observation Group
. required 158
. . Column: Sequence Step
. required 159
. . Column: Response Value
. required 160
. . . Name
. required 161
. . . Column Key
. required 162
. . . Property Scope
. optional 163
. . . Property Key
. optional 164
. . . Section Key
. optional 165
. . Column: Technical Outlier Flag
. required 166
. . Column: Position Factor
. optional 167
. . CHOICE
. required 168
. . . Column: Boolean
. optional 169
. . . Column: Date
. optional 170
. . . Column: Date/Time
. optional 171
. . . Column: Floating Point Number
. optional 172
. . . Column: Integer
. optional 173
. . . Column: Memo (Multiline Text)
. optional 174
. . . Column: Text
. optional 175
. . . Column: Time
. optional 176
. Analysis required 177
. . Analytical Model required 178
. . . CHOICE required 179
. . . . No Response Adjustment required 180
. . . . Response Adjustment by Control Line required 181
. . . . Response Adjustment By Fixed Value required 182
. . . Response Transformation required 183
. . . CHOICE required 184
. . . . Model: Linear Parallel Line required 185
. . . . Model: 4 Parameter Logistic Fit required 186
. . . . . Include Control Line optional 187
. . . . Model: 5 Parameter Logistic Fit required 188
. . . . Model: 3 Parameter Logistic Fit with fixed lower required
189
asymptote
. . . . . CHOICE required 190
. . . . . . Model3PfAsymptoteFixedByControlLine required 191
. . . . . . Model3PfAsymptoteFixedValue required 192
. . . . Model: 3 Parameter Logistic Fit with fixed upper required
193
asymptote
. . . . . CHOICE required 194
. . . . . . Model3PfAsymptoteFixedByControlLine required 195
. . . . . . Model3PfAsymptoteFixedValue required 196
. . . . Model: Slope Ratio required 197
. . . . . Include Control Line optional 198
. . . Analyze as multiplex assay required 199
. . . Potency Estimation Confidence Level required 200
. . . Calculate mean potency estimate of test samples required 201
. . . Advanced Settings required 202

22
 Quantitative Response Assays

. . . ANOVA Model
. required 203
. . . ANOVA with consideration of additional factors
. required 204
. . . Logarithm Base
. required 205
. . . Invert Potency
. required 206
. . . Replace Outliers
. optional 207
. . . Report Excluded / Invalid Elements
. optional 208
. . . Potency Confidence Interval Calculation Method
. required 209
. . Data Selection Schemes required 210
. . . Configuration Optimizer Allocation Range optional 211
. . . Data Selection Scheme required 212
. . . . Name required 213
. . . . CHOICE required 214
. . . . . No Outlier Detection required 215
. . . . . Dixon Test for Data Outliers required 216
. . . . . . Alpha required 217
. . . . . . Recursive required 218
. . . . . Grubbs Test required 219
. . . . . . Alpha required 220
. . . . . . Recursive required 221
. . . . . (Externally) Studentized Residuals required 222
. . . . . . Alpha required 223
. . . . . . Recursive required 224
. . . . . Standard Deviation Test required 225
. . . . . . nSigma required 226
. . . . CHOICE required 227
. . . . . RangeFull required 228
. . . . . RangePartial required 229
. . . . . . StepStart required 230
. . . . . . Step Stop required 231
. . . . CHOICE required 232
. . . . . OptimizationOff required 233
. . . . . OptimizationOn required 234
. . . . . . IdenticalRange required 235
. . . . . . IdenticalTreatmentNumber required 236
. . . . . . Include50PercentResponse required 237
. . . . . . CHOICE required 238
. . . . . . . MinimalNumberOfSteps required 239
. . . . . . . ExcactNumberOfSteps required 240
. . Suitability Tests required 241
. . . Assay Suitability Tests required 242
. . . . F-Test (Hypothesis Test) optional 243
. . . . . Type required 244
. . . . . Confidence Level (%) required 245
. . . . . Scope of the Test optional 246
. . . . . Severity Level of the Test optional 247
. . . . Equivalence Test (Parameter Estimate) optional 248
. . . . . Parameter required 249
. . . . . Upper Margin required 250
. . . . . Lower Margin required 251
. . . . . Confidence Level (%) required 252
. . . . . Scope of the Test optional 253
. . . . . Severity Level of the Test optional 254
. . . . Equivalence Test (Difference of Parameter Estimates) optional 255

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Parameter
. . required 256
. . . Upper Margin
. . required 257
. . . Lower Margin
. . required 258
. . . Confidence Level (%)
. . required 259
. . . Scope of the Test
. . optional 260
. . . Severity Level of the Test
. . optional 261
. . Equivalence Test (Ratio of Parameter Estimates)
. . optional 262
. . . Parameter
. . required 263
. . . Upper Margin
. . required 264
. . . Lower Margin
. . required 265
. . . Confidence Level (%)
. . required 266
. . . Scope of the Test
. . optional 267
. . . Severity Level of the Test
. . optional 268
. . Equivalence Test (Scaled Parameter Range)
. . optional 269
. . . Parameter
. . required 270
. . . Upper Margin
. . required 271
. . . Lower Margin
. . required 272
. . . Scaling Parameter
. . required 273
. . . Confidence Level (%)
. . required 274
. . . Scope of the Test
. . optional 275
. . . Severity Level of the Test
. . optional 276
. . Equivalence test on the asymptote range
. . optional 277
. . . Upper Margin
. . required 278
. . . Lower Margin
. . required 279
. . . Confidence Level (%)
. . required 280
. . . Scope of the Test
. . optional 281
. . . Severity Level of the Test
. . optional 282
. . Equivalence test on ratio of the asymptotes
. . optional 283
. . . Upper Margin
. . required 284
. . . Lower Margin
. . required 285
. . . Confidence Level (%)
. . required 286
. . . Scope of the Test
. . optional 287
. . . Severity Level of the Test
. . optional 288
. . . Equivalence test on the scaled range of the optional
.
289
asymptotes
. . . . . Upper Margin required 290
. . . . . Lower Margin required 291
. . . . . Scaling Parameter required 292
. . . . . Confidence Level (%) required 293
. . . . . Scope of the Test optional 294
. . . . . Severity Level of the Test optional 295
. . . . Additional Test: Sum of Squares Non-Linearity optional 296
. . . . . Upper Margin required 297
. . . . . Scope of the Test optional 298
. . . . . Severity Level of the Test optional 299
. . . . Additional Test: Maximal Number of Outliers optional 300
. . . . . Upper Margin required 301
. . . . . Scope of the Test optional 302
. . . . . Severity Level of the Test optional 303
. . . . . Extent of the Test required 304
. . . . Additional test: Maximal Sequence Step CV (%) optional 305
. . . . . Upper Margin required 306
. . . . . Scope of the Test optional 307

24
 Quantitative Response Assays

. . . . . Severity Level of the Test optional 308

. . . . Additional Test: Response Value Range optional 309
. . . . . Upper Margin required 310
. . . . . Lower Margin required 311
. . . . . Scope of the Test optional 312
. . . . . Severity Level of the Test optional 313
. . . . Additional Test: Potency Value optional 314
. . . . . Upper Margin required 315
. . . . . Lower Margin required 316
. . . . . Scope of the Test optional 317
. . . . . Severity Level of the Test optional 318
. . . . . Potency Type optional 319
. . . . Additional Test: Potency Confidence Interval optional 320
. . . . . Upper Margin required 321
. . . . . Lower Margin required 322
. . . . . Scope of the Test optional 323
. . . . . Severity Level of the Test optional 324
. . . . . Potency Type optional 325
. . . . Additional Test: Relative Potency Range (%) optional 326
. . . . . Upper Margin required 327
. . . . . Scope of the Test optional 328
. . . . . Severity Level of the Test optional 329
. . . . Additional Test: Minimal R² optional 330
. . . . . Upper Margin required 331
. . . . . Scope of the Test optional 332
. . . . . Severity Level of the Test optional 333
. . . . Additional Test: Weight W optional 334
. . . . . Lower Margin required 335
. . . . . Scope of the Test optional 336
. . . . . Severity Level of the Test optional 337
. . . Sample Suitability Tests required 338
. . . . F-Test (Hypothesis Test) optional 339
. . . . . Type required 340
. . . . . Confidence Level (%) required 341
. . . . . Scope of the Test optional 342
. . . . . Severity Level of the Test optional 343
. . . . Equivalence Test (Parameter Estimate) optional 344
. . . . . Parameter required 345
. . . . . Upper Margin required 346
. . . . . Lower Margin required 347
. . . . . Confidence Level (%) required 348
. . . . . Scope of the Test optional 349
. . . . . Severity Level of the Test optional 350
. . . . Equivalence Test (Difference of Parameter Estimates) optional 351
. . . . . Parameter required 352
. . . . . Upper Margin required 353
. . . . . Lower Margin required 354
. . . . . Confidence Level (%) required 355
. . . . . Scope of the Test optional 356
. . . . . Severity Level of the Test optional 357
. . . . Equivalence Test (Ratio of Parameter Estimates) optional 358
. . . . . Parameter required 359
. . . . . Upper Margin required 360

25
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Lower Margin
. . required 361
. . . Confidence Level (%)
. . required 362
. . . Scope of the Test
. . optional 363
. . . Severity Level of the Test
. . optional 364
. . Equivalence Test (Scaled Parameter Range)
. . optional 365
. . . Parameter
. . required 366
. . . Upper Margin
. . required 367
. . . Lower Margin
. . required 368
. . . Scaling Parameter
. . required 369
. . . Confidence Level (%)
. . required 370
. . . Scope of the Test
. . optional 371
. . . Severity Level of the Test
. . optional 372
. . Equivalence test on the asymptote range
. . optional 373
. . . Upper Margin
. . required 374
. . . Lower Margin
. . required 375
. . . Confidence Level (%)
. . required 376
. . . Scope of the Test
. . optional 377
. . . Severity Level of the Test
. . optional 378
. . Equivalence test on ratio of the asymptotes
. . optional 379
. . . Upper Margin
. . required 380
. . . Lower Margin
. . required 381
. . . Confidence Level (%)
. . required 382
. . . Scope of the Test
. . optional 383
. . . Severity Level of the Test
. . optional 384
. . . Equivalence test on the scaled range of the optional
.
385
asymptotes
. . . . . Upper Margin required 386
. . . . . Lower Margin required 387
. . . . . Scaling Parameter required 388
. . . . . Confidence Level (%) required 389
. . . . . Scope of the Test optional 390
. . . . . Severity Level of the Test optional 391
. . . . Additional Test: Sum of Squares Non-Linearity optional 392
. . . . . Upper Margin required 393
. . . . . Scope of the Test optional 394
. . . . . Severity Level of the Test optional 395
. . . . Additional Test: Maximal Number of Outliers optional 396
. . . . . Upper Margin required 397
. . . . . Scope of the Test optional 398
. . . . . Severity Level of the Test optional 399
. . . . . Extent of the Test required 400
. . . . Additional test: Maximal Sequence Step CV (%) optional 401
. . . . . Upper Margin required 402
. . . . . Scope of the Test optional 403
. . . . . Severity Level of the Test optional 404
. . . . Additional Test: Response Value Range optional 405
. . . . . Upper Margin required 406
. . . . . Lower Margin required 407
. . . . . Scope of the Test optional 408
. . . . . Severity Level of the Test optional 409
. . . . Additional Test: Potency Value optional 410
. . . . . Upper Margin required 411
. . . . . Lower Margin required 412

26
 Quantitative Response Assays

. . . . . Scope of the Test optional 413

. . . . . Severity Level of the Test optional 414
. . . . . Potency Type optional 415
. . . Additional Test: Potency Confidence Interval
. optional 416
. . . . Upper Margin
. required 417
. . . . Lower Margin
. required 418
. . . . Scope of the Test
. optional 419
. . . . Severity Level of the Test
. optional 420
. . . . Potency Type
. optional 421
. . . Additional Test: Relative Potency Range (%)
. optional 422
. . . . Upper Margin
. required 423
. . . . Scope of the Test
. optional 424
. . . . Severity Level of the Test
. optional 425
. . . Additional Test: Minimal R²
. optional 426
. . . . Upper Margin
. required 427
. . . . Scope of the Test
. optional 428
. . . . Severity Level of the Test
. optional 429
. . . Additional Test: Weight W
. optional 430
. . . . Lower Margin
. required 431
. . . . Scope of the Test
. optional 432
. . . . Severity Level of the Test
. optional 433
. . Document Suitability Tests
. optional 434
. . . Signature State
. optional 435
. . . . Number of Signatures
. optional 436
. . . . Meaning
. optional 437
. . . . Scope of the Test
. optional 438
. . . . Severity Level of the Test
. optional 439
. . . Test on User Variable
. optional 440
. . . . Key
. required 441
. . . . Value
. optional 442
. . . . Severity Level of the Test
. optional 443
. Comment optional 444
. . Subject optional 445
. . Text optional 446
. . Linked Document optional 447
. . Date required 448
. . Author required 449

27
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

DOCUMENT ELEMENT REFERENCE

/ 001
Quantitative Response Assay USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

QuantitativeResponseAssay xs:empty 1…1 <NONE>

A Quantitative Response Assay is a dilution assay based on a quantitative response. In
contrast to dichotomous assays quantitative response assays are based on a continuous
response scale. Parallel line assays and slope ratio assays belong to this kind of assay. Please
go through the properties and select the required settings for this quantitative response
assay. Unfold to see the document's sections Name , Date , Documentation>, Setup and
Analysis (left click on the plus sign in front of the element). You can use the creation panel or
the context menu, to add the Identification or to add an arbitrary number of Comment
sections.

/Quantitative Response Assay/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Documents are usally identified by their names. It is recommend to use unique names for
your document, but this is not strictly required.

/Quantitative Response Assay/ 003

Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Identification xs:token 0…1 <NONE>

Enter a identification string for the assay. This is an alternative to the use of name to identify
the assay. It is recommend to use unique identifications for your document, but this is not
strictly required.

/Quantitative Response Assay/ 004

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

You can enter a date for the assay. Per default the document's creation date is entered here
automatically. However this can be changed. The date can be used for sorting in aggregation
documents.

28
 Quantitative Response Assays

/Quantitative Response Assay/ 005

Documentation USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Documentation T_Documentation 0…1 <NONE>

Here you can give the details about operators, used reagents and equipment. Unfold to see
the subsections (left click on the plus sign in front of the element). You can use the creation
panel to add new documentation sections.

/Quantitative Response Assay/Documentation/ 006

Assay Purpose USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayPurpose xs:string 0…1 <NONE>

Document the purpose of this assay. E.g. Identify the analyte or target of the assay, and it's
unique identification.

/Quantitative Response Assay/Documentation/ 007

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Documentation/CHOICE: 008

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Quantitative Response Assay/Documentation/CHOICE: 009

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Quantitative Response Assay/Documentation/ 010

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

29
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Documentation/ 011

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Quantitative Response Assay/Documentation/ 012

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Documentation/ 013

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Quantitative Response Assay/Documentation/ 014

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Quantitative Response Assay/Documentation/ 015

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Quantitative Response Assay/Documentation/ 016

Operator USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:empty 0…* <NONE>

Information about an operator. Unfold to see the details (left click on the plus sign in front of
the element). You can assign a role to an operator. Add a Role element by selecting it on the
creation panel.

30
 Quantitative Response Assays

/Quantitative Response Assay/Documentation/Operator/ 017

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Documentation/Operator/CHOICE: 018

Operator Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorName xs:token 1…1 <NONE>

Enter the operator's name. You can use the choice selector to swicth to Operator Reference ,
where you can assign the operator by a reference on a operator document.

/Quantitative Response Assay/Documentation/Operator/CHOICE: 019

Operator Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorReference T_OperatorReference 1…1 <NONE>

Reference to a operator document. You can use the choice selector to switch to Operator
Name , where you can enter a operator name dirctly.

/Quantitative Response Assay/Documentation/Operator/ 020

Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:token 0…1 <NONE>

Enter the operator role here.

/Quantitative Response Assay/Documentation/ 021

Reagent USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Reagent xs:empty 0…* <NONE>

Enter information about the reagent. Unfold to see the details (left click on the plus sign in
front of the element).

/Quantitative Response Assay/Documentation/Reagent/ 022

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

31
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Documentation/Reagent/CHOICE: 023

Reagent Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentName xs:token 0…1 <NONE>

Name of the the reagent.

/Quantitative Response Assay/Documentation/Reagent/CHOICE: 024

Reagent Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentReference DocumentReference.Reagent 0…1 <NONE>

Choose a reagent document.

/Quantitative Response Assay/Documentation/Reagent/ 025

Reagent Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentId xs:token 0…1 <NONE>

Identification information for the reagent.

/Quantitative Response Assay/Documentation/Reagent/ 026

Reagent Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Quantitative Response Assay/Documentation/Reagent/ 027

Reagent Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Documentation/Reagent/ 028

Reagent Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentVariant xs:token 0…1 <NONE>

The variant of the reagent.

32
 Quantitative Response Assays

/Quantitative Response Assay/Documentation/Reagent/ 029

Reagent Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentClass xs:token 0…1 <NONE>

The class of the reagent, e.g. drug class.

/Quantitative Response Assay/Documentation/Reagent/ 030

Reagent Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentDescription xs:string 0…1 <NONE>

Textual description of the reagent.

/Quantitative Response Assay/Documentation/Reagent/ 031

Amount USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount xs:string 0…1 <NONE>

Enter the amount of the substance in the assay.

/Quantitative Response Assay/Documentation/ 032

Equipment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Equipment xs:empty 0…* <NONE>

Information about equipment used to perform the assay. For documentation purposes.
Unfold to see the details.

/Quantitative Response Assay/Documentation/Equipment/ 033

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Documentation/Equipment/CHOICE: 034

Equipment Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentName xs:token 1…1 <NONE>

Enter the equipment's name. You can use the choice selector to swicth to Equipment
Reference , where you can assign the equipment by a reference on a equipment document.

33
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Documentation/Equipment/CHOICE: 035

Equipment Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentReference T_EquipmentReference 1…1 <NONE>

Reference to a equipment document. You can use the choice selector to switch to
Equipment Name , where you can enter a equipment name directly.

/Quantitative Response Assay/Documentation/ 036

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Quantitative Response Assay/Documentation/User Variable/ 037

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Documentation/User Variable/ 038

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Quantitative Response Assay/Documentation/ 039

Data Source USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSource xs:empty 0…* <NONE>

Unfold to see information about the data source of imported data. The subelements are
filled automatically.

/Quantitative Response Assay/Documentation/Data Source/ 040

Filename USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Filename xs:token 0…1 <NONE>

Filename of the data source. Filled automatically.

34
 Quantitative Response Assays

/Quantitative Response Assay/Documentation/Data Source/ 041

Import Timestamp USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportTimestamp xs:dateTime 0…1 <NONE>

Timestamp of the data import. Filled automatically.

/Quantitative Response Assay/Documentation/Data Source/ 042

Import Modul Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportModuleIdentification xs:token 0…1 <NONE>

Filled automatically.

/Quantitative Response Assay/Documentation/Data Source/ 043

Import Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportComment xs:string 0…1 <NONE>

A single comments to this assay.

/Quantitative Response Assay/ 044

Setup USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Setup xs:empty 1…1 <NONE>

In this section you can define the assay setup. Unfold to see the subsection (left click on the
plus sign in front of the element). Subsections are Assay Elements : Details about assay
elements like standard and test samples. Preaparation Schemes : Definition of preparation
schemes including the dose sequence informations. Observation Data : Setup of the
observation table. Usually filled automatically, but here you can define additional data
columns (e.g. position factors).

/Quantitative Response Assay/Setup/ 045

Assay Elements USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Elements xs:empty 1…1 <NONE>

Unfold to see the already defined assay elements (left click on the plus sign in front of the
element). Assay Elements are the building blocks of a biological assay. An assay consists of
one standard sample, one or more preparation samples (test samples or control samples)
and optional control lines or control samples. Standard, preaparation, and control samples
are diluted samples. Control lines could be positive, negative or blank control lines, that are
not diluted. By using the context menu you can add Test Sample : Samples for which a
relative potency should be calculated. Control Sample : Usually used to define additional
accepting criteriums. Control Line : Objects like positive or negative controls.

35
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Setup/Assay Elements/ 046

Standard Sample USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Standard T_AE_Standard 1…1 <NONE>

The standard sample or standard preparation or standard is required in quantitative assays.
The potency of the preparations is calculated compared to this standard. Unfold to see the
definition details (left click on the plus sign in front of the alement). You can use the creation
panel to add substance information as Substance Name or Substance Reference .

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 047

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 STD

Enter the name of the standard assay element. Examples: "Standard", "Std", "Reference
Standard" Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to the standard. We recommend to use unique names for assay elements in an
assay document. But this is not required. Internal the Observation Group Id is used for the
identification of assay elements.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 048

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 049

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

36
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 050

Data Selection Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionSchemeReference xs:string 1…1 <NONE>

Assign a Data Selection Schme to the assay element. A Data Selection Scheme defines the
range selection settings (including the configuration optimizer) and outlier detection method
of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 051

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 052

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/User Variable/ 053

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/User Variable/ 054

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 055

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

37
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/CHOICE: 056

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/CHOICE: 057

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 058

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 059

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 060

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 061

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

38
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 062

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Quantitative Response Assay/Setup/Assay Elements/Standard Sample/ 063

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Quantitative Response Assay/Setup/Assay Elements/ 064

Test Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Test T_AE_Test 0…* <NONE>

The potency of the preparation (aka preparation sample, test sample, unknown) is
calculated in comparison to the standard. Unfold to see the definition details (left click on
the plus sign in front of the alement). You can use the creation panel to add substance
information as Substance Name or Substance Reference . Additionally you have the
possibility to add Group to define, which assay elements should be combined in a
combination calculation (Note: The combination calculation itself is done in a combination of
assay results document).

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 065

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of this test assay element. Examples: "Preparation 1", "Unknown 3", "Test 2"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to this test assay element. We recommend to use unique names for assay
elements in an assay document. But this is not required. Internal the Observation Group Id is
used for the identification of assay elements.

39
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 066

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 067

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 068

Data Selection Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionSchemeReference xs:string 1…1 <NONE>

Assign a Data Selection Schme to the assay element. A Data Selection Scheme defines the
range selection settings (including the configuration optimizer) and outlier detection method
of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 069

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 070

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

40
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/User Variable/ 071

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/User Variable/ 072

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 073

Group USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

COAGroup xs:token 0…1 <NONE>

Enter the group name for the combination of assay results calculation. Additional remarks:
Ignored by the assay calculation. This group specification only affects a combination of assay
results document, that references this assay document. All test samples assigned to the
same group are there combined in one combination calculation. Note, that the assay results
used in a combination calculation are assumed to be independent.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 074

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/CHOICE: 075

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/CHOICE: 076

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

41
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/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 077

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 078

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 079

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 080

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 081

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 082

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

42
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Test Sample/ 083

Exclude from Analysis / Invalid Assay Element USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcludeFromAnalysis xs:boolean 1…1 false

Select true to exclude the assay element from the analysis or false to include it in the
analysis. Additional remarks: If an assay element is excluded from analysis, the assay and all
data and settings (like test definitions for teh assay element) will be completely ignored.
However there will be a notification in the report, that the assay element is excluded from
analysis.

/Quantitative Response Assay/Setup/Assay Elements/ 084

Control Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Control T_AE_Control 0…* <NONE>

The potency of a control sample is calculated in the same manner as the test sample. The
control sample can be used to set up specific suitability tests for the assay. The control
sample will not be included in a combination of assay results calculation. Unfold to see the
definition details (left click on the plus sign in front of the alement). You can use the creation
panel to add substance information as Substance Name or Substance Reference .

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 085

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of this control assay element. Examples: "Assay Control", "Control 3", "Ctr"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to this control assay element. We recommend to use unique names for assay
elements in an assay document. But this is not required. Internal the Observation Group Id is
used for the identification of assay elements.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 086

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/CHOICE: 087

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

43
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/Quantitative Response Assay/Setup/Assay Elements/Control Sample/CHOICE: 088

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 089

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 090

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 091

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 092

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 093

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

44
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 094

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 095

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 096

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 097

Data Selection Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionSchemeReference xs:string 1…1 <NONE>

Assign a Data Selection Schme to the assay element. A Data Selection Scheme defines the
range selection settings (including the configuration optimizer) and outlier detection method
of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 098

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

45
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/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 099

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/User Variable/ 100

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/User Variable/ 101

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Control Sample/ 102

Exclude from Analysis / Invalid Assay Element USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcludeFromAnalysis xs:boolean 1…1 false

Select true to exclude the assay element from the analysis or false to include it in the
analysis. Additional remarks: If an assay element is excluded from analysis, the assay and
all data and settings (like test definitions for teh assay element) will be completely ignored.
However there will be a notification in the report, that the assay element is excluded from
analysis.

/Quantitative Response Assay/Setup/Assay Elements/ 103

Control Line USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ControlLine T_AE_ControlLine 0…* <NONE>

A control line refines the characteristics of an assay. It can be used for response adjustment
or for enhanced model building. In contrast to controls control lines do not have a dilution or
dose. Unfold to see the definition details (left click on the plus sign in front of the alement).

46
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 104

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of the control line. Examples: "Positive Control", "Negative Control", "Blank"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to this control line. We recommend to use unique names for assay elements in an
assay document. But this is not required. Internal the Observation Group Id is used for the
identification of assay elements.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 105

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/CHOICE: 106

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/CHOICE: 107

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 108

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 109

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

47
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/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 110

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 111

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 112

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 113

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 114

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

48
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 115

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 116

Data Selection Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionSchemeReference xs:string 1…1 <NONE>

Assign a Data Selection Schme to the assay element. A Data Selection Scheme defines the
range selection settings (including the configuration optimizer) and outlier detection method
of an assay element.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 117

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 118

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/User Variable/ 119

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Setup/Assay Elements/Control Line/User Variable/ 120

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

49
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/Quantitative Response Assay/Setup/Assay Elements/Control Line/ 121

Exclude from Analysis / Invalid Assay Element USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcludeFromAnalysis xs:boolean 1…1 false

Select true to exclude the assay element from the analysis or false to include it in the
analysis. Additional remarks: If an assay element is excluded from analysis, the assay and
all data and settings (like test definitions for teh assay element) will be completely ignored.
However there will be a notification in the report, that the assay element is excluded from
analysis.

/Quantitative Response Assay/Setup/ 122

Preparation Schemes USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemes xs:empty 1…1 <NONE>

You can define multiple preparation schemes to describe the doses and dimension of your
different treatments. By default all assay element are bound to the first Preparation Scheme.
In more complex assays more than one scheme can be required. Unfold to see the already
defined preparation schmes (left click on the plus sign in front of the element). You can add
a new preparation scheme by using the context menu

/Quantitative Response Assay/Setup/Preparation Schemes/ 123

PreparationScheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationScheme xs:empty 1…* <NONE>

The setup of the considered dose sequence, absolute potency settings and dilution factors
are defined in a preparation scheme. Each assay element has to refer to exactly one
preparation scheme. However you can use one preperation scheme for mor than one assay
element. Unfold to set up the details of the preparation scheme.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 124

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

The name of the preparation scheme. This name has to be unique for the assay.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 125

Step Count USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StepCount xs:positiveInteger 1…1 <NONE>

The number of dose steps for the according assay element.

50
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 126

Replicate Count USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReplicateCount xs:positiveInteger 1…1 <NONE>

The number of replicates per step for the according assay element.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 127

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 128

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition T_Empty 1…1 <NONE>

This scheme does not define an absolute dose for the connected assay element. A backfit
calculation for absolute potencies will not be carried out with this option. You can use the
choice selector to switch to the alternatives Absolute Potency: defined by Raw Material or
Absolute Potency: defined by Stock Solution . Unfold to see the definition details (left click
on the plus sign in front of the element).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 129

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. Define the
absolute potency per amount units, the amount used for preparation and the volume of the
solvent. Note: the absolute potency has to be defined per amount units for a correct
calculation. You can use the choice selector to switch to the alternatives Absolute Potency:
not defined or Absolute Potency: defined by Stock Solution . Unfold to see the definition
details (left click on the plus sign in front of the element). Estimated Potency of the test
sample = calculated relative potency &#8901; assigend potency of the standard sample
&#8901; amount of the standard &#8901; solvent volume of the test sample amount of
the test sample &#8901; solvent volume of the standard sample .

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: defined

by Raw Material/
130
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

51
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/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency:

defined by Raw Material/Assigned/Assumed Potency (Summary)/
131
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency T_PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 132

defined by Raw Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 133

defined by Raw Material/
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 134

defined by Raw Material/Amount (Summary)/
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount T_PositiveDouble 1…1 <NONE>

The amount of the substance.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 135

defined by Raw Material/Amount (Summary)/
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 136

defined by Raw Material/
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

52
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency:

defined by Raw Material/Solvent (Summary)/
137
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume T_PositiveDouble 1…1 <NONE>

The solvent's volume.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency:

defined by Raw Material/Solvent (Summary)/
138
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 139

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute Potency: not
defined . Unfold to see the definition details (left click on the plus sign in front of the
element). Estimated potency for the test sample = calculated relative potency &#8901;
assigned potency of the standard sample .

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency: 140

defined by Stock Solution/
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency T_PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Absolute Potency:

defined by Stock Solution/
141
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

53
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/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 142

Dilution Factors USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors defined here. Dilution factors
are taken into account after calculation of the relative potency (so they don't enter the
calculation fo the model fit).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/Dilution Factors/ 143

Dilution Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor T_PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/ 144

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 145

N-Fold Geometrical Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NFoldSequence T_SequenceNFold 1…1 <NONE>

Chosen dose sequence is the n-fold sequence (or geometric sequence). The dose value of a
n-Fold sequence for step number j is given by First Dose &#8901; Base (1 - j) . You can
use the choice selector to switch to the alternatives Linear Seqence and Defined Sequence .

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:N-Fold Geometrical

Sequence/
146
USAGE
First Dose required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Factor T_NonNegativeDouble 1…1 <NONE>

Define the first dose of a linear sequence. Additional remarks: Has to be a non-negative
decimal number. The dose value of a n-Fold sequence for step number j is given by First
Dose &#8901; Base (1 - j) .

54
 Quantitative Response Assays

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:N-Fold Geometrical

Sequence/
147
USAGE
Base required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Base T_PositiveDouble 1…1 <NONE>

Define the dose of a n-Fold-Sequence. Additional remarks: Has to be a positive decimal
number. The dose value of a n-Fold sequence for step number j is given by First Dose
&#8901; Base (1 - j) .

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 148

Linear Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquidistantSequence T_SequenceEquidistant 1…1 <NONE>

Chosen sequence is the linear dequence (a sequence with equidistant steps). The dose value
for step number j of a linear sequence is given by First Dose + Delta &#8901; ( Step
Number - 1). You can use the choice selector to switch to the alternatives N-Fold Seqence
and Defined Sequence .

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Linear Sequence/ 149

First Dose USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FirstDose T_NonNegativeDouble 1…1 <NONE>

Define the first dose of a linear sequence. Additional remarks: Has to be a non-negative
decimal number. The dose value for step number j of a linear sequence is given by First
Dose + Delta &#8901; ( Step Number - 1).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Linear Sequence/ 150

Delta USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Delta xs:double 1…1 <NONE>

Define the differnce between to dose values of a linear sequence. Additional remarks: Has
to be a non-negative decimal number. The dose value for step number j of a linear sequence
is given by First Dose + Delta &#8901; ( Step Number - 1).

/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE: 151

Defined Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedSequence T_SequenceDefined 1…1 <NONE>

Chosen sequence is the defined dequence (a sequence with equidistant steps). You can use
the choice selector to switch to the alternatives N-Fold Seqence and Linear Sequence .

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/Quantitative Response Assay/Setup/Preparation Schemes/PreparationScheme/CHOICE:Defined Sequence/ 152

Dose Value USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DoseValue T_NonNegativeDouble 1…* <NONE>

Define a dose value for a defined sequence. Additional remarks: Each is internally
connected to a dose step number (starting at '1').

/Quantitative Response Assay/Setup/ 153

Observation Data USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Dataset xs:empty 1…1 <NONE>

The data editor allows to view and modify the dose and response data and other factors of
the assay. You can add aditional factors to the table.

/Quantitative Response Assay/Setup/Observation Data/ 154

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

/Quantitative Response Assay/Setup/Observation Data/ 155

Column: Document Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentReference ds:T_ReferenceColumn 0…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Quantitative Response Assay/Setup/Observation Data/ 156

Column: Section USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Section ds:T_ReferenceSectionColumn 0…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Quantitative Response Assay/Setup/Observation Data/ 157

Row Order USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder ds:T_RowOrder 0…1 <NONE>

Define a sort order for the data rows.

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/Quantitative Response Assay/Setup/Observation Data/ 158

Column: Observation Group USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroup ds:T_ObservationGroupColumn 1…1 <NONE>

The observation group factor binds a single observation (measurement) to the
corresponding assay element. The maximum number of observation groups setting defines
how many slots are displayed in the data editors. If you have more assay elements than this
number, simply select a higher number.

/Quantitative Response Assay/Setup/Observation Data/ 159

Column: Sequence Step USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Step ds:T_SequenceStepColumn 1…1 <NONE>

The sequence step factor contains the number of the step in a defined sequence. Note: The
maximum number of steps and replicates are defined in the corresponding Preparation
Schemes.

/Quantitative Response Assay/Setup/Observation Data/ 160

Column: Response Value USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Response T_ResponseFactor 1…1 <NONE>

The sequence step factor contains the number of the step in a defined sequence.

/Quantitative Response Assay/Setup/Observation Data/Column: Response Value/ 161

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter the label of the response column.

/Quantitative Response Assay/Setup/Observation Data/Column: Response Value/ 162

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

The column key is used to identify the column for example in an optionally defined order
column.

/Quantitative Response Assay/Setup/Observation Data/Column: Response Value/ 163

Property Scope USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyScope ds:T_PropertyScope 0…1 <NONE>

The property scope. Only relevant for document aggregation. Can have the values Document
or section to specify the source of the aggregated property.

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/Quantitative Response Assay/Setup/Observation Data/Column: Response Value/ 164

Property Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyKey xs:token 0…1 <NONE>

Only relevant in case of document aggregation, the property key identifies the data to
aggregate.

/Quantitative Response Assay/Setup/Observation Data/Column: Response Value/ 165

Section Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionKey xs:token 0…1 <NONE>

Only relevant in case of document aggregation. In case of a given section key, only the
specified section will be considered as property source.

/Quantitative Response Assay/Setup/Observation Data/ 166

Column: Technical Outlier Flag USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TechnicalOutlier ds:T_TechnicalOutlierColumn 1…1 <NONE>

Data column for marking technical outliers.

/Quantitative Response Assay/Setup/Observation Data/ 167

Column: Position Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Position ds:T_PositionColumn 0…3 <NONE>

Column for specifying the column of the measurement on the plate.

/Quantitative Response Assay/Setup/Observation Data/ 168

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 169

Column: Boolean USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

BooleanFactor ds:T_BooleanColumn 0…* <NONE>

Column for specifying the row of the measurement on the plate.

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/Quantitative Response Assay/Setup/Observation Data/CHOICE: 170

Column: Date USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DateFactor ds:T_DateColumn 0…* <NONE>

User defined date column.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 171

Column: Date/Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DateTimeFactor ds:T_DateTimeColumn 0…* <NONE>

User defined date / time column.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 172

Column: Floating Point Number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DoubleFactor ds:T_DoubleColumn 0…* <NONE>

User defined column for floating point double precission numbers.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 173

Column: Integer USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IntegerFactor ds:T_IntegerColumn 0…* <NONE>

User defined column for integer values.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 174

Column: Memo (Multiline Text) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MemoFactor ds:T_MemoColumn 0…* <NONE>

User defined column for multiline text..

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 175

Column: Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StringFactor ds:T_TextColumn 0…* <NONE>

User defined column for single line text.

/Quantitative Response Assay/Setup/Observation Data/CHOICE: 176

Column: Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TimeFactor ds:T_TimeColumn 0…* <NONE>

User defined time column.

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/Quantitative Response Assay/ 177

Analysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Analysis xs:empty 1…1 <NONE>

In the analysis section you can define settings like the regression model, data selection (e. g.
the use of the configuration optimizer or outlier tests) or the statistical tests, that should be
performed during calculation. Unfold to see the subsections (left click on the plus sign in
front of the element).

/Quantitative Response Assay/Analysis/ 178

Analytical Model USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model xs:empty 1…1 <NONE>

The analytical model defines the common analytical model settings for all assay elements.

/Quantitative Response Assay/Analysis/Analytical Model/ 179

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 180

No Response Adjustment USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseAdjustmentNone T_Empty 1…1 <NONE>

No Response Adjustment will be done. Please use the choice selector to switch to the
alternatives Response Adjustment by Control Line or Response Adjustment by Fixed Value .

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 181

Response Adjustment by Control Line USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseAdjustmentByControlLine xs:string 1…1 <NONE>

Response adjustment by control line is selected. Please use the choice selector to switch to
the alternatives No Response Adjustment or Response Adjustment by Fixed Value . Please
select the control line for the adjustment. The mean response of the chosen control line will
be subtracted from all response values (the referenced control line not included). If
additionally a response transformation is defined, it will be done after the response
adjustment.

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/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 182

Response Adjustment By Fixed Value USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseAdjustmentByFixedValue xs:double 1…1 <NONE>

Response adjustment by fixed value is selected. Please use the choice selector to switch to
the alternatives No Response Adjustment or Response Adjustment by Control line . Please
the value for the adjustment. The entered value will be subtracted from all response values.
If additionally a response transformation is defined, it will be done after the response
adjustment.

/Quantitative Response Assay/Analysis/Analytical Model/ 183

Response Transformation USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseTransformation T_ResponseTransformation 1…1 None

Please use the selector in the value column for chosing the response transformation.
Supported methods are no response transformation logarithmic response transformation
square response transformation square root response transformation

/Quantitative Response Assay/Analysis/Analytical Model/ 184

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 185

Model: Linear Parallel Line USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ModelLinear T_Empty 1…1 <NONE>

The linear parallel line regression model will be used to estimate the relative potency. Model
Formula Response = m &#8901; log b ( Dose ) + n

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 186

Model: 4 Parameter Logistic Fit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model4PF xs:empty 1…1 <NONE>

The selected regression model is the 4 parameter logistic fit. You can select an other model
by using the choice selector. Over the context section ot the creation bar, it is possible to
unclude a defined control line in the regression model. In this case the values of the control
line will be used for calculating the upper or lower margin. Model Formula Response = D
+ A - D 1 - b - B &#8901; ( log b ( Dose ) - C)

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/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 4 Parameter Logistic Fit/ 187

Include Control Line USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IncludeControlLine xs:string 0…1 <NONE>

Additional element, that is only considered in case of a 4 parameter logistic fit. Please
choose a control line to be included in the fit. The data of the control line will be used as
additional data to estimate the upper or lower asymptote.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 188

Model: 5 Parameter Logistic Fit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model5PF T_Empty 1…1 <NONE>

The selected regression model is the 4 parameter logistic fit. You can select an other model
by using the choice selector. Model Formula Response = D + A - D 1 - b - B
&#8901; ( log b ( Dose ) - C) G

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 189

Model: 3 Parameter Logistic Fit with fixed lower USAGE
asymptote required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfFixedLowerAsymptote xs:empty 1…1 <NONE>

The selected regression model is the 3 parameter logistic fit with fixed lower asymptote. You
can select an other model by using the choice selector. Model Formula Response = fixed
Value + A - fixed Value 1 - b - B &#8901; ( log b ( Dose ) - C)

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed

lower asymptote/
190
USAGE
CHOICE required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed lower 191
asymptote/CHOICE:
USAGE
Model3PfAsymptoteFixedByControlLine required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfAsymptoteFixedByControlLine xs:string 1…1 <NONE>

Please select the control line. The mean of the control line's response values will be used as
value of the fixed asymptote.

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/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed lower
asymptote/CHOICE:
192
USAGE
Model3PfAsymptoteFixedValue required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfAsymptoteFixedValue xs:double 1…1 <NONE>

The entered value will be used as value of the fixed asymptote.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 193

Model: 3 Parameter Logistic Fit with fixed upper USAGE
asymptote required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfFixedUpperAsymptote xs:empty 1…1 <NONE>

The selected regression model is the 3 parameter logistic fit with fixed upper asymptote. You
can select an other model by using the choice selector. Response = D + fixed value - D
1 - b - B &#8901; ( log b ( Dose ) - C)

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed

upper asymptote/
194
USAGE
CHOICE required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed upper 195
asymptote/CHOICE:
USAGE
Model3PfAsymptoteFixedByControlLine required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfAsymptoteFixedByControlLine xs:string 1…1 <NONE>

Please select the control line. The mean of the control line's response values will be used as
value of the fixed asymptote.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: 3 Parameter Logistic Fit with fixed

upper asymptote/CHOICE:
196
USAGE
Model3PfAsymptoteFixedValue required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model3PfAsymptoteFixedValue xs:double 1…1 <NONE>

The entered value will be used as value of the fixed asymptote.

/Quantitative Response Assay/Analysis/Analytical Model/CHOICE: 197

Model: Slope Ratio USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SlopeRatioModel xs:empty 1…1 <NONE>

The selected regression model is the slope ratio model. You can select an other model by
using the choice selector. Model Formula Response = m &#8901; Dose + n

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/Quantitative Response Assay/Analysis/Analytical Model/CHOICE:Model: Slope Ratio/ 198

Include Control Line USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SlopeRatioControlLine xs:string 0…1 <NONE>

Additional element, to include a control line in the fit of a slope ratio model. Please choose a
control line to be included in the fit. The data of the control line will be used as additional
data to estimate the upper or lower asymptote.

/Quantitative Response Assay/Analysis/Analytical Model/ 199

Analyze as multiplex assay USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IsMultiplexAssay xs:boolean 1…1 false

You can select, whether the assay is evaluated as multiplex assay ('true') or as a collection of
standard-test-sample comparisons ('false'). Note: The evaluation time for multiplex assays
in combination with range optimization can be very long.

/Quantitative Response Assay/Analysis/Analytical Model/ 200

Potency Estimation Confidence Level USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyEstimationConfidenceInterval T_ConfidenceLevel 1…1 0.95

Please select the confidence level of the potency confidence interval. A commonly used
value is 95 %.

/Quantitative Response Assay/Analysis/Analytical Model/ 201

Calculate mean potency estimate of test samples USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

CalculateMeanPotencyEstimates xs:boolean 1…1 false

If you set this to 'true', the mean of the potency estimates will be reported.

/Quantitative Response Assay/Analysis/Analytical Model/ 202

Advanced Settings USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdvancedSettings xs:empty 1…1 <NONE>

Here you can find additional settings for the assay calculation.

/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 203

ANOVA Model USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AnovaModel T_AnovaType 1…1 PureErrorAnova

Please select the ANOVA Model. The selection of the ANOVA will effect the calculation of the
parameter standard errors and the error term used in the test on regression, linearity and
parallelism. Select one of the alternatives Pure Error ANOVA and Residual Error ANOVA .

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/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 204

ANOVA with consideration of additional factors USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AnovaAdditionalFactors xs:boolean 1…1 true

If this is set to true, the ANOVA will be calculated taking into account the position factors (if
there are any position factors defined).

/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 205

Logarithm Base USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LogType T_LogType 1…1 Log2

Here you can choose the logarithm base used for dose or response transformation. Select
one off binary logarithm (logarithm base 2) natural logarithm (logarithm base e) decimal
logarithm (logarithm base 10)

/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 206

Invert Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

InvertPotency xs:boolean 1…1 false

If this is set to true the potency ratio will be inverted.

/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 207

Replace Outliers USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReplaceOutliers xs:boolean 0…1 false

If this is set to true, outlier response values will be replaced by the arithmetic mean of the
non-outlier repsonses of the corresponding step and assay element. Should not be used in
combination with considering position effects in the ANOVA. Note: It is not recommended
to use outlier replacement in new assay. It should only be used to evaluate old authorized
assays.

/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 208

Report Excluded / Invalid Elements USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReportExcludedOrInvalidElements xs:boolean 0…1 false

If this is set to true, excluded or invalid assay elements will be reported and can be used in
subsequent documents (such as Combination of Assay Results).

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/Quantitative Response Assay/Analysis/Analytical Model/Advanced Settings/ 209

Potency Confidence Interval Calculation Method USAGE

required
TECHNICAL NAME DATA TYPE DEFAULT VALUE

PotencyConfidenceIntervalCalculat T_PotencyConfidenceIntervalCalcula MULTI- PLICITY AnovaEr

ionMethod tionMethod 1…1 ror
Defines the way, how the potency confidence interval is calculated. You can either select
'based on ANOVA error'. In this case, the potency confidence interval are adjusted by the
pure error in case of the pure error ANOVA and the residual error (the residual error of the
full model) in case of the residual error ANOVA. The other possibility is 'based on restricted
mode error'. In this case, the confidence intervals are adjusted by the residual error of the
restricted fit. In case of parallel linear line bioassays the error based on the ANOVA model is
commonly used (and this is the default in previous PLA versions). For nonlinear models the
restricted model error is more common. In previous PLA versions, the restricted model error
has been used to evaluate nonlinear models, if the residual error ANOVA was selected.
Otherwise the error based on the ANOVA model has been used.

/Quantitative Response Assay/Analysis/ 210

Data Selection Schemes USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionSchemes xs:empty 1…1 <NONE>

You can define multiple data selection schemes for an assay. A data selection scheme
contains settings about outlier detection, range optimization and range selection. Every
assay element has to refer one of the data selection schemes defined in this section. Unfold
to see the existing data selection schemes (by left click on the little plus sign in front of the
element). You can add a new scheme by e. g. selecting Data Selection Scheme in the context
section of the creation panel.

/Quantitative Response Assay/Analysis/Data Selection Schemes/ 211

Configuration Optimizer Allocation Range USAGE

optional
TECHNICAL NAME DATA TYPE DEFAULT VALUE

ConfigurationOptimizerAllocatio T_ConfigurationOptimizerAllocatio MaximumRa MULTI-

PLICITY

nStrategy nStrategy 0…1 nge

If you select Maximum Range , the range optimizer tries to find good configurations with
preferably large ranges. Otherwise you can choose Best Range

/Quantitative Response Assay/Analysis/Data Selection Schemes/ 212

Data Selection Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSelectionScheme xs:empty 1…* <NONE>

A Data Selection Scheme contains settings about range restrictions, configurations optimizer
settings an doutlier detection methods. Every assay element has to refer to exactly one data
selection scheme. However it is possible, that a scheme is refered by more then one assay
element.

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/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/ 213

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

You can enter a name for the data selection scheme. The name should be unique, but this is
not strictly recommended.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/ 214

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE: 215

No Outlier Detection USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoOutlierDetection T_Empty 1…1 <NONE>

No outlier detection will be performed for the referencing assay elements.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE: 216

Dixon Test for Data Outliers USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DixonTest xs:empty 1…1 <NONE>

A statistical test for data outliers based on W.J. Dixon, J. Bioanalytics 1954, p62. The test is
based on replicates. Sensitivity is defined by the respective &#945; value.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:Dixon Test for 217
Data Outliers/
USAGE
Alpha required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Alpha T_Alpha 1…1 0.05

The alpha value of the test (alpha = 1 - significance level of the test). Higher values of alpha
make the test less sensitive.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:Dixon Test for

Data Outliers/
218
USAGE
Recursive required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Recursive xs:boolean 1…1 true

If you set this value to true, the outlier test will be performed gain, without prviously found
outliers as long as the outliers are detected and the number of values is large equal 3.

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/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE: 219

Grubbs Test USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GrubbsTest xs:empty 1…1 <NONE>

A statistical test for data outliers based on Grubbs, XXX. The test is based on replicates.
Sensitivity is defined by the respective &#945; value.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:Grubbs Test/ 220

Alpha USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Alpha T_Alpha 1…1 0.05

The alpha value of the test (alpha = 1 - significance level of the test). Higher values of alpha
make the test less sensitive.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:Grubbs Test/ 221

Recursive USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Recursive xs:boolean 1…1 true

If you set this value to true, the outlier test will be performed again, without prviously found
outliers as long as the outliers are detected and the number of values is large equal 3.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE: 222

(Externally) Studentized Residuals USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StudentizedResidualsTest xs:empty 1…1 <NONE>

A model based approach for outlier detection.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:(Externally)

Studentized Residuals/
223
USAGE
Alpha required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Alpha T_Alpha 1…1 0.05

The alpha value of the test (alpha = 1 - significance level of the test). Higher values of alpha
make the test less sensitive.

/Quantitative Response Assay/Analysis/Data Selection Schemes/Data Selection Scheme/CHOICE:(Externally)

Studentized Residuals/
224
USAGE
Recursive required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Recursive xs:boolean 1…1 true

If you set this value to true, the outlier test will be performed again, without prviously found
outliers as long as the outliers are detected and the number of values is large equal 3.

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Standard Deviation Test USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StandardDeviationTest xs:empty 1…1 <NONE>

Statistical outlier detection method based on multiples of the standard deviation.

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Deviation Test/
226
USAGE
nSigma required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

nSigma T_PositiveDouble 1…1 3.0

The factor to be multiplied with the standard deviation.

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CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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RangeFull USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RangeFull T_Empty 1…1 <NONE>

Use the full dose range for potency calculation. You can use the choice selector for switching
to the alternative Range Partial .

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RangePartial USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RangePartial xs:empty 1…1 <NONE>

Use a partial range starting at Step Start and stopping by Step Stop . You can use the choice
selector for switching to the alternative Full Range .

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StepStart USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StepStart xs:positiveInteger 1…1 1

Step number of the start step for a partial range definition.

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Step Stop USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StepStop xs:positiveInteger 1…1 2

Step number of the stop step for a partial range definition.

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CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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OptimizationOff USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OptimizationOff T_Empty 1…1 <NONE>

No configuration optimizer will be used to analyze the according assay element. You can use
the choice selector to switch to the alternative Optimization On . Note: The evaluation time
for multiplex assays in combination with range optimization can be very long.

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OptimizationOn USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OptimizationOn xs:empty 1…1 <NONE>

The configurtaion optimizer will be used to analyze the according assay element. You can
use the choice selector to switch to the alternative Optimization Off . Unfold for further
settings of the configuration optimizer. Note: The evaluation time for multiplex assays in
combination with range optimization can be very long.

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Assay/Analysis/Data Selection Schemes/Data Selection 235
USAGE
IdenticalRange required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IdenticalRange xs:boolean 1…1 false

If identical range is true, only configurations using the same step numbers are taken into
account. In case of non-multiplex assays this has to hold for the assiciated standard - test /
control assay. Otherwise it has to hold for all assay elements except from control lines.

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Assay/Analysis/Data Selection Schemes/Data Selection 236
USAGE
IdenticalTreatmentNumber required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IdenticalTreatmentNumber xs:boolean 1…1 false

If identical treatment number is true, only configurations are considered, where the
assiciated test sample has the same number of treatments (steps) as the standard sample.
Will be ignored, if identical range is true.

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Scheme/CHOICE:OptimizationOn/
USAGE
Include50PercentResponse required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Include50PercentResponse xs:boolean 1…1 false

If this is set to true, only configurations are considered, that include the 50 % response.

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Scheme/CHOICE:OptimizationOn/
USAGE
CHOICE required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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Scheme/CHOICE:OptimizationOn/CHOICE:
Selection Schemes/Data Selection 239
USAGE
MinimalNumberOfSteps required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MinimalNumberOfSteps xs:positiveInteger 1…1 3

Only configurations are considered, that have at least the specified number of steps. You can
use the choice selector to switch to the alternative Exact Number of Steps .

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Scheme/CHOICE:OptimizationOn/CHOICE:
USAGE
ExcactNumberOfSteps required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcactNumberOfSteps xs:positiveInteger 1…1 3

Only configurations are considered, that have exactly the specified number of steps. You can
use the choice selector to switch to the alternative Minimal Number of Steps .

/Quantitative Response Assay/Analysis/ 241

Suitability Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Tests xs:empty 1…1 <NONE>

This section contains the subsection Assay Suitability Tests , Sample Suitability Tests and
Document Suitability Tests , where the statistical tests of the assay can be defined. Unfold to
see the subsections (left click on the plus sign in front of the element). Suitability tests are
required to prove the validity of your assay run.

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Assay Suitability Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssaySuitabilityTests T_SuitabilityTests 1…1 <NONE>

Add any number of assay suitability tests here. The result of an assay suitability test affects
the whole assay and not only the actually considered standard - test - comparison. In case of
multiplex assays there is no difference between the evaluation of assay suitability tests and
sample suitability tests.

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F-Test (Hypothesis Test) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FTest xs:empty 0…* <NONE>

Add a F-Test definition to the assay. After adding the test definition you can choose along
the following types: F-Test on the significance of non-parallelism F-Test on the significance
of non-linearity F-Test on the significance of regression F-Test on the significance of non-
similarity F-Test on the significance of slope F-Test on the significnace of the square
coefficient F-Test on the significance of non-parallelism Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote Assay elements Standard, Test, Control F-
Test on the significance of non-linearity Models Parallel-Linear-Line, 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote Assay elements Standard, Test, Control F-Test on the
significance of regression Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed
upper asymptote Assay elements Standard, Test, Control F-Test on the significance of non-
similarity Models Slope-Ratio Assay elements Standard, Test, Control F-Test on the
significance of slope Models all Assay elements Standard, Test, Control F-Test on the
significnace of the square coefficient Models all Assay elements Standard, Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Type USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type T_FTests 1…1 FTestNonParallelism

Details of the standard. Identify the standard, and it's unique identification. Optional Fields
(use Create Element , to create them): Unique Identification Date of Production Annotations

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Confidence Level (%) USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Parameter Estimate) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestParameter xs:empty 0…* <NONE>

Add equivalence test(s) for a single parameter to the assay. After adding the test definition
you have to select the parameter: Equivalence test on parameter slope Equivalence test on
the C Parameter of the nonlinear model Equivalence test on parameter lower asymptote
Equivalence test on parameter upper asymptote Equivalence test on the asymmetry
parameter Equivalence test on the Y-axis intercept Equivalence test on parameter slope
Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic
with fixed lower asymptote, 3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio
Assay elements Standard, Test, Control Equivalence test on the C Parameter of the
nonlinear model Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Standard, Test, Control Equivalence test on parameter lower
asymptote Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with
fixed upper asymptote Assay elements Standard, Test, Control Equivalence test on
parameter upper asymptote Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote Assay elements Standard, Test, Control
Equivalence test on the asymmetry parameter Models 5 Parameter-Logsitic Assay elements
Standard, Test, Control Equivalence test on the Y-axis intercept Models Parallel-Linear-
Line, Slope-Ratio Assay elements Standard, Test, Control Additional remarks: It depends on
the actually marked element, where the test definition is added. If Assay Suitability Tests or
one of its child is selected, the test will be added as a assay suitability test. If Sample
Suitability Tests or one of its child is selected, the test will be added as a samples suitability
test. If a test definition is chosen, that is not valid for the model ore the selected scope, it
will be ignored without notification.

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USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameter 1…1 Slope

Please select the parameter to be considered in this test.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Estimate)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Estimate)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Difference of Parameter Estimates) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestDifferenceOfParameters xs:empty 0…* <NONE>

Add equivalence test(s) for the difference of test/control-parameter minus standard-
parameter to the assay. After adding the test definition you have to select the parameter:
Equivalence test on the differnence of slopes Equivalence test on the differnence of lower
asymptotes Equivalence test on the differnence of upper asymptotes Equivalence test on
the differnence of the asymmetry parameters Equivalence test on the differnence of the Y-
axis intercepts Equivalence test on the differnence of slopes Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote Assay elements Test, Control Equivalence
test on the differnence of lower asymptotes Models 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed upper asymptote Assay elements Test, Control
Equivalence test on the differnence of upper asymptotes Models 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote Assay elements Test,
Control Equivalence test on the differnence of the asymmetry parameters Models 5
Parameter-Logsitic Assay elements Test, Control Equivalence test on the differnence of the
Y-axis intercepts Models Slope-Ratio Assay elements Test, Control Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Parameter Estimates)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Parameter Estimates)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Ratio of Parameter Estimates) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestRatioOfParameters xs:empty 0…* <NONE>

Add equivalence test(s) for the ratio of test/control-parameter over standard-parameter to
the assay. After adding the test definition you have to select the parameter: Equivalence
test on the ratio of slopes Equivalence test on the ratio of lower asymptotes Equivalence test
on the ratio of upper asymptotes Equivalence test on the ratio of the asymmetry
parameters Equivalence test on the ratio of the Y-axis intercepts Equivalence test on the
ratio of slopes Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Test, Control Equivalence test on the ratio of lower asymptotes
Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Test, Control Equivalence test on the ratio of upper asymptotes
Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower
asymptote Assay elements Test, Control Equivalence test on the ratio of the asymmetry
parameters Models 5 Parameter-Logsitic Assay elements Test, Control Equivalence test on
the ratio of the Y-axis intercepts Models Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification. The equivalence tests
on parameter ratios make use of Fieller's formula. If this formula has no varlid result, the test
result is set to not calculated (NC).

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Estimates)/
USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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Parameter Estimates)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Scaled Parameter Range) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestScaledParameterRange xs:empty 0…* <NONE>

Add equivalence test(s) for the scaled range of the test/control-parameter to the standard-
parameter (divided by the scaling parameter) to the assay. After adding the test definition
you have to select the parameter: Equivalence test on the scaled slope range Equivalence
test on the scaled lower asymptote range Equivalence test on the scaled upper asymptote
range Equivalence test on the scaled asymmetry parameter range Equivalence test on the
scaled Y-axis intercept range Equivalence test on the scaled slope range Models Parallel-
Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed
lower asymptote, 3 Parameter-Logistic with fixed upper asymptote Assay elements Test,
Control Equivalence test on the scaled lower asymptote range Models 4 Parameter-
Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed upper asymptote Assay
elements Test, Control Equivalence test on the scaled upper asymptote range Models 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote
Assay elements Test, Control Equivalence test on the scaled asymmetry parameter range
Models 5 Parameter-Logsitic Assay elements Test, Control Equivalence test on the scaled Y-
axis intercept range Models Slope-Ratio Assay elements Test, Control Additional remarks:
It depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Parameter Range)/
USAGE
Scaling Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ScalingParameter xs:decimal 1…1 1.0

Enter the scaling parameter of the test as positiv decimal number. The observed confidence
interval is divided by the scaling parameter before it is compared to the margins. Additional
Remarks As scaling parameter is usually chosen from historical data during assay
development. You can use the Equivalenc Margin Report of PLA for this purpose.

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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence test on the asymptote range USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestDifferenceOfAsymptotes xs:string 0…* <NONE>

Add Add equivalence test(s) for the difference of upper asymptote minus lower asymptote
to the assay. Models 4 Parameter-Logistic, 5 Parameter-Logsitic Assay elements Standard,
Test, Control Additional remarks: It depends on the actually marked element, where the
test definition is added. If Assay Suitability Tests or one of its child is selected, the test will
be added as a assay suitability test. If Sample Suitability Tests or one of its child is selected,
the test will be added as a samples suitability test. If a test definition is chosen, that is not
valid for the model ore the selected scope, it will be ignored without notification.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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range/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence test on ratio of the asymptotes USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestRatioOfAsymptotes xs:string 0…* <NONE>

Add Add equivalence test(s) for the ratui of upper asymptote over lower asymptote to the
assay. Models 4 Parameter-Logistic, 5 Parameter-Logsitic Assay elements Standard, Test,
Control Additional remarks: It depends on the actually marked element, where the test
definition is added. If Assay Suitability Tests or one of its child is selected, the test will be
added as a assay suitability test. If Sample Suitability Tests or one of its child is selected, the
test will be added as a samples suitability test. If a test definition is chosen, that is not valid
for the model ore the selected scope, it will be ignored without notification. The test make
use of Fieller's formula. If this formula has no varlid result, the test result is set to not
calculated (NC).

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence test on the scaled range of the asymptotes USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestScaledRangeOfAsymptotes xs:string 0…* <NONE>

Add equivalence test(s) for the scaled range of upper asymptote minus lower asymptote
(divided by the scaling parameter) to the assay. Models 4 Parameter-Logistic, 5 Parameter-
Logsitic Assay elements Test, Control Additional remarks: It depends on the actually marked
element, where the test definition is added. If Assay Suitability Tests or one of its child is
selected, the test will be added as a assay suitability test. If Sample Suitability Tests or one of
its child is selected, the test will be added as a samples suitability test. If a test definition is
chosen, that is not valid for the model ore the selected scope, it will be ignored without
notification.

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range of the asymptotes/
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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Scaling Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ScalingParameter xs:decimal 1…1 1.0

Enter the scaling parameter of the test as positiv decimal number. The observed confidence
interval is divided by the scaling parameter before it is compared to the margins. Additional
Remarks As scaling parameter is usually chosen from historical data during assay
development. You can use the Equivalenc Margin Report of PLA for this purpose.

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range of the asymptotes/
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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Sum of Squares Non-Linearity USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestSumOfSquaresNonLinearity xs:string 0…* <NONE>

Add additional test(s) for teh sum of squares non-linearity (also know as sum of squares lack
of fit) to the assay. The test is passed, if the sum of squares non-linearity (from the ANOVA
table) does not exceed the upper margin given in the test definition. Models Parallel-Linear-
Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower
asymptote, 3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements
Test, Control Additional remarks: We recommend not to use this test, when (statistical
and/or technical) outliers occured. The historical assays used for margin development should
have had the same number of observations as the assay for which the test ist defined. It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Non-Linearity/
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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299
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Maximal Number of Outliers USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMaximalNumberOfOutliers xs:empty 0…* <NONE>

Add additional test(s) for the maximal numbers of outliers to the assay. The test is passed, if
the number of technical and statistical outliers of the assay element do not exceed the
upper margin given in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic,
5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote, Slope-Ratio Assay elements Standard, Test, Control, Baseline
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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301
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:nonNegativeInteger 1…1 1

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

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302
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Number of Outliers/
303
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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304
USAGE
Extent of the Test required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Extent T_Extent 1…1 AssayElement

The test counts technical outliers, statistical outliers and missing values. Define the test's
extent. You can choose along: Assay Element to perform the test only for the data of a
single assay element. Assay to perform the test for the whole assay data. Treatment Step to
perform the test for the treatment steps of an assay element.

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Additional test: Maximal Sequence Step CV (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMaximalPercentualSequenceStepCV xs:string 0…* <NONE>

Add additional test(s) for the maximal percentual CV of a sequence step. The test is passed,
if all sequence step CV are smaller equal than the given margin. Models Parallel-Linear-Line,
4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote,
3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Standard,
Test, Control, Baseline

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Sequence Step CV (%)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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307
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Sequence Step CV (%)/
308
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Response Value Range USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestResponseValueRange xs:string 0…* <NONE>

Add additional test(s) for the response value range to the assay. The test is passed, if the
minmal response value of the assay element is greater equal than the lower margin given in
the test definition and the if the maximal response value of the assay element is smaller
equal than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Standard, Test,
Control, Baseline Additional remarks: The test considers only untransformed response
values. So response adjustment or response transformation will not be taken into account. It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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310
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Range/
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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312
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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313
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Potency Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyValue xs:string 0…* <NONE>

Add additional test(s) for the potency value to the assay. The test is passed, if the potency
value is greater equal than the lower margin given in the test definition and smaller equal
than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Lower Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Potency Type USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyType T_TestParameterPotencyType 0…1 RelativePotency

You can choose 'Relative Potency', 'Raw Material Potency' or 'Stock Solution Potency'. The
test is evaluated based on the selected potency type. The assay has to be set up, such that
the selected potency type is calculated (by defining suitable preparation schemes). If no
potency for the selected type is calculated, the test result is 'not calculated'.

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Additional Test: Potency Confidence Interval USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyConfidenceInterval xs:string 0…* <NONE>

Add additional test(s) for the potency confidence interval to the assay. The test is passed, if
the lower confidence limit of the relative potency is greater equal than the lower margin
given in the test definition and if the upper confidence limit of the potency is smaller equal
than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Confidence Interval/
321
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Confidence Interval/
322
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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324
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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USAGE
Potency Type optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyType T_TestParameterPotencyType 0…1 RelativePotency

You can choose 'Relative Potency', 'Raw Material Potency' or 'Stock Solution Potency'. The
test is evaluated based on the selected potency type. The assay has to be set up, such that
the selected potency type is calculated (by defining suitable preparation schemes). If no
potency for the selected type is calculated, the test result is 'not calculated'.

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Additional Test: Relative Potency Range (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyRange xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence range to the assay. The test is
passed, if the percentual relative potency range is smaller equal than the upper margin given
in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed
upper asymptote, Slope-Ratio Assay elements Test, Control Additional remarks: It depends
on the actually marked element, where the test definition is added. If Assay Suitability Tests
or one of its child is selected, the test will be added as a assay suitability test. If Sample
Suitability Tests or one of its child is selected, the test will be added as a samples suitability
test. If a test definition is chosen, that is not valid for the model ore the selected scope, it
will be ignored without notification.

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Range (%)/
327
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Range (%)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Potency Range (%)/
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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Minimal R² USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinRSquared xs:string 0…* <NONE>

Add additional test(s) for the minimal R² to the assay. The test is passed, if the R² of the
restricted regression fit is smaller equal than the lower margin given in the test definition.
Models Parallel-Linear-Line, Slope-Ratio Assay elements Test, Control Additional remarks:
It depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Weight W USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinimalWeight xs:string 0…* <NONE>

Add additional test(s) for the weight. The test is passed, if the potency weight is greater
equal than the lower margin given in the test definition and smaller equal than the upper
margin given in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote, Slope-Ratio Assay elements Test, Control Additional remarks:
The definition of the weight can be found in the European Pharmacopeia Chapter 5.3,
formula (6.2.1.-1) It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Lower Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Sample Suitability Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SampleSuitabilityTests T_SuitabilityTests 1…1 <NONE>

Add any number of sample suitability tests here. The result of an sample suitability test
affects only the actually considered standard - test - comparison and not the whole assay. In
case of multiplex assays there is no difference between the evaluation of assay suitability
tests and sample suitability tests.

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F-Test (Hypothesis Test) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FTest xs:empty 0…* <NONE>

Add a F-Test definition to the assay. After adding the test definition you can choose along
the following types: F-Test on the significance of non-parallelism F-Test on the significance
of non-linearity F-Test on the significance of regression F-Test on the significance of non-
similarity F-Test on the significance of slope F-Test on the significnace of the square
coefficient F-Test on the significance of non-parallelism Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote Assay elements Standard, Test, Control F-
Test on the significance of non-linearity Models Parallel-Linear-Line, 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote Assay elements Standard, Test, Control F-Test on the
significance of regression Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed
upper asymptote Assay elements Standard, Test, Control F-Test on the significance of non-
similarity Models Slope-Ratio Assay elements Standard, Test, Control F-Test on the
significance of slope Models all Assay elements Standard, Test, Control F-Test on the
significnace of the square coefficient Models all Assay elements Standard, Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Test)/
USAGE
Type required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type T_FTests 1…1 FTestNonParallelism

Details of the standard. Identify the standard, and it's unique identification. Optional Fields
(use Create Element , to create them): Unique Identification Date of Production Annotations

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Confidence Level (%) USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Parameter Estimate) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestParameter xs:empty 0…* <NONE>

Add equivalence test(s) for a single parameter to the assay. After adding the test definition
you have to select the parameter: Equivalence test on parameter slope Equivalence test on
the C Parameter of the nonlinear model Equivalence test on parameter lower asymptote
Equivalence test on parameter upper asymptote Equivalence test on the asymmetry
parameter Equivalence test on the Y-axis intercept Equivalence test on parameter slope
Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic
with fixed lower asymptote, 3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio
Assay elements Standard, Test, Control Equivalence test on the C Parameter of the
nonlinear model Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Standard, Test, Control Equivalence test on parameter lower
asymptote Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with
fixed upper asymptote Assay elements Standard, Test, Control Equivalence test on
parameter upper asymptote Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote Assay elements Standard, Test, Control
Equivalence test on the asymmetry parameter Models 5 Parameter-Logsitic Assay elements
Standard, Test, Control Equivalence test on the Y-axis intercept Models Parallel-Linear-
Line, Slope-Ratio Assay elements Standard, Test, Control Additional remarks: It depends on
the actually marked element, where the test definition is added. If Assay Suitability Tests or
one of its child is selected, the test will be added as a assay suitability test. If Sample
Suitability Tests or one of its child is selected, the test will be added as a samples suitability
test. If a test definition is chosen, that is not valid for the model ore the selected scope, it
will be ignored without notification.

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USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameter 1…1 Slope

Please select the parameter to be considered in this test.

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Estimate)/
347
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Estimate)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Estimate)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Difference of Parameter Estimates) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestDifferenceOfParameters xs:empty 0…* <NONE>

Add equivalence test(s) for the difference of test/control-parameter minus standard-
parameter to the assay. After adding the test definition you have to select the parameter:
Equivalence test on the differnence of slopes Equivalence test on the differnence of lower
asymptotes Equivalence test on the differnence of upper asymptotes Equivalence test on
the differnence of the asymmetry parameters Equivalence test on the differnence of the Y-
axis intercepts Equivalence test on the differnence of slopes Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote Assay elements Test, Control Equivalence
test on the differnence of lower asymptotes Models 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed upper asymptote Assay elements Test, Control
Equivalence test on the differnence of upper asymptotes Models 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote Assay elements Test,
Control Equivalence test on the differnence of the asymmetry parameters Models 5
Parameter-Logsitic Assay elements Test, Control Equivalence test on the differnence of the
Y-axis intercepts Models Slope-Ratio Assay elements Test, Control Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Parameter Estimates)/
USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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Parameter Estimates)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Parameter Estimates)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Parameter Estimates)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Ratio of Parameter Estimates) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestRatioOfParameters xs:empty 0…* <NONE>

Add equivalence test(s) for the ratio of test/control-parameter over standard-parameter to
the assay. After adding the test definition you have to select the parameter: Equivalence
test on the ratio of slopes Equivalence test on the ratio of lower asymptotes Equivalence test
on the ratio of upper asymptotes Equivalence test on the ratio of the asymmetry
parameters Equivalence test on the ratio of the Y-axis intercepts Equivalence test on the
ratio of slopes Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3
Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Test, Control Equivalence test on the ratio of lower asymptotes
Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed upper
asymptote Assay elements Test, Control Equivalence test on the ratio of upper asymptotes
Models 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower
asymptote Assay elements Test, Control Equivalence test on the ratio of the asymmetry
parameters Models 5 Parameter-Logsitic Assay elements Test, Control Equivalence test on
the ratio of the Y-axis intercepts Models Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification. The equivalence tests
on parameter ratios make use of Fieller's formula. If this formula has no varlid result, the test
result is set to not calculated (NC).

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Estimates)/
USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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Parameter Estimates)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Parameter Estimates)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence Test (Scaled Parameter Range) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestScaledParameterRange xs:empty 0…* <NONE>

Add equivalence test(s) for the scaled range of the test/control-parameter to the standard-
parameter (divided by the scaling parameter) to the assay. After adding the test definition
you have to select the parameter: Equivalence test on the scaled slope range Equivalence
test on the scaled lower asymptote range Equivalence test on the scaled upper asymptote
range Equivalence test on the scaled asymmetry parameter range Equivalence test on the
scaled Y-axis intercept range Equivalence test on the scaled slope range Models Parallel-
Linear-Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed
lower asymptote, 3 Parameter-Logistic with fixed upper asymptote Assay elements Test,
Control Equivalence test on the scaled lower asymptote range Models 4 Parameter-
Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed upper asymptote Assay
elements Test, Control Equivalence test on the scaled upper asymptote range Models 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote
Assay elements Test, Control Equivalence test on the scaled asymmetry parameter range
Models 5 Parameter-Logsitic Assay elements Test, Control Equivalence test on the scaled Y-
axis intercept range Models Slope-Ratio Assay elements Test, Control Additional remarks:
It depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Range)/
USAGE
Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Parameter T_EquivalenceTestParameterWOInflectionPoint 1…1 Slope

Please select the parameter to be considered in this test.

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Parameter Range)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Parameter Range)/
USAGE
Scaling Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ScalingParameter xs:decimal 1…1 1.0

Enter the scaling parameter of the test as positiv decimal number. The observed confidence
interval is divided by the scaling parameter before it is compared to the margins. Additional
Remarks As scaling parameter is usually chosen from historical data during assay
development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Parameter Range)/
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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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Parameter Range)/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence test on the asymptote range USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestDifferenceOfAsymptotes xs:string 0…* <NONE>

Add Add equivalence test(s) for the difference of upper asymptote minus lower asymptote
to the assay. Models 4 Parameter-Logistic, 5 Parameter-Logsitic Assay elements Standard,
Test, Control Additional remarks: It depends on the actually marked element, where the
test definition is added. If Assay Suitability Tests or one of its child is selected, the test will
be added as a assay suitability test. If Sample Suitability Tests or one of its child is selected,
the test will be added as a samples suitability test. If a test definition is chosen, that is not
valid for the model ore the selected scope, it will be ignored without notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Equivalence test on the

asymptote range/
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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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asymptote range/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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asymptote range/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Equivalence test on ratio of the asymptotes USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestRatioOfAsymptotes xs:string 0…* <NONE>

Add Add equivalence test(s) for the ratui of upper asymptote over lower asymptote to the
assay. Models 4 Parameter-Logistic, 5 Parameter-Logsitic Assay elements Standard, Test,
Control Additional remarks: It depends on the actually marked element, where the test
definition is added. If Assay Suitability Tests or one of its child is selected, the test will be
added as a assay suitability test. If Sample Suitability Tests or one of its child is selected, the
test will be added as a samples suitability test. If a test definition is chosen, that is not valid
for the model ore the selected scope, it will be ignored without notification. The test make
use of Fieller's formula. If this formula has no varlid result, the test result is set to not
calculated (NC).

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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Equivalence test on ratio of the 381
asymptotes/
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Equivalence test on ratio of the

asymptotes/
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USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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asymptotes/
383
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/ 385

Equivalence test on the scaled range of the asymptotes USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquivalenceTestScaledRangeOfAsymptotes xs:string 0…* <NONE>

Add equivalence test(s) for the scaled range of upper asymptote minus lower asymptote
(divided by the scaling parameter) to the assay. Models 4 Parameter-Logistic, 5 Parameter-
Logsitic Assay elements Test, Control Additional remarks: It depends on the actually marked
element, where the test definition is added. If Assay Suitability Tests or one of its child is
selected, the test will be added as a assay suitability test. If Sample Suitability Tests or one of
its child is selected, the test will be added as a samples suitability test. If a test definition is
chosen, that is not valid for the model ore the selected scope, it will be ignored without
notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Equivalence test on the scaled

range of the asymptotes/
386
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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range of the asymptotes/
USAGE
Scaling Parameter required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ScalingParameter xs:decimal 1…1 1.0

Enter the scaling parameter of the test as positiv decimal number. The observed confidence
interval is divided by the scaling parameter before it is compared to the margins. Additional
Remarks As scaling parameter is usually chosen from historical data during assay
development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Equivalence test on the scaled

range of the asymptotes/
389
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

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range of the asymptotes/
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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Sum of Squares Non-Linearity USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestSumOfSquaresNonLinearity xs:string 0…* <NONE>

Add additional test(s) for teh sum of squares non-linearity (also know as sum of squares lack
of fit) to the assay. The test is passed, if the sum of squares non-linearity (from the ANOVA
table) does not exceed the upper margin given in the test definition. Models Parallel-Linear-
Line, 4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower
asymptote, 3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements
Test, Control Additional remarks: We recommend not to use this test, when (statistical
and/or technical) outliers occured. The historical assays used for margin development should
have had the same number of observations as the assay for which the test ist defined. It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Non-Linearity/
393
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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Non-Linearity/
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Maximal Number of Outliers USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMaximalNumberOfOutliers xs:empty 0…* <NONE>

Add additional test(s) for the maximal numbers of outliers to the assay. The test is passed, if
the number of technical and statistical outliers of the assay element do not exceed the
upper margin given in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic,
5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote, Slope-Ratio Assay elements Standard, Test, Control, Baseline
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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of Outliers/
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USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:nonNegativeInteger 1…1 1

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

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398
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Number of Outliers/
399
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Number of Outliers/
400
USAGE
Extent of the Test required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Extent T_Extent 1…1 AssayElement

The test counts technical outliers, statistical outliers and missing values. Define the test's
extent. You can choose along: Assay Element to perform the test only for the data of a
single assay element. Assay to perform the test for the whole assay data. Treatment Step to
perform the test for the treatment steps of an assay element.

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Additional test: Maximal Sequence Step CV (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMaximalPercentualSequenceStepCV xs:string 0…* <NONE>

Add additional test(s) for the maximal percentual CV of a sequence step. The test is passed,
if all sequence step CV are smaller equal than the given margin. Models Parallel-Linear-Line,
4 Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote,
3 Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Standard,
Test, Control, Baseline

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Sequence Step CV (%)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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403
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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404
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Response Value Range USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestResponseValueRange xs:string 0…* <NONE>

Add additional test(s) for the response value range to the assay. The test is passed, if the
minmal response value of the assay element is greater equal than the lower margin given in
the test definition and the if the maximal response value of the assay element is smaller
equal than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Standard, Test,
Control, Baseline Additional remarks: The test considers only untransformed response
values. So response adjustment or response transformation will not be taken into account. It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Range/
406
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Range/
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Range/
408
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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409
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Potency Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyValue xs:string 0…* <NONE>

Add additional test(s) for the potency value to the assay. The test is passed, if the potency
value is greater equal than the lower margin given in the test definition and smaller equal
than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Lower Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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414
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Value/
USAGE
Potency Type optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyType T_TestParameterPotencyType 0…1 RelativePotency

You can choose 'Relative Potency', 'Raw Material Potency' or 'Stock Solution Potency'. The
test is evaluated based on the selected potency type. The assay has to be set up, such that
the selected potency type is calculated (by defining suitable preparation schemes). If no
potency for the selected type is calculated, the test result is 'not calculated'.

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Additional Test: Potency Confidence Interval USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyConfidenceInterval xs:string 0…* <NONE>

Add additional test(s) for the potency confidence interval to the assay. The test is passed, if
the lower confidence limit of the relative potency is greater equal than the lower margin
given in the test definition and if the upper confidence limit of the potency is smaller equal
than the upper margin given in the test definition. Models Parallel-Linear-Line, 4
Parameter-Logistic, 5 Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3
Parameter-Logistic with fixed upper asymptote, Slope-Ratio Assay elements Test, Control
Additional remarks: It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Confidence Interval/
417
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The upper margin has to be greater
equal than the lower margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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Confidence Interval/
418
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The lower margin has to be smaller
equal than the upper margin of the test. Please find further informaion in the test
description. Additional Remarks Margins for tests are usually chosen from historical data
during assay development. You can use the Equivalenc Margin Report of PLA for this
purpose.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Potency

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420
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Confidence Interval/
421
USAGE
Potency Type optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyType T_TestParameterPotencyType 0…1 RelativePotency

You can choose 'Relative Potency', 'Raw Material Potency' or 'Stock Solution Potency'. The
test is evaluated based on the selected potency type. The assay has to be set up, such that
the selected potency type is calculated (by defining suitable preparation schemes). If no
potency for the selected type is calculated, the test result is 'not calculated'.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/ 422

Additional Test: Relative Potency Range (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyRange xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence range to the assay. The test is
passed, if the percentual relative potency range is smaller equal than the upper margin given
in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic, 5 Parameter-
Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic with fixed
upper asymptote, Slope-Ratio Assay elements Test, Control Additional remarks: It depends
on the actually marked element, where the test definition is added. If Assay Suitability Tests
or one of its child is selected, the test will be added as a assay suitability test. If Sample
Suitability Tests or one of its child is selected, the test will be added as a samples suitability
test. If a test definition is chosen, that is not valid for the model ore the selected scope, it
will be ignored without notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Relative

Potency Range (%)/
423
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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424
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Relative

Potency Range (%)/
425
USAGE
Severity Level of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Additional Test: Minimal R² USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinRSquared xs:string 0…* <NONE>

Add additional test(s) for the minimal R² to the assay. The test is passed, if the R² of the
restricted regression fit is smaller equal than the lower margin given in the test definition.
Models Parallel-Linear-Line, Slope-Ratio Assay elements Test, Control Additional remarks:
It depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Minimal R²/ 427
Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Minimal R²/ 428
Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/ 430

Additional Test: Weight W USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinimalWeight xs:string 0…* <NONE>

Add additional test(s) for the weight. The test is passed, if the potency weight is greater
equal than the lower margin given in the test definition and smaller equal than the upper
margin given in the test definition. Models Parallel-Linear-Line, 4 Parameter-Logistic, 5
Parameter-Logsitic, 3 Parameter-Logistic with fixed lower asymptote, 3 Parameter-Logistic
with fixed upper asymptote, Slope-Ratio Assay elements Test, Control Additional remarks:
The definition of the weight can be found in the European Pharmacopeia Chapter 5.3,
formula (6.2.1.-1) It depends on the actually marked element, where the test definition is
added. If Assay Suitability Tests or one of its child is selected, the test will be added as a
assay suitability test. If Sample Suitability Tests or one of its child is selected, the test will be
added as a samples suitability test. If a test definition is chosen, that is not valid for the
model ore the selected scope, it will be ignored without notification.

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Lower Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Quantitative Response Assay/Analysis/Suitability Tests/Sample Suitability Tests/Additional Test: Weight W/ 432

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform
the test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Quantitative Response Assay/Analysis/Suitability Tests/ 434

Document Suitability Tests USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentSuitabilityTests T_DocumentSuitabilityTests 0…1 <NONE>

Add any number of document suitability tests here. The result of an document suitability
test the whole assay and not only the actually considered standard - test - comparison.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/ 435

Signature State USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestSignatureState xs:empty 0…* <NONE>

Add test(s) for the signature state. It is required to enter a scope (dataset or content) for the
test. Additionally it is possible to specify meaning and number.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/Signature State/ 436

Number of Signatures USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Number xs:decimal 0…1 1.0

The required number of signatures of the considered type.

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Meaning USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Meaning xs:string 0…1 <NONE>

Enter a signature meaning. Only signatures with the entered meaning are considered in the
test.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/Signature State/ 438

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeContent

Define which part of the document should be signed. You can choose along: Content : Only
signatures on the content part of the document are considered by the test. Dataset : Only
signatures on the whole document are considered by the test.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/Signature State/ 439

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/ 440

Test on User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestOnUserVariable xs:empty 0…* <NONE>

Add test(s) on the user variable. If only a key is defined, only existence is checked. In case of
a given value, the value for the key is checked also.

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Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:string 1…1 <NONE>

Identification key for the user variable.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/Test on User Variable/ 442

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Quantitative Response Assay/Analysis/Suitability Tests/Document Suitability Tests/Test on User Variable/ 443

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Quantitative Response Assay/ 444

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comments to this assay. You cann add a Subject or Document Link by using the
creation panel.

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/Quantitative Response Assay/Comment/ 445

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Optional comment subject.

/Quantitative Response Assay/Comment/ 446

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

/Quantitative Response Assay/Comment/ 447

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

/Quantitative Response Assay/Comment/ 448

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Quantitative Response Assay/Comment/ 449

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES
Substance and Operator information can be aggregated from the generator document, if
given.

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com

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Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Document Title Title of the Docu- String http://purl.org/dc/terms/title
ment.
Date Date DateTime [SSY]/bioassay/date
Status Status of the String [SSY]/bioassay/status
Document.
Assay Elment Type of the assay String [SSY]/bioassay/elementtype
Type element (Standard,
Test or Control)
Rel. Potency Relative Potency Va- Double [SSY]/bioassay/relativepotency
lue.
Rel. Potency Lower Confidence Double [SSY]/bioassay/relativepotency_lowerlimit
Lower Conf. Limit of the Relative
Limit Potency.
Rel. Potency Upper Confidence Double [SSY]/bioassay/relativepotency_upperlimit
Upper Conf. Limit of the Relative
Limit Potency.
Abs. Potency Absolute Potency Double [SSY]/bioassay/absolutepotency
Value.
Abs. Potency Lower Confidence Double [SSY]/bioassay/absolutepotency_lowerlimit
Lower Conf. Limit of the Absolute
Limit Potency.
Abs. Potency Upper Confidence Double [SSY]/bioassay/absolutepotency_upperlimit
Upper Conf. Limit of the Absolute
Limit Potency.
Weight So called potency Double [SSY]/bioassay/potency_weight
weight, which is used
in a weighted combi-
nation of independ-
ent assays.
Degrees of The degreese of free- Integer [SSY]/bioassay/coa_df
Freedom dom used for the
calculation of the
potency confidence
interval. This depends
on the chosen ANO-
VA model.
Overall Test The assay's overall String [SSY]/bioassay/testresult
Result test result.
Regression The regression model String [SSY]/bioassay/coa_model
Model used for analyzing the
assay.
Group ID The group ID deter- String [SSY]/bioassay/coa_group
mining, which ele-
ments will be com-
bined in the same

150
 Quantitative Response Assays

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
combination of inde-
pendent assay calcu-
lation.
Potency Con- The confidence level Integer [SSY]/bioassay/coa_confidence_level
fidence Level of the calculated po-
tency confidence in-
tervals.
Parameter A The estimated pa- Double [SSY]/bioassay/emd_tst_a
(Test) rameter value of the
upper asymptote of
the test sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_a_se
rameter A ard deviation of the
(Test) upper asymptote of
the test sample.
Parameter A The estimated pa- Double [SSY]/bioassay/emd_std_a
(Standard) rameter value of the
upper asymptote of
the Standard sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_a_se
rameter A ard deviation of the
(Standard) upper asymptote of
the standard sample.
Parameter B The estimated pa- Double [SSY]/bioassay/emd_tst_b
(Test) rameter value of the
slope of the test
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_b_se
rameter B ard deviation of the
(Test) slope of the test
sample.
Parameter B The estimated pa- Double [SSY]/bioassay/emd_std_b
(Standard) rameter value of the
slope of the standard
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_b_se
rameter C ard deviation of the C
(Standard) Parameter of the
standard sample.
Parameter C The estimated pa- Double [SSY]/bioassay/emd_tst_c
(Test) rameter value of the
C Parameter of the
test sample. In case
of a 4-parameter-
logistic fit this is the

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Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
log inflection point.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_c_se
rameter C ard deviation of the C
(Test) Parameter of the test
sample.
Parameter C The estimated pa- Double [SSY]/bioassay/emd_std_c
(Standard) rameter value of the
C Parameter of the
standard sample. In
case of a 4-
parameter-logistic fit
this is the log inflec-
tion point.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_c_se
rameter C ard deviation of the C
(Standard) Parameter of the
standard sample.
Parameter D The estimated pa- Double [SSY]/bioassay/emd_tst_d
(Test) rameter value of the
lower asymptote of
the test sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_d_se
rameter D ard deviation of the
(Test) lower asymptote of
the test sample.
Parameter D The estimated pa- Double [SSY]/bioassay/emd_std_d
(Standard) rameter value of the
lower asymptote of
the standard sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_d_se
rameter D ard deviation of the
(Standard) lower asymptote of
the standard sample.
Parameter G The estimated pa- Double [SSY]/bioassay/emd_tst_g
(Test) rameter value of the
asymmetry parame-
ter of the test sam-
ple.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_g_se
rameter G ard deviation value of
(Test) the asymmetry pa-
rameter of the test
sample.
Parameter G The estimated pa- Double [SSY]/bioassay/emd_std_g
(Standard) rameter value of the

152
 Quantitative Response Assays

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
asymmetry parame-
ter of the standard
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_g_se
rameter G ard deviation value of
(Standard) the asymmetry pa-
rameter of the stand-
ard sample.
Slope (Test) The estimated pa- Double [SSY]/bioassay/emd_tst_m
rameter value of the
slope of the test
sample.
Std. Dev. Slope The estimated stand- Double [SSY]/bioassay/emd_tst_m_se
(Test) ard deviation of the
slope of the test
sample.
Slope (Stan- The estimated pa- Double [SSY]/bioassay/emd_std_m
dard) rameter value of the
slope of the standard
sample.
Std. Dev. Slope The estimated stand- Double [SSY]/bioassay/emd_std_m_se
(Standard) ard deviation of the
slope of the standard
sample.
Y-Axis Inter- The estimated pa- Double [SSY]/bioassay/emd_tst_n
cept rameter value of the
y-axis intercept of the
test sample.
Std. Dev. Y-Axis The estimated stand- Double [SSY]/bioassay/emd_tst_n_se
Intercept (Test) ard deviation of the
y-axis intercept of the
test sample.
Y-Axis Inter- The estimated pa- Double [SSY]/bioassay/emd_std_n
cept (Standard) rameter value of the
y-axis intercept of the
standard sample.
Std. Dev. Y-Axis The estimated stand- Double [SSY]/bioassay/emd_std_n_se
Intercept ard deviation of the
(Standard) y-axis intercept of the
standard sample.
Covariance Estimated covariance Double [SSY]/bioassay/emd_std_a_d_cov
Upper/Lower of upper and lower
Asymptote asymptote of the
(Standard) standard sample.
Sum of Squares Sum of squares non- Double [SSY]/bioassay/emd_ss_lof

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Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Non-Linearity linearity (lack of fit)
(LoF)
Estimated Va- The estimated vari- Double [SSY]/bioassay/emd_var
riance ance. This value de-
pends on the chosen
ANOVA model.

154
 Dichotomous Assays

DICHOTOMOUS ASSAYS

DESCRIPTION
Purpose of the Dichotomous Assay document type is the calculation of relative potencies. If
information about stock solution or the raw material is given, the document type performs a
backfit calculation for absolute potencies.

A Dichotomous Assay is a dilution assay containing at least one reference and one test or
control sample to calculate the potency. An assay consists of different elements with meas-
urement data at different concentrations (or dilutions) of the active ingredient. The assay
can be calculated using the Logit or Probit method.

Data values are given in a binary form: A number of specimen m out of a total n shows a giv-
en response. Both values m and n must be given for the analysis.

ASSAY ELEMENTS
Assay Elements are the building blocks for an assay.

The assay elements are

Standard Sample The reference standard of the assay. Relative potency is calculated
against this element. Each assay document has exactly one Standard
Sample. The Standard Sample is a series of measurements at different
dilution or concentration levels.

Exactly 1 Standard Element is required for each assay.

Test Sample The calculation of the potency of the test sample is the aim of the doc-
ument. The Test Sample is a series of measurements at different dilu-
tion or concentration levels.

The element is optional but at least one test sample or control sample
is required. Any number of elements is supported.
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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

Control Sample A control sample is a “well-known” test sample. Usually it is used as

the basis of an assay acceptance test. The Control Sample is a series of
measurements at different dilution or concentration levels.

The element is optional but at least one test sample or control sample
is required. Any number of elements is supported.

CALCULATION OVERVIEW
The calculation is carried out following a number of steps.

The calculation can be started after the assay has been set up. As a result the assay docu-
ment will contain the results of the calculation.

R EGRESSION A NALYSIS
The regression analysis is carried out be running two regressions. In the full model all regres-
sion parameters are defined per assay element. The system is able to find the best fit for the
system. The restricted model restricts the regression model to describe only the difference
of the elements. The latter analysis is used to carry out the potency calculation. The full
model or the difference between the full and the restricted model is used to describe the
suitability of the system in the later step of suitability testing.

The following regression models are supported:

• Probit-Analysis
• Logit-Analysis

M ULTIPLEX A SSAYS
As a standard all assay regressions are carried out one-by-one, which means that all regres-
sions are done pair-wise. In a multiplex assay all regressions are carried out at once in a sin-
gle model. This type of assay can be used to address incomplete data in single assay ele-
ments.

156
 Dichotomous Assays

ANALYSIS OF VARIANCE
The variance analysis describes the regression system. The influence of different compo-
nents is being used to get a good overall description of the system.

POTENCY CALCULATION
The primary target of the method is the calculation of a relative potency between the test
sample and the standard sample. However, the system can carry out various backfit calcula-
tions if the absolute potencies of the stock solution and or the raw material are given. The
system calculates the relative potency and all additional absolute potencies.

The dilution model follows this path:

From a raw material the concentration of a stock solution can be calculated. From the stock
solution the concentration of the measurement doses can be calculated.

Since the definition of the stock solution and the raw material is optional the system can
carry out different types of backfit calculations depending on the definitions.

Defined Potency Infor- Calculated Potency Information

mation
Standard Test Relative Po-
S1 S2 T1 T2 tency Absolute Potency

X Always No
X calculated
X (*) Stock Solution

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X X
X X
X (*)
X X
X X Raw Material
(*) When no stock solution potency of the test is given, it is assumed to be 1.

Note: For the correct calculation of the stock solution the Dilution Factors for all assay ele-
ments have to be defined.

TEST SYSTEM
A major advantage of assay based on curve similarity is the option to prove the validity of
the calculation each time the calculation is performed.

As a rule of thumb at least one parallelism test or one test of common intercept should be
defined for a valid result.

T EST S YSTEM L OGIC

The test system of PLA 3.0 allows sophisticated test setups. Three different aspects are rele-
vant to setup the test system logic:

• Test Level
• Test Severity
• Test Scope

TEST LEVEL
The test system distinguishes assay suitability tests and sample suitability tests. If an assay
suitability test fails this has an impact on all assay elements. E.g. you can setup an assay suit-
ability test for a (well-known) control sample. If this test fails, all results for all assay ele-
ments will fail. A sample suitability test only fails the corresponding sample.

TEST SEVERITY
Three different severity levels allow flexible reactions of the system.

Highest Test Severity of a Impact on assay result when test fails

Failed Test
(No Test Failed) None.
Information None, but an information message is dis-
played
Warning FAILED, but potency will be calculat-
ed/reported
Reject FAILED, no potency is calculated/reported

TEST SCOPE
Test can have different scopes. The test scopes define whether a test is relevant in a specific
scenario.

158
 Dichotomous Assays

Available Scopes:

• All Assay Elements: The test is performed for every element.

• Standard only: Test is performed only for standard elements. Note: Only tests for sin-
gle assay elements are being calculated (e.g. test for parallelism would be ignored).
• Tests Samples only: The test is performed with every test sample but not with other
elements.
• Control Samples only: The test is performed with every control sample but not with
other elements.
• Control Lines only: The test is performed with every control line but not with other
elements. Note: only tests available for control lines are being calculated. Others are
ignored.

C HI -S QUARE -T ESTS
Different Chi-Square-Tests are available to the system:

• Significance of Regression
• Significance of Non-Parallelism
• Significance of Non-Linearity
• Significance of the Slope
• Significance of Quadratic Coefficient

A DDITIONAL T ESTS
A range of additional tests is also available:

• Relative Potency Value

• Relative Potency Confidence Interval
• Relative Potency Range (%)
• Weight W

CONCEPTS
A few technical concepts are required to understand the structure of a Quantitative Re-
sponse Document.

PREPARATION SCHEME
In most assays all or at least several assay elements are prepared in the same way. This
means the number of dilution steps, the number of replicates etc. is identical. The prepara-
tion schemes simplify identical definitions. Each assay element must be linked to a prepara-
tion scheme. At least one preparation scheme must exist in the document.

E.g. When you setup a 3x3 parallel line assay, all assay elements have 3 dose steps and 3
replicates. You can set up a named preparation scheme called “3x3 preparation scheme” to
define the number of replicates, dilution steps, the dilutions etc. Once finished select the
assay elements and select the “3x3 preparation scheme” from the dropdown box.

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The preparation scheme contains the following information:

• Step Count
• Number of Replicates
• Absolute Potency Definitions (Stock solution or raw material) [optional]
• Dilution Factors [optional]
• Definition of the dose steps
o Geometrical dose definition (default)
o Defined Dilution Sequence (direct input)

SUITABILITY TESTS
Suitability tests need to be added to the assay definition. When no tests are added a relative
potency can still be calculated, but its validity is not proven.

LITERATURE
• European Pharmacopoeia 6th Edition chapter 5.3
• US Pharmacopeia <111>, <1032>, <1033>, <1034>
• Finney, Biological Assay, 3rd Edition

REPORTS
• Detail Report

TASKS
• Calculate – performs the calculation process
Note: If the calculation cannot be performed the reports contain more detailed error
information.

DOCUMENT STRUCTURE
DOCUMENT OUTLINE
The overall structure of the Dichotomous Assay document is hierarchically organized. The
main sections are the Setup section and the Analysis section. The Setup section contains all
data describing the observation data and the measurement incl. dilution steps, response
values etc. The Analysis section describes the flow of the statistical analysis of the assay.

Quantitative Response Assay

• Setup Setup of the Assay System
o Assay Elements Container for all defined assay elements
 Named Assay Elements Every defined assay element is listed here
o Preparation Schemes Container Element for all defined prepara-
tion schemes
o Observation Data Definitions of the data table
• Analysis Setup of the Analytical Model
o Analytical Model Regression model and analytical proper-
ties
160
 Dichotomous Assays

o Suitability Tests Container of the Suitability Tests

DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for a Dichotomous As-
say document. It is indicated whether a field is required or optional. The number is a refer-
ence to the following section with more reference data for every field.

Dichotomous Assay (Quantal Response Assay) required 001

. Name required 002
. Identification optional 003
. Date required 004
. Documentation optional 005
. . Assay Purpose optional 006
. . CHOICE required 007
. . . Substance Name optional 008
. . . Substance Reference optional 009
. . Substance Identification optional 010
. . Substance Batch/Lot number optional 011
. . Substance Sub-Batch/Sub-Lot number optional 012
. . Substance Variant optional 013
. . Substance Class optional 014
. . Substance Description optional 015
. . Operator optional 016
. . . CHOICE required 017
. . . . Operator Name required 018
. . . . Operator Reference required 019
. . . Role optional 020
. . Reagent optional 021
. . . CHOICE required 022
. . . . Reagent Name optional 023
. . . . Reagent Reference optional 024
. . . Reagent Identification optional 025
. . . Reagent Batch/Lot number optional 026
. . . Reagent Sub-Batch/Sub-Lot number optional 027
. . . Reagent Variant optional 028
. . . Reagent Class optional 029
. . . Reagent Description optional 030
. . . Amount optional 031
. . Equipment optional 032
. . . CHOICE required 033
. . . . Equipment Name required 034
. . . . Equipment Reference required 035
. . User Variable optional 036
. . . Key required 037
. . . Value optional 038
. . Data Source optional 039
. . . Filename optional 040
. . . Import Timestamp optional 041
. . . Import Modul Identification optional 042
. . . Import Comment optional 043
. Setup required 044

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . Assay Elements required 045

. . . Standard Sample required 046
. . . . Name required 047
. . . . CHOICE required 048
. . . . . Substance Name optional 049
. . . . . Substance Reference optional 050
. . . . Substance Identification optional 051
. . . . Substance Batch/Lot number optional 052
. . . . Substance Sub-Batch/Sub-Lot number optional 053
. . . . Substance Variant optional 054
. . . . Substance Class optional 055
. . . . Substance Description optional 056
. . . . Observation Group Id required 057
. . . . Preparation Scheme required 058
. . . . Display Color required 059
. . . . User Variable optional 060
. . . . . Key required 061
. . . . . Value optional 062
. . . Test Sample optional 063
. . . . Name optional 064
. . . . CHOICE required 065
. . . . . Substance Name optional 066
. . . . . Substance Reference optional 067
. . . . Substance Identification optional 068
. . . . Substance Batch/Lot number optional 069
. . . . Substance Sub-Batch/Sub-Lot number optional 070
. . . . Substance Variant optional 071
. . . . Substance Class optional 072
. . . . Substance Description optional 073
. . . . Observation Group Id required 074
. . . . Preparation Scheme required 075
. . . . Display Color required 076
. . . . User Variable optional 077
. . . . . Key required 078
. . . . . Value optional 079
. . . . Group optional 080
. . . . ExcludeFromAnalysis required 081
. . . Control Sample optional 082
. . . . Name required 083
. . . . CHOICE required 084
. . . . . Substance Name optional 085
. . . . . Substance Reference optional 086
. . . . Substance Identification optional 087
. . . . Substance Batch/Lot number optional 088
. . . . Substance Sub-Batch/Sub-Lot number optional 089
. . . . Substance Variant optional 090
. . . . Substance Class optional 091
. . . . Substance Description optional 092
. . . . Observation Group Id required 093
. . . . Preparation Scheme required 094
. . . . Display Color required 095
. . . . User Variable optional 096
. . . . . Key required 097

162
 Dichotomous Assays

. . . . . Value optional 098

. . . . Exclude From Analysis required 099
. . PreparationSchemes required 100
. . . Preparation Scheme required 101
. . . . Name required 102
. . . . Step Count required 103
. . . . Replicate Count required 104
. . . . CHOICE required 105
. . . . . Absolute Potency: not defined required 106
. . . . . Absolute Potency: defined by Raw Material required 107
. . . . . . Assigned/Assumed Potency (Summary) required 108
. . . . . . . Assigned/Assumed Potency required 109
. . . . . . . Assigned Assumed Potency Units required 110
. . . . . . Amount (Summary) required 111
. . . . . . . Amount required 112
. . . . . . . Amount Units required 113
. . . . . . Solvent (Summary) required 114
. . . . . . . Solvent Volume required 115
. . . . . . . Solvent Volume Units required 116
. . . . . Absolute Potency: defined by Stock Solution required 117
. . . . . . Assigned/Assumed Potency required 118
. . . . . . Assigned/Assumed Potency Units required 119
. . . . Dilution Factors required 120
. . . . . Dilution Factor optional 121
. . . . CHOICE required 122
. . . . . N-Fold Geometrical Sequence required 123
. . . . . . Factor required 124
. . . . . . Base required 125
. . . . . Linear Sequence required 126
. . . . . . FirstDose required 127
. . . . . . Delta required 128
. . . . . Defined Sequence required 129
. . . . . . DoseValue required 130
. . Observation Data required 131
. . . Observation Source required 132
. . . RowOrder optional 133
. . . Column: Observation Group required 134
. . . Step required 135
. . . Column: Response (Affected) required 136
. . . . Name required 137
. . . . ColumnKey required 138
. . . . PropertyScope optional 139
. . . . PropertyKey optional 140
. . . . SectionKey optional 141
. . . Column: Response (Tested) required 142
. . . . Name required 143
. . . . ColumnKey required 144
. . . . PropertyScope optional 145
. . . . PropertyKey optional 146
. . . . SectionKey optional 147
. . . Column: Technical Outlier required 148
. . . CHOICE required 149
. . . . Column: Boolean optional 150

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Column: Date
. optional 151
. . . Column: Date Time
. optional 152
. . . Column: Floating Point Number
. optional 153
. . . Column: Integer
. optional 154
. . . Column: Floating Point Numbe
. optional 155
. . . Column: String
. optional 156
. . . Column: Time
. optional 157
. Analysis required 158
. . Analytical Model required 159
. . . CHOICE required 160
. . . . Model: Probit required 161
. . . . Model: Logit required 162
. . . Analyze as multiplex assay required 163
. . . Potency Estimation Confidence Level required 164
. . . Advanced Settings required 165
. . . . Logarithm Base required 166
. . . . Invert Potency required 167
. . . . TheoreticalVariance required 168
. . . . Calculate mean potency estimate of test samples required 169
. . Suitability Tests required 170
. . . Assay Suitability Tests required 171
. . . . Chi-Square-Test (Hypothesis Test) optional 172
. . . . . Type required 173
. . . . . Confidence Level (%) required 174
. . . . . Scope of the Test optional 175
. . . . . Severity optional 176
. . . . . Custom Message Test Passed optional 177
. . . . . Custom Message Test Failed optional 178
. . . . Additional Test: Relative Potency Value optional 179
. . . . . Upper Margin required 180
. . . . . Lower Margin required 181
. . . . . Scope of the Test optional 182
. . . . . Severity optional 183
. . . . . Custom Message Test Passed optional 184
. . . . . Custom Message Test Failed optional 185
. . . . Additional Test: Relative Potency Confidence Interval optional 186
. . . . . Upper Margin required 187
. . . . . Lower Margin required 188
. . . . . Scope of the Test optional 189
. . . . . Severity optional 190
. . . . . Custom Message Test Passed optional 191
. . . . . Custom Message Test Failed optional 192
. . . . Additional Test: Relative Potency Range (%) optional 193
. . . . . Upper Margin required 194
. . . . . Scope of the Test optional 195
. . . . . Severity optional 196
. . . . . Custom Message Test Passed optional 197
. . . . . Custom Message Test Failed optional 198
. . . . Additional Test: Weight W optional 199
. . . . . Lower Margin required 200
. . . . . Scope of the Test optional 201
. . . . . Severity optional 202
. . . . . Custom Message Test Passed optional 203

164
 Dichotomous Assays

. . . . Custom Message Test Failed

. optional 204
. . SampleSuitabilityTests
. required 205
. . . Chi-Square-Test (Hypothesis Test)
. optional 206
. . . . Type
. required 207
. . . . Confidence Level (%)
. required 208
. . . . Scope of the Test
. optional 209
. . . . Severity
. optional 210
. . . . Custom Message Test Passed
. optional 211
. . . . Custom Message Test Failed
. optional 212
. . . Additional Test: Relative Potency Value
. optional 213
. . . . Upper Margin
. required 214
. . . . Lower Margin
. required 215
. . . . Scope of the Test
. optional 216
. . . . Severity
. optional 217
. . . . Custom Message Test Passed
. optional 218
. . . . Custom Message Test Failed
. optional 219
. . . Additional Test: Relative Potency Confidence Interval
. optional 220
. . . . Upper Margin
. required 221
. . . . Lower Margin
. required 222
. . . . Scope of the Test
. optional 223
. . . . Severity
. optional 224
. . . . Custom Message Test Passed
. optional 225
. . . . Custom Message Test Failed
. optional 226
. . . Additional Test: Relative Potency Range (%)
. optional 227
. . . . Upper Margin
. required 228
. . . . Scope of the Test
. optional 229
. . . . Severity
. optional 230
. . . . Custom Message Test Passed
. optional 231
. . . . Custom Message Test Failed
. optional 232
. . . Additional Test: Weight W
. optional 233
. . . . Lower Margin
. required 234
. . . . Scope of the Test
. optional 235
. . . . Severity
. optional 236
. . . . Custom Message Test Passed
. optional 237
. . . . Custom Message Test Failed
. optional 238
. Comment optional 239
. . Subject optional 240
. . Text optional 241
. . Linked Document optional 242
. . Date required 243
. . Author required 244

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

DOCUMENT ELEMENT REFERENCE

/ 001
Dichotomous Assay (Quantal Response Assay) USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DichotomousAssay xs:empty 1…1 <NONE>

Dilution Assay based on a quantal (dichotomous) response. In contrast to quantitative
response assays are they based on a discrete response scale. Please go through the
properties and select the required settings for this quantal response assay. Unfold to see the
document's sections Name , Date , Documentation , Setup and Analysis (left click on the plus
sign in front of the element). You can use the creation panel or the context menu, to add the
Identification or to add an arbitrary number of Comment sections.

/Dichotomous Assay (Quantal Response Assay)/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Documents are usally identified by their names. It is recommend to use unique names for
your document, but this is not strictly required.

/Dichotomous Assay (Quantal Response Assay)/ 003

Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Identification xs:token 0…1 <NONE>

Enter a identification string for the assay. This is an alternative to the use of name to identify
the assay. It is recommend to use unique Identifications for your document, but this is not
strictly required.

/Dichotomous Assay (Quantal Response Assay)/ 004

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

You can enter a date for the assay. Per default the document's creation date is entered here
automatically. However this can be changed. The date can be used for sorting in aggregation
documents.

/Dichotomous Assay (Quantal Response Assay)/ 005

Documentation USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Documentation T_Documentation 0…1 <NONE>

Here you can give the details about operators, used reagents and equipment. Unfold to see
the subsections (left click on the plus sign in front of the element). You can use the creation
panel to add new documentation sections.

166
 Dichotomous Assays

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 006

Assay Purpose USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayPurpose xs:string 0…1 <NONE>

Details of the analyte. Identify the analyte or target of the assay, and it's unique
identification. Leave the analyte details at this level out, if this assay has multiple analytes. In
the latter case, the analyte details can be set at the corresponding test sample.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 007

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Documentation/CHOICE: 008

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Dichotomous Assay (Quantal Response Assay)/Documentation/CHOICE: 009

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 010

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 011

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

167
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 012

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 013

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 014

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 015

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 016

Operator USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:empty 0…* <NONE>

Information about an operator. Unfold to see the details (left click on the plus sign in front of
the element). You can assign a role to an operator. Add a Role element by selecting it on the
creation panel.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Operator/ 017

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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/Dichotomous Assay (Quantal Response Assay)/Documentation/Operator/CHOICE: 018

Operator Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorName xs:token 1…1 <NONE>

Enter the operator's name. You can use the choice selector to swicth to Operator Reference ,
where you can assign the operator by a reference on a operator document.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Operator/CHOICE: 019

Operator Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorReference T_OperatorReference 1…1 <NONE>

Reference to a operator document. You can use the choice selector to switch to Operator
Name , where you can enter a operator name dirctly.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Operator/ 020

Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:token 0…1 <NONE>

Enter the operator role here.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 021

Reagent USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Reagent xs:empty 0…* <NONE>

Enter information about the reagent. Unfold to see the details (left click on the plus sign in
front of the element).

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 022

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/CHOICE: 023

Reagent Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentName xs:token 0…1 <NONE>

Name of the the reagent.

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/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/CHOICE: 024

Reagent Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentReference DocumentReference.Reagent 0…1 <NONE>

Choose a reagent document.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 025

Reagent Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentId xs:token 0…1 <NONE>

Identification information for the reagent.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 026

Reagent Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 027

Reagent Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 028

Reagent Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentVariant xs:token 0…1 <NONE>

The variant of the reagent.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 029

Reagent Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentClass xs:token 0…1 <NONE>

The class of the reagent, e.g. drug class.

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/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 030

Reagent Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReagentDescription xs:string 0…1 <NONE>

Textual description of the reagent.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Reagent/ 031

Amount USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount xs:string 0…1 <NONE>

Enter the amount of the substance in the assay.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 032

Equipment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Equipment xs:empty 0…* <NONE>

Information about equipment used to perform the assay. For documentation purposes.
Unfold to see the details.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Equipment/ 033

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Equipment/CHOICE: 034

Equipment Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentName xs:token 1…1 <NONE>

Enter the equipment's name. You can use the choice selector to swicth to Equipment
Reference , where you can assign the equipment by a reference on a equipment document.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Equipment/CHOICE: 035

Equipment Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentReference T_EquipmentReference 1…1 <NONE>

Reference to a equipment document. You can use the choice selector to switch to
Equipment Name , where you can enter a equipment name dirctly.

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/Dichotomous Assay (Quantal Response Assay)/Documentation/ 036

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Dichotomous Assay (Quantal Response Assay)/Documentation/User Variable/ 037

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Dichotomous Assay (Quantal Response Assay)/Documentation/User Variable/ 038

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Dichotomous Assay (Quantal Response Assay)/Documentation/ 039

Data Source USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DataSource xs:empty 0…* <NONE>

Unfold to see information about the data source of imported data. The subelements are
filled automatically.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Data Source/ 040

Filename USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Filename xs:token 0…1 <NONE>

Filename of the data source. Filled automatically.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Data Source/ 041

Import Timestamp USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportTimestamp xs:dateTime 0…1 <NONE>

Timestamp of the data import. Filled automatically.

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/Dichotomous Assay (Quantal Response Assay)/Documentation/Data Source/ 042

Import Modul Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportModuleIdentification xs:token 0…1 <NONE>

Filled automatically.

/Dichotomous Assay (Quantal Response Assay)/Documentation/Data Source/ 043

Import Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ImportComment xs:string 0…1 <NONE>

A single comments to this assay.

/Dichotomous Assay (Quantal Response Assay)/ 044

Setup USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Setup xs:empty 1…1 <NONE>

In this section you can define the assay setup. Unfold to see the subsection (left click on the
plus sign in front of the element). Subsections are Assay Elements : Details about assay
elements like standard and test samples. Preaparation Schemes : Definition of preparation
schemes including the dose sequence informations. Observation Data : Setup of the
observation table. Usually filled automatically, but here you can define additional data
columns (e.g. position factors).

/Dichotomous Assay (Quantal Response Assay)/Setup/ 045

Assay Elements USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Elements xs:empty 1…1 <NONE>

Unfold to see the already defined assay elements (left click on the plus sign in front of the
element). Assay Elements are the building blocks of a biological assay. An assay consists of
one standard sample, one or more preparation samples (test samples or control samples)
and optional control lines or control samples. Standard, preaparation, and control samples
are diluted samples. Control lines could be positive, negative or blank control lines, that are
not diluted. By using the context menu you can add Test Sample : Samples for which a
relative potency should be calculated. Control Sample : Usually used to define additional
accepting criteriums. Control Line : Objects like positive or negative controls.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/ 046

Standard Sample USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Standard T_AE_Standard 1…1 <NONE>

The standard sample or standard preparation or standard is required in dichotomous assays.
The potency of the preparations is calculated compared to this standard.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 047

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 STD

Enter the name of the standard assay element. Examples: "Standard", "Std", "Reference
Standard" Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to the standard. We recommend to use unique names for assay elements in an
assay document. But this is not required. Internal the Observation Group Id is used for the
identification of assay elements.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 048

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/CHOICE: 049

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/CHOICE: 050

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 051

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 052

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

174
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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 053

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 054

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 055

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 056

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 057

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 058

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 059

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/ 060

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/User Variable/ 061

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Standard Sample/User Variable/ 062

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/ 063

Test Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Test T_AE_Test 0…* <NONE>

The potency of the preparation (aka preparation sample, test sample, unknown) is
calculated in comparison to the standard.

176
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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 064

Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 0…1 <NONE>

Enter the name of this test assay element. Examples: "Preparation 1", "Unknown 3", "Test 2"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estimates
connected to this test assay element. We recommend to use unique names for assay
elements in an assay document. But this is not required. Internal the Observation Group Id is
used for the identification of assay elements.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 065

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/CHOICE: 066

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/CHOICE: 067

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 068

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 069

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

177
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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 070

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 071

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 072

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 073

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 074

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

178
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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 075

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 076

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 077

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/User Variable/ 078

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/User Variable/ 079

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 080

Group USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

COAGroup xs:token 0…1 <NONE>

For combination of assay result calculation the test samples can be assigned to different
groups. Each group is identified by a name. All test samples assigned to the same group are
calculated independently.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Test Sample/ 081

ExcludeFromAnalysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcludeFromAnalysis xs:boolean 1…1 false

Select yes to exclude the assay element from the analysis or no to include it in the analysis.
Additional remarks: If an assay element is excluded from analysis, the assay and all data and
settings (like test definitions for teh assay element) will be completely ignored. However
there will be a notification in the report, that the assay element is excluded from analysis.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/ 082

Control Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Control T_AE_Control 0…* <NONE>

The potency of a control sample is calculated in the same manner as the test sample. The
control sample can be used to set up specific suitability tests for the assay. The control
sample will not be included in a combination of assay results calculation.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 083

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 084

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/CHOICE: 085

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/CHOICE: 086

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

180
 Dichotomous Assays

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 087

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 088

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 089

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 090

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 091

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 092

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 093

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. Is
automatically defined and has to be unique, i.e. no other assay element of the assay is
allowed to have the same Observation Group Id. We do not recommend to change this value
manually. Additional remarks: A manual change of the Observation Group Id in the assay
element definition will not change the Observation Group Id of possibly assigned
observations. The Observation Group Id is shown in squared brackets in the Observation
Group Column of the Observation Editor.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 094

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemeReference xs:string 1…1 <NONE>

Assign a Preparation scheme to the assay element. A Preparation Scheme defines the
dilution series, absolute potency settings and pre dilution settings of an assay element.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 095

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the assay element's data or its estimates. The color is
automatically assigned, but you can change it manually by left-clicking on the selector
button.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 096

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/User Variable/ 097

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/User Variable/ 098

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Dichotomous Assay (Quantal Response Assay)/Setup/Assay Elements/Control Sample/ 099

Exclude From Analysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ExcludeFromAnalysis xs:boolean 1…1 false

Select yes to exclude the assay element from the analysis or no to include it in the analysis.
Additional remarks: If an assay element is excluded from analysis, the assay and all data and
settings (like test definitions for teh assay element) will be completely ignored. However
there will be a notification in the report, that the assay element is excluded from analysis.

/Dichotomous Assay (Quantal Response Assay)/Setup/ 100

PreparationSchemes USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationSchemes xs:empty 1…1 <NONE>

You can define multiple preparation schemes to describe the doses and dimension of your
different treatments. By default all assay element are bound to the first Preparation Scheme.
In more complex assays more than one scheme can be required. Unfold to see the already
defined preparation schmes (left click on the littel plus sign in front of the element). You can
add a new preparation scheme by using the context menu

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/ 101

Preparation Scheme USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreparationScheme xs:empty 1…* <NONE>

The setup of the considered dose sequence, absolute potency settings and dilution factors
are defined in a preparation scheme. Each assay element has to refer to exactly one
preparation scheme. However you can use one preperation scheme for mor than one assay
element. Unfold to set up the details of the preparation scheme.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/ 102

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

The name of the preparation scheme. This name has to be unique for the assay.

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Step Count USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StepCount xs:positiveInteger 1…1 <NONE>

The number of dose steps for the according assay element.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/ 104

Replicate Count USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReplicateCount xs:positiveInteger 1…1 <NONE>

The number of replicates per step for the according assay element.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/ 105

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 106

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition T_Empty 1…1 <NONE>

This scheme does not define an absolute dose for the connected assay element. A backfit
calculation for absolute potencies will not be carried out with this option. You can use the
choice selector to switch to the alternatives Absolute Potency: defined by Raw Material or
Absolute Potency: defined by Stock Solution . Unfold to see the definition details (left click
on the plus sign in front of the element).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 107

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. You have to
define the absolute potency per amount units, the amount used for preparation and the
volume of the solvent. Note: the absolute potency has to be defined per amount units for a
correct calculation. You can use the choice selector to switch to the alternatives Absolute
Potency: not defined or Absolute Potency: defined by Stock Solution . Unfold to see the
definition details (left click on the plus sign in front of the element). Estimated Potency of
the test sample = calculated relative potency * assigend potency of the standard sample *
amount of the standard * solvent volume of the test sample / (amount of the test sample *
solvent volume of the standard sample)

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Potency: defined by Raw Material/
108
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Assigned/Assumed Potency (Summary)/
109
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency T_PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 110

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 111

Scheme/CHOICE:Absolute Potency: defined by Raw Material/
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 112

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Amount (Summary)/
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount T_PositiveDouble 1…1 <NONE>

The amount of the substance.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 113

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Amount (Summary)/
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

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Assay)/Setup/PreparationSchemes/Preparation 114
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Solvent (Summary)/
115
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume T_PositiveDouble 1…1 <NONE>

The solvent's volume.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 116

Scheme/CHOICE:Absolute Potency: defined by Raw Material/Solvent (Summary)/
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 117

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute Potency: not
defined . Unfold to see the definition details (left click on the plus sign in front of the
element). Estimated potency for the test sample = calculated relative potency * assigned
potency of the standard sample.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation 118

Scheme/CHOICE:Absolute Potency: defined by Stock Solution/
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency T_PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Dichotomous Assay (Quantal Response

Scheme/CHOICE:Absolute Potency: defined by Stock Solution/
Assay)/Setup/PreparationSchemes/Preparation 119
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

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Dilution Factors USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors defined here. Dilution factors
are taken into account after calculation of the relative potency (so they don't enter the
calculation fo the model fit).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/Dilution Factors/ 121

Dilution Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor T_PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/ 122

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 123

N-Fold Geometrical Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NFoldSequence T_SequenceNFold 1…1 <NONE>

Chosen dose sequence is the n-fold sequence (or geometric sequence). You can use the
choice selector to switch to the alternatives Linear Seqence and Defined Sequence .

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE:N-Fold

Geometrical Sequence/
124
USAGE
Factor required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Factor T_PositiveDouble 1…1 <NONE>

Define the factor of a n-Fold-Sequence. Additional remarks: Has to be a non-negative
decimal number. The dose value of a n-Fold sequence is given by Factor * Base^(1 - Step
Number).

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/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE:N-Fold

Geometrical Sequence/
125
USAGE
Base required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Base T_PositiveDouble 1…1 <NONE>

Define the dose of a n-Fold-Sequence. Additional remarks: Has to be a positive decimal
number. The dose value of a n-Fold sequence is given by Factor * Base^(1 - Step Number).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 126

Linear Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquidistantSequence T_SequenceEquidistant 1…1 <NONE>

Chosen sequence is the linear dequence (a sequence with equidistant steps). You can use
the choice selector to switch to the alternatives N-Fold Seqence and Defined Sequence .

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE:Linear

Sequence/
127
USAGE
FirstDose required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FirstDose T_PositiveDouble 1…1 <NONE>

Define the first dose of a linear sequence. Additional remarks: Has to be a non-negative
decimal number. The dose value of a linear sequence is given by First Dose + Delta * (Step
Number - 1).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE:Linear 128

Sequence/
USAGE
Delta required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Delta xs:double 1…1 <NONE>

Define the differnce between to dose values of a linear sequence. Additional remarks: Has
to be a non-negative decimal number. The dose value of a linear sequence is given by First
Dose + Delta * (Step Number - 1).

/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE: 129

Defined Sequence USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedSequence T_SequenceDefined 1…1 <NONE>

Chosen sequence is the defined dequence (a sequence with equidistant steps). You can use
the choice selector to switch to the alternatives N-Fold Seqence and Linear Sequence .

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/Dichotomous Assay (Quantal Response Assay)/Setup/PreparationSchemes/Preparation Scheme/CHOICE:Defined

Sequence/
130
USAGE
DoseValue required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DoseValue T_NonNegativeDouble 1…* <NONE>

Define a dose value for a defined sequence. Additional remarks: Each is internally
connected to a dose step number (starting at '1').

/Dichotomous Assay (Quantal Response Assay)/Setup/ 131

Observation Data USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Dataset xs:empty 1…1 <NONE>

The data editor allows to view and modify the dose and response data and other factors of
the assay. You can add aditional factors to the table.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 132

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 133

RowOrder USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder ds:T_RowOrder 0…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 134

Column: Observation Group USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroup ds:T_ObservationGroupColumn 1…1 <NONE>

The observation group factor binds a single observation (measurement) to the
corresponding assay element. The maximum number of observation groups setting defines
how many slots are displayed in the data editors. If you have more assay elements than this
number, simply select a higher number.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 135

Step USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Step ds:T_SequenceStepColumn 1…1 <NONE>

The sequence step column contains the number of the step in a defined sequence. Note: The
maximum number of steps and replicates are defined in the corresponding Preparation
Schemes.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 136

Column: Response (Affected) USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseEffected T_ResponseAffectedFactor 1…1 <NONE>

The number of affected responses.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Affected)/ 137

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Affected)/ 138

ColumnKey USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Affected)/ 139

PropertyScope USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyScope ds:T_PropertyScope 0…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Affected)/ 140

PropertyKey USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyKey xs:token 0…1 <NONE>

[NO DETAILS]

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SectionKey USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionKey xs:token 0…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 142

Column: Response (Tested) USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ResponseTested T_ResponseTestedFactor 1…1 <NONE>

The total number of tested responses.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Tested)/ 143

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Tested)/ 144

ColumnKey USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Tested)/ 145

PropertyScope USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyScope ds:T_PropertyScope 0…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Tested)/ 146

PropertyKey USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyKey xs:token 0…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/Column: Response (Tested)/ 147

SectionKey USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionKey xs:token 0…1 <NONE>

[NO DETAILS]

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Column: Technical Outlier USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TechnicalOutlier ds:T_TechnicalOutlierColumn 1…1 <NONE>

Column for marking data values as technical outliers.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/ 149

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 150

Column: Boolean USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

BooleanFactor ds:T_BooleanColumn 0…* <NONE>

Additional data column for boolean values (true / false).

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 151

Column: Date USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DateFactor ds:T_DateColumn 0…* <NONE>

Additional column for date values.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 152

Column: Date Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DateTimeFactor ds:T_DateTimeColumn 0…* <NONE>

Additional column for date / time values

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 153

Column: Floating Point Number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DoubleFactor ds:T_DoubleColumn 0…* <NONE>

Additional column for double precission folating point numbers.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 154

Column: Integer USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IntegerFactor ds:T_IntegerColumn 0…* <NONE>

Additional column for integer values.

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/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 155

Column: Floating Point Numbe USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MemoFactor ds:T_MemoColumn 0…* <NONE>

Additional column for multiline text.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 156

Column: String USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StringFactor ds:T_TextColumn 0…* <NONE>

Additional column for single line text.

/Dichotomous Assay (Quantal Response Assay)/Setup/Observation Data/CHOICE: 157

Column: Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TimeFactor ds:T_TimeColumn 0…* <NONE>

Additional column for time entries.

/Dichotomous Assay (Quantal Response Assay)/ 158

Analysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Analysis xs:empty 1…1 <NONE>

In the analysis section you can define settings like the regression model, data selection (e. g.
the use of the configuration optimizer or outlier tests) or the statistical tests, that should be
performed during calculation. Unfold to see the subsections (left click on the littel plus sign
in front of the element).

/Dichotomous Assay (Quantal Response Assay)/Analysis/ 159

Analytical Model USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model xs:empty 1…1 <NONE>

The analytical model defines the common analytical model settings for all assay elements.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/ 160

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/CHOICE: 161

Model: Probit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Probit T_Empty 1…1 <NONE>

Analysis based on the probit model. You can use the choice selector to switch to the Logit -
Model. Model Formula P( Dose ) = &#934; m &#8901; log b ( Dose ) + n

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/CHOICE: 162

Model: Logit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Logit T_Empty 1…1 <NONE>

Analysis based on the logit model. You can use the choice selector to switch to the Probit -
Model. Model Formula log b P( Dose ) 1 - P( Dose ) = m &#8901; log b (
Dose ) + n

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/ 163

Analyze as multiplex assay USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

IsMultiplexAssay xs:boolean 1…1 false

You can select, whether the assay is evaluated as multiplex assay ('true') or as a collection of
standard-test-sample comparisons ('false').

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/ 164

Potency Estimation Confidence Level USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyEstimationConfidenceInterval T_ConfidenceLevel 1…1 0.95

Please select the confidence level of the potency confidence interval. A commonly used
value is 95 %.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/ 165

Advanced Settings USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdvancedSettings xs:empty 1…1 <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/Advanced Settings/ 166

Logarithm Base USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LogType T_LogType 1…1 Log2

Here you can choose the logarithm base used for dose or response transformation. You have
to select on off binary logarithm (logarithm base 2) natural logarithm (logarithm base e)
decimal logarithm (logarithm base 10)

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/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/Advanced Settings/ 167

Invert Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

InvertPotency xs:boolean 1…1 false

If this is set to true the potency ratio will be inverted.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/Advanced Settings/ 168

TheoreticalVariance USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TheoreticalVariance T_NonNegativeDouble 1…1 1.0

You can enter a theoretical variance, which will affect the anova based tests. Default value is
1.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Analytical Model/Advanced Settings/ 169

Calculate mean potency estimate of test samples USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

CalculateMeanPotencyEstimates xs:boolean 1…1 false

If you set this to 'true', the mean of the potency estimates will be reported.

/Dichotomous Assay (Quantal Response Assay)/Analysis/ 170

Suitability Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Tests xs:empty 1…1 <NONE>

This section contains the subsection Assay Suitability Tests and Sample Suitability Tests ,
where the statistical tests of the assay can be defined. Unfold to see the subsections (left
click on the littel plus sign in front of the element). Suitability tests are required to prove the
validity of your assay run.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/ 171

Assay Suitability Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssaySuitabilityTests T_SuitabilityTests 1…1 <NONE>

Add any number of assay suitability tests here. The result of an assay suitability test affects
the whole assay and not only the actually considered standard - test - comparison. In case of
multiplex assays there is no difference between the evaluation of assay suitability tests and
sample suitability tests.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/ 172

Chi-Square-Test (Hypothesis Test) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FTest xs:empty 0…* <NONE>

[NO DETAILS]

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Square-Test (Hypothesis Test)/
173
USAGE
Type required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type T_FTests 1…1 FTestNonParallelism

It is required to select one of Significance of Non-Parallelism Significance of Non-Linearity
(Lack of Fit) Significance of Square Coefficient Significance of Non-Linearity (Lack of Fit) for a
single assay element Significance of Square Coefficient for a single assay element

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Chi-Square-Test 174

(Hypothesis Test)/
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Chi-Square-Test 175

(Hypothesis Test)/
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Chi-Square-Test 178

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USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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Additional Test: Relative Potency Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyValue xs:string 0…* <NONE>

Add additional test(s) for the relative potency value to the assay. The test is passed, if the
relative potency value is greater equal than the lower margin given in the test definition and
smaller equal than the upper margin given in the test definition. Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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Relative Potency Value/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

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181
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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183
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Relative Potency Value/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

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USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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Additional Test: Relative Potency Confidence Interval USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyConfidenceInterval xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence interval to the assay. The test is
passed, if the lower confidence limit of the relative potency is greater equal than the lower
margin given in the test definition and if the upper confidence limit of the relative potency is
smaller equal than the upper margin given in the test definition. Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

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187
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

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188
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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189
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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190
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Relative Potency Confidence Interval/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

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USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/ 193

Additional Test: Relative Potency Range (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyRange xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence range to the assay. The test is
passed, if the percentual relative potency range is smaller equal than the upper margin given
in the test definition. Additional remarks: It depends on the actually marked element, where
the test definition is added. If Assay Suitability Tests or one of its child is selected, the test
will be added as a assay suitability test. If Sample Suitability Tests or one of its child is
selected, the test will be added as a samples suitability test. If a test definition is chosen, that
is not valid for the model ore the selected scope, it will be ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Additional Test: 194
Relative Potency Range (%)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Additional Test:

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195
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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196
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Relative Potency Range (%)/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

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Relative Potency Range (%)/
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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Additional Test: Weight W USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinimalWeight xs:string 0…* <NONE>

Add additional test(s) for the weight. The test is passed, if the potency weight is greater
equal than the lower margin given in the test definition and smaller equal than the upper
margin given in the test definition. Additional remarks: The definition of the weight can be
found in the European Pharmacopeia Chapter 5.3, formula (6.2.1.-1) It depends on the
actually marked element, where the test definition is added. If Assay Suitability Tests or one
of its child is selected, the test will be added as a assay suitability test. If Sample Suitability
Tests or one of its child is selected, the test will be added as a samples suitability test. If a
test definition is chosen, that is not valid for the model ore the selected scope, it will be
ignored without notification.

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Weight W/
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Additional Test:

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201
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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Weight W/
202
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

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Weight W/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/Assay Suitability Tests/Additional Test: 204
Weight W/
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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SampleSuitabilityTests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SampleSuitabilityTests T_SuitabilityTests 1…1 <NONE>

Add any number of sample suitability tests here. The result of an sample suitability test
affects only the actually considered standard - test - comparison and not the whole assay. In
case of multiplex assays there is no difference between the evaluation of assay suitability
tests and sample suitability tests.

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Chi-Square-Test (Hypothesis Test) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FTest xs:empty 0…* <NONE>

[NO DETAILS]

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Chi-

Square-Test (Hypothesis Test)/
207
USAGE
Type required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type T_FTests 1…1 FTestNonParallelism

It is required to select one of Significance of Non-Parallelism Significance of Non-Linearity
(Lack of Fit) Significance of Square Coefficient Significance of Non-Linearity (Lack of Fit) for a
single assay element Significance of Square Coefficient for a single assay element

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(Hypothesis Test)/
208
USAGE
Confidence Level (%) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 0.95

Choose the confidence level of the test as percentual vaule. The entered value has to be a
decimal number between 0 % and 100 % (borders not included). A common value is 95 %.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Chi-Square-Test 209

(Hypothesis Test)/
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

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(Hypothesis Test)/
210
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Chi-Square-Test 211

(Hypothesis Test)/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Chi-Square-Test 212

(Hypothesis Test)/
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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Additional Test: Relative Potency Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyValue xs:string 0…* <NONE>

Add additional test(s) for the relative potency value to the assay. The test is passed, if the
relative potency value is greater equal than the lower margin given in the test definition and
smaller equal than the upper margin given in the test definition. Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 214

Relative Potency Value/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

Relative Potency Value/
215
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

208
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216
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

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217
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 218

Relative Potency Value/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

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219
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/ 220

Additional Test: Relative Potency Confidence Interval USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyConfidenceInterval xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence interval to the assay. The test is
passed, if the lower confidence limit of the relative potency is greater equal than the lower
margin given in the test definition and if the upper confidence limit of the relative potency is
smaller equal than the upper margin given in the test definition. Additional remarks: It
depends on the actually marked element, where the test definition is added. If Assay
Suitability Tests or one of its child is selected, the test will be added as a assay suitability
test. If Sample Suitability Tests or one of its child is selected, the test will be added as a
samples suitability test. If a test definition is chosen, that is not valid for the model ore the
selected scope, it will be ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

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221
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as natural number (zero not included). The test failes, if
the observed value is larger than the upper margin. Additional Remarks Margins for tests
are usually chosen from historical data during assay development.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

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222
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

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223
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

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224
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 225

Relative Potency Confidence Interval/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

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226
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/ 227

Additional Test: Relative Potency Range (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestRelativePotencyRange xs:string 0…* <NONE>

Add additional test(s) for the relative potency confidence range to the assay. The test is
passed, if the percentual relative potency range is smaller equal than the upper margin given
in the test definition. Additional remarks: It depends on the actually marked element, where
the test definition is added. If Assay Suitability Tests or one of its child is selected, the test
will be added as a assay suitability test. If Sample Suitability Tests or one of its child is
selected, the test will be added as a samples suitability test. If a test definition is chosen, that
is not valid for the model ore the selected scope, it will be ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 228

Relative Potency Range (%)/
USAGE
Upper Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Enter the upper margin of the test as decimal number. The test failes, if the observed value
is larger than the upper margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

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229
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

212
 Dichotomous Assays

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

Relative Potency Range (%)/
230
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 231

Relative Potency Range (%)/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 232

Relative Potency Range (%)/
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

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Additional Test: Weight W USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AdditionalTestMinimalWeight xs:string 0…* <NONE>

Add additional test(s) for the weight. The test is passed, if the potency weight is greater
equal than the lower margin given in the test definition and smaller equal than the upper
margin given in the test definition. Additional remarks: The definition of the weight can be
found in the European Pharmacopeia Chapter 5.3, formula (6.2.1.-1) It depends on the
actually marked element, where the test definition is added. If Assay Suitability Tests or one
of its child is selected, the test will be added as a assay suitability test. If Sample Suitability
Tests or one of its child is selected, the test will be added as a samples suitability test. If a
test definition is chosen, that is not valid for the model ore the selected scope, it will be
ignored without notification.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 234

Weight W/
USAGE
Lower Margin required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Enter the lower margin of the test as decimal number. The test failes, if the observed value is
smaller than the lower margin. You can find the valid range of values in the description of
the test. Additional Remarks Margins for tests are usually chosen from historical data during
assay development. You can use the Equivalenc Margin Report of PLA for this purpose.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

Weight W/
235
USAGE
Scope of the Test optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeAll

Define for which assay elements a test will be performed. You can choose along: All Assay
Elements to perform the test for every possible assay element. Standard only to perform the
test only for the standard sample. Test Samples only to perform the test only for test
samples. Control Samples only to performa the test only for control samples. Control Lines
only to perform the test only for control lines. Additional Remarks The exact behavior of
the selection depends on the test. Some tests can only be performed for some type of assay
elements (e.g. equivalence test for the differnence of slope can only be defined for test and
control samples). However the possible values of the test scope are the same for all tests.
Additionally it can depend on the model, whether a test definition is possible or not. Please
consider the help section of the corresponding test for more information. If the scope
selection leads to an invalid test definition (maybe because the test can't be defined for the
selected assay element type), the definition is ignored without notification.

214
 Dichotomous Assays

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test:

Weight W/
236
USAGE
Severity optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 237

Weight W/
USAGE
Custom Message Test Passed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestPassedMessage xs:string 0…1 <NONE>

Define a customized message for a passed test.

/Dichotomous Assay (Quantal Response Assay)/Analysis/Suitability Tests/SampleSuitabilityTests/Additional Test: 238

Weight W/
USAGE
Custom Message Test Failed optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestFailedMessage xs:string 0…1 <NONE>

Define a customized message for a failed test.

/Dichotomous Assay (Quantal Response Assay)/ 239

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comment to this assay.

215
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/Dichotomous Assay (Quantal Response Assay)/Comment/ 240

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Text content of this comment.

/Dichotomous Assay (Quantal Response Assay)/Comment/ 241

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

/Dichotomous Assay (Quantal Response Assay)/Comment/ 242

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

/Dichotomous Assay (Quantal Response Assay)/Comment/ 243

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Dichotomous Assay (Quantal Response Assay)/Comment/ 244

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES
Substance and Operator information can be aggregated from the generator document, if
given.

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Document Title Title of the Docu- String http://purl.org/dc/terms/title
ment.

216
 Dichotomous Assays

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Date Date DateTime [SSY]/bioassay/date
Status Status of the String [SSY]/bioassay/status
Document.
Assay Elment Type of the assay String [SSY]/bioassay/elementtype
Type element (Standard,
Test or Control)
Rel. Potency Relative Potency Va- Double [SSY]/bioassay/relativepotency
lue.
Rel. Potency Lower Confidence Double [SSY]/bioassay/relativepotency_lowerlimit
Lower Conf. Limit of the Relative
Limit Potency.
Rel. Potency Upper Confidence Double [SSY]/bioassay/relativepotency_upperlimit
Upper Conf. Limit of the Relative
Limit Potency.
Abs. Potency Absolute Potency Double [SSY]/bioassay/absolutepotency
Value.
Abs. Potency Lower Confidence Double [SSY]/bioassay/absolutepotency_lowerlimit
Lower Conf. Limit of the Absolute
Limit Potency.
Abs. Potency Upper Confidence Double [SSY]/bioassay/absolutepotency_upperlimit
Upper Conf. Limit of the Absolute
Limit Potency.
Weight So called potency Double [SSY]/bioassay/potency_weight
weight, which is used
in a weighted combi-
nation of independ-
ent assays.
Degrees of The degreese of free- Integer [SSY]/bioassay/coa_df
Freedom dom used for the
calculation of the
potency confidence
interval. This depends
on the chosen ANO-
VA model.
Overall Test The assay's overall String [SSY]/bioassay/testresult
Result test result.
Regression The regression model String [SSY]/bioassay/coa_model
Model used for analyzing the
assay.
Group ID The group ID deter- String [SSY]/bioassay/coa_group
mining, which ele-
ments will be com-
bined in the same
combination of inde-
pendent assay calcu-

217
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
lation.
Potency Con- The confidence level Integer [SSY]/bioassay/coa_confidence_level
fidence Level of the calculated po-
tency confidence in-
tervals.
Parameter A The estimated pa- Double [SSY]/bioassay/emd_tst_a
(Test) rameter value of the
upper asymptote of
the test sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_a_se
rameter A ard deviation of the
(Test) upper asymptote of
the test sample.
Parameter A The estimated pa- Double [SSY]/bioassay/emd_std_a
(Standard) rameter value of the
upper asymptote of
the Standard sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_a_se
rameter A ard deviation of the
(Standard) upper asymptote of
the standard sample.
Parameter B The estimated pa- Double [SSY]/bioassay/emd_tst_b
(Test) rameter value of the
slope of the test
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_b_se
rameter B ard deviation of the
(Test) slope of the test
sample.
Parameter B The estimated pa- Double [SSY]/bioassay/emd_std_b
(Standard) rameter value of the
slope of the standard
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_b_se
rameter C ard deviation of the C
(Standard) Parameter of the
standard sample.
Parameter C The estimated pa- Double [SSY]/bioassay/emd_tst_c
(Test) rameter value of the
C Parameter of the
test sample. In case
of a 4-parameter-
logistic fit this is the
log inflection point.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_c_se

218
 Dichotomous Assays

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
rameter C ard deviation of the C
(Test) Parameter of the test
sample.
Parameter C The estimated pa- Double [SSY]/bioassay/emd_std_c
(Standard) rameter value of the
C Parameter of the
standard sample. In
case of a 4-
parameter-logistic fit
this is the log inflec-
tion point.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_c_se
rameter C ard deviation of the C
(Standard) Parameter of the
standard sample.
Parameter D The estimated pa- Double [SSY]/bioassay/emd_tst_d
(Test) rameter value of the
lower asymptote of
the test sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_d_se
rameter D ard deviation of the
(Test) lower asymptote of
the test sample.
Parameter D The estimated pa- Double [SSY]/bioassay/emd_std_d
(Standard) rameter value of the
lower asymptote of
the standard sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_d_se
rameter D ard deviation of the
(Standard) lower asymptote of
the standard sample.
Parameter G The estimated pa- Double [SSY]/bioassay/emd_tst_g
(Test) rameter value of the
asymmetry parame-
ter of the test sam-
ple.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_tst_g_se
rameter G ard deviation value of
(Test) the asymmetry pa-
rameter of the test
sample.
Parameter G The estimated pa- Double [SSY]/bioassay/emd_std_g
(Standard) rameter value of the
asymmetry parame-
ter of the standard

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
sample.
Std. Dev. Pa- The estimated stand- Double [SSY]/bioassay/emd_std_g_se
rameter G ard deviation value of
(Standard) the asymmetry pa-
rameter of the stand-
ard sample.
Slope (Test) The estimated pa- Double [SSY]/bioassay/emd_tst_m
rameter value of the
slope of the test
sample.
Std. Dev. Slope The estimated stand- Double [SSY]/bioassay/emd_tst_m_se
(Test) ard deviation of the
slope of the test
sample.
Slope (Stan- The estimated pa- Double [SSY]/bioassay/emd_std_m
dard) rameter value of the
slope of the standard
sample.
Std. Dev. Slope The estimated stand- Double [SSY]/bioassay/emd_std_m_se
(Standard) ard deviation of the
slope of the standard
sample.
Y-Axis Inter- The estimated pa- Double [SSY]/bioassay/emd_tst_n
cept rameter value of the
y-axis intercept of the
test sample.
Std. Dev. Y-Axis The estimated stand- Double [SSY]/bioassay/emd_tst_n_se
Intercept (Test) ard deviation of the
y-axis intercept of the
test sample.
Y-Axis Inter- The estimated pa- Double [SSY]/bioassay/emd_std_n
cept (Standard) rameter value of the
y-axis intercept of the
standard sample.
Std. Dev. Y-Axis The estimated stand- Double [SSY]/bioassay/emd_std_n_se
Intercept ard deviation of the
(Standard) y-axis intercept of the
standard sample.
Covariance Estimated covariance Double [SSY]/bioassay/emd_std_a_d_cov
Upper/Lower of upper and lower
Asymptote asymptote of the
(Standard) standard sample.
Sum of Squares Sum of squares non- Double [SSY]/bioassay/emd_ss_lof
Non-Linearity linearity (lack of fit)
(LoF)

220
 Dichotomous Assays

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Estimated Va- The estimated vari- Double [SSY]/bioassay/emd_var
riance ance. This value de-
pends on the chosen
ANOVA model.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

BASIC BIOASSAY PROTOCOL

DESCRIPTION
The Basic Bioassay Protocol is a sophisticated protocol approach within PLA 3.0. It links In-
dependent Quantitative Response Assays to corresponding Combination Calculations.

With the release of Biological Assay Package 18 the functionality of the Protocol has been
improved. Older versions of the Protocol can be updated to this new approach by using “Up-
grade Structure”.

The Basic Bioassay Protocol covers a typical workflow for the creation of reportable num-
bers. It supports the following features:

• Two different execution modes

o Assay Replicate Mode
o Assay Element Mode
• Running multi-product assay (e.g. Standard, Product 1 and Product 2) in one assay
• Assay templates for every different assay replicate
• Multiple combination calculations for a product or the whole system
• Raising replicate numbers after initial execution to deal with unacceptable samples.

GENERAL WORKFLOW
Calculate
Generate Perform
Setup Protocol Reportable
Documents Assays
Values

The workflow for the Basic Bioassay Protocol consists of four steps:

1. Definition of the Setup. This can be considered as setting up a worklist or workplan.

You create the protocol. Define its properties.
2. Generate: By pressing generate all required Quantitative Response Assay Documents
and the Combination Calculation Documents are created and linked to the protocol.
3. Acquire Data & Perform Calculations. First of all the Quantitative Response Assay
need to be performed. Open them, acquire the data, calculate the results of the in-
dependent run.
4. After all Quantitative Response Assay have been calculated open all Combination
Calculations and perform their calculations.

TEMPLATES
The Basic Bioassay Protocol requires the use of Templates for the Quantitative Response
Assays and the Combination Calculations. It is not possible to perform any actions without
specifying templates. These templates have to reflect the requirements of your assay and
combination calculation. Depending on the selected mode the Generate process of the Basic

222
 Basic Bioassay Protocol

Bioassay Protocol takes care of modifying parts of the resulting documents to match the
needs of your protocol specification.

The Basic Bioassay Protocol is able to use different templates for different replicates. E.g. if
you need to specify different plate layouts for every assay run, you will create one template
for every run and assign these templates to their corresponding steps.

The Basic Bioassay Protocol allows the definition of any number of combination calculations.
This can used to focus different criteria e.g. for product release. Each combination calcula-
tion aggregates all corresponding data from the assay runs and perform the calculation of
different reportable values.

In Assay Element Mode it is also possible to specify combination calculations per assay ele-
ment. This allows defining multi product assays. With per element combination calculations
you receive one report per assay element (product) without showing the results of other
assay elements.

EXECUTION MODES
The protocol covers two different modes:

• Assay Replicate Mode

• Assay Element Mode

These modes define the level of detail defined in the protocol.

In Assay Replicate Mode the protocol document only covers the information about the
number of assay replicates to be performed. You can run different templates for every assay
run (replicate). The combination will always hold information about all assay elements.

When you raise the number of Replicates after the first Generate, a second Generate Run
will create the added replicates.

In Assay Element Mode it is possible to specify many details of the assay element on the
protocol level. These details are automatically transferred to the generated documents. You
can specify assay element details (e.g. Batch ID, assigned potencies and other details) and
you are able to request assay element specific combination calculations.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

The options are identical to the specifications of assay elements in the Quantitative Re-
sponse Assay (see above) with a few additional options:

• Observation Group ID: You need to keep track of the observation group id in your as-
say templates. The assay elements are assigned to the ids. If you create a template
with a plate layout the assay elements defined in the protocol are assigned to the
same observation group id in the template. E.g. UnK1 in the above picture is in all
replicates assigned to observation group id 2. This is necessary to support different
plate layouts in different samples.
• Potency Definition: there is an additional option to use the specification from the as-
say template (‘defined by template’)
• Dilution Factors: : there is an additional option to use the specification from the assay
template (‘defined by template’)
• Number of Replicates: This defines in how many assay replicates the corresponding
assay element will occur. E.g. if you specify two test samples UNK1 and UNK2. UNK1
has 2 replicates and UNK2 has 3 replicates. The Generate process will now create 3
independent assay replicates: Replicate 1 and 2 contain UNK1 and UNK2; replicate 3
will only contain UNK2. The number of assay replicates can be raised after the initial
Generate. When you click again the Generate button, missing Assay element repli-
cates will be created in new documents. This allows to raise the number of replicates
if one replicate failed. Note: In asymmetric configurations it might be necessary to
modify created Bioassay documents to prevent the display of unassigned assay ele-
ments.

SPECIFYING COMBINATION CALCULATIONS

Combination calculations need to be requested in the document. This is done by adding
Combination calculations to the Assay Element or the whole protocol.

224
 Basic Bioassay Protocol

When you specify the template for a combination calculation in the Template section, a
name is automatically assigned to every template configuration. The default name (Configu-
ration-1) can be changed. To request a combination calculation add a “Combination Calcula-
tion” on the protocol level or a “Combination Calculation (Sample Only)” to a specific assay
element (both has been done in the picture). When you add the element, you have to
choose a specified template configuration (Configuration-1). In the above picture the Gener-
ate process has not been performed yet.

When you press Generate the corresponding documents will be created and assigned:

You can add additional combination calculations at any time.

STRUCTURE OF THE PROTOCOL

• Documentation options
• Mode Selection with optional assay element specification
• Combination Calculations on element and protocol level

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

REPORTS
• Detailed Report showing Definitions and if aggregated an overview of results

TASKS
• Generate: Creates the required documents. The remaining protocol document will be
protected in all areas that are not supported for a later update of the structures.

DOCUMENT STRUCTURE
DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for a Basic Bioassay Pro-
tocol document. It is indicated whether a field is required or optional. The number is a refer-
ence to the following section with more reference data for every field.

Basic Bioassay Protocol required 001

. Name required 002
. Documentation required 003
. . CHOICE required 004
. . . Substance Name optional 005
. . . Substance Reference optional 006
. . Substance Identification optional 007
. . Substance Batch/Lot number optional 008
. . Substance Sub-Batch/Sub-Lot number optional 009
. . Substance Variant optional 010
. . Substance Class optional 011
. . Substance Description optional 012
. . Operator optional 013
. . . CHOICE required 014
. . . . Operator Name required 015
. . . . Operator Reference required 016
. . . Role optional 017
. CHOICE required 018
. . Mode: Assay Replicate required 019
. . . Number of Replicates required 020
. . Mode: Assay Element required 021
. . . Standard Sample required 022
. . . . Name required 023
. . . . Observation Group Id required 024
. . . . CHOICE required 025
. . . . . Substance Name optional 026
. . . . . Substance Reference optional 027
. . . . Substance Identification optional 028
. . . . Substance Batch/Lot number optional 029
. . . . Substance Sub-Batch/Sub-Lot number optional 030
. . . . Substance Variant optional 031
. . . . Substance Class optional 032
. . . . Substance Description optional 033
. . . . CHOICE required 034
. . . . . Absolute Potency: defined by Template required 035
. . . . . Absolute Potency: not defined required 036

226
 Basic Bioassay Protocol

. . . . Absolute Potency: defined by Raw Material

. required 037
. . . . . Assigned/Assumed Potency (Summary)
. required 038
. . . . . . Assigned/Assumed Potency
. required 039
. . . . . . Assigned/Assumed Potency Units
. required 040
. . . . . Amount (Summary)
. required 041
. . . . . . Amount
. required 042
. . . . . . Amount Units
. required 043
. . . . . Solvent (Summary)
. required 044
. . . . . . Solvent Volume
. required 045
. . . . . . Solvent Volume Units
. required 046
. . . . Absolute Potency: defined by Stock Solution
. required 047
. . . . . Assigned/Assumed Potency
. required 048
. . . . . Assigned/Assumed Potency Units
. required 049
. . . . CHOICE required 050
. . . . . Dilution Factors: defined By Template required 051
. . . . . Dilution Factors: Manual Input required 052
. . . . . . Dilution Factor optional 053
. . . Test Sample optional 054
. . . . Name required 055
. . . . Observation Group Id required 056
. . . . Group optional 057
. . . . CHOICE required 058
. . . . . Substance Name optional 059
. . . . . Substance Reference optional 060
. . . . Substance Identification optional 061
. . . . Substance Batch/Lot number optional 062
. . . . Substance Sub-Batch/Sub-Lot number optional 063
. . . . Substance Variant optional 064
. . . . Substance Class optional 065
. . . . Substance Description optional 066
. . . . CHOICE required 067
. . . . . Absolute Potency: defined by Template required 068
. . . . . Absolute Potency: not defined required 069
. . . . . Absolute Potency: defined by Raw Material required 070
. . . . . . Assigned/Assumed Potency (Summary) required 071
. . . . . . . Assigned/Assumed Potency required 072
. . . . . . . Assigned/Assumed Potency Units required 073
. . . . . . Amount (Summary) required 074
. . . . . . . Amount required 075
. . . . . . . Amount Units required 076
. . . . . . Solvent (Summary) required 077
. . . . . . . Solvent Volume required 078
. . . . . . . Solvent Volume Units required 079
. . . . . Absolute Potency: defined by Stock Solution required 080
. . . . . . Assigned/Assumed Potency required 081
. . . . . . Assigned/Assumed Potency Units required 082
. . . . CHOICE required 083
. . . . . Dilution Factors: defined By Template required 084
. . . . . Dilution Factors: Manual Input required 085
. . . . . . Dilution Factor optional 086
. . . . Number of Replicates required 087
. . . . Combination Calculation (Sample Only) optional 088
. . . . . Configuration Name optional 089

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . . . Document Name optional 090

. . . . . Combination Document Reference optional 091
. . . Control Sample optional 092
. . . . Name required 093
. . . . Observation Group Id required 094
. . . . CHOICE required 095
. . . . . Substance Name optional 096
. . . . . Substance Reference optional 097
. . . . Substance Identification optional 098
. . . . Substance Batch/Lot number optional 099
. . . . Substance Sub-Batch/Sub-Lot number optional 100
. . . . Substance Variant optional 101
. . . . Substance Class optional 102
. . . . Substance Description optional 103
. . . . CHOICE required 104
. . . . . Absolute Potency: defined by Template required 105
. . . . . Absolute Potency: not defined required 106
. . . . . Absolute Potency: defined by Raw Material required 107
. . . . . . Assigned/Assumed Potency (Summary) required 108
. . . . . . . Assigned/Assumed Potency required 109
. . . . . . . Assigned/Assumed Potency Units required 110
. . . . . . Amount (Summary) required 111
. . . . . . . Amount required 112
. . . . . . . Amount Units required 113
. . . . . . Solvent (Summary) required 114
. . . . . . . Solvent Volume required 115
. . . . . . . Solvent Volume Units required 116
. . . . . Absolute Potency: defined by Stock Solution required 117
. . . . . . Assigned/Assumed Potency required 118
. . . . . . Assigned/Assumed Potency Units required 119
. . . . CHOICE required 120
. . . . . Dilution Factors: defined By Template required 121
. . . . . Dilution Factors: Manual Input required 122
. . . . . . Dilution Factor optional 123
. . . . Number of Replicates required 124
. . . Control Line optional 125
. . . . Name required 126
. . . . Observation Group Id required 127
. . . . CHOICE required 128
. . . . . Substance Name optional 129
. . . . . Substance Reference optional 130
. . . . Substance Identification optional 131
. . . . Substance Batch/Lot number optional 132
. . . . Substance Sub-Batch/Sub-Lot number optional 133
. . . . Substance Variant optional 134
. . . . Substance Class optional 135
. . . . Substance Description optional 136
. . . . CHOICE required 137
. . . . . Absolute Potency: defined by Template required 138
. . . . . Absolute Potency: not defined required 139
. . . . . Absolute Potency: defined by Raw Material required 140
. . . . . . Assigned/Assumed Potency (Summary) required 141
. . . . . . . Assigned/Assumed Potency required 142

228
 Basic Bioassay Protocol

. . . . . Assigned/Assumed Potency Units

. . required 143
. . . . Amount (Summary)
. . required 144
. . . . . Amount
. . required 145
. . . . . Amount Units
. . required 146
. . . . Solvent (Summary)
. . required 147
. . . . . Solvent Volume
. . required 148
. . . . . Solvent Volume Units
. . required 149
. . . Absolute Potency: defined by Stock Solution
. . required 150
. . . . Assigned/Assumed Potency
. . required 151
. . . . Assigned/Assumed Potency Units
. . required 152
. . . CHOICE
. required 153
. . . . Dilution Factors: defined By Template
. required 154
. . . . Dilution Factors: Manual Input
. required 155
. . . . . Dilution Factor
. optional 156
. Assay Replicate optional 157
. . Assay Replicate Document optional 158
. Combination Calculation optional 159
. . Configuration Name optional 160
. . Document Name optional 161
. . Combination Document Reference optional 162
. Templates required 163
. . Assay Templates required 164
. . . Force Common Replicate Number required 165
. . . Assay Template optional 166
. . . . Template required 167
. . . . Valid for Replicate optional 168
. . Combination Calculation Templates required 169
. . . Configuration optional 170
. . . . Configuration Name required 171
. . . . Template required 172
. Reportable Values required 173
. . Observation Source required 174
. . Row Order optional 175
. . Document Reference required 176
. . . Name optional 177
. . . Column Key required 178
. . . Edit Mode optional 179
. . . Update Mode optional 180
. . . Template Key optional 181
. . . Folder Key optional 182
. . . Allow Subfolder optional 183
. . . Document Mode optional 184
. . . Document Property Filter optional 185
. . . Section Property Filter optional 186
. . Group required 187
. . . Name optional 188
. . . Column Key required 189
. . . PropertyFilter optional 190
. . Selected Method required 191
. . . Name required 192
. . Absolute Potency required 193
. . . Name required 194
. . Absolute Potency Unit required 195

229
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Name required 196

. . Absolute Potency Lower Confidence Limit required 197
. . . Name required 198
. . Absolute Potency Upper Confidence Limit required 199
. . . Name required 200
. . Absolute Potency Status required 201
. . . Name required 202
. . Relative Potency required 203
. . . Name required 204
. . Relative Potency Lower Confidence Limit required 205
. . . Name required 206
. . Relative Potency Upper Confidence Limit required 207
. . . Name required 208
. . Relative Potency Status required 209
. . . Name required 210
. Comment optional 211
. . Subject optional 212
. . Text optional 213
. . Linked Document optional 214
. . Date required 215
. . Author required 216

DOCUMENT ELEMENT REFERENCE

/ 001
Basic Bioassay Protocol USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

BasicBioassayProtocol xs:empty 1…1 <NONE>

The basic bioassay protocol is a document type for the calculation of reportable potency
values from assay replicates (independent biological assays).

/Basic Bioassay Protocol/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Documents are usally identified by their names. It is recommend to use unique names for
your document, but this is not strictly required.

/Basic Bioassay Protocol/ 003

Documentation USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Documentation xs:empty 1…1 <NONE>

Here you can give the details about operators and analyte. Unfold to see the subsections
(left click on the plus sign in front of the element).

230
 Basic Bioassay Protocol

/Basic Bioassay Protocol/Documentation/ 004

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/Documentation/CHOICE: 005

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Basic Bioassay Protocol/Documentation/CHOICE: 006

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Basic Bioassay Protocol/Documentation/ 007

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Basic Bioassay Protocol/Documentation/ 008

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Basic Bioassay Protocol/Documentation/ 009

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

231
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/Documentation/ 010

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Basic Bioassay Protocol/Documentation/ 011

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Basic Bioassay Protocol/Documentation/ 012

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Basic Bioassay Protocol/Documentation/ 013

Operator USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:string 0…1 <NONE>

Information about an operator. Unfold to see the details (left click on the plus sign in front of
the element). You can assign a role to an operator. Add a Role element by selecting it on the
creation panel.

/Basic Bioassay Protocol/Documentation/Operator/ 014

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/Documentation/Operator/CHOICE: 015

Operator Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorName xs:token 1…1 <NONE>

Enter the operator's name. You can use the choice selector to swicth to Operator Reference ,
where you can assign the operator by a reference on a operator document.

232
 Basic Bioassay Protocol

/Basic Bioassay Protocol/Documentation/Operator/CHOICE: 016

Operator Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorReference DocumentReference.Operator 1…1 <NONE>

Reference to a operator document. You can use the choice selector to switch to Operator
Name , where you can enter a operator name dirctly.

/Basic Bioassay Protocol/Documentation/Operator/ 017

Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:token 0…1 <NONE>

Enter the operator role here.

/Basic Bioassay Protocol/ 018

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE: 019

Mode: Assay Replicate USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ProtocolModePerReplicate xs:empty 1…1 <NONE>

The basic bioassay protocol supports two protocol modes. 'Mode: Assay Replicate' supports
generation of replicates based on a quantitative response assay template. It is possible to
use different templates for different replicates. Combination calculatio

/Basic Bioassay Protocol/CHOICE:Mode: Assay Replicate/ 020

Number of Replicates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NumberOfReplicates PositiveInteger0 1…1 1

Number of assay replicates. The generate button will generate the specified number of
quantitative response assays (that do not already exist).

/Basic Bioassay Protocol/CHOICE: 021

Mode: Assay Element USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ProtocolModePerElement xs:string 1…1 <NONE>

The basic bioassay protocol supports two protocol modes. 'Mode: Assay Replicate' supports
generation of replicates based on a quantitative response assay template. It is possible to
use different templates for different replicates. Combination calculatio

233
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/ 022

Standard Sample USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Standard xs:empty 1…1 <NONE>

The standard sample or standard preparation or standard is required in quantitative assays.
The potency of the preparations is calculated compared to this standard. Unfold to see the
definition details (left click on the plus sign in front of the alement

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 023

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 STD

Enter the name of the standard assay element. Examples: "Standard", "Std", "Reference
Standard" Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or e

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 024

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. It is very
important, that the given observation group ID is the same as in the template used to
generate the assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 025

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 026

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 027

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

234
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 028

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 029

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 030

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 031

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 032

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 033

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

235
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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 034

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 035

Absolute Potency: defined by Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the absolute potency settings. If
not defined by template is selected, the settings defined in the basic bioassay protocol will
be used for the absolute potency in the generated assay replicate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 036

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition EmptyElement 1…1 <NONE>

This scheme does not define an absolute dose for the assay element. A backfit calculation
for absolute potencies will not be carried out with this option. You can use the choice
selector to switch to the alternatives Absolute Potency: defined by Raw Mate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 037

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. Define the
absolute potency per amount units, the amount used for preparation and the volume of the
solvent. Note: the absolute potency has to be defined per amount units for a cor

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Raw Material/
038
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Raw Material/Assigned/Assumed Potency (Summary)/
039
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

236
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Raw Material/Assigned/Assumed Potency (Summary)/
040
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Raw Material/
041
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by 042

Raw Material/Amount (Summary)/
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount PositiveDouble 1…1 <NONE>

The amount of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by 043

Raw Material/Amount (Summary)/
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by 044

Raw Material/
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by 045

Raw Material/Solvent (Summary)/
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume PositiveDouble 1…1 <NONE>

The solvent's volume.

237
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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Raw Material/Solvent (Summary)/
046
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 047

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by

Stock Solution/
048
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Absolute Potency: defined by 049

Stock Solution/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/ 050

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 051

Dilution Factors: defined By Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactorsDefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the dilution factors. If not
defined by template is selected, the settings defined in the basic bioassay protocol will be
used for the dilution factors in the generated assay replicate.

238
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE: 052

Dilution Factors: Manual Input USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Standard Sample/CHOICE:Dilution Factors: Manual

Input/
053
USAGE
Dilution Factor optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/ 054

Test Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Test xs:empty 0…* <NONE>

The potency of the preparation (aka preparation sample, test sample, unknown) is
calculated in comparison to the standard. Unfold to see the definition details (left click on
the plus sign in front of the alement). You can use the creation panel to add s

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 055

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of this test assay element. Examples: "Preparation 1", "Unknown 3", "Test 2"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or estim

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 056

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. It is very
important, that the given observation group ID is the same as in the template used to
generate the assay replicate.

239
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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 057

Group USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

COAGroup xs:token 0…1 <NONE>

Enter the group name for the combination of assay results calculation. Additional remarks:
Ignored by the assay calculation. This group specification only affects a combination of assay
results document, that references this assay document. All test sa

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 058

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 059

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 060

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 061

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 062

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

240
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 063

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 064

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 065

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 066

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 067

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 068

Absolute Potency: defined by Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the absolute potency settings. If
not defined by template is selected, the settings defined in the basic bioassay protocol will
be used for the absolute potency in the generated assay replicate

241
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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 069

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition EmptyElement 1…1 <NONE>

This scheme does not define an absolute dose for the assay element. A backfit calculation
for absolute potencies will not be carried out with this option. You can use the choice
selector to switch to the alternatives Absolute Potency: defined by Raw Mate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 070

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. Define the
absolute potency per amount units, the amount used for preparation and the volume of the
solvent. Note: the absolute potency has to be defined per amount units for a cor

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw

Material/
071
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 072
Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 073
Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 074
Material/
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

242
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw

Material/Amount (Summary)/
075
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount PositiveDouble 1…1 <NONE>

The amount of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw

Material/Amount (Summary)/
076
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 077
Material/
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 078
Material/Solvent (Summary)/
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume PositiveDouble 1…1 <NONE>

The solvent's volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Raw 079
Material/Solvent (Summary)/
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 080

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute

243
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Stock

Solution/
081
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Absolute Potency: defined by Stock 082
Solution/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 083

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 084

Dilution Factors: defined By Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactorsDefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the dilution factors. If not
defined by template is selected, the settings defined in the basic bioassay protocol will be
used for the dilution factors in the generated assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE: 085

Dilution Factors: Manual Input USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/CHOICE:Dilution Factors: Manual Input/ 086
Dilution Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

244
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 087

Number of Replicates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NumberOfReplicates PositiveInteger0 1…1 1

Number of replicates for this assay element.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/ 088

Combination Calculation (Sample Only) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestSampleCombinationCalculation xs:string 0…* <NONE>

Defines a combination calculation based on the specified configuration. Combination
calculations specified here will aggregate only the potency data this test sample in
(calculated) assay replicates generated by this basic bioassay protocol.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/Combination Calculation (Sample Only)/ 089
Configuration Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UsedCombinationTemplate xs:token 0…1 <NONE>

Select the configuration for this combination calculation.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/Combination Calculation (Sample Only)/ 090
Document Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentName xs:token 0…1 <NONE>

Enables you to overrule the default naming of the generated document.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Test Sample/Combination Calculation (Sample Only)/ 091
Combination Document Reference USAGE

optiona
l
TECHNICAL NAME DATA TYPE DEFAULT VALUE

CombinationDocumen DocumentReference.CombinationOfAssayResult MULTIPLICI-

TY <NONE
t s 0…1 >
Reference to a Combination of Assay Results document.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/ 092

Control Sample USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Control xs:empty 0…* <NONE>

The potency of a control sample is calculated in the same manner as the test sample. The
control sample can be used to set up specific suitability tests for the assay. The control
sample will not be included in a combination of assay results calculation.

245
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 093

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of this control assay element. Examples: "Assay Control", "Control 3", "Ctr"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or esti

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 094

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. It is very
important, that the given observation group ID is the same as in the template used to
generate the assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 095

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 096

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 097

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 098

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

246
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 099

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 100

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 101

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 102

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 103

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 104

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

247
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 105

Absolute Potency: defined by Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the absolute potency settings. If
not defined by template is selected, the settings defined in the basic bioassay protocol will
be used for the absolute potency in the generated assay replicate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 106

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition EmptyElement 1…1 <NONE>

This scheme does not define an absolute dose for the assay element. A backfit calculation
for absolute potencies will not be carried out with this option. You can use the choice
selector to switch to the alternatives Absolute Potency: defined by Raw Mate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 107

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. Define the
absolute potency per amount units, the amount used for preparation and the volume of the
solvent. Note: the absolute potency has to be defined per amount units for a cor

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by Raw

Material/
108
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by

Raw Material/Assigned/Assumed Potency (Summary)/
109
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 110

Raw Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

248
 Basic Bioassay Protocol

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by

Raw Material/
111
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by

Raw Material/Amount (Summary)/
112
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount PositiveDouble 1…1 <NONE>

The amount of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 113

Raw Material/Amount (Summary)/
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 114

Raw Material/
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 115

Raw Material/Solvent (Summary)/
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume PositiveDouble 1…1 <NONE>

The solvent's volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 116

Raw Material/Solvent (Summary)/
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 117

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by

Stock Solution/
118
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Absolute Potency: defined by 119

Stock Solution/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 120

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 121

Dilution Factors: defined By Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactorsDefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the dilution factors. If not
defined by template is selected, the settings defined in the basic bioassay protocol will be
used for the dilution factors in the generated assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE: 122

Dilution Factors: Manual Input USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/CHOICE:Dilution Factors: Manual Input/ 123
Dilution Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Sample/ 124

Number of Replicates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NumberOfReplicates PositiveInteger0 1…1 1

Number of replicates for this assay element.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/ 125

Control Line USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ControlLine xs:empty 0…* <NONE>

A control line refines the characteristics of an assay. It can be used for response adjustment
or for enhanced model building. In contrast to controls control lines do not have a dilution or
dose. Unfold to see the definition details (left click on the p

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 126

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Enter the name of the control line. Examples: "Positive Control", "Negative Control", "Blank"
Additional remarks: The Name is shown in the Observation Group Column of the
Observation Editor and used for ther reporting of test results, data values or es

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 127

Observation Group Id USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationGroupId xs:positiveInteger 1…1 <NONE>

Natural number (zero not included) to connect the assay element to the data. It is very
important, that the given observation group ID is the same as in the template used to
generate the assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 128

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 130

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 131

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 132

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 133

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 134

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 135

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 136

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 137

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 138

Absolute Potency: defined by Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the absolute potency settings. If
not defined by template is selected, the settings defined in the basic bioassay protocol will
be used for the absolute potency in the generated assay replicate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 139

Absolute Potency: not defined USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

NoPotencyDefinition EmptyElement 1…1 <NONE>

This scheme does not define an absolute dose for the assay element. A backfit calculation
for absolute potencies will not be carried out with this option. You can use the choice
selector to switch to the alternatives Absolute Potency: defined by Raw Mate

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 140

Absolute Potency: defined by Raw Material USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByRawMaterial xs:empty 1…1 <NONE>

This scheme calculates the absolute potency starting from a raw material. Define the
absolute potency per amount units, the amount used for preparation and the volume of the
solvent. Note: the absolute potency has to be defined per amount units for a cor

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw

Material/
141
USAGE
Assigned/Assumed Potency (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencySummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw

Material/Assigned/Assumed Potency (Summary)/
142
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw 143
Material/Assigned/Assumed Potency (Summary)/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw 144
Material/
USAGE
Amount (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw 145
Material/Amount (Summary)/
USAGE
Amount required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Amount PositiveDouble 1…1 <NONE>

The amount of the substance.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw 146
Material/Amount (Summary)/
USAGE
Amount Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AmountUnits xs:string 1…1 <NONE>

The amount's unit used for reporting.

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw

Material/
147
USAGE
Solvent (Summary) required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventSummary xs:empty 1…1 <NONE>

Unfold to see the definition details (left click on the plus sign in front of the element).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw

Material/Solvent (Summary)/
148
USAGE
Solvent Volume required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolume PositiveDouble 1…1 <NONE>

The solvent's volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Raw 149
Material/Solvent (Summary)/
USAGE
Solvent Volume Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SolventVolumeUnits xs:string 1…1 <NONE>

The unit of the solvent volume.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 150

Absolute Potency: defined by Stock Solution USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyDefinitionByStockSolution xs:empty 1…1 <NONE>

With this scheme the absolute absolute potency is given directly. A backfit calculation is
performed when the calculation is carried out. You can use the choice selector to switch to
the alternatives Absolute Potency: defined by Raw Material or Absolute

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Stock 151
Solution/
USAGE
Assigned/Assumed Potency required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotency PositiveDouble 1…1 <NONE>

The assigned potency (in case of a standard sample) or assumed potency (in case of a test
sample).

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Absolute Potency: defined by Stock 152
Solution/
USAGE
Assigned/Assumed Potency Units required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssignedAssumedPotencyUnits xs:string 1…1 <NONE>

The unit of the assigned / assumed potency for the reporting.

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/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/ 153

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 154

Dilution Factors: defined By Template USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactorsDefinedByTemplate EmptyElement 1…1 <NONE>

The settings of the selected template will be used to define the dilution factors. If not
defined by template is selected, the settings defined in the basic bioassay protocol will be
used for the dilution factors in the generated assay replicate.

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE: 155

Dilution Factors: Manual Input USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactors xs:empty 1…1 <NONE>

You can define multiple dilution factors. You can use for example the context section of the
creation panel for adding a new dilution factor. During the assay analyzation a final dilution
factor will be calculated by multiplying all the dilution factors

/Basic Bioassay Protocol/CHOICE:Mode: Assay Element/Control Line/CHOICE:Dilution Factors: Manual Input/ 156
Dilution Factor USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PreDilutionFactor PositiveDouble 0…* <NONE>

A single dilution factor inputed as reciprocal value (so in the calculation 1 / Dilution Factor)
will be considered.

/Basic Bioassay Protocol/ 157

Assay Replicate USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayReplicate xs:empty 0…* <NONE>

/Basic Bioassay Protocol/Assay Replicate/ 158

Assay Replicate Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayDocument DocumentReference.QuantitativeResponseAssay 0…1 <NONE>

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 Basic Bioassay Protocol

/Basic Bioassay Protocol/ 159

Combination Calculation USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

CombinationCalculation xs:string 0…* <NONE>

Defines a combination calculation based on the specified configuration. Combination
calculations specified here will aggregate the potency data of all test samples in (calculated)
assay replicates generated by this basic bioassay protocol.

/Basic Bioassay Protocol/Combination Calculation/ 160

Configuration Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UsedCombinationTemplate xs:token 0…1 <NONE>

Select the configuration for this combination calculation.

/Basic Bioassay Protocol/Combination Calculation/ 161

Document Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentName xs:token 0…1 <NONE>

Enables you to overrule the default naming of the generated document.

/Basic Bioassay Protocol/Combination Calculation/ 162

Combination Document Reference USAGE

optiona
l
TECHNICAL NAME DATA TYPE DEFAULT VALUE

CombinationDocumen DocumentReference.CombinationOfAssayResult MULTIPLICI-

TY <NONE
t s 0…1 >
Reference to a Combination of Assay Results document.

/Basic Bioassay Protocol/ 163

Templates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Templates xs:empty 1…1 <NONE>

This section allows to specify the templates used to generate the assay replicates and the
combination calculations.

/Basic Bioassay Protocol/Templates/ 164

Assay Templates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayTemplates xs:empty 1…1 <NONE>

This section contains the templates for the quantitative response assay documents.

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/Basic Bioassay Protocol/Templates/Assay Templates/ 165

Force Common Replicate Number USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ForceCommonReplicateNumber xs:boolean 1…1 true

Impacts only the 'Mode: Assay Element' and controls the way, assay replicated are
generated, if already assay replicates have been generated. If set to true, a additional
generation after increasing all or some of the number of replicates of the test or

/Basic Bioassay Protocol/Templates/Assay Templates/ 166

Assay Template USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayTemplate xs:empty 0…* <NONE>

Please select the assay template reference. Additionally it is possible to add the field 'valid
for replicate' for this assay template, to control for which replicate the template will be used.

/Basic Bioassay Protocol/Templates/Assay Templates/Assay Template/ 167

Template USAGE

require
d
TECHNICAL NAME DATA TYPE DEFAULT VALUE

AssayTemplateReferenc TemplateReference.QuantitativeResponseAss MULTIPLICI- TY <NONE

e ay 1…1 >
Select a quantitative response assay template. If more then one quantitative response assay
template is defined, only one template with no 'valid for replicate' restriction is allowed.

/Basic Bioassay Protocol/Templates/Assay Templates/Assay Template/ 168

Valid for Replicate USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ValidForReplicate xs:positiveInteger 0…* 1

The template is only used for the generation of the specified replicate number. If no
template exists with the required replicate number the template with no specified 'valid for
replicate' will be used. Only one template per replicate number is allowed.

/Basic Bioassay Protocol/Templates/ 169

Combination Calculation Templates USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

CombinationCalculationTemplates xs:empty 1…1 <NONE>

This section contains the templates for the combination of assay result documents. It is
possible to add configurations. For every configuration a template can be defined.

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/Basic Bioassay Protocol/Templates/Combination Calculation Templates/ 170

Configuration USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

CombinationCalculationTemplate xs:empty 0…* <NONE>

Please specify the configuration name and the used template.

/Basic Bioassay Protocol/Templates/Combination Calculation Templates/Configuration/ 171

Configuration Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

You can specify a name for this configuration.

/Basic Bioassay Protocol/Templates/Combination Calculation Templates/Configuration/ 172

Template USAGE

requir
ed
TECHNICAL NAME DATA TYPE DEFAULT

CombinationCalculationTemplateR TemplateReference.CombinationOfAs VALUE

MULTI-
<NON
eference sayResults PLICITY

1…1 E>
Please select a combination of assay result template for this configurtaion.

/Basic Bioassay Protocol/ 173

Reportable Values USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

COAResults xs:empty 1…1 <NONE>

Contains settings about the data set structure for summarizing the reportable values
generated by the combination of assay results documents.

/Basic Bioassay Protocol/Reportable Values/ 174

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

/Basic Bioassay Protocol/Reportable Values/ 175

Row Order USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder ds:T_RowOrder 0…1 <NONE>

Define a sort order for the data rows.

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/Basic Bioassay Protocol/Reportable Values/ 176

Document Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentReference DatasetColumn.Reference 1…1 <NONE>

Column for the document reference.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 177

Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 0…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 178

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

Cannot be changed for this column. Column keys are required for defining a sort order
considering this column.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 179

Edit Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EditMode ds:T_EditMode 0…1 <NONE>

Possible values are Select or Create .

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 180

Update Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpdateMode ds:T_UpdateMode 0…1 <NONE>

Select the mode, how the document references (and the according values) are updated.
Possible values are Auto All : The data will be automatically updated from all matching
documents in the data base. The update is done, when the referencing document is

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 181

Template Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TemplateKey xs:token 0…1 <NONE>

You can enter a template key. In this case, the referenced documents have to be generated
by the specified template.

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 Basic Bioassay Protocol

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 182

Folder Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FolderKey xs:token 0…1 <NONE>

You can enter a folder key. In this case, the referenced documents have to elements of the
specified folder. If you additionally set Allow Subfolder to true , the referenced documents
have to be elements of the specified folder or one of its subfolder.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 183

Allow Subfolder USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AllowSubfolder xs:boolean 0…1 <NONE>

Only relevant, if a folder key is entered. If you set set Allow Subfolder to true , the
referenced documents have to be elements of the specified folder or one of its subfolder.
Otherwise the subfolders are excluded.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 184

Document Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentMode ds:T_DocumentMode 0…1 <NONE>

You can select a document mode. In this case, the referenced documents have to be of the
specified mode.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 185

Document Property Filter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentPropertyFilter ds:T_DocumentPropertyFilterForDocuments 0…* <NONE>

Define a filter based on a document property. Referenced documents have to pass the
defined filter.

/Basic Bioassay Protocol/Reportable Values/Document Reference/ 186

Section Property Filter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionPropertyFilter ds:T_SectionPropertyFilterForDocuments 0…* <NONE>

Define a filter based on a section property. Referenced documents have to pass the defined
filter.

/Basic Bioassay Protocol/Reportable Values/ 187

Group USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Section DatasetColumn.ReferenceSection 1…1 <NONE>

Column for the group information of the combination calculation.

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/Basic Bioassay Protocol/Reportable Values/Group/ 188

Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 0…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/Group/ 189

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

Cannot be changed for this column. Column keys are required for defining a sort order
considering this column.

/Basic Bioassay Protocol/Reportable Values/Group/ 190

PropertyFilter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyFilter ds:T_PropertyFilterForSections 0…1 <NONE>

Define a section property filter that is used for data aggregation.

/Basic Bioassay Protocol/Reportable Values/ 191

Selected Method USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SelectedMethod DatasetColumn.SelectedMethod 1…1 <NONE>

Column for the selected combination method.

/Basic Bioassay Protocol/Reportable Values/Selected Method/ 192

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 193

Absolute Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Potency DatasetColumn.ResultPotencyMean 1…1 <NONE>

Column for the combined potency.

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 Basic Bioassay Protocol

/Basic Bioassay Protocol/Reportable Values/Absolute Potency/ 194

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 195

Absolute Potency Unit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyUnit DatasetColumn.PotencyUnit 1…1 <NONE>

Column for the potency unit.

/Basic Bioassay Protocol/Reportable Values/Absolute Potency Unit/ 196

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Basic Bioassay Protocol/Reportable Values/ 197

Absolute Potency Lower Confidence Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyLowerLimit DatasetColumn.PotencyLowerLimit 1…1 <NONE>

Column for the lower confidence limit of the potency.

/Basic Bioassay Protocol/Reportable Values/Absolute Potency Lower Confidence Limit/ 198

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 199

Absolute Potency Upper Confidence Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyUpperLimit DatasetColumn.PotencyUpperLimit 1…1 <NONE>

Column for the upper confidence limit of the potency.

/Basic Bioassay Protocol/Reportable Values/Absolute Potency Upper Confidence Limit/ 200

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

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/Basic Bioassay Protocol/Reportable Values/ 201

Absolute Potency Status USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyStatus DatasetColumn.PotencyStatus 1…1 <NONE>

/Basic Bioassay Protocol/Reportable Values/Absolute Potency Status/ 202

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 203

Relative Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotency DatasetColumn.RelativePotency 1…1 <NONE>

Column for the combined relative potency.

/Basic Bioassay Protocol/Reportable Values/Relative Potency/ 204

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 205

Relative Potency Lower Confidence Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotencyLowerLimit DatasetColumn.RelativePotencyLowerLimit 1…1 <NONE>

Column for the lower confidence limit of the combined relative potency.

/Basic Bioassay Protocol/Reportable Values/Relative Potency Lower Confidence Limit/ 206

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 207

Relative Potency Upper Confidence Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotencyUpperLimit DatasetColumn.RelativePotencyUpperLimit 1…1 <NONE>

Column for the upper confidence limit of the combined relative potency.

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 Basic Bioassay Protocol

/Basic Bioassay Protocol/Reportable Values/Relative Potency Upper Confidence Limit/ 208

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/Reportable Values/ 209

Relative Potency Status USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotencyStatus DatasetColumn.RelativePotencyStatus 1…1 <NONE>

/Basic Bioassay Protocol/Reportable Values/Relative Potency Status/ 210

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Basic Bioassay Protocol/ 211

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment xs:empty 0…* <NONE>

A single comments to this assay. You cann add a Subject or Document Link by using the
creation panel.

/Basic Bioassay Protocol/Comment/ 212

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Optional comment subject.

/Basic Bioassay Protocol/Comment/ 213

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Basic Bioassay Protocol/Comment/ 214

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

/Basic Bioassay Protocol/Comment/ 215

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Basic Bioassay Protocol/Comment/ 216

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

266
 Equivalence Margin Development

EQUIVALENCE MARGIN DEVELOPMENT

DESCRIPTION
The Equivalence Margin Development document type is a special document type to support
the development of equivalence margins.

In the observation/reference table various information are defined to carry out the Equiva-
lence Margin Development calculations. They can be given manually or usually by aggregat-
ing data from Quantitative Response Assays.

Usually you select a number of acceptable Quantitative Response Assay from your historic
data. The calculation process then delivers a number of up to 30 different Equivalence Mar-
gins with some quality information. You can use this data for your decision to select specific
Equivalence Margins for your assay tests.

A confidence level and a tolerance level are available to fine tune the calculation process.
Values marked as Technical Outliers are excluded from analysis.

LITERATURE
• Callahan, J. D.; Sajjadi, N. C. Testing the null hypothesis for a specified difference -
The right way to test for parallelism. Bioprocessing Journal. 2003, 2, 71 – 78
• Hauck, W. W.; Carpen, R. C.; Callahan, J. D.; De Muth, J. E.; Hsu, H.; Lansky, D.; Sajjadi,
N. C.; Seaver, S. S.; Singer, R. R.; Weisman, D. Assessing parallelism prior to determin-
ing relative potency. PDA Journal of Pharmaceutical Science and Technology. 2005,
59, 127 - 137.
• The United States Pharmacopeia Convention. <1032> Design and development of bi-
ological assays. 2010.
• The United States Pharmacopeia Convention. <1034> Analysis of biological assays.
2010.

REPORTS
• Standard Report

TASKS
• Calculate – performs the calculation process

DOCUMENT STRUCTURE
DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for an Equivalence Mar-
gin Development document. It is indicated whether a field is required or optional. The num-
ber is a reference to the following section with more reference data for every field.

Equivalence Margin Development for Biological Assays required 001

. Name required 002

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. Identification optional 003

. Date required 004
. Observed Data required 005
. . Observation Source required 006
. . Row Order optional 007
. . Column: Document Reference required 008
. . Column: Section required 009
. . . Name optional 010
. . . Column Key required 011
. . . Property Filter optional 012
. . . . PropertyKey required 013
. . . . Term required 014
. . Column: Exclude from Analysis required 015
. . STD_A required 016
. . . Name required 017
. . STD_A_SE required 018
. . . Name required 019
. . STD_B required 020
. . . Name required 021
. . STD_B_SE required 022
. . . Name required 023
. . STD_C required 024
. . . Name required 025
. . STD_C_SE required 026
. . . Name required 027
. . STD_D required 028
. . . Name required 029
. . STD_D_SE required 030
. . . Name required 031
. . STD_G required 032
. . . Name required 033
. . STD_G_SE required 034
. . . Name required 035
. . STD_M required 036
. . . Name required 037
. . STD_M_SE required 038
. . . Name required 039
. . STD_N required 040
. . . Name required 041
. . STD_N_SE required 042
. . . Name required 043
. . TST_A required 044
. . . Name required 045
. . TST_A_SE required 046
. . . Name required 047
. . TST_B required 048
. . . Name required 049
. . TST_B_SE required 050
. . . Name required 051
. . TST_C required 052
. . . Name required 053
. . TST_C_SE required 054
. . . Name required 055

268
 Equivalence Margin Development

. . TST_D required 056

. . . Name required 057
. . TST_D_SE required 058
. . . Name required 059
. . TST_G required 060
. . . Name required 061
. . TST_G_SE required 062
. . . Name required 063
. . TST_M required 064
. . . Name required 065
. . TST_M_SE required 066
. . . Name required 067
. . TST_N required 068
. . . Name required 069
. . TST_N_SE required 070
. . . Name required 071
. . STD_A_D_COV required 072
. . . Name required 073
. . SS_LOF required 074
. . . Name required 075
. . VAR required 076
. . . Name required 077
. . df required 078
. . . Name required 079
. . TST_RESULT required 080
. . . Name required 081
. Confidence Level required 082
. Tolerance Level required 083
. Comment optional 084
. . Subject optional 085
. . Text optional 086
. . Linked Document optional 087
. . Date required 088
. . Author required 089

DOCUMENT ELEMENT REFERENCE

/ 001
Equivalence Margin Development for Biological Assays USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EMD xs:empty 1…1 <NONE>

Document for the development of equivalence margins. In case of document aggregation,
only test samples can be used as data source. Please unfold (left-click on the plus sign in fron
of the element) to see further settings. You can add any number of comments e.g. by using
the context section of creation panel.

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/Equivalence Margin Development for Biological Assays/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Documents are usally identified by their names. It is recommend to use unique names for
your document, but this is not strictly required.

/Equivalence Margin Development for Biological Assays/ 003

Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Identification xs:token 0…1 <NONE>

Enter a identification string for the assay. This is an alternative to the use of name to identify
the assay. It is recommend to use unique Identifications for your document, but this is not
strictly required.

/Equivalence Margin Development for Biological Assays/ 004

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

You can enter a date for the assay. Per default the document's creation date is entered here
automatically. However this can be changed. The date can be used for sorting in aggregation
documents.

/Equivalence Margin Development for Biological Assays/ 005

Observed Data USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Dataset xs:empty 1…1 <NONE>

The dataset setup to calculate the margins. Most of it's content is filled automatically and
not visible in the content editor. Please unfold to see the sub elements (left click on the plus
sign in front of the element).

/Equivalence Margin Development for Biological Assays/Observed Data/ 006

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

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 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Observed Data/ 007

Row Order USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder ds:T_RowOrder 0…1 <NONE>

Define a sort order for the data rows.

/Equivalence Margin Development for Biological Assays/Observed Data/ 008

Column: Document Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentReference ds:T_ReferenceColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/ 009

Column: Section USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Section T_EMDReferenceSectionFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/Column: Section/ 010

Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 0…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/Column: Section/ 011

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

[NO DETAILS]

/Equivalence Margin Development for Biological Assays/Observed Data/Column: Section/ 012

Property Filter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyFilter T_EMDPropertyFilterForSections 0…* <NONE>

Define a section property filter that is used for data aggregation.

/Equivalence Margin Development for Biological Assays/Observed Data/Column: Section/Property Filter/ 013
PropertyKey USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyKey xs:token 1…1 <NONE>

[NO DETAILS]

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Equivalence Margin Development for Biological Assays/Observed Data/Column: Section/Property Filter/ 014
Term USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Term xs:string 1…1 <NONE>

[NO DETAILS]

/Equivalence Margin Development for Biological Assays/Observed Data/ 015

Column: Exclude from Analysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TechnicalOutlier ds:T_TechnicalOutlierColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/ 016

STD_A USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_A T_STD_A 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_A/ 017

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 018

STD_A_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_A_SE T_STD_A_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_A_SE/ 019

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 020

STD_B USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_B T_STD_B 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

272
 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Observed Data/STD_B/ 021

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 022

STD_B_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_B_SE T_STD_B_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_B_SE/ 023

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 024

STD_C USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_C T_STD_C 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_C/ 025

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 026

STD_C_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_C_SE T_STD_C_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_C_SE/ 027

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

273
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Equivalence Margin Development for Biological Assays/Observed Data/ 028

STD_D USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_D T_STD_D 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_D/ 029

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 030

STD_D_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_D_SE T_STD_D_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_D_SE/ 031

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 032

STD_G USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_G T_STD_G 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_G/ 033

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 034

STD_G_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_G_SE T_STD_G_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

274
 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Observed Data/STD_G_SE/ 035

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 036

STD_M USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_M T_STD_M 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_M/ 037

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 038

STD_M_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_M_SE T_STD_M_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_M_SE/ 039

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 040

STD_N USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_N T_STD_N 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_N/ 041

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

275
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Equivalence Margin Development for Biological Assays/Observed Data/ 042

STD_N_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_N_SE T_STD_N_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_N_SE/ 043

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 044

TST_A USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_A T_TST_A 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_A/ 045

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 046

TST_A_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_A_SE T_TST_A_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_A_SE/ 047

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 048

TST_B USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_B T_TST_B 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

276
 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Observed Data/TST_B/ 049

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 050

TST_B_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_B_SE T_TST_B_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_B_SE/ 051

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 052

TST_C USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_C T_TST_C 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_C/ 053

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 054

TST_C_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_C_SE T_TST_C_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_C_SE/ 055

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Equivalence Margin Development for Biological Assays/Observed Data/ 056

TST_D USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_D T_TST_D 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_D/ 057

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 058

TST_D_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_D_SE T_TST_D_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_D_SE/ 059

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 060

TST_G USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_G T_TST_G 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_G/ 061

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 062

TST_G_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_G_SE T_TST_G_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

278
 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Observed Data/TST_G_SE/ 063

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 064

TST_M USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_M T_TST_M 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_M/ 065

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 066

TST_M_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_M_SE T_TST_M_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_M_SE/ 067

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 068

TST_N USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_N T_TST_N 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_N/ 069

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

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/Equivalence Margin Development for Biological Assays/Observed Data/ 070

TST_N_SE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_N_SE T_TST_N_SE 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_N_SE/ 071

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 072

STD_A_D_COV USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

STD_A_D_COV T_STD_A_D_COV 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/STD_A_D_COV/ 073

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Equivalence Margin Development for Biological Assays/Observed Data/ 074

SS_LOF USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SS_LOF T_SS_LOF 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/SS_LOF/ 075

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Equivalence Margin Development for Biological Assays/Observed Data/ 076

VAR USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

VAR T_VAR 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

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/Equivalence Margin Development for Biological Assays/Observed Data/VAR/ 077

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 078

df USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

df T_DF 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/df/ 079

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/Observed Data/ 080

TST_RESULT USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TST_RESULT T_AssayTestStateFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Equivalence Margin Development for Biological Assays/Observed Data/TST_RESULT/ 081

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Equivalence Margin Development for Biological Assays/ 082

Confidence Level USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ConfidenceLevel T_ConfidenceLevel 1…1 <NONE>

In case of margins for confidence intervals this defines the confidence level for which
margins are calculated. A commonly used value is 95%. Larger Confidence levels lead to
larger margin intervals.

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/Equivalence Margin Development for Biological Assays/ 083

Tolerance Level USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ToleranceLevel T_ToleranceLevel 1…1 <NONE>

The tolerance level specifies the amount of data to enter the final calculation. For example if
you set this to 90%, the outer 10% data values will not enter the calculation. A common
value is 90%. Larger tolerance levels lead to larger margin intervals.

/Equivalence Margin Development for Biological Assays/ 084

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comments to this assay.

/Equivalence Margin Development for Biological Assays/Comment/ 085

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Enter a subject for this comment.

/Equivalence Margin Development for Biological Assays/Comment/ 086

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

/Equivalence Margin Development for Biological Assays/Comment/ 087

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

/Equivalence Margin Development for Biological Assays/Comment/ 088

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

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 Equivalence Margin Development

/Equivalence Margin Development for Biological Assays/Comment/ 089

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

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COMBINATION OF ASSAY RESULTS

DESCRIPTION
Combination of Assay Results is a document type for performing combination calculation for
Quantitative Response Assays. Depending on the input data the calculation combines rela-
tive potencies and/or absolute potencies of test samples.

There are several types of combination calculations available:

• Unweighted Combination
• Homogeneously Weighted Combination
• Heterogeneously Weighted Combination

You can either select a combination calculation or let the system decide by the result of the
homogeneity test.

For heterogeneously weighted combination the system support three different approaches:

• Heterogeneously weighted according to European Pharmacopoeia

• Heterogeneously weighted according to US Pharmacopeia <111>
• Heterogeneously weighted according to US Pharmacopeia <1034>

There are a few additional settings available for fine tuning the calculation process.

Data values marked as invalid in the Test State column or by manually setting those to Tech-
nical Outliers are not combined.

The Combination of Assay Results document also supports Groups of combinations. If the
Test Samples are assigned to a group label, only single results with the same group label are
combined together.

DATA SOURCE
In the Potency Data Section of the document you can set the Observation Source property to
User Input or Aggregation (the default setting). When set to user input you can directly in-
put the required data in the Observations table. The usual way is to aggregate the data by
referencing calculated Quantitative Response Assays. In the References Table you can direct-
ly add Reference to Quantitative Response Assays to the system.

SETTING UP DATA AGGREGATION

Data aggregation is a very powerful tool in PLA 3.0. There are several properties to fine tune
the aggregation process. Without fine tuning the Combination of Assay Results document
you can select any documents in the database as a data source for the table. In most cases
this will not make any sense. With the tuning options below you use several properties to
define the source documents. E.g. you can setup control charts for specific projects, folders
or documents with specific properties.

284
 Combination of Assay Results

Useful options:

Document Type Select a specific document type as data source. E.g. Quantitative
Response Assays
Template Key Accept only documents created from the specified template
Folder Key Accept only documents in the specified folder
Allow Subfolder Specify whether documents are accepted from subfolders
Generator Key Accept only documents created from a specified generator docu-
ment
Document Property Accept only documents that are accepted by the defined filter
Filter

TEST SYSTEM
A few tests are available to check the validity of a result:

• Test of Relative Potency value. Specify an upper and lower limit for the relative po-
tency.
• Test of Relative Potency confidence interval. Specify an upper and lower limit for the
relative potency confidence interval
• Test of Relative Potency Range. Specify an upper limit for the combined relative po-
tency range.

CONCEPTS
COMBINATION GROUPS
Every line in the Observations/Reference table can be assigned to a Group. Only those lines
with identical group assignment are combined together. If you use Data Aggregation the
group assignment is aggregated directly from the combination group assignment in the
Quantitative Response Assay documents.

This feature allows setting up Quantitative Response Assays with different Test Samples and
then combining the correct Test Samples together. E.g. if you setup a number of Quantita-
tive Response Assays with two Test Samples A and B, you can assign them to Group A and B,
receiving combinations for all the Test Sample A and for all the Test Samples B in one single
combination calculation:

• Assay 1
o Test Sample A (assigned to group A)
o Test Sample B (assigned to group B)
• Assay 2
o Test Sample A (assigned to group A)
o Test Sample B (assigned to group B)
• Assay 3
o Test Sample A (assigned to group A)
o Test Sample B (assigned to group B)

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• Combination of Assay 1 – 3
o Combined Results of Group A
o Combined Results of Group B

LITERATURE
• European Pharmacopoeia 6th Edition, chapter 5.3
• US Pharmacopeia <111>
• US Pharmacopeia <1034>

REPORTS
• Standard Report

TASKS
• Calculate – performs the calculation process

DOCUMENT STRUCTURE
DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for a Combination of
Assay Results document. It is indicated whether a field is required or optional. The number is
a reference to the following section with more reference data for every field.

Combination of Independent Assay Results required 001

. Name required 002
. Documentation optional 003
. . Assay Purpose optional 004
. . CHOICE required 005
. . . Substance Name optional 006
. . . Substance Reference optional 007
. . Substance Identification optional 008
. . Substance Batch/Lot number optional 009
. . Substance Sub-Batch/Sub-Lot number optional 010
. . Substance Variant optional 011
. . Substance Class optional 012
. . Substance Description optional 013
. . Operator optional 014
. . . CHOICE required 015
. . . . Operator Name required 016
. . . . Operator Reference required 017
. . . Role optional 018
. . Equipment optional 019
. . . CHOICE required 020
. . . . Equipment Name required 021
. . . . Equipment Reference required 022
. . User Variable optional 023
. . . Key required 024
. . . Value optional 025
. Group Information required 026

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 Combination of Assay Results

. . Group optional 027

. . . Name required 028
. . . CHOICE required 029
. . . . Substance Name optional 030
. . . . Substance Reference optional 031
. . . Substance Identification optional 032
. . . Substance Batch/Lot number optional 033
. . . Substance Sub-Batch/Sub-Lot number optional 034
. . . Substance Variant optional 035
. . . Substance Class optional 036
. . . Substance Description optional 037
. Potency Data required 038
. . Observation Source required 039
. . RowOrder optional 040
. . Column: Document Reference required 041
. . . Name optional 042
. . . Column Key required 043
. . . Edit Mode optional 044
. . . Update Mode optional 045
. . . Document Type optional 046
. . . Template Key optional 047
. . . Folder Key optional 048
. . . Allow Subfolder optional 049
. . . Generator Key optional 050
. . . Document Mode optional 051
. . . Document Property Filter optional 052
. . . Section Property Filter optional 053
. . Column: Section required 054
. . . Name optional 055
. . . Column Key required 056
. . . Property Filter required 057
. . . . Property Key required 058
. . . . Term required 059
. . Column: Group required 060
. . . Name required 061
. . Column: Relative Potency required 062
. . . Name required 063
. . . ColumnKey optional 064
. . Column: Relative Potency Lower Limit required 065
. . . Name required 066
. . Column: Relative Potency Upper Limit required 067
. . . Name required 068
. . Column: Potency required 069
. . . Name required 070
. . Column: Potency Unit required 071
. . . Name required 072
. . Column: Potency Lower Limit required 073
. . . Name required 074
. . Column: Potency Upper Limit required 075
. . . Name required 076
. . Column: Model required 077
. . . Name required 078
. . Column: Degrees of Freedom required 079

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

. . . Name required 080

. . Column: Potency Confidence Level required 081
. . . Name required 082
. . Column: Assay Test State required 083
. . . Name required 084
. . Column: Exclude from Calculation required 085
. Weighting required 086
. Heterogeneous Weighting Type required 087
. Chi² Significance required 088
. Report Homogeneity Test required 089
. Logarithm Type required 090
. Tests required 091
. . Test on Potency Value optional 092
. . . Upper Margin required 093
. . . Lower Margin required 094
. . . Severity Level of the Test optional 095
. . . Scope of the Test optional 096
. . Test on Potency Confidence Interval (%) optional 097
. . . Upper Margin optional 098
. . . Lower Margin optional 099
. . . Severity Level of the Test optional 100
. . . Scope of the Test optional 101
. . Chi² Homogeneity Test optional 102
. . . Significance required 103
. . . Severity Level of the Test optional 104
. . . Scope of the Test optional 105
. . Test on Potency Confidence Interval optional 106
. . . Upper Margin optional 107
. . . Lower Margin optional 108
. . . Severity Level of the Test optional 109
. . . Scope of the Test optional 110
. . Test on Potency Coefficient of Variation (%) optional 111
. . . Upper Margin required 112
. . . Severity Level of the Test optional 113
. . . Scope of the Test optional 114
. . Test on Potency Range (%) optional 115
. . . Upper Margin required 116
. . . Severity Level of the Test optional 117
. . . Scope of the Test optional 118
. . Test on (Log) Potency Range optional 119
. . . Upper Margin required 120
. . . Severity Level of the Test optional 121
. . . Scope of the Test optional 122
. . Test on (Log) Potency Confidence Interval Length optional 123
. . . Upper Margin required 124
. . . Severity Level of the Test optional 125
. . . Scope of the Test optional 126
. . Test on Number of Valid Assays optional 127
. . . Upper Margin optional 128
. . . Lower Margin optional 129
. . . Severity Level of the Test optional 130
. . . Scope of the Test optional 131
. . Test on Sum of Weights optional 132

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 Combination of Assay Results

. . Upper Margin
. optional 133
. . Lower Margin
. optional 134
. . Severity Level of the Test
. optional 135
. . Scope of the Test
. optional 136
. . Signature State optional 137
. . . Number of Signatures optional 138
. . . Meaning optional 139
. . . Scope of the Test optional 140
. . . Severity Level of the Test optional 141
. Comment optional 142
. . Subject optional 143
. . Text optional 144
. . Linked Document optional 145
. . Date required 146
. . Author required 147

DOCUMENT ELEMENT REFERENCE

/ 001
Combination of Independent Assay Results USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

COA xs:empty 1…1 <NONE>

For the generation of a reportable value a combination calculation is required. In case of
document aggregation, only test samples can be considered. There are several ways how to
calculate a combination of assay result. The methods can be distingushed in Unweigthed
Calculation Weighted Calculation Homogeneously weighted calculation Heterogeneously
weighted calculation according to European Pharmacopoeia Chapter 5.3 US Pharmacopoeia
<111> (semi-weighted) US Pharmacopoeia <1034>

/Combination of Independent Assay Results/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Documents are usally identified by their names. It is recommend to use unique names for
your document, but this is not strictly required.

/Combination of Independent Assay Results/ 003

Documentation USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Documentation T_Documentation 0…1 <NONE>

Here you can give the details about operators, used reagents and equipment. Unfold to see
the subsections (left click on the plus sign in front of the element). You can use the creation
panel to add new documentation sections.

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/Combination of Independent Assay Results/Documentation/ 004

Assay Purpose USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayPurpose xs:string 0…1 <NONE>

Document the purpose of this assay. E.g. Identify the analyte or target of the assay, and it's
unique identification.

/Combination of Independent Assay Results/Documentation/ 005

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Combination of Independent Assay Results/Documentation/CHOICE: 006

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Combination of Independent Assay Results/Documentation/CHOICE: 007

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Combination of Independent Assay Results/Documentation/ 008

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Combination of Independent Assay Results/Documentation/ 009

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

290
 Combination of Assay Results

/Combination of Independent Assay Results/Documentation/ 010

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Combination of Independent Assay Results/Documentation/ 011

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Combination of Independent Assay Results/Documentation/ 012

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Combination of Independent Assay Results/Documentation/ 013

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Combination of Independent Assay Results/Documentation/ 014

Operator USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:empty 0…* <NONE>

Information about an operator. Unfold to see the details (left click on the plus sign in front of
the element). You can assign a role to an operator. Add a Role element by selecting it on the
creation panel.

/Combination of Independent Assay Results/Documentation/Operator/ 015

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Combination of Independent Assay Results/Documentation/Operator/CHOICE: 016

Operator Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorName xs:token 1…1 <NONE>

Enter the operator's name. You can use the choice selector to swicth to Operator Reference ,
where you can assign the operator by a reference on a operator document.

/Combination of Independent Assay Results/Documentation/Operator/CHOICE: 017

Operator Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorReference T_OperatorReference 1…1 <NONE>

Reference to a operator document. You can use the choice selector to switch to Operator
Name , where you can enter a operator name dirctly.

/Combination of Independent Assay Results/Documentation/Operator/ 018

Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:token 0…1 <NONE>

Enter the operator role here.

/Combination of Independent Assay Results/Documentation/ 019

Equipment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Equipment xs:empty 0…* <NONE>

Information about equipment used to perform the assay. For documentation purposes.
Unfold to see the details.

/Combination of Independent Assay Results/Documentation/Equipment/ 020

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Combination of Independent Assay Results/Documentation/Equipment/CHOICE: 021

Equipment Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentName xs:token 1…1 <NONE>

Enter the equipment's name. You can use the choice selector to swicth to Equipment
Reference , where you can assign the equipment by a reference on a equipment document.

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 Combination of Assay Results

/Combination of Independent Assay Results/Documentation/Equipment/CHOICE: 022

Equipment Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EquipmentReference T_EquipmentReference 1…1 <NONE>

Reference to a equipment document. You can use the choice selector to switch to
Equipment Name , where you can enter a equipment name dirctly.

/Combination of Independent Assay Results/Documentation/ 023

User Variable USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variable xs:empty 0…* <NONE>

User variables can be used for customized report and have noch functionality in the
standard reports.

/Combination of Independent Assay Results/Documentation/User Variable/ 024

Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Key xs:token 1…1 <NONE>

Identification key for the user variable.

/Combination of Independent Assay Results/Documentation/User Variable/ 025

Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value xs:string 0…1 <NONE>

Value of the user variable.

/Combination of Independent Assay Results/ 026

Group Information USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GroupInformation xs:string 1…1 <NONE>

You can add group(s). A group usually corresponds to a reportable value. By defining groups,
it is possible to add substance information, that are also printed in the report.

/Combination of Independent Assay Results/Group Information/ 027

Group USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Group xs:empty 0…* <NONE>

Add substance information for a combination group. The name of the group has to be
identical to the entry in the group column of the dataset. In case of aggregation, this value
can be defined in the group field of the test sample definition in the assay document.

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/Combination of Independent Assay Results/Group Information/Group/ 028

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

You should define a name of the group. The name of the group has to be identical to the
entry in the group column of the dataset. In case of aggregation, this value can be defined in
the group field of the test sample definition in the assay document.

/Combination of Independent Assay Results/Group Information/Group/ 029

CHOICE USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE
CHOICE 1…1
Select one of the elements on the next level.

/Combination of Independent Assay Results/Group Information/Group/CHOICE: 030

Substance Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceName xs:token 0…1 <NONE>

Name of the the substance.

/Combination of Independent Assay Results/Group Information/Group/CHOICE: 031

Substance Reference USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceReference DocumentReference.Substance 0…1 <NONE>

Choose a substance document.

/Combination of Independent Assay Results/Group Information/Group/ 032

Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identification information for the substance.

/Combination of Independent Assay Results/Group Information/Group/ 033

Substance Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceLot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

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 Combination of Assay Results

/Combination of Independent Assay Results/Group Information/Group/ 034

Substance Sub-Batch/Sub-Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceSublot xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Combination of Independent Assay Results/Group Information/Group/ 035

Substance Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceVariant xs:token 0…1 <NONE>

The variant of the substance.

/Combination of Independent Assay Results/Group Information/Group/ 036

Substance Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceClass xs:token 0…1 <NONE>

The class of the substance, e.g. drug class.

/Combination of Independent Assay Results/Group Information/Group/ 037

Substance Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceDescription xs:string 0…1 <NONE>

Textual description of the substance.

/Combination of Independent Assay Results/ 038

Potency Data USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Dataset xs:empty 1…1 <NONE>

The dataset setup. Usually filled automatically. Please unfold to see the details (left click on
the plus sign in front of the element).

/Combination of Independent Assay Results/Potency Data/ 039

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

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RowOrder USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder ds:T_RowOrder 0…1 <NONE>

[NO DETAILS]

/Combination of Independent Assay Results/Potency Data/ 041

Column: Document Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentReference T_COAReferenceFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 042

Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 0…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 043

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

Cannot be changed for this column. Column keys are required for defining a sort order
considering this column.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 044

Edit Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EditMode ds:T_EditMode 0…1 <NONE>

Possible values are Select or Create .

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Update Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpdateMode ds:T_UpdateMode 0…1 <NONE>

Select the mode, how the document references (and the according values) are updated.
Possible values are Auto All : The data will be automatically updated from all matching
documents in the data base. The update is done, when the referencing document is opend
or closed. Only documents with read permission for the requesting user will be considered.
Auto Data : The data of already referenced documents will be automatically updated. The
update is done, when the referencing document is opend or closed. Only documents with
read permission for the requesting user will be considered. Manual All : The data will be
manually updated from all matching documents in the data base. The update command can
be given in the references dialog. Only documents with read permission for the requesting
user will be considered. Manual Data : the data of already referenced docuemnts will be
manually updated. The update command can be given in the references dialog. Only
documents with read permission for the requesting user will be considered.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 046

Document Type USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentType xs:token 0…1 <NONE>

Enter the document type to be considered for referenced docuemnts.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 047

Template Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TemplateKey xs:token 0…1 <NONE>

You can enter a template key. In this case, the referenced documents have to be generated
by the specified template.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 048

Folder Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FolderKey xs:token 0…1 <NONE>

You can enter a folder key. In this case, the referenced documents have to elements of the
specified folder. If you additionally set Allow Subfolder to true , the referenced documents
have to be elements of the specified folder or one of its subfolder.

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Allow Subfolder USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AllowSubfolder xs:boolean 0…1 <NONE>

Only relevant, if a folder key is entered. If you set set Allow Subfolder to true , the
referenced documents have to be elements of the specified folder or one of its subfolder.
Otherwise the subfolders are excluded.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 050

Generator Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

GeneratorKey xs:token 0…1 <NONE>

You can enter a generator key. In this case, the referenced documents have to be generated
by the specified document. Default value is {generator}, which means, that only documents
are considered, that have the same generator document as this document.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 051

Document Mode USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentMode ds:T_DocumentMode 0…1 <NONE>

You can select a document mode. In this case, the referenced documents have to be of the
specified mode.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 052

Document Property Filter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentPropertyFilter ds:T_DocumentPropertyFilterForDocuments 0…* <NONE>

Define a filter based on a document property. Referenced documents have to pass the
defined filter.

/Combination of Independent Assay Results/Potency Data/Column: Document Reference/ 053

Section Property Filter USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionPropertyFilter ds:T_SectionPropertyFilterForDocuments 0…* <NONE>

Define a filter based on a section property. Referenced documents have to pass the defined
filter.

/Combination of Independent Assay Results/Potency Data/ 054

Column: Section USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Section T_COAReferenceSectionFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

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Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 0…1 <NONE>

You can enter a column name.

/Combination of Independent Assay Results/Potency Data/Column: Section/ 056

Column Key USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 1…1 <NONE>

Cannot be changed for this column. Column keys are required for defining a sort order
considering this column.

/Combination of Independent Assay Results/Potency Data/Column: Section/ 057

Property Filter USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyFilter T_COAPropertyFilterForSections 1…* <NONE>

[NO DETAILS]

/Combination
Results/Potency
of Independent Assay
Data/Column:
058
Section/Property Filter/
USAGE
Property Key required
TECHNICAL NAME DATA TYPE DEFAULT VALUE

PropertyKe xs:toke MULTIPLICI-

TY http://www.stegmannsystems.com/bioassay/elementtyp
y n 1…1 e
Enter the property key for the section property the filter is based on. Only documents in
which an element has this property key will be considered for aggregation. Only relevant for
aggregation of document data.

/Combination of Independent Assay Results/Potency Data/Column: Section/Property Filter/ 059

Term USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Term xs:string 1…1 Test

You can enter a term to specify the value of the according property. If Term does not extist,
only the existence of a property with property key Property Key is relevant for the filter. The
value of Term can be truncated by '*'. In this case it is only checked, that the property value
with property key Property Key starts with the value of Term in front of '*'.

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Column: Group USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Group T_Group 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Group/ 061

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

[NO DETAILS]

/Combination of Independent Assay Results/Potency Data/ 062

Column: Relative Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotency T_RelativePotencyFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Relative Potency/ 063

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/Column: Relative Potency/ 064

ColumnKey USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 0…1 <NONE>

[NO DETAILS]

/Combination of Independent Assay Results/Potency Data/ 065

Column: Relative Potency Lower Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotencyLowerLimit T_RelativePotencyFactorLowerLimit 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Relative Potency Lower Limit/ 066
Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

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/Combination of Independent Assay Results/Potency Data/ 067

Column: Relative Potency Upper Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RelativePotencyUpperLimit T_RelativePotencyFactorUpperLimit 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Relative Potency Upper Limit/ 068
Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 069

Column: Potency USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Potency T_PotencyFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Potency/ 070

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 071

Column: Potency Unit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyUnit T_PotencyUnit 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Potency Unit/ 072

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 073

Column: Potency Lower Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyLowerLimit T_PotencyFactorLowerLimit 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

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/Combination of Independent Assay Results/Potency Data/Column: Potency Lower Limit/ 074

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 075

Column: Potency Upper Limit USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyUpperLimit T_PotencyFactorUpperLimit 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Potency Upper Limit/ 076

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 077

Column: Model USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Model T_Model 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Model/ 078

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 079

Column: Degrees of Freedom USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DegreesOfFreedom T_dfFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Degrees of Freedom/ 080

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

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Column: Potency Confidence Level USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PotencyConfidenceLevel T_PotencyConfidenceLevelFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Potency Confidence Level/ 082

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 083

Column: Assay Test State USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

AssayTestState T_AssayTestStateFactor 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/Potency Data/Column: Assay Test State/ 084

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter an other label for the according data column.

/Combination of Independent Assay Results/Potency Data/ 085

Column: Exclude from Calculation USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TechnicalOutlier ds:T_TechnicalOutlierColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Combination of Independent Assay Results/ 086

Weighting USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Weighting xs:string 1…1 <NONE>

Select the type of the combination calculation. You can choose along by homogeneity : The
result of the chi² test on homogeneity desides, whether the combination is done by
homogeneous weighting or by heterogeneous weighting. The type of heterogeneous
weighting is set in the element heterogeneous weighting type. homogeneous weighted :
Calculation will be done by homogeneous weighting. heterogeneous weighted : Calculation
will be done by heterogeneous weighting. The type of heterogeneous weighting is set in the
element heterogeneous weighting type. unweighted : Only unweighted combination will be
calculated.

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/Combination of Independent Assay Results/ 087

Heterogeneous Weighting Type USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

HeterogeneousWeightingType xs:string 1…1 <NONE>

There are several methods for performing the heterogeneous weighting combination
calculation. The selection only affects the heterogeneous weighting. You can chose along EP
: The heterogeneous weighting is done as described in the European Pharmacopeia.
USP<111> : The heterogeneous weighting is done as described in the chapter 111 of the US
Pharamcopeia. This is also known as semi-weighting. USP<1034> : The heterogeneous
weighting is done as described in the (new) chapter 1034 of the US Pharamcopeia.

/Combination of Independent Assay Results/ 088

Chi² Significance USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Chi2Significance T_ConfidenceLevel 1…1 <NONE>

Significance Level of the chi² homogeneity test.

/Combination of Independent Assay Results/ 089

Report Homogeneity Test USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ReportHomogeneityTest xs:boolean 1…1 true

If you set this to false, the result of the homogeneity test will not be reported.

/Combination of Independent Assay Results/ 090

Logarithm Type USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LogarithmType T_LogarithmType 1…1 Log

Select the logarithm type (logarithm base).

/Combination of Independent Assay Results/ 091

Tests USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Tests T_Tests 1…1 <NONE>

You can add any number of tests to your combination calculation.

/Combination of Independent Assay Results/Tests/ 092

Test on Potency Value USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnValue xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). Test
on the combined relative / absolute potency value.

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Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Please enter the upper margin for the test.

/Combination of Independent Assay Results/Tests/Test on Potency Value/ 094

Lower Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 1…1 0.0

Please enter the lower margin for the test.

/Combination of Independent Assay Results/Tests/Test on Potency Value/ 095

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Potency Value/ 096

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

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/Combination of Independent Assay Results/Tests/ 097

Test on Potency Confidence Interval (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnPercentualPotencyConfidenceInterval xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). You
can define upper / lower margins for the percentual potency confidence interval (the
confidence interval relative to the absolute / relative potency value expressed as percentual
value).

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval (%)/ 098

Upper Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 0…1 0.0

Please enter the upper margin for the test.

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval (%)/ 099

Lower Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 0…1 0.0

Please enter the lower margin for the test.

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval (%)/ 100

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

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Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 102

Chi² Homogeneity Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ChiSquareHomogeneityTest xs:empty 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). This
adds the chi square homogeneity test as suitability test.

/Combination of Independent Assay Results/Tests/Chi² Homogeneity Test/ 103

Significance USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Significance T_ConfidenceLevel 1…1 0.95

Select the significance level of the test.

/Combination of Independent Assay Results/Tests/Chi² Homogeneity Test/ 104

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

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/Combination of Independent Assay Results/Tests/Chi² Homogeneity Test/ 105

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 106

Test on Potency Confidence Interval USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnLocationOfConfidenceInterval xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). Test
on the absolute / relative potecny confidence interval.

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval/ 107

Upper Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 0…1 0.0

Please enter the upper margin for the test.

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval/ 108

Lower Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 0…1 0.0

Please enter the lower margin for the test.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Potency Confidence Interval/ 110

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 111

Test on Potency Coefficient of Variation (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnPercentualCoefficientOfVariation xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). Test
on the percentual relative / absolute potency coefficient of variation.

/Combination of Independent Assay Results/Tests/Test on Potency Coefficient of Variation (%)/ 112

Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Please enter the upper margin for the test.

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Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Potency Coefficient of Variation (%)/ 114

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 115

Test on Potency Range (%) USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnPercentualRelativeRange xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). Test
on the percentual relative / absolute potency range.

/Combination of Independent Assay Results/Tests/Test on Potency Range (%)/ 116

Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Please enter the upper margin for the test.

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 Combination of Assay Results

/Combination of Independent Assay Results/Tests/Test on Potency Range (%)/ 117

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Potency Range (%)/ 118

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 119

Test on (Log) Potency Range USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOfRangeOfLogPotencyValues xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front).
Usually this test checks the range of the log relative potency / absolute potency values
entering the combination caluclation. In case of the slope ratio models, this test checks the
relative potency / potency values instead of the log relative potency / potency values.

/Combination of Independent Assay Results/Tests/Test on (Log) Potency Range/ 120

Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Please enter the upper margin for the test.

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/Combination of Independent Assay Results/Tests/Test on (Log) Potency Range/ 121

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on (Log) Potency Range/ 122

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 123

Test on (Log) Potency Confidence Interval Length USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOfLogPotencyConfidenceIntervalLength xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front).
Usually this test checks the length of the combined log relative potency / absolute potency
confidence interval. In case of the slope ratio models, this test checks the relative potency /
potency confidence interval instead of the log relative potency / potency confidence
interval.

/Combination of Independent Assay Results/Tests/Test on (Log) Potency Confidence Interval Length/ 124
Upper Margin USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 1…1 0.0

Please enter the upper margin for the test.

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 Combination of Assay Results

/Combination of Independent Assay Results/Tests/Test on (Log) Potency Confidence Interval Length/ 125
Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on (Log) Potency Confidence Interval Length/ 126
Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 127

Test on Number of Valid Assays USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnNumberOfValidAssays xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). The
test allows to define upper and lower margins for the number of valid assays, i.e. assays with
test state 'Passed' or 'PassedInfo'

/Combination of Independent Assay Results/Tests/Test on Number of Valid Assays/ 128

Upper Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 0…1 0.0

Please enter the upper margin for the test.

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/Combination of Independent Assay Results/Tests/Test on Number of Valid Assays/ 129

Lower Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 0…1 0.0

Please enter the lower margin for the test.

/Combination of Independent Assay Results/Tests/Test on Number of Valid Assays/ 130

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Number of Valid Assays/ 131

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 132

Test on Sum of Weights USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestOnSumOfWeights xs:string 0…* <NONE>

Please unfold to see the details of the test definition (left click on the plus sign in front). The
test allows to define upper and lower margins for the sum of weights. Weights means here
the homogeneous weights (so not the corrected weights used for the heterogenous
weighting).

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 Combination of Assay Results

/Combination of Independent Assay Results/Tests/Test on Sum of Weights/ 133

Upper Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperMargin xs:decimal 0…1 0.0

Please enter the upper margin for the test.

/Combination of Independent Assay Results/Tests/Test on Sum of Weights/ 134

Lower Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerMargin xs:decimal 0…1 0.0

Please enter the lower margin for the test.

/Combination of Independent Assay Results/Tests/Test on Sum of Weights/ 135

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the
combination calculations are summarized by an overall test result. If there is at least one
failed test with severity Reject , the overall test result of the combination calculation is
Rejected . If there ist no failed test with severity Rejected but at least one failed test with
severity Failed , the overall test reuslt of the combination calculation is Failed . If there are
not failed test with severity Failed or Rejected but at least one failed test with severity
Information , the overall test result of the combination calculation is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed .

/Combination of Independent Assay Results/Tests/Test on Sum of Weights/ 136

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 RelativePotency

Select the scope of the test. You can choose along: Relative Potency : The test will be
performed for the relative potency combination calculation. Absolute Potency : The test
will be performed for the absolute potency combination calculation.

/Combination of Independent Assay Results/Tests/ 137

Signature State USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TestSignatureState xs:empty 0…* <NONE>

Add test(s) for the signature state.

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/Combination of Independent Assay Results/Tests/Signature State/ 138

Number of Signatures USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Number xs:decimal 0…1 1.0

The required number of signatures of the considered type.

/Combination of Independent Assay Results/Tests/Signature State/ 139

Meaning USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Meaning xs:string 0…1 <NONE>

Enter a signature meaning. Only signatures with the entered meaning are considered in the
test.

/Combination of Independent Assay Results/Tests/Signature State/ 140

Scope of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Scope xs:string 0…1 ScopeContent

Define which part of the document should be signed. You can choose along: Content : Only
signatures on the content part of the document are considered by the test. Dataset : Only
signatures on the whole document are considered by the test.

/Combination of Independent Assay Results/Tests/Signature State/ 141

Severity Level of the Test USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 Warning

Select the severity level of the test. The severity controls the effects of a failed test. You can
choose along: Reject : If the test fails, no potency will be reported and regarding the overall
test result the test is considered as Rejected . Warning : If the test fails, potency will be
reported and regarding the overall test result the test is considered as Failed . Information :
If the test fails, potency will be reported and regarding the overall test result the test is
considered as Passed (info available) . Additional Remarks The test results of the assay are
summarized by an overall test result. If there is at least one failed test with severity Reject ,
the overall test result of the assay is Rejected . If there ist no failed test with severity
Rejected but at least one failed test with severity Failed , the overall test reuslt of the assay
is Failed . If there are not failed test with severity Failed or Rejected but at least one failed
test with severity Information , the overall test result of the assay is Passed (info available) .
If there are not failed tests, the overall test reuslt is Passed . Sometimes it can happen, that
a test can't be calculated (if for example Fieller's formula is needed to calculate the test
result and the values computed there are outside of the valid range). In this case the test is
reported as NC and will not be considered for calculating the overall test result. In case of
non-multiplex assays, the term assay means here the individual standard-test-assay. If the
test is classified as assay suitability test, the test also counts for the calculation of the overall
test results of teh other individualstandard-test-assays of the assay.

316
 Combination of Assay Results

/Combination of Independent Assay Results/ 142

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comments to this assay.

/Combination of Independent Assay Results/Comment/ 143

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Optional comment subject.

/Combination of Independent Assay Results/Comment/ 144

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

/Combination of Independent Assay Results/Comment/ 145

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

/Combination of Independent Assay Results/Comment/ 146

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Combination of Independent Assay Results/Comment/ 147

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES
N/A

DIGEST RESULTS
N/A

317
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

318
 Control Chart

CONTROL CHART

DESCRIPTION
The Control Chart document type is intended for the aggregation of several aspects of a bio-
logical assay in one control chart.

The following example shows a control chart with a complex control limit setup:

A Control Chart plots data from the data table in one or more Control Charts. So the basic
steps in the setup of Control Charts are the definition of the data table and the definition of
the chart setup. In addition to these basic updates it may be useful to setup specific proper-
ties for the data aggregation.

There are two different ways how to deal with control charting:

• Select a predefined control chart

• Define a control chart on your own

PREDEFINED CONTROL CHARTS

Predefined Control Chart templates may be available for easy chart setup.

The process for setting up a predefined control chart is:

1. Create a new Control Chart from a template

Usually the following control charts are available:
o Potency Ratio and Confidence Limits
o Regression Parameters 4PL
o Regression Parameters 5PL
2. Add References to the Control Chart
Select the Quantitative Response Assays to be charted
3. Press Refresh to create an updated Control Chart

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Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

Once the control chart has been created, you can set up multiple limits. See below.

USER DEFINED CONTROL CHARTS

The setup of a user defined control chart is slightly more complex, since you need to setup
the data sources for the Control Chart.

Tip: Start by creating a document from a template. Then modify the corresponding settings
by opening the control chart document with elevated privileges.

C REATE A NEW C ONTROL C HART (W ITHOUT A T EMPLATE )

Open the Document New Editor and select Control Chart as a document type.

D EFINE O BSERVATION S OURCE

By default the Observation Source is set to Aggregation. The data is acquired by data aggre-
gation from different document. When set to User Input observation data is directly entered
into the system.

320
 Control Chart

DEFINE THE DATA COLUMNS

In the Control Chart all floating point columns are plotted. A floating point column is as-
signed to a control chart. Several values can be defined:

Name: Name of the Column

Chart: Assign the column to a chart (note these charts have to be declared in the Charts-
Section of the document.
Color: Select the plotting color

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D EFINE THE C HARTING O PTIONS

You can setup any number of charts in the control chart documents. Each chart has a name
(Control Chart-n by default) and optional Control Limit Definitions. To select data for a con-
trol chart column you need to open the corresponding Floating Point Column in the Dataset
section. Simply select the previously defined chart.

C ONTROL L IMIT D EFINITIONS

You can setup any number of control limits for a chart. A control limit is a pair of two values
that define an upper and a lower margin of an acceptable range. Any value displayed in the
Control Chart that violates these margins is printed in a table of limit violations in the corre-
sponding report.

A Control Limit Definition has the following properties:

Name Description Default

Name Name of the Control Limit Name-n
Upper Control Upper margin of the limit 0
Limit
Lower Control Lower margin of the limit 0
Limit
Display Color Color of the limit line in the chart Auto selected by the
system
Severity Severity of a limit violation. Select one of Warning
Warning, Rejection, Information
Start Time Optionally define a date when the limit is set Current date
active. When no Start Time is given the limit is
active immediately
End Time Optionally define a date when the limit gets Current date
inactive. If no End Time is given the limit does
not get inactive
Remark Optional remark for a limit -

This control limit system allows setting up multiple limits with different severities (e.g. a
warning and a rejection limit). The system also allows defining limit changes at certain dates.

Note changing limits require dates in the data table.

SETTING UP DATA AGGREGATION

Data aggregation is a very powerful tool in PLA 3.0. There are several properties to fine tune
the aggregation process. Without fine tuning the control chart can select any documents in
the database as a data source for the table. In most cases this will not make any sense. With
the tuning options below you use several properties to define the source documents. E.g.
you can setup control charts for specific projects, folders or documents with specific proper-
ties.

322
 Control Chart

Useful options:

Document Type Select a specific document type as data source. E.g. Quantitative
Response Assays
Template Key Accept only documents created from the specified template
Folder Key Accept only documents in the specified folder
Allow Subfolder Specify whether documents are accepted from subfolders
Generator Key Accept only documents created from a specified generator docu-
ment
Document Property Accept only documents that are accepted by the defined filter
Filter

REPORTS
• Standard report

TASKS
• Refresh – performs the calculation process

DOCUMENT STRUCTURE
DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for a Control Chart doc-
ument. It is indicated whether a field is required or optional. The number is a reference to
the following section with more reference data for every field.

Control Chart required 001

. Name required 002
. Date required 003
. Charts required 004
. . Chart required 005
. . . Name required 006
. . . Control Limit Definition optional 007
. . . . Name required 008
. . . . Upper Control Limit optional 009
. . . . Lower Control Limit optional 010
. . . . Start Time optional 011
. . . . End Time optional 012
. . . . Display Color required 013
. . . . Severity Level of the Margin optional 014
. . . . Remark optional 015
. . . Marker Definition optional 016
. . . . Name required 017
. . . . Marker Comment optional 018
. . . . Marker Time required 019
. . . . Display Color optional 020
. Dataset required 021

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. . Observation Source required 022

. . Row Order required 023
. . Column: Document Reference required 024
. . Column: Section required 025
. . Column: Exclude from Analysis required 026
. . Column: Date/Time required 027
. . . Name required 028
. . . Column Key optional 029
. . . Property Scope optional 030
. . . Property Key optional 031
. . . Section Key optional 032
. . Column: Floating Point Number optional 033
. . . Chart required 034
. . . Display Color required 035
. Comment optional 036
. . Subject optional 037
. . Text optional 038
. . Linked Document optional 039
. . Date required 040
. . Author required 041

DOCUMENT ELEMENT REFERENCE

/ 001
Control Chart USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ControlChart xs:empty 1…1 <NONE>

Control Charts can be used to plot and analyse evolution of frequently observed data over
time. Unfold to see the document's sections (left click on the plus sign in front of the
element). You can use the creation panel or the context menu, to add an arbitrary number
of Comment sections.

/Control Chart/ 002

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

You can enter a document name. Documents are usally identified by their names. It is
recommend to use unique names for your documents, but this is not strictly required.

/Control Chart/ 003

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

You can enter a date for the assay. Per default the document's creation date is entered here
automatically. However this can be changed. The date can be used for sorting in aggregation
documents.

324
 Control Chart

/Control Chart/ 004

Charts USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Charts xs:empty 1…1 <NONE>

Here you can add charts to the document. Required is at least one chart, but there can be
defined more then one.

/Control Chart/Charts/ 005

Chart USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Chart xs:empty 1…* <NONE>

Data columns assigned to the same chart are plotted together. Define the settings for this
chart.

/Control Chart/Charts/Chart/ 006

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

You can enter a name for the chart. The name should be unique, but this is not strictly
recommended.

/Control Chart/Charts/Chart/ 007

Control Limit Definition USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ControlLimitDefinition T_ControlLimitDefinition 0…* <NONE>

Define a set of control limits for this chart. Usually this means to define an upper and a lower
control limit. But you can choose to have only one of them.

/Control Chart/Charts/Chart/Control Limit Definition/ 008

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

Define the name of the control limit. The name is automatically assigned, but can be
changed.

/Control Chart/Charts/Chart/Control Limit Definition/ 009

Upper Control Limit USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpperControlLimit xs:double 0…1 <NONE>

Define the value of the upper control limit.

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/Control Chart/Charts/Chart/Control Limit Definition/ 010

Lower Control Limit USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LowerControlLimit xs:double 0…1 <NONE>

Define the value of the lower control limit.

/Control Chart/Charts/Chart/Control Limit Definition/ 011

Start Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

StartTime xs:dateTime 0…1 <NONE>

Define the date und time of the limits start point.

/Control Chart/Charts/Chart/Control Limit Definition/ 012

End Time USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EndTime xs:dateTime 0…1 <NONE>

Define the date und time of the limits end point.

/Control Chart/Charts/Chart/Control Limit Definition/ 013

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for plots of the Control Limit(s). The color is automatically assigned, but you
can change it manually by left-clicking on the selector button.

/Control Chart/Charts/Chart/Control Limit Definition/ 014

Severity Level of the Margin USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Severity xs:string 0…1 SeverityWarning

Select the severity level of the Margin. The severity controls the reporting of data outside
the margin. You can choose along: Reject Warning Information

/Control Chart/Charts/Chart/Control Limit Definition/ 015

Remark USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Remark xs:string 0…1 <NONE>

Remark for this control limit definition.

326
 Control Chart

/Control Chart/Charts/Chart/ 016

Marker Definition USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MarkerDefinition T_MarkerDefinition 0…* <NONE>

Define a marker, that is plotted as vertical line in the plot.

/Control Chart/Charts/Chart/Marker Definition/ 017

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Label xs:string 1…1 <NONE>

Define a label for the marker, that is used in the plot. The label is automatically assigned, but
can be changed.

/Control Chart/Charts/Chart/Marker Definition/ 018

Marker Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MarkerComment xs:string 0…1 <NONE>

Remark comment for this control limit definition.

/Control Chart/Charts/Chart/Marker Definition/ 019

Marker Time USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MarkerTime xs:dateTime 1…1 <NONE>

Date of the marker. The marker is used in the plot at the given date/time. If date and time
are identical to one of the given datapoints, the marker is plotted at this data point index.
Otherwise it is reported between two such indexes.

/Control Chart/Charts/Chart/Marker Definition/ 020

Display Color USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 0…1 <NONE>

Define the color for plots of the marker. The color is automatically assigned, but you can
change it manually by left-clicking on the selector button.

/Control Chart/ 021

Dataset USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Dataset xs:empty 1…1 <NONE>

Contains settings about the data set structure. Here you can define additional data columns
for the observation data.

327
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Control Chart/Dataset/ 022

Observation Source USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ObservationSource ds:T_RowSource 1…1 <NONE>

The source of the observation data. Possible values are User Input , Aggregation and Import .
By selecting user input, the data is entered manually, aggregation uses document
aggregation by specifying document references and import uses imported data.

/Control Chart/Dataset/ 023

Row Order USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

RowOrder T_RedefinedSortOrder 1…1 <NONE>

Define a sort order for the data rows.

/Control Chart/Dataset/ 024

Column: Document Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DocumentReference ds:T_ReferenceColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Control Chart/Dataset/ 025

Column: Section USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Section ds:T_ReferenceSectionColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Control Chart/Dataset/ 026

Column: Exclude from Analysis USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

TechnicalOutlier ds:T_TechnicalOutlierColumn 1…1 <NONE>

Please unfold (left click on the plus sign in front of the element) to see the definition details.

/Control Chart/Dataset/ 027

Column: Date/Time USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date T_RestrictedDateTimeColumn 1…1 <NONE>

User defined date / time column.

328
 Control Chart

/Control Chart/Dataset/Column: Date/Time/ 028

Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:string 1…1 <NONE>

You can enter a column name.

/Control Chart/Dataset/Column: Date/Time/ 029

Column Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ColumnKey xs:token 0…1 <NONE>

You can enter a column key. Column keys are required for defining a sort order considering
this column.

/Control Chart/Dataset/Column: Date/Time/ 030

Property Scope USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyScope ds:T_PropertyScope 0…1 <NONE>

Define the scope of the property. Possible values are Document and Section .

/Control Chart/Dataset/Column: Date/Time/ 031

Property Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

PropertyKey xs:token 0…1 <NONE>

The property key specifies which data element of the aggregated documents should be used
for this column. Only used for document aggregation.

/Control Chart/Dataset/Column: Date/Time/ 032

Section Key USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SectionKey xs:token 0…1 <NONE>

The section of data of aggregated documents has to match the section key given here. Only
used for document aggregation.

/Control Chart/Dataset/ 033

Column: Floating Point Number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DoubleFactor T_ControlChartDoubleColumn 0…* <NONE>

User defined column for floating point double precission numbers.

329
Document Package: Biological Assays - Reference Manual for Biological Assay Package 18

/Control Chart/Dataset/Column: Floating Point Number/ 034

Chart USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ChartReference xs:string 1…1 <NONE>

Assigne a chart to this data column.

/Control Chart/Dataset/Column: Floating Point Number/ 035

Display Color USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Color xs:string 1…1 <NONE>

Define the color for the data of this column. The color is automatically assigned, but you can
change it manually by left-clicking on the selector button.

/Control Chart/ 036

Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comments to this assay. You cann add a Subject or Document Link by using the
creation panel.

/Control Chart/Comment/ 037

Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Optional comment subject.

/Control Chart/Comment/ 038

Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this comment.

/Control Chart/Comment/ 039

Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

An annotation to this event.

330
 Control Chart

/Control Chart/Comment/ 040

Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Control Chart/Comment/ 041

Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES
N/A

DIGEST RESULTS
N/A

331
DOCUMENT PACKAGE: GENERIC DOCUMENTS
Reference Manual
Document Package: Generic Documents - Reference Manual

OVERVIEW
The Generic Document Package is a document package that covers a set of four standard
document types:

Contact A contact document allows documenting standard contact data.

Note A note document is just a small document that allows you to leave
notes in the folders of the database.
Appointment An appointment document is a calendar entry.

Task A task document represents a simple task.

HOW TO USE THIS MANUAL

This manual is a reference manual for a document package. The structure of this document
is as follows:

Description of the different document types

• Description of the document

• Literature References (optional)
• Document concepts (optional)
• Available Reports
• Available Tasks

Reference Information

• Document Outlines – describe the overall structure of the documents

• Document Structure – overall list of all document elements
• Element Reference – description of every field
• Aggregation Opportunities – which data could be aggregated from other documents
• Digests – data that can be used by other documents

2
 Table of Contents

TABLE OF CONTENTS
Overview ................................................................................................................................................................. 2
How to use this manual ...................................................................................................................................... 2
Table of Contents .................................................................................................................................................... 3
Welcome ................................................................................................................................................................. 4
Contact .................................................................................................................................................................... 5
Description .......................................................................................................................................................... 5
Concepts.......................................................................................................................................................... 5
Reports ................................................................................................................................................................ 5
Tasks .................................................................................................................................................................... 5
Note ........................................................................................................................................................................ 6
Description .......................................................................................................................................................... 6
Concepts.......................................................................................................................................................... 6
Reports ................................................................................................................................................................ 7
Tasks .................................................................................................................................................................... 7
Appointment ........................................................................................................................................................... 8
Description .......................................................................................................................................................... 8
Reports ................................................................................................................................................................ 8
Tasks .................................................................................................................................................................... 8
Task ......................................................................................................................................................................... 9
Description .......................................................................................................................................................... 9
Reports ................................................................................................................................................................ 9
Tasks .................................................................................................................................................................... 9
Reference .............................................................................................................................................................. 10
Document Outline ......................................................................................................................................... 10
Document Structure ...................................................................................................................................... 10
Document Element Reference ...................................................................................................................... 11
Aggregation Opportunities............................................................................................................................ 16
Digest Results ................................................................................................................................................ 16

3
Document Package: Generic Documents - Reference Manual

WELCOME
Welcome to the reference documentation for the generic documents document package. This handbook is
intended for users and functional administrators of PLA 3.0.

The reference documentation for generic documents describes all aspects of the generic document types Ap-
pointment, Contact, Note and Task.

4
 Contact

CONTACT

DESCRIPTION
A Contact document allows leaving contact details in a folder. A contact can be an organiza-
tion or an individual. The contact basically consists of

• Identification (Names, Title, Company)

• Communication (Phone, Fax, E-Mail)
• Adresses (one or more adresses)

The contact document is represented on the dashboard.

CONCEPTS
Any number of adresses or communication data can be held in the document just by adding
additional adress or communication fields to the dataset.

REPORTS
• None

TASKS
• None

5
Document Package: Generic Documents - Reference Manual

NOTE

DESCRIPTION
A note document allows leaving a note in a folder. A note basically consists of:

• Author
• Timestamp
• Title
• Text

The note is represented on the dashboard.

CONCEPTS
The text-section of a note allows to make use of simple Wiki-notation for a few formatting
capabilities. The syntax is derived from from a typical wiki system, but only a few markups
are supported:

Markup Formatting Sample

=H1= Heading Level 1 =Main Heading=
==H2== Heading Level 2 ==A second level heading==
…
=====H5===== Heading Level 5 =====A fifth Level Head-
ing=====
* Bullet List Bullet List Level 1 * Sample
** Bullet List Bullet List Level 2 ** Level 2 Sample
# Numbered List Numbered List Level 1 # Sample

6
 Note

Markup Formatting Sample

## Numbered List Numbered List Level 2 ## Sample Level 2
*bold* Bold Markup *Sample*
_italic_ Italic Markup _Sample_

Paragraphs are separated by an empty line.

REPORTS
• None

TASKS
• None

7
Document Package: Generic Documents - Reference Manual

APPOINTMENT

DESCRIPTION
An appointment document allows leaving appointment data in a folder. Appointments in-
formation basically consists of

• Date (Day and Time)

• Topic
• Details
• Author

The appointment is represented on the dashboard.

REPORTS
• None

TASKS
• None

8
 Task

TASK

DESCRIPTION
A task document allows leaving task descriptions in a folder. A task basically consists of:

• Topic
• State (Completed or open)
• Assignee
• Details

The task is represented on the dashboard.

REPORTS
• None

TASKS
• None

9
Document Package: Generic Documents - Reference Manual

REFERENCE
DOCUMENT OUTLINE
The overall structure of the Note, Appointment and Task document is not hierarchical. In the
Contact document the adresses are shown as a hierarchy.

Contact
• Contact Root of the ContactDocument
o Adress A single adress
Note
• Note Root of the Note Document
Appointment
• Appointment Root of the Appointment Document
Task
• Task Root of the Task Document

DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for the different generic
documents. It is indicated wether a field is required or optional. The number is a reference
to the following section with more reference data for every field.

Contact required 1
. Salutation optional 2
. First Name optional 3
. Middle Name optional 4
. Last Name optional 5
. Title optional 6
. Company optional 7
. Department optional 8
. Phone optional 9
. Fax optional 10
. e-Mail optional 11
. Website optional 12
. Address optional 13
. . Type of the Address optional 14
. . Address Line required 15
. Remark optional 16

Note required 17
. Author required 18
. Date optional 19
. Topic required 20
. Text required 21

Appointment required 22
. Date required 23
. Topic required 24
. Details optional 25
. Author optional 26

10
 Reference

Task required 27
. Topic required 28
. Task Completed? required 29
. Assignee optional 30
. Due Date optional 31
. Details optional 32
. Author optional 33

DOCUMENT ELEMENT REFERENCE

/ 1
Contact USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Contact xs:empty 1…1 <NONE>

Document a contact related to this database, project or folder. A contact can have multiple
addresses and remarks. Some of the fields are optional. Simply delete them, if they are not
required. Other elements (e.g. phone number) can occur multiple times. Add them as often
as they are required.

/Contact/ 2
Salutation USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Salutation xs:token 0…1 <NONE>

Salutation of the contact person. Remove this field, if it is not required.

/Contact/ 3
First Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

FirstName xs:token 0…1 <NONE>

First Name of the contact person. Remove this field, if it is not required.

/Contact/ 4
Middle Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

MiddleName xs:token 0…1 <NONE>

Middle Name of the contact person. Remove this field, if it is not required.

/Contact/ 5
Last Name USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LastName xs:token 0…1 <NONE>

Last Name of the contact person. Remove this field, if it is not required.

11
Document Package: Generic Documents - Reference Manual

/Contact/ 6
Title USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Title xs:token 0…1 <NONE>

Title of the contact person. Remove this field, if it is not required.

/Contact/ 7
Company USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Company xs:token 0…1 <NONE>

Company name of the contact. Remove this field, if it is not required.

/Contact/ 8
Department USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Department xs:token 0…1 <NONE>

Department name of the contact. Remove this field, if it is not required. You can add
multiple department lines if they are required.

/Contact/ 9
Phone USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Phone xs:token 0…* <NONE>

Phone number for the contact. Remove this field, if it is not required. You can add multiple
phone numbers if required.

/Contact/ 10
Fax USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Fax xs:token 0…1 <NONE>

Fax number of the contact. Remove this field, if it is not required.

/Contact/ 11
e-Mail USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EMail xs:token 0…1 <NONE>

e-Mail Address of the contact. Remove this field, if it is not required. You can add multiple e-
mail addresses lines if required.

12
 Reference

/Contact/ 12
Website USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Website xs:token 0…* <NONE>

Website URL of the contact. Remove this field, if it is not required. You can add multiple
websites if they are required.

/Contact/ 13
Address USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Address xs:empty 0…* <NONE>

An address of the contact. Remove this field, if it is not required. You can add multiple
addresses if required. Addresses simply consist of address lines, to meet international
requirements.

/Contact/Address/ 14
Type of the Address USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type xs:token 0…1 <NONE>

Describe the type of address to distingush multiple addresses.

/Contact/Address/ 15
Address Line USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Adressline xs:token 1…* <NONE>

An address consists of as many address line, which are required to display the address in a
'natural' manner, to meet international requirements.

/Contact/ 16
Remark USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Remarks xs:string 0…* <NONE>

Any remarks for this contact. You may add any number of remarks.

/ 17
Note USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Note xs:empty 1…1 <NONE>

A Note related to this database, project or folder.

13
Document Package: Generic Documents - Reference Manual

/Note/ 18
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the Note.

/Note/ 19
Date USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 0…1 <NONE>

The date when the Note has been written.

/Note/ 20
Topic USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Topic xs:token 1…1 <NONE>

The topic of the Note.

/Note/ 21
Text USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 1…* <NONE>

The content of the Note.

/ 22
Appointment USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Appointment xs:empty 1…1 <NONE>

An apointment related to this database, project or folder.

/Appointment/ 23
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

The date/time of the appointment.

/Appointment/ 24
Topic USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Topic xs:token 1…1 <NONE>

The topic of the appointment.

14
 Reference

/Appointment/ 25
Details USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Details xs:string 0…* <NONE>

Details of the appointment.

/Appointment/ 26
Author USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 0…1 <NONE>

The author of this appointment entry.

/ 27
Task USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Task xs:empty 1…1 <NONE>

A task related to this database, project or folder.

/Task/ 28
Topic USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Topic xs:token 1…1 <NONE>

The topic of the task.

/Task/ 29
Task Completed? USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Completed xs:boolean 1…1 <NONE>

Is the task completed?

/Task/ 30
Assignee USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Assignee xs:token 0…1 <NONE>

The assignee of this task.

/Task/ 31
Due Date USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DueDate xs:date 0…1 <NONE>

The due date of the task.

15
Document Package: Generic Documents - Reference Manual

/Task/ 32
Details USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Details xs:string 0…* <NONE>

Details of the task.

/Task/ 33
Author USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 0…1 <NONE>

The author of this task.

AGGREGATION OPPORTUNITIES
N/A

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Document Title Title of the Docu- String http://purl.org/dc/terms/title
ment.

16
 DOCUMENT PACKAGE:
MEASUREMENT DOCUMENTATION
Reference Manual
Document Package: Measurement Documentation - Reference Manual

OVERVIEW
The Measurement Documentation Package is a universal document package for document-
ing different aspects of a measurement. It is intended to serve as a package whose docu-
ments are referenced by other document types (e.g. Quantitative Response Assays).

Three different document types are part of the package:

Operator – An operator is a person that had a role during the preparation, execution or
analysis of a measurement. The operator document contains necessary contact data, a jour-
nal and a comment section.

Equipment – this document represents any type of equipment involved with the measure-
ment process. Basic information about the equipment can be document (e.g. support con-
tact, support cycles etc.). A journal and a comment section are available.

Substance – this document represents a substance involved in the measurement. The sub-
stance could have any role: e.g. supporting agent, the active ingrediant or a reference stand-
ard. A journal and a comment section are available.

Operator An operator is a person that had a role during the preparation, exe-
cution or analysis of a measurement. The operator document con-
tains necessary contact data and a comment section.
Equipment This document represents any type of equipment involved with the
measurement process. Basic information about the equipment can
be document (e.g. support contact, support cycles etc.). A journal
and a comment section are available.
Substance This document represents a substance involved in the measure-
ment. The substance could have any role: e.g. supporting agent,
the active ingrediant or a reference standard. A journal and a
comment section are available.

HOW TO USE THIS MANUAL

This manual is a reference manual for a document package. The structure of this document
is as follows:

Description of the different document types

• Description of the document

• Literature References (optional)
• Document concepts (optional)
• Available Reports
• Available Tasks

2
 Overview

Reference Information

• Document Outlines – describe the overall structure of the documents

• Document Structure – overall list of all document elements
• Element Reference – description of every field
• Aggregation Opportunities – which data could be aggregated from other documents
• Digests – data that can be used by other documents

3
Document Package: Measurement Documentation - Reference Manual

TABLE OF CONTENTS
Overview ................................................................................................................................................................. 2
How to use this Manual ...................................................................................................................................... 2
Table of Contents .................................................................................................................................................... 4
Welcome ................................................................................................................................................................. 5
Operator.................................................................................................................................................................. 6
Description .......................................................................................................................................................... 6
Concepts.......................................................................................................................................................... 6
Simplified Wiki-Notation ............................................................................................................................. 6
Reports ................................................................................................................................................................ 7
Tasks .................................................................................................................................................................... 7
Equipment ............................................................................................................................................................... 8
Description .......................................................................................................................................................... 8
Concepts.......................................................................................................................................................... 8
Journal Capabilities ..................................................................................................................................... 8
Simplified Wiki-Notation ............................................................................................................................. 8
Reports ................................................................................................................................................................ 9
Tasks .................................................................................................................................................................... 9
Substance .............................................................................................................................................................. 10
Description ........................................................................................................................................................ 10
Concepts........................................................................................................................................................ 10
Journal Capabilities ................................................................................................................................... 10
Wiki-Notation ............................................................................................................................................ 10
Reports .............................................................................................................................................................. 11
Tasks .................................................................................................................................................................. 11
Reference .............................................................................................................................................................. 12
Document Outline ......................................................................................................................................... 12
Document Structure ...................................................................................................................................... 12
Document Element Reference ...................................................................................................................... 14
Aggregation Opportunities............................................................................................................................ 25
Digest Results ................................................................................................................................................ 25

4
 Welcome

WELCOME
Welcome to the reference documentation for the measurement documentation document package. This
handbook is intended for users and functional administrators of PLA 3.0.

The reference documentation for measurement documentation describes all aspects of the measurement
documentation types Operator, Substance and Equipment.

5
Document Package: Measurement Documentation - Reference Manual

OPERATOR

DESCRIPTION
The operator document represents a single operator involved in the measurement process.
It is intended to be used as a reference base. If you create operator documents for every
team member you can easily select the operator in a refering document just by typing a
partial name. In the operator document the following information can be documented:

• Name of the operator

• Contact Data (phone, e-Mail)
• A link to a contact document with full contact details
• Comments

CONCEPTS

S IMPLIFIED W IKI -N OTATION

The comments section of an operator document allows to make use of simple Wiki-notation
for a few formatting capabilities. But only a few markups are supported:

Markup Formatting Sample

=H1= Heading Level 1 =Main Heading=
==H2== Heading Level 2 ==A second level heading==
…
=====H5===== Heading Level 5 =====A fifth Level Head-
ing=====
* Bullet List Bullet List Level 1 * Sample

6
 Operator

Markup Formatting Sample

** Bullet List Bullet List Level 2 ** Level 2 Sample
# Numbered List Numbered List Level 1 # Sample
## Numbered List Numbered List Level 2 ## Sample Level 2
*bold* Bold Markup *Sample*
_italic_ Italic Markup _Sample_

REPORTS
• None

TASKS
• None

7
Document Package: Measurement Documentation - Reference Manual

EQUIPMENT

DESCRIPTION
The equipment document represents equipment involved in the measurement process. It is
intended to be used as a reference base. If you create equipment documents for every rele-
vant equipment you can easily document the used equipment in your measurement process.

In the equipment document the following information can be documented:

• Name and Identification

• Location
• Operators
• Contacts
• Upcoming Events (e.g. maintenance, recalibration)
• Journal
• Comments

CONCEPTS

J OURNAL C APABILITIES
This document type supports journals. A journal consists of journal entrees, which may be
used to document any relevant event concerning the described entity.

S IMPLIFIED W IKI -N OTATION

The comments and the journal section of an equipment document allows to make use of
simple Wiki-notation for a few formatting capabilities. Only a few markups are supported:
8
 Equipment

Markup Formatting Sample

=H1= Heading Level 1 =Main Heading=
==H2== Heading Level 2 ==A second level heading==
…
=====H5===== Heading Level 5 =====A fifth Level Head-
ing=====
* Bullet List Bullet List Level 1 * Sample
** Bullet List Bullet List Level 2 ** Level 2 Sample
# Numbered List Numbered List Level 1 # Sample
## Numbered List Numbered List Level 2 ## Sample Level 2
*bold* Bold Markup *Sample*
_italic_ Italic Markup _Sample_

REPORTS
• None

TASKS
• None

9
Document Package: Measurement Documentation - Reference Manual

SUBSTANCE

DESCRIPTION
The substance document represents any substance involved in the measurement process. It
is intended to be used as a reference base. If you create a substance document for every
relevant substance you can easily document all substances relevant for your measurement
process. The term “substance” has been choosen as a neutral description. A substance doc-
ument can document any agent, active ingrediant or reference standard.

In the substance document the following information can be documented:

• Name and Identification

• Type
• Potency
• Journal
• Comments

CONCEPTS

J OURNAL C APABILITIES
This document type supports journals. A journal consists of journal entrees, which may be
used to document any relevant event concerning the described entity.

W IKI -N OTATION
The comments and the journal section of a substance document allows to make use of sim-
ple Wiki-notation for a few formatting capabilities. Only a few markups are supported:
10
 Substance

Markup Formatting Sample

=H1= Heading Level 1 =Main Heading=
==H2== Heading Level 2 ==A second level heading==
…
=====H5===== Heading Level 5 =====A fifth Level Head-
ing=====
* Bullet List Bullet List Level 1 * Sample
** Bullet List Bullet List Level 2 ** Level 2 Sample
# Numbered List Numbered List Level 1 # Sample
## Numbered List Numbered List Level 2 ## Sample Level 2
*bold* Bold Markup *Sample*
_italic_ Italic Markup _Sample_

REPORTS
• None

TASKS
• None

11
Document Package: Measurement Documentation - Reference Manual

REFERENCE
DOCUMENT OUTLINE
The overall structure of the Quantitative Response Assay document is hierarchically orga-
nized. The main sections are the Setup section and the Analysis section. The Setup section
contains all data describing the observation data and the measurement inkl. dilution steps,
response values etc. The Analysis section describes the flow of the statistical analysis of the
assay.

Quantitative Response Assay

Operator
• Operator Root of the Operator document
o Comment Single comments
Equipment
• Equipment Root of the Note Document
o Contact Details Contact Data associated with the Equip-
ment
o Journal Journal
o Comment Single Comments
Substance
• Substance Root of the Substance Document
o Journal Journal
o Comment Single Comments

DOCUMENT STRUCTURE
The following table lists the complete structure of all available fields for the documents in
the Measurement Documentation package. It is indicated wether a field is required or op-
tional. The number is a reference to the following section with more reference data for eve-
ry field.

Operator required 1
. Name required 2
. Title optional 3
. Function optional 4
. Department optional 5
. Phone optional 6
. . Type optional 7
. . Number required 8
. e-Mail optional 9
. . Type optional 10
. . Address required 11
. Contact Details optional 12
. Comment optional 13
. . Subject optional 14
. . Text optional 15
. . Linked Document optional 16
. . Date required 17
. . Author required 18

12
 Reference

Equipment required 19
. Name required 20
. Device Identification optional 21
. Serial Number optional 22
. Location required 23
. Status optional 24
. Upcoming Events optional 25
. . Event required 26
. . Event Description optional 27
. . Date optional 28
. Operator optional 29
. . Role optional 30
. . Operator Reference required 31
. Contact optional 32
. . Role optional 33
. . Contact Reference required 34
. Journal optional 35
. . Journal Entry optional 36
. . . Subject optional 37
. . . Text optional 38
. . . Date required 39
. . . Author required 40
. Comment optional 41
. . Subject optional 42
. . Text optional 43
. . Linked Document optional 44
. . Date required 45
. . Author required 46

Substance required 47
. Type required 48
. Name required 49
. Substance Identification optional 50
. Batch/Lot number optional 51
. Sub-batch/Sub-lot number optional 52
. Variant optional 53
. Class optional 54
. Description optional 55
. Potency/Concentration optional 56
. . Value required 57
. . Units required 58
. Details optional 59
. Journal optional 60
. . Journal Entry optional 61
. . . Subject optional 62
. . . Text optional 63
. . . Date required 64
. . . Author required 65
. Comment optional 66
. . Subject optional 67
. . Text optional 68
. . Linked Document optional 69

13
Document Package: Measurement Documentation - Reference Manual

. . Date required 70
. . Author required 71

DOCUMENT ELEMENT REFERENCE

/ 1
Operator USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:empty 1…1 <NONE>

An operator involved with a measurement. Add the required contact data and comments. If
you need full contact details, add a reference to a contact document.

/Operator/ 2
Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Full name of the operator.

/Operator/ 3
Title USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Title xs:token 0…1 <NONE>

Title of the operator. Remove this field, if it is not required.

/Operator/ 4
Function USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Function xs:token 0…1 <NONE>

Describe the job function of the operator. Remove this field, if it is not required.

/Operator/ 5
Department USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Department xs:token 0…1 <NONE>

Department name of the operator. Remove this field, if it is not required. You can add
multiple department lines if they are required.

14
 Reference

/Operator/ 6
Phone USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Phone xs:empty 0…* <NONE>

Phone number for the operator. Remove this field, if it is not required. You can add multiple
phone numbers if required.

/Operator/Phone/ 7
Type USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type xs:string 0…1 <NONE>

Type of the phone number.

/Operator/Phone/ 8
Number USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Number xs:string 1…1 <NONE>

The phone number of the operator.

/Operator/ 9
e-Mail USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

EMail xs:empty 0…* <NONE>

E-mail address of the operator. Remove this field, if it is not required. You can add multiple
e-mail addresses if required.

/Operator/e-Mail/ 10
Type USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type xs:string 0…1 <NONE>

Type of the e-mail address.

/Operator/e-Mail/ 11
Address USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Address xs:string 1…1 <NONE>

The e-mail address of the operator.

15
Document Package: Measurement Documentation - Reference Manual

/Operator/ 12
Contact Details USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ContactDetails T_ContactReference 0…1 <NONE>

Full contact details can be documented in a contact document. You can link or create a
contact document.

/Operator/ 13
Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comment to this document.

/Operator/Comment/ 14
Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Subject of the comment.

/Operator/Comment/ 15
Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of the comment.

/Operator/Comment/ 16
Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

A reference to another document.

/Operator/Comment/ 17
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

16
 Reference

/Operator/Comment/ 18
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

/ 19
Equipment USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Equipment xs:empty 1…1 <NONE>

Equipment used for a measurement.

/Equipment/ 20
Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

Name of the equipment.

/Equipment/ 21
Device Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

DeviceId xs:token 0…1 <NONE>

Device identification of the equipment. Remove this field, if it is not required.

/Equipment/ 22
Serial Number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SerialNo xs:token 0…1 <NONE>

Serial number of the equipment. Remove this field, if it is not required.

/Equipment/ 23
Location USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Location xs:token 1…1 <NONE>

Location (e.g. room number) of the equipment.

/Equipment/ 24
Status USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Status T_Status 0…1 <NONE>

Status of the equipment (e.g. OK, retired)

17
Document Package: Measurement Documentation - Reference Manual

/Equipment/ 25
Upcoming Events USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

UpcomingEvent xs:empty 0…* <NONE>

Document upcoming events for this equipment. E.g. calibration, maintenance, validation.

/Equipment/Upcoming Events/ 26
Event USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Event xs:token 1…1 <NONE>

Name of the event.

/Equipment/Upcoming Events/ 27
Event Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Description xs:string 0…1 <NONE>

Details of an event. Remove this field, if it is not required.

/Equipment/Upcoming Events/ 28
Date USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:date 0…1 <NONE>

Date of the upcoming event. Remove this field, if it is not required.

/Equipment/ 29
Operator USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Operator xs:empty 0…* <NONE>

Document operators and their roles for the equipment.

/Equipment/Operator/ 30
Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:string 0…1 <NONE>

Role of the operator

18
 Reference

/Equipment/Operator/ 31
Operator Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

OperatorReference T_OperatorReference 1…1 <NONE>

Reference an operator document. You can link or create an operator document from this
element.

/Equipment/ 32
Contact USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Contact xs:empty 0…* <NONE>

Further contact details can be documented in a contact document.

/Equipment/Contact/ 33
Role USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Role xs:string 0…1 <NONE>

Role of the contact (e.g. vendor, support)

/Equipment/Contact/ 34
Contact Reference USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

ContactReference T_ContactReference 1…1 <NONE>

Reference to a contact document. You can link or create a contact element from this
element.

/Equipment/ 35
Journal USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Journal T_Journal 0…1 <NONE>

Journal for this equipment.

/Equipment/Journal/ 36
Journal Entry USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

JournalEntry T_JournalEntry 0…* <NONE>

A single entry in the journal for this document.

19
Document Package: Measurement Documentation - Reference Manual

/Equipment/Journal/Journal Entry/ 37
Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Subject of this journal entry

/Equipment/Journal/Journal Entry/ 38
Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this journal entry.

/Equipment/Journal/Journal Entry/ 39
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of this journal entry.

/Equipment/Journal/Journal Entry/ 40
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of this journal entry. Filled automatically with the current user name.

/Equipment/ 41
Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A single comment for this document.

/Equipment/Comment/ 42
Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Subject of the comment.

/Equipment/Comment/ 43
Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of the comment.

20
 Reference

/Equipment/Comment/ 44
Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

A reference to another document.

/Equipment/Comment/ 45
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Equipment/Comment/ 46
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

/ 47
Substance USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Substance xs:empty 1…1 <NONE>

A substance document represents a substance in&#8230; There are several properties to
identify substances. These properties are optional and not all of them may be required in
specifics contexts. Name Substance Identification (e.g. product number) Bat

/Substance/ 48
Type USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Type T_SubstanceTypes 1…1 <NONE>

The type of the substance. Choose between Analyte Reagent Reference Standard Other

/Substance/ 49
Name USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Name xs:token 1…1 <NONE>

The name of the substance.

21
Document Package: Measurement Documentation - Reference Manual

/Substance/ 50
Substance Identification USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubstanceId xs:token 0…1 <NONE>

Identfication Information for the substance (e.g. product number).

/Substance/ 51
Batch/Lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

BatchId xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a batch (or lot) and
from which the production and distribution history can be determined.

/Substance/ 52
Sub-batch/Sub-lot number USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

SubBatchId xs:token 0…1 <NONE>

A unique combination of numbers, letters, and/or symbols that identifies a sub-batch (or
sub-lot) and from which the production and distribution history can be determined.

/Substance/ 53
Variant USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Variant xs:token 0…1 <NONE>

Additional Identification information e.g. for repeated measurements.

/Substance/ 54
Class USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Class xs:token 0…1 <NONE>

Optional entry of a substance class for reporting and grouping.

/Substance/ 55
Description USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Description xs:string 0…1 <NONE>

Textual description of this substance.

22
 Reference

/Substance/ 56
Potency/Concentration USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Potency xs:empty 0…1 <NONE>

Potency or concentration of the substance.

/Substance/Potency/Concentration/ 57
Value USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Value T_PositiveDouble 1…1 <NONE>

The numerical part of the potency/concentration of the substance.

/Substance/Potency/Concentration/ 58
Units USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Units xs:token 1…1 <NONE>

The units part of the potency/concentration of the substance.

/Substance/ 59
Details USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Details xs:string 0…* <NONE>

Further details of for the substance document.

/Substance/ 60
Journal USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Journal T_Journal 0…1 <NONE>

Journal of the substance.

/Substance/Journal/ 61
Journal Entry USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

JournalEntry T_JournalEntry 0…* <NONE>

A single entry in the journal for this document.

/Substance/Journal/Journal Entry/ 62
Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Subject of this journal entry

23
Document Package: Measurement Documentation - Reference Manual

/Substance/Journal/Journal Entry/ 63
Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of this journal entry.

/Substance/Journal/Journal Entry/ 64
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of this journal entry.

/Substance/Journal/Journal Entry/ 65
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of this journal entry. Filled automatically with the current user name.

/Substance/ 66
Comment USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Comment T_Comment 0…* <NONE>

A comment to this document.

/Substance/Comment/ 67
Subject USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Subject xs:token 0…1 <NONE>

Subject of the comment.

/Substance/Comment/ 68
Text USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Text xs:string 0…* <NONE>

Text content of the comment.

/Substance/Comment/ 69
Linked Document USAGE

optional
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

LinkedDocument dr:T_DocumentReference 0…* <NONE>

A reference to another document.

24
 Reference

/Substance/Comment/ 70
Date USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Date xs:dateTime 1…1 <NONE>

Date of comment

/Substance/Comment/ 71
Author USAGE

required
TECHNICAL NAME DATA TYPE MULTIPLICITY DEFAULT VALUE

Author xs:token 1…1 <NONE>

The author of the comment. Filled automatically with the current user name.

AGGREGATION OPPORTUNITIES
N/A

DIGEST RESULTS
The following information can be found in the digest and is accessible through other docu-
ments.

Label Description Data Key

Type [SSY] =
http://www.stegmannsystems.com
Document Title Title of the Docu- String http://purl.org/dc/terms/title
ment.

25
 PLA 3.0
Administratorhandbuch
PLA 3.0 - Administratorhandbuch

COPYRIGHT
©2015 by Stegmann Systems GmbH, Rodgau, Germany.
All rights reserved.

KONTAKT
Stegmann Systems GmbH
Raiffeisenstr. 2 // C1, C2
63110 Rodgau
Germany

Telefon: +49 6106 770100

Fax: +49 6106 7701029

www.bioassay.de
[email protected]

2
 Inhalt

INHALT
Copyright ............................................................................................ 2
Kontakt ........................................................................................... 2
Inhalt .................................................................................................. 3
Willkommen ..................................................................................... 12
Pakete verwalten ............................................................................. 13
Konzepte ...................................................................................... 13
Pakete ...................................................................................... 13
Versionen ................................................................................. 14
Lokale Installation und Deinstallation .......................................... 15
Installation und Deinstallation eines Pakets in der Datenbank ... 15
Anmerkung ............................................................................... 16
Vorlagen verwalten .......................................................................... 18
Konzepte ...................................................................................... 18
Vorlagen erstellen ........................................................................ 18
Vorlagen bearbeiten .................................................................... 19
Element sehen ......................................................................... 20
Element entfernen ................................................................... 20
Wert bearbeiten ....................................................................... 20
Kindelement hinzufügen .......................................................... 21
Auf Unterelemente anwenden ................................................ 21
Initialer Wert ............................................................................ 21
Platzhalter ............................................................................ 21
Currentdatetime .............................................................. 21

3
PLA 3.0 - Administratorhandbuch

Currentdate ...................................................................... 22
Currenttime ...................................................................... 22
Digest:DOCKEY:SECTIONKEY:PROPERTY .......................... 22
Elementcolor .................................................................... 22
Elementcounter................................................................ 22
Empty ............................................................................... 22
Generator ......................................................................... 23
Keyedcounter:KEY ............................................................ 23
Userdisplayname .............................................................. 23
Userloginname ................................................................. 23
Vorlagen verwenden .................................................................... 23
Einstellungen zur Benutzung von Vorlagen verwalten ................ 23
Verfügbare Vorlagen beschränken .......................................... 24
Neue Dokumente benötigen zur Erstellung eine Vorlage ........ 25
Dokumenttypspezifische Vorlagen .......................................... 25
Datenbankeinstellungen verwalten ................................................. 26
Konzepte ...................................................................................... 26
Kennwortrichtlinien ..................................................................... 26
Minimale Länge ........................................................................ 27
Mindestzahl an Sonderzeichen ................................................ 27
Maximale Länge ....................................................................... 28
Maximales Kennwortalter ........................................................ 28
Warnalter ................................................................................. 28
Mindestalter ............................................................................. 28

4
 Inhalt

Abgelaufenes Kennwort sperrt Konto...................................... 28

Maximale Anzahl an Fehlversuchen ......................................... 28
Sperrdauer der Anmeldesperre ............................................... 28
Länge der Kennworthistorie ..................................................... 29
Liste an ungültigen Kennwörtern ............................................. 29
Sicherheitsrichtlinien ................................................................... 29
Sperrung bei Inaktivität ............................................................ 30
Signaturrichtlinien ........................................................................ 30
Benutzername benötigt ........................................................... 31
Vorlagen für elektronische Signaturen .................................... 32
Entfernen von Signaturen verbieten ........................................ 32
Löschung signierter Dokumente verbieten .............................. 33
Löschung teilweiser signierter Dokumente verbieten ............. 33
21 CRF Part 11 Signaturen........................................................ 33
Nachvollziehbarkeitsrichtlinien .................................................... 34
Änderungen am Dokument .................................................. 34
Nie .................................................................................... 35
Optional............................................................................ 35
Immer ............................................................................... 35
Immer nach dem ersten Speichern .................................. 35
Änderungen an geschützten Werten ................................... 35
Erlaubt .............................................................................. 35
Erlaubt mit Begründung ................................................... 36
Erlaubt mit Begründung und Signatur.............................. 36

5
PLA 3.0 - Administratorhandbuch

Verboten .......................................................................... 36
Datenbankeigenschaften ............................................................. 36
Bezeichnung ............................................................................. 36
Beschreibung............................................................................ 36
Dashboard ................................................................................ 37
Konfigurationsbericht erstellen ................................................... 39
Einstellungen ............................................................................ 40
Ordnereinstellungen verwalten ....................................................... 41
Konzepte ...................................................................................... 41
Verwalten von Ordnern ............................................................... 41
Dokumentschlüssel verwalten ..................................................... 41
Modifizieren eines Schlüsselformats ....................................... 42
Modifizieren eines dokumenttypspezifischen Schlüsselformats
................................................................................................. 43
Dokumenttyp ....................................................................... 43
Dokumentschlüssel .............................................................. 43
Vorlagenschlüssel ................................................................. 44
Benutzerdefinierte Dokumentschlüssel aktivieren .................. 44
Dokumentbeschränkungen .......................................................... 44
Sicherheitskontext zuweisen........................................................ 46
Berechtigungen verwalten ............................................................... 48
Konzepte ...................................................................................... 48
Berechtigungen ........................................................................ 48
Übersetzungen ......................................................................... 48
Benutzerkontenverwaltung ......................................................... 49

6
 Inhalt

Globale Rollen verwalten ............................................................. 50

Globale Berechtigungen ........................................................... 51
IQ ausführen......................................................................... 51
OQ ausführen ....................................................................... 51
PQ ausführen ....................................................................... 51
Eigenes Konto verwalten...................................................... 52
Audit Trail (Ereignisprotokoll) anzeigen ............................... 52
Komponentenpakete ansehen ............................................. 52
Komponentenpakete verwalten .......................................... 52
Konten Verwalten ................................................................ 52
Sitzungen verwalten ............................................................. 53
Datenbankrichtlinien editieren ............................................ 53
Datenbank sperren............................................................... 53
HTML-Fragment verwalten .................................................. 53
Dokumentrollen verwalten .......................................................... 54
Dokumentberechtigungen ....................................................... 57
Anlegen neuer Kindobjekte .................................................. 57
Dokumente lesen ................................................................. 57
Dokumente editieren ........................................................... 57
Dokumente entfernen.......................................................... 57
Dokumente bewegen ........................................................... 57
Eigene Elektronische Signatur entfernen ............................. 57
Elektronische Signatur anbringen ........................................ 58
Elektronische Signaturen bestätigen.................................... 58

7
PLA 3.0 - Administratorhandbuch

Entfernen aller elektronischen Signaturen .......................... 58

Sicherheitskontext ändern ................................................... 58
Ansehen der Ordnereigenschaften ...................................... 59
Bearbeiten des Feldschutzes ................................................ 59
Gruppen verwalten ...................................................................... 59
Beschreibung............................................................................ 60
Gültig bis .................................................................................. 60
Gruppe ist deaktiviert .............................................................. 60
Avatar ändern .......................................................................... 61
Sicherheitskontexte verwalten .................................................... 62
Benutzer verwalten ...................................................................... 65
Anzeigename ............................................................................ 66
Gültig bis .................................................................................. 66
Benutzerkonto ist deaktiviert .................................................. 66
Sperre ....................................................................................... 67
Kennwort muss bei der nächsten Anmeldung geändert werden
................................................................................................. 67
Kennwort setzen ...................................................................... 67
Kennwort zurücksetzen............................................................ 67
Avatar ändern .......................................................................... 67
Datenbanken überwachen ............................................................... 68
Konzepte ...................................................................................... 68
Systemereignisprotokoll .......................................................... 68
Dokumentereignisprotokoll ..................................................... 68
Sitzungsverwaltung .................................................................. 68

8
 Inhalt

Ereignisprotokolle ........................................................................ 69
Aktionen ................................................................................... 69
USER_LOGIN ......................................................................... 69
USER_LOGOUT ..................................................................... 69
USER_LOGINREJECTED ......................................................... 69
USER_PWCHANGE ................................................................ 69
USER_RESETPW .................................................................... 69
DB_INITIALIZED .................................................................... 70
DB_ADMINACCESS_ON ........................................................ 70
DB_ADMINACCESS_OFF ....................................................... 70
DB_ADD_SESSION ................................................................ 70
DB_DELETE_SESSION ........................................................... 70
DB_KILL_SESSION ................................................................. 70
DB_KILL_LOCK ...................................................................... 70
DB_KILL_ALL_LOCKS ............................................................. 70
OPTION_MODIFIED .............................................................. 70
SYSTEM_ERROR .................................................................... 71
IQ_EXECUTED ....................................................................... 71
OQ_EXECUTED ..................................................................... 71
PQ_EXECUTED ...................................................................... 71
COMPONENT_INIITIAL ......................................................... 71
COMPONENT_SAVED ........................................................... 71
COMPONENT_UPDATED ...................................................... 71
COMPONENT_IMPORTED .................................................... 71

9
PLA 3.0 - Administratorhandbuch

COMPONENT_DELETE .......................................................... 71
GROUP_INITIAL .................................................................... 71
GROUP_SAVED ..................................................................... 71
GROUP_DELETE .................................................................... 72
SECURITYCONTEXT_INITIAL ................................................. 72
SECURITYCONTEXT_SAVED .................................................. 72
SECURITYCONTEXT_DELETE ................................................. 72
ROLE_INITIAL ........................................................................ 72
ROLE_SAVED ........................................................................ 72
ROLE_DELETE ....................................................................... 72
HTMLFRAGMENT_INITIAL .................................................... 72
HTMLFRAGMENT_SAVED ..................................................... 72
DATA_ACQUIRED ................................................................. 72
DOC_KEY_CHANGED ............................................................ 72
OBJECT_COPIED_FROM ....................................................... 73
OBJECT_COPIED_TO ............................................................. 73
OBJECT_EXECUTE_TASK ....................................................... 73
OBJECT_EXPORTED .............................................................. 73
OBJECT_INITIAL .................................................................... 73
OBJECT_MOVED ................................................................... 73
OBJECT_REMOVESIGNATURE .............................................. 73
OBJECT_SAVED ..................................................................... 73
OBJECT_SIGN........................................................................ 73
OBJECT_UPGRADE................................................................ 73

10
 Inhalt

OBJECT_DELETE.................................................................... 73
FOLDER_PROPERTIES_MODIFIED......................................... 74
OQ_EXPORTED ..................................................................... 74
PQ_EXPORTED ...................................................................... 74
Exportieren............................................................................... 74
Sitzungen verwalten ..................................................................... 74
Aktualisierungsrate .................................................................. 75
Aktualisieren ............................................................................ 75
Sitzung beenden....................................................................... 75
Alle entsperren ......................................................................... 75
Objekt entsperren .................................................................... 75

11
PLA 3.0 - Administratorhandbuch

WILLKOMMEN
Willkommen zum PLA 3.0 Administratorhandbuch. Dieses Handbuch
richtet sich vor allem an die PLA 3.0 Administratoren (Funktionaler
Administrator) und Systemadministratoren.

Das PLA 3.0 Administratorhandbuch erklärt Ihnen wie Sie Doku-

mentvorlagen, Benutzerkonten, Berechtigungen, Sicherheitskontex-
te und Datenbanken einrichten und verwalten.

12
 Pakete verwalten

PAKETE VERWALTEN

KONZEPTE
PAKETE
Pakete ermöglichen es PLA 3.0 um neue Dokumentarten inklusive
Mathematik und Vorlagen zu Berichterstellung oder Importmodule
zu ergänzen. Auch Aktualisierungen für bestehende Pakete können
installiert werden. Komponenten werden in der Datenbank instal-
liert und können von allen Benutzern der Datenbank genutzt wer-
den. Hiermit ist immer gewährleistet, dass alle Benutzer der Daten-
bank dieselben Komponenten benutzen. Der zentrale Punkt für
Pakete in PLA 3.0 ist die Paketverwaltung. Hier kann man einsehen
welche Pakete in welcher Version vorliegen und diese installieren
oder deinstallieren.

13
PLA 3.0 - Administratorhandbuch

Neue Komponenten müssen zuerst lokal mit Hilfe des Installations-

programms der Komponente installiert werden, um sie anschlie-
ßend in der Paketverwaltung von PLA 3.0 zu installieren und somit
in die Datenbank zu übertragen. Ist dies geschehen besteht zwi-
schen dem Paket in der Datenbank und dem lokal installierten Paket
keine Anhängigkeit mehr und das lokal installierte Paket kann wie-
der deinstalliert werden.

VERSIONEN
Neue Versionen sind grundlegen immer Verbesserungen gegenüber
einer älteren Version eines Dokumenttyps. Zum Beispiel können
Umstrukturierungen am Dokumenttypen oder eine Änderung in der
Mathematik vorgenommen worden sein. Daher werden Dokumente
nicht automatisch auf die neue Dokumenttypenversion gehoben, da
hierbei alle Ergebnisse innerhalb des Dokuments verworfen wer-

14
 Pakete verwalten

den. Es wird jedoch sichergestellt, dass sobald eine neuere Version

eines Dokumenttyps installiert ist nur mit der neusten Version ge-
arbeitet werden kann. Für Dokumente in einer älteren Doku-
menttypversion gibt es einen schreibgeschützten Modus und die
Möglichkeit das Dokument auf die neue Version zu heben.

LOKALE INSTALLATION UND DEINSTALLATION

Um ein Paket mit Hilfe des Installationsprogramms des Pakets in-
stallieren zu können benötigen sie administrative Rechte auf dem
Computer. Falls Sie nicht mit einem solchen Benutzerkonto ange-
meldet sind werden sie vom Betriebssystem dazu aufgefordert. Sie
müssen den Lizenzvereinbarungen zustimmen um die Installation
erfolgreich durchzuführen.

Zur Deinstallation eines Pakets benötigen Sie ebenfalls administrati-

ve Rechte. Wählen Sie in der Microsoft Windows Systemsteuerung
die Option Programme deinstallieren aus und deinstallieren Sie das
gewünschte Paket.

INSTALLATION UND DEINSTALLATION EINES PAKETS IN

DER DATENBANK
Für die Installation sowie für die Deinstallation benötigen Sie in
PLA3 die Berechtigung Komponentenpakete verwalten.

Zugriff auf die Paketverwaltung erhalten Sie über das System-Menü.

Links sind die lokal installierten Pakete sichtbar und rechts die in der
Datenbank installierten. Die Pakete auf der linken Seite werden
noch darin unterschieden ob sie bereits auf der Datenbank instal-
liert sind oder nur lokal vorhanden .

Pakete haben untereinander häufig Anhängigkeiten. Daher kann es

sein, dass aufgrund von nicht erfüllten Abhängigkeiten, ein Paket

15
PLA 3.0 - Administratorhandbuch

nicht installiert werden kann. Sobald das Paket auf den die Abhän-
gigkeit besteht installiert ist, kann dann das eigentlich zu installie-
rende Paket installiert werden. Im Fall des Deinstallierens ist es
nicht möglich Pakete zu deinstallieren, wenn andere Pakete von
ihnen abhängen. Zusätzlich dürfen, wenn ein Paket mit Dokument-
typen deinstalliert wird, keine Dokumente von einem der zu dein-
stallierenden Dokumenttypen in der Datenbank vorhanden sein.

ANMERKUNG
Beim Installieren einer neuen Version eines Pakets, die einen Do-
kumenttyp beinhaltet werden Dokumente dieses Dokumenttyps
nicht automatisch auf die neue Version gehoben.

16
 Pakete verwalten

Beim Öffnen eines Dokuments in einer älteren Version kann der

Benutzer daher entscheiden, ob er das Dokument aktualisiert und
somit eventuell vorhandene Ergebnisse verwirft, oder eine Kopie
des Dokuments auf die neue Version aktualisiert und das original
Dokument unangetastet bleibt.

Es ist nicht möglich auf die ältere Version eines Dokumenttyps zu-
rückzufallen.

17
PLA 3.0 - Administratorhandbuch

VORLAGEN VERWALTEN

KONZEPTE
PLA 3.0 bietet Ihnen für die Durchsetzung Ihrer Firmenrichtlinien
und zur einfachen Übernahme von Einstellungen einen detaillierten
Vorlageneditor. Alle Einstellungen, die Sie auf ein Element treffen,
können auch auf die darunterliegenden Elemente übernommen
werden. Sie können initiale Werte für Elemente festlegen, die sta-
tisch oder über Platzhalter eingetragen werden können. Zusätzlich
können Sie die Sichtbarkeit und den Schreibschutz anpassen und Sie
haben die Möglichkeit das Erstellen von Unterelementen zu verbie-
ten.

Über einen besonderen Editormodus und die Berechtigung Bearbei-

ten des Feldschutz ist es möglich, die über ein Template erstellten
Restriktionen zu verändern.

VORLAGEN ERSTELLEN
Vorlagen sind dokumenttypspezifisch. Es gibt zwei Wege wie Sie
Vorlagen erstellen können. Sie können bei der Erstellung eines neu-
en Dokuments auswählen ob dieses Dokument als Vorlage erstellt
werden soll.

18
 Vorlagen verwalten

Alternativ können Sie aus einem bereits bestehenden Dokument

eine Vorlage erzeugen indem Sie es im Editor öffnen und die Aktion
Als Vorlage speichern auswählen. Nach dem Speichervorgang wird
die Vorlage im Editor geöffnet. Das existierende Dokument bleibt
bestehen.

VORLAGEN BEARBEITEN
Eine gespeicherte Vorlage sieht grundlegend aus wie das Dokument
aus dem sie erstellt wurde, jedoch gibt es auf der Inhalt-Seite einen

19
PLA 3.0 - Administratorhandbuch

zusätzlichen Bereich im unteren Teil des Editors. In diesem Bereich

können die Funktionen der Vorlage bearbeitet werden. Die initialen
Werte aller Elemente sind im folgenden Bild zu sehen.

Alle Elemente eines Dokuments das aus einer solchen Vorlage er-
stellt wird sind frei editierbar.

ELEMENT SEHEN
Das Deaktivieren dieser Option bewirkt, dass in einem aus der Vor-
lage erstellten Dokument dieses Feld nicht sichtbar ist. Bei der Be-
rechnung oder anderer Verarbeitung wird es jedoch berücksichtigt.

ELEMENT ENTFERNEN
Das Deaktivieren dieser Option verbietet das Entfernen eines Ele-
ments.

Hinweis: Es gibt Elemente in Dokumenten, die unabhängig von der

Einstellung dieser Option nicht entfernt werden können, da sie für
den Gesamtzusammenhang des Dokuments von Bedeutung sind.

WERT BEARBEITEN
Durch Deaktivieren dieser Option ist es möglich das Element gegen
Schreibzugriff zu schützen.

20
 Vorlagen verwalten

KINDELEMENT HINZUFÜGEN
Das Deaktivieren dieser Option bewirkt, dass keine Unterelemente
unter diesem Element erstellt werden können.

Hinweis: Es ist durch den Dokumenttyp definiert welche Unterele-

mente für welches Element erstellt werden können.

AUF UNTERELEMENTE ANWENDEN

Die aktuellen Optionen werden auf alle Unterelemente des Ele-
ments übertragen.

INITIALER WERT
An dieser Stelle können entweder statisch initiale Werte für das
Element angegeben werden oder Werte über ein oder mehrere
Platzhalter und optional statische Teile definiert werden.

Durch Betätigen von STRG + Leertaste öffnet sich eine Box mit mög-
lichen Platzhaltern, aus denen die benötigten ausgewählt werden
können

P LATZHALTER

C URRENTDATETIME
Gibt den Zeitpunkt im ISO-8601 Extended Format (UTC) an dem das
Element erzeugt wurde an.

21
PLA 3.0 - Administratorhandbuch

C URRENTDATE
Gibt das Datum im ISO-8601 Extended Format (UTC) an, an dem das
Element erzeugt wurde an.

C URRENTTIME
Gibt die Uhrzeit im ISO-8601 Extended Format (UTC) an, zu der das
Element erzeugt wurde.

D IGEST :DOCKEY:SECTIONKEY:PROPERTY
Liefert für ein bestimmtes Dokument Informationen aus dem Di-
gest.

DOCKEY: Dokumentschlüssel des Dokuments aus dem die Informa-

tion bezogen werden soll.

SECTIONKEY: Bei Informationen die nicht auf eine spezielle Sektion

bezogen sind bleibt dieser Wert leer. Ansonsten wird der Name der
Sektion angegeben. Im Fall von Quantitative Response Assays sind
dies die Werte der Name-Elemente von Control-, Standard- und
Test-Elementen.

PROPERTYKEY: Diese Schlüssel referenzieren feste Werte im Digest

des Dokuments.

E LEMENTCOLOR
Liefert aus einem Set aus vordefinierten Farben den ersten verfüg-
baren Farbwert, der noch nicht verwendet wird.

E LEMENTCOUNTER
Liefert die erste Ganzzahl, die in diesem Dokument noch nicht ver-
wendet wird. Nicht mehr verwendete Zahlen werden wieder neu
vergeben.

E MPTY
Leert ein in der Vorlage gefülltes Feld.

22
 Vorlagen verwalten

G ENERATOR
Liefert den Schlüssel des Dokuments aus dem dieses Dokument
generiert wurde

K EYEDCOUNTER :KEY
Liefert für einen bestimmten Schlüssel die erste verfügbare Ganz-
zahl.

Bsp.:

Initialer Wert: Sample {keyedcounter:Sample}

Entspricht den Werten im Dokument: Sample 1, Sample 2, Sample

3, …

U SERDISPLAYNAME
Liefert den Anzeigenamen des Benutzers der das Element erzeugt
hat.

U SERLOGINNAME
Liefert den Benutzernamen des Benutzers der das Element erzeugt
hat.

VORLAGEN VERWENDEN
Das Erstellen von Dokumenten aus Vorlagen kann über Neues Do-
kument aus Vorlage erstellen oder über Neu… und das auswählen
des Dokumenttyps und der gewünschten Vorlage erfolgen.

EINSTELLUNGEN ZUR BENUTZUNG VON VORLAGEN VER-

WALTEN
Ohne Einstellungen ist es Benutzern freigestellt ob sie Vorlagen
beim Erstellen von Dokumenten benutzen. Für jeden Ordner gibt es
die Möglichkeit die Verwendung von Vorlagen einzufordern, nur

23
PLA 3.0 - Administratorhandbuch

Vorlagen aus einem bestimmten Ordner zu verwenden oder für

jeden Dokumenttyp eine zu verwendende Vorlage vorzuschreiben.
Diese Option finden Sie in den Ordnereigenschaften des Ordners.

Um die Richtlinien zur Benutzung von Vorlagen anzupassen müssen

sie zuerst Konfiguration ändern betätigen. Über Konfiguration zu-
rücksetzen setzen Sie alle Einstellungen bezüglich Vorlagen für die-
sen Ordner zurück.

VERFÜGBARE VORLAGEN BESCHRÄNKEN

Aktiviere Sie diese Option und wählen Sie einen Ordner aus welcher
die Vorlagen für die Dokumente, die dieser Ordner beinhalten soll,
enthält.

24
 Vorlagen verwalten

NEUE DOKUMENTE BENÖTIGEN ZUR ERSTELLUNG EINE VORLAGE

Mit dieser Option können keine Dokumente mehr ohne Vorlage
erstellt werden.

Achtung: Falls keine Vorlagen auf der Datenbank oder im Vorlagen-

ordner verfügbar sind, können keine neuen Dokumente angelegt
werden!

DOKUMENTTYPSPEZIFISCHE VORLAGEN
Hier können Sie pro Dokumenttyp eine spezifische Vorlage auswäh-
len, die ausschließlich für die Erstellung von Dokumenten dieses
Typs verwendet wird.

25
PLA 3.0 - Administratorhandbuch

DATENBANKEINSTELLUNGEN VERWALTEN

KONZEPTE
Einstellungen zu Kennwort-, Signatur-, und Änderungsgrund-
Richtlinien werden in PLA 3.0 pro Datenbank festgelegt und in den
Datenbankrichtlinien festgehalten. Dies ermöglicht Unterschiede in
den Einstellungen wie zum Beispiel zwischen einer produktiven und
einer Test-Datenbank. Diese Einstellungen können Sie im System-
Menü unter Datenbankrichtlinien finden.

Kennwortrichtlinien dienen dazu zu gewährleisten, dass Benutzer

sichere Kennworte erstellen und diese in regelmäßigen Abständen
wechseln. Um ein sicheres Kennwort zu erstellen sollte es nicht zu
kurz sein und eine hohe Komplexität durch die Verwendung von
Sonderzeichen haben.

Signaturrichtlinien ermöglichen es Vorlagen für Signaturgründe zu

erstellen und zu bearbeiten und 21 CFR Part 11 konforme Signatu-
ren zu erstellen.

Änderungsgründe sollen helfen den Werdegang eines Dokuments

zu dokumentieren und werden als zusätzliche Information im Do-
kument gespeichert.

Schutz von importierten Werten und Technical Outlier-Werten soll

es ermöglichen Werte gegen Veränderung zu schützen, da sie einen
besonderen Status genießen. Es ist anpassbar auf welche Art diese
Werte editiert werden dürfen.

KENNWORTRICHTLINIEN
Die Kennwortrichtlinien finden Sie im Reiter Sicherheit der Daten-
bankrichtlinien.

26
 Datenbankeinstellungen verwalten

MINIMALE LÄNGE
Gibt die minimale Zeichenanzahl an aus der ein Kennwort bestehen
muss.

MINDESTZAHL AN SONDERZEICHEN
Gibt die Anzahl der Sonderzeichen an die in einem Kennwort ent-
halten sein müssen. Als Sonderzeichen gelten alle Zeichen, welche
keine Zahl oder Buchstabe sind.

27
PLA 3.0 - Administratorhandbuch

MAXIMALE LÄNGE
Gibt die maximale Anzahl an Zeichen an aus denen ein Kennwort
bestehen muss.

MAXIMALES KENNWORTALTER
Gibt das maximale Alter eines Kennworts in Tagen an. Wenn dieses
Alter erreicht ist muss der Benutzer sein Kennwort ändern. Wählen
Sie 0 aus um diese Option zu deaktivieren.

WARNALTER
Gibt das Alter in Tagen an nach welchem der Benutzer daran erin-
nert wird sein Kennwort zu ändern. Setzen Sie den Wert auf 0 um
diese Funktion zu deaktivieren.

MINDESTALTER
Gibt das Mindestalter eines Kennworts in Tagen an bevor es geän-
dert werden kann. Setzen Sie den Wert auf 0 um diese Option zu
deaktivieren.

ABGELAUFENES KENNWORT SPERRT KONTO

Bei aktivierter Option wird ein Benutzerkonto gesperrt wenn ein
Kennwort das maximale Kennwortalter erreicht.

MAXIMALE ANZAHL AN FEHLVERSUCHEN

Gibt die Anzahl der fehlerhaften Kennworteingaben an die zu einer
Sperre des Benutzerkontos führen. Der Benutzer kann manuell über
die Benutzerkontenverwaltung entsperrt werden.

SPERRDAUER DER ANMELDESPERRE

Gibt die Dauer der Sperre bei Erreichen der maximalen Anzahl an
Fehlversuchen in Minuten an. Wenn der Wert 0 ist wird der Benut-
zer permanent gesperrt und muss manuell entsperrt werden.

28
 Datenbankeinstellungen verwalten

LÄNGE DER KENNWORTHISTORIE

Gib an wie viele Kennwörter ein Benutzer in Verwendung gehabt
haben muss bis er ein Kennwort erneut benutzen kann. Wenn die
Länge auf 0 gesetzt ist sind bereits verwendete Kennwörter nicht
mehr erneut als Kennwort verwendbar.

LISTE AN UNGÜLTIGEN KENNWÖRTERN

Hier können Sie eine Liste an Kennwörtern angeben, die nicht von
Benutzern verwendbar sein sollen.

SICHERHEITSRICHTLINIEN
In den Datenbankrichtlinien im Reiter Sicherheit kann die Dauer
eingestellt werden nach wie langer Inaktivität des Benutzers PLA 3.0

29
PLA 3.0 - Administratorhandbuch

automatisch gesperrt werden soll. Der Benutzer muss sich anschlie-

ßend mit seinem Kennwort anmelden um das System zu entsper-
ren.

SPERRUNG BEI INAKTIVITÄT

Gibt die Zeit in Minuten an, die ein Benutzer inaktiv sein muss damit
sich das System automatisch sperrt.

SIGNATURRICHTLINIEN
Die Signaturrichtlinien finden Sie in den Datenbankrichtlinien im
Reiter Signatur.

30
 Datenbankeinstellungen verwalten

BENUTZERNAME BENÖTIGT
Durch das aktivieren dieser Einstellung muss beim Signieren eines
Dokuments explizit erneut der Benutzername angegeben werden.
Es ist nur möglich den Benutzernamen des gerade angemeldeten
Benutzers zu verwenden. Das Aktivieren dieser Einstellung wird
dann benötigt, wenn sie 21 CRF Part 11 konforme Signaturen an
ihre Dokumente anbringen möchten. Bei deaktivierter Option wird

31
PLA 3.0 - Administratorhandbuch

automatisch der Benutzername des angemeldeten Benutzers für

den Signiervorgang eingetragen.

VORLAGEN FÜR ELEKTRONISCHE SIGNATUREN

Hier können Sie Vorlagen für Signaturgründe angeben. Diese Grün-
de sind dann beim Erstellen einer Signatur auswählbar.

ENTFERNEN VON SIGNATUREN VERBIETEN

Diese Einstellung verbietet jegliches Entfernen von Signaturen, auch
wenn der Benutzer die Berechtigungen zur Entfernung von Signatu-
ren hat.

32
 Datenbankeinstellungen verwalten

LÖSCHUNG SIGNIERTER DOKUMENTE VERBIETEN

Diese Einstellung verbietet jegliches Löschen signierter Dokumente,
auch wenn der Benutzer entsprechende Berechtigungen hat.

LÖSCHUNG TEILWEISER SIGNIERTER DOKUMENTE VERBIETEN

Diese Einstellung verbietet jegliches Löschen teilweiser signierter
Dokumente, auch wenn der Benutzer entsprechende Berechtigun-
gen hat.

21 CRF PART 11 SIGNATUREN

Um 21 CFR Part 11 konforme Signaturen zu erstellen müssen „Be-
nutzername benötigt“, „Entfernen von Signaturen verbieten“, „Lö-
schung signierter Dokumente verbieten“ und „Löschung teilweiser
signierter Dokumente verbieten“ aktiviert sein.

33
PLA 3.0 - Administratorhandbuch

NACHVOLLZIEHBARKEITSRICHTLINIEN

Ä NDERUNGEN AM D OKUMENT
Die Einstellung für Änderungsgründe finden Sie im Nachvollziehbar-
keit-Reiter der Datenbankrichtlinien. Die Aufforderung einen Ände-
rungsgrund anzugeben erscheint, wenn aktiviert, beim Speichervor-
gang.

34
 Datenbankeinstellungen verwalten

N IE
Der Benutzer erhält keine Möglichkeit beim Speichern einen Ände-
rungsgrund anzugeben

O PTIONAL
Bei jedem Speichern öffnet sich ein Dialog der dem Benutzer die
Möglichkeit gibt einen Änderungsgrund anzugeben. Wenn kein
Änderungsgrund angegeben werden soll kann der Dialog direkt
bestätigt werden.

I MMER
Bei jedem Speichern öffnet sich der Dialog zum Eingeben des Ände-
rungsgrunds. Der Dialog kann nicht mit leerem Änderungsgrund
bestätigt werden.

I MMER NACH DEM ERSTEN S PEICHERN

Beim initialen Speichern des Dokuments gibt es keine Möglichkeit
den Änderungsgrund anzugeben, bei jedem weiteren Speichern ist
die Angabe eines Änderungsgrunds verpflichtend.

Ä NDERUNGEN AN GESCHÜTZTEN W ERTEN

Die Einstellung zu Änderungen an geschützten Werten befindet sich
auf dem Nachvollziehbarkeit-Reiter in den Datenbankrichtlinien. Es
ist separat definierbar wie Änderungen an importierten Werten und
Änderungen an Technical Outlier-Werten behandelt werden sollen,
beide sind jedoch gleich aufgebaut. Es gibt vier unterschiedliche
Abstufungen wie Werte geschützt werden sollen. In jedem Fall wird
jedoch eine Annotation angelegt, die über die Annotationsansicht
angesehen werden kann.

E RLAUBT

35
PLA 3.0 - Administratorhandbuch

Benutzer können geschützte Werte ohne zusätzliche Angaben ver-

ändern.

E RLAUBT MIT B EGRÜNDUNG

Benutzer können geschützte Werte unter Angabe des Änderungs-
grunds ändern.

E RLAUBT MIT B EGRÜNDUNG UND S IGNATUR

Benutzer können geschützte Werte unter Angabe eines Änderungs-
grunds und Abgabe einer Signatur ändern.

V ERBOTEN
Geschützte Werte sind nicht änderbar.

DATENBANKEIGENSCHAFTEN
Die Datenbankeigenschaften sind über Datenbankeigenschaften im
System-Menü zugänglich.

BEZEICHNUNG
Die Bezeichnung einer Datenbank wird bei der Erstellung einer
Datenbank aus einer benutzerdefinierten Vorlage angezeigt.

BESCHREIBUNG
Die Beschreibung einer Datenbank wird bei der Erstellung einer
Datenbank aus einer benutzerdefinierten Vorlage angezeigt und soll
Informationen über die Datenbank enthalten.

36
 Datenbankeinstellungen verwalten

DASHBOARD
Hier kann ein HTML-Fragment mit Ihrem Inhalt in das Datenbank-
Dashboard, das im Reiter Start liegt, eingefügt werden um zusätzli-
che Informationen für alle Benutzer der Datenbank an einem zent-
ralen Platz bereitzustellen.

37
PLA 3.0 - Administratorhandbuch

38
 Datenbankeinstellungen verwalten

KONFIGURATIONSBERICHT ERSTELLEN
PLA 3.0 bietet die Möglichkeit einen Konfigurationsbericht zu erstel-
len. Dieser fasst Einstellungen der Datenbank zusammen und stellt
sie als PDF zur Verfügung. Es ist möglich, nur Teilberichte zu erstel-
len. Die Erstellung des Berichts unterliegt den jeweiligen Rechtebe-
schränkungen.

Der Konfigurationsbericht kann unter System -> Konfigurationsbe-

richt erstellt werden.

39
PLA 3.0 - Administratorhandbuch

EINSTELLUNGEN
Wählen Sie hier einen Zielordner, in dem der Bericht gespeichert
werden soll, und wählen Sie einzelne Teilberichte, die erstellt wer-
den sollen, aus.

40
 Ordnereinstellungen verwalten

ORDNEREINSTELLUNGEN VERWALTEN

KONZEPTE
PLA 3.0 bietet die Möglichkeit die Schlüssel von Dokumenten, Vor-
lagen und Ordnern nach einem bestimmten Muster zu gestalten,
um zum Beispiel zur Übersichtlichkeit beizutragen oder auch um die
Zugehörigkeit zu bestimmten Projekten klar hervorzuheben. Falls
benötigt können auch für einzelne Dokumenttypen bestimmte
Schlüssel spezifiziert werden. Weiterhin bietet PLA 3.0 die Möglich-
keit nur bestimmte Dokumentarten zuzulassen. Diese Optionen
können für jeden Ordner einzeln ausgewählt werden um größtmög-
liche Flexibilität zu gewährleisten.

VERWALTEN VON ORDNERN

Das Anlegen, Öffnen, Verschieben, Löschen, Kopieren und Umbe-
nennen von Ordnern können sie im Benutzerhandbuch unter Ord-
ner verwalten nachlesen.

DOKUMENTSCHLÜSSEL VERWALTEN
Die Einstellungen zum Schlüsselformat finden sie in den Optionen
eines Ordners im Reiter Dokumentschlüsselformat. Standardmäßig
haben Dokumente, Vorlagen und Ordner unterschiedliche Schlüssel
und der numerische Teil des Schlüssels wird unabhängig voneinan-
der hochgezählt. Um Zugang zu den Einstellungen zu erhalten, müs-
sen sie zunächst Konfiguration ändern auswählen. Durch die Funkti-
on Konfiguration zurücksetzen werden alle Schlüsselformate wieder
auf den Standardwert zurückgesetzt.

41
PLA 3.0 - Administratorhandbuch

MODIFIZIEREN EINES SCHLÜSSELFORMATS

Das Modifizieren eines Schlüsselformats ist für Dokumente, Vorla-
gen und Ordner gleich.

42
 Ordnereinstellungen verwalten

Sie haben die Möglichkeit ein Präfix oder ein Suffix für den Zähler
anzugeben und können wählen ob und wie viele führende Nullen
der Zähler erhalten soll.

MODIFIZIEREN EINES DOKUMENTTYPSPEZIFISCHEN SCHLÜSSEL-

FORMATS
Das Modifizieren des Schlüsselformats eines bestimmten Doku-
menttypen ist für jeden Dokumenttyp gleich.

D OKUMENTTYP
Wählen sie hier bitte den Dokumenttyp aus, der ein besonderes
Dokumentschlüsselformat erhalten soll.

D OKUMENTSCHLÜSSEL
Wählen Sie hier das Schlüsselformat für Dokumente des selektier-
ten Typs. Die Funktionsweise ist identisch mit dem Modifizieren
eines Standardschlüssels.

43
PLA 3.0 - Administratorhandbuch

V ORLAGENSCHLÜSSEL
Wählen Sie hier das Schlüsselformat für Vorlagen des selektierten
Typs. Die Funktionsweise ist identisch mit dem Modifizieren eines
Standardschlüssels.

BENUTZERDEFINIERTE DOKUMENTSCHLÜSSEL AKTIVIEREN

Wenn diese Option aktiviert ist, hat der Benutzer die Möglichkeit
den Zähler des Dokumentschlüssels frei zu bestimmen. Dies ist über
die Aktion Dokumentschlüssel ändern möglich.

DOKUMENTBESCHRÄNKUNGEN
Einschränkungen auf gewisse Dokumenttypen können in den Eigen-
schaften eines Ordners im Reiter Dokumentbeschränkungen einge-
stellt werden. Dokumentbeschränkungen können in Kombination
mit der Vergabe spezifischer Vorlagen oder auch ohne eingestellt
werden.

44
 Ordnereinstellungen verwalten

Für Dokumenttypbeschränkungen muss die Option In diesem Ord-

ner können nur Dokumente des aufgeführten Typs gespeichert
werden aktiviert sein. Die darüberstehende Liste gibt an welche
Dokumenttypen in diesem Ordner erlaubt sind.

Über Hinzufügen können Sie die gewünschten Dokumenttypen

auswählen und ggf. eine Vorlage für diesen Dokumenttyp auswäh-
len.

45
PLA 3.0 - Administratorhandbuch

SICHERHEITSKONTEXT ZUWEISEN
Das Zuweisen eines Sicherheitskontexts zu einem Ordner erfolgt
über die Ordneroptionen des Ordners im Reiter Allgemein.

46
 Ordnereinstellungen verwalten

Hier können Sie nun auswählen welcher Sicherheitskontext für

diesen Ordner gelten soll.

47
PLA 3.0 - Administratorhandbuch

BERECHTIGUNGEN VERWALTEN

KONZEPTE
BERECHTIGUNGEN
Das Berechtigungssystem von PLA 3.0 ist flexibel anpassbar. Es ba-
siert darauf, dass man Benutzer und Gruppen mit Rollen, die Be-
rechtigungen enthalten, in einem Sicherheitskontext zusammen-
fasst und diesen dann auf Ordner anwendet.

Es gibt zwei unterschiedliche Arten von Rollen. Dokumentrollen

können nur Dokument-spezifische Berechtigungen zugewiesen
werden, wie das Editieren oder Signieren von Dokumenten. Globale
Rollen beziehen sich auf die administrativen Tätigkeiten und auf die
gesamte Datenbank. Man kann sie daher nicht über einen Sicher-
heitskontext zuweisen, sondern man weist sie Benutzern oder
Gruppen direkt zu.

Ein Benutzer muss keiner Gruppe angehören, es bietet sich jedoch

an Gruppen einzurichten, wenn mehrere Benutzer dieselben Be-
rechtigungen erhalten sollen.

Sicherheitskontexte fassen zusammen welche Gruppe oder welcher

Benutzer welche Rollen und damit Berechtigungen erhält. Anschlie-
ßend wird ein Sicherheitskontext einem oder mehreren Ordnern
zugewiesen in welchen dann die Zuordnung der Berechtigungen gilt.

ÜBERSETZUNGEN
Für alle Elemente in der Benutzerkontenverwaltung können Über-
setzungen angegeben werden. PLA 3.0 versucht dann eine Überset-
zung in der Sprache des Betriebssystems zu finden. Wenn keine
Übersetzung gefunden wird fällt das System auf die initial angege-
bene Bezeichnung zurück.

48
 Berechtigungen verwalten

BENUTZERKONTENVERWALTUNG
Die Benutzerkontenverwaltung ist über das System-Menü erreich-
bar. Dort sind bereits beim Erstellen einer Datenbank einige Stan-
dard-Rollen und Gruppen, der Hauptsicherheitskontext und das
Administrator-Benutzerkonto vordefiniert. Diese können nach Be-
darf angepasst werden. Es können aber auch zusätzliche benutzer-
spezifische Elemente angelegt werden.

49
PLA 3.0 - Administratorhandbuch

GLOBALE ROLLEN VERWALTEN

Eine neue globale Rolle fügen Sie hinzu, indem Sie Globale Rollen
und Hinzufügen auswählen.

Sie können eine globale Rolle bearbeiten indem Sie sie auf Globale
Rollen gehen, die globale Rolle selektieren und Bearbeiten auswäh-
len, oder indem Sie die Rolle im Navigator unter Globale Rollen
selektieren.

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 Berechtigungen verwalten

Hier können Sie Berechtigungen anpassen und Übersetzungen ein-

fügen.

GLOBALE BERECHTIGUNGEN

IQ AUSFÜHREN
Diese Berechtigung ermöglicht es Ihnen die Installationsqualifizie-
rung (IQ) durchzuführen, welche der Verifizierung einer korrekten
PLA 3.0 Installation dient. Sie finden die Installationsqualifizierung
im Validierung-Menü.

OQ AUSFÜHREN
Mit dieser Berechtigung können Sie die Funktionsqualifizierung
(OQ) durchführen, welche dazu dient anhand eines von Stegmann
Systems zusammengestellten Paketes an Dokumenten zu prüfen, ob
korrekte Ergebnisse auf dieser PLA 3.0 Installation und Datenbank
erzielt werden. Für diese Funktion wird eine PLA 3.0 Validierungsli-
zenz benötigt.

PQ AUSFÜHREN
Durch diese Berechtigung können Sie die Leistungsqualifizierung
(PQ) durchführen und selbst PQ-Pakete erstellen und exportieren.

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PLA 3.0 - Administratorhandbuch

Sie können mit Hilfe der PQ anhand Ihrer eigenen Daten in Form
eines PQ-Paketes prüfen, ob auf dieser PLA 3.0 Installation und
Datenbank korrekte Ergebnisse erzielt werden. Für diese Funktion
wird eine PLA 3.0 Validierungslizenz benötigt.

E IGENES K ONTO VERWALTEN

Dies berechtigt den Benutzer seine persönlichen Daten wie E-Mail
oder Telefonnummer selbst zu ändern. Diese Daten können im
System-Menü unter Mein Benutzerkonto angepasst werden.

A UDIT T RAIL (E REIGNISPROTOKOLL ) ANZEIGEN

Diese Berechtigung ermöglicht dem Benutzer sich das Ereignispro-
tokoll der Datenbank anzusehen. Das gesamte Ereignisprotokoll
können Sie im System-Menü unter Ereignisprotokoll ansehen, zu-
sätzlich hat jedes Dokument ein Ereignisprotokoll, das nur Einträge
für dieses Dokument enthält und auch ohne diese Berechtigung zur
Verfügung steht.

K OMPONENTENPAKETE ANSEHEN
Sie können mit dieser Berechtigung in der Paketverwaltung im Sys-
tem-Menü einsehen welche Pakete auf der Datenbank in welcher
Version installiert sind.

K OMPONENTENPAKETE VERWALTEN
Mit dieser Berechtigung können sie Pakete in der Paketverwaltung
installieren und deinstallieren. Diese Berechtigung ist ein Zusatz für
die Berechtigung Komponenten ansehen, welche zusätzlich benötigt
wird.

K ONTEN V ERWALTEN
Diese Berechtigung bewirkt, dass der Benutzer vollständigen Zugang
zur Benutzerkontenverwaltung hat. Sie beinhaltet das Recht Benut-

52
 Berechtigungen verwalten

zerkonten, Gruppen, Globale Rollen, Dokumentrollen und Sicher-

heitskontexte zu erstellen und zu verändern.

Anmerkung: Das Zuweisen eines Sicherheitskontexts auf einen Ord-

ner ist nicht inbegriffen.

S ITZUNGEN VERWALTEN
Mit dieser Berechtigung ist es möglich die Sitzungsverwaltung aus
dem System-Menü aufzurufen. Dort können Sie alle momentan auf
die Datenbank verbundenen Sitzungen und deren Sperren auf Do-
kumente einsehen und bei Bedarf entfernen.

D ATENBANKRICHTLINIEN EDITIEREN
Diese Berechtigung erlaubt es, Einstellungen auf der Datenbank
vorzunehmen, die sich auf alle Mitbenutzer auswirken. Dazu gehö-
ren Nutzung einer Datenbank als Vorlage, Kennwortrichtlinien,
Einstellungen für elektronische Signaturen, Änderungsgründe und
die Benutzung von Komponenten im Entwurfszustand.

D ATENBANK SPERREN
Mit dieser Berechtigung kann ein Benutzer die Datenbank sperren,
sodass sich keine anderen Benutzer während dieser Sperre an der
Datenbank anmelden können. Eine Datenbanksperre sollte wäh-
rend großflächiger Umstrukturierung von Berechtigungen oder dem
Verändern der Komponentenpakete in der Datenbank durchgeführt
werden. Die Datenbanksperrung und Entsperrung ist über das Sys-
tem-Menü erreichbar. Die Datenbanksperre bleibt auch nach dem
Abmelden des Benutzers der sie ausgeführt hat aktiv. Dieser kann
sich jedoch anschließend wieder anmelden und die Datenbank ent-
sperren.

HTML-F RAGMENT VERWALTEN

53
PLA 3.0 - Administratorhandbuch

Mit dieser Berechtigung können Sie den Inhalt des Datenbank-

Dashboard um ihre eigenen HTML-Inhalte ergänzen. Diese Funktion
ist über Datenbankeigenschaften im System-Menü verfügbar. Zu-
sätzlich wird die Berechtigung Datenbankeigenschaften verwalten
benötigt.

DOKUMENTROLLEN VERWALTEN

Eine neue Dokumentrolle fügen Sie hinzu indem Sie Dokumentrol-

len und hinzufügen auswählen.

Zum Bearbeiten einer Dokumentrolle selektieren Sie diese unter

Dokumentrollen und wählen Bearbeiten aus, oder selektieren Sie
die Dokumentrolle im Navigator unter Dokumentrollen.

54
 Berechtigungen verwalten

Sie können nun Berechtigungen anpassen, diese auf Dokumentty-

pen einschränken und die Beschreibung internationalisieren.

55
PLA 3.0 - Administratorhandbuch

Die Berechtigungen einer Dokumentrolle können an einen be-

stimmten Dokumenttyp, Dokumentmodus und Signaturstatus ge-
bunden werden.

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 Berechtigungen verwalten

DOKUMENTBERECHTIGUNGEN

A NLEGEN NEUER K INDOBJEKTE

Diese Berechtigung erlaubt es dem Benutzer neue Dokumente und
Ordner zu erstellen, sie wird aber auch benötigt um Dokumente und
Ordner zu kopieren, verschieben, generieren und importieren und
für die Durchführung der Funktions- und Leistungsqualifizierung.

D OKUMENTE LESEN
Mit dieser Berechtigung können Sie Dokumente des ausgewählten
Dokumenttyps im Navigator sehen und sie im schreibgeschützten
Modus des Editors öffnen.

D OKUMENTE EDITIEREN
Diese Berechtigung erlaubt es Dokumente im Editor zu öffnen, zu
bearbeiten und Ordner zu verändern.

D OKUMENTE ENTFERNEN
Diese Berechtigung erlaubt es dem Benutzer Dokumente und Ord-
ner zu löschen. Sie wird auch beim Verschieben von Dokumenten
und Ordnern benötigt.

D OKUMENTE BEWEGEN
Diese Berechtigung ermöglicht es dem Benutzer Dokumente zu
exportieren, kopieren und verschieben. Für das Verschieben benö-
tigen Sie zusätzlich die Berechtigungen Dokumente entfernen und
Anlegen neuer Kindobjekte.

E IGENE E LEKTRONISCHE S IGNATUR ENTFERNEN

Mit dieser Berechtigung ist es dem Benutzer möglich seine eigenen
Signaturen zu entfernen. Für das Entfernen einer Signatur muss das
Dokument im Editor geöffnet werden, daher wird mindestens die
Berechtigung Dokumente lesen benötigt. Weiterhin ist es möglich

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PLA 3.0 - Administratorhandbuch

unabhängig von dieser Berechtigung das Entfernen von Signaturen

auf der gesamten Datenbank über die Datenbankrichtlinien zu ver-
bieten. Die Einstellung in den Datenbankrichtlinien hat immer Vor-
rang vor Berechtigungen.

E LEKTRONISCHE S IGNATUR ANBRINGEN

Diese Berechtigung erlaubt das grundsätzliche Anbringen von Signa-
turen an Dokumenten. Für das Signieren eines Dokuments muss
dieses im Editor geöffnet werden, daher wird mindestens die Be-
rechtigung Dokumente lesen benötigt.

E LEKTRONISCHE S IGNATUREN BESTÄTIGEN

Mit dieser Berechtigung ist es nur möglich Signaturen anzubringen,
wenn das Dokument bereits signiert wurde. Für das Signieren eines
Dokuments muss dieses im Editor geöffnet werden, daher wird
mindestens die Berechtigung Dokumente lesen benötigt.

E NTFERNEN ALLER ELEKTRONISCHEN S IGNATUREN

Durch diese Berechtigung ist es dem Benutzer möglich jegliche
Signaturen an einem Dokument zu entfernen. Für das Entfernen
einer Signatur muss das Dokument im Editor geöffnet werden, da-
her wird mindestens die Berechtigung Dokumente lesen benötigt.
Weiterhin ist es möglich unabhängig von dieser Berechtigung das
Entfernen von Signaturen auf der gesamten Datenbank über die
Datenbankrichtlinien zu verbieten. Die Einstellung in den Datenban-
krichtlinien hat immer Vorrang vor Berechtigungen.

S ICHERHEITSKONTEXT ÄNDERN
Mit dieser Berechtigung kann der Sicherheitskontext eines Ordners
in den Ordneroptionen verändert werden. Zusätzlich werden die
Berechtigungen Ändern der Ordnereigenschaften, Ansehen der
Ordnereigenschaften, Dokumente editieren und Dokumente lesen
benötigt.

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 Berechtigungen verwalten

A NSEHEN DER O RDNEREIGENSCHAFTEN

Mit dieser Berechtigungen können Sie die Einstellungen in den Ei-
genschaften eines Ordners ansehen, jedoch nicht editieren. Diese
beinhalten den Namen des Ordners, die verwendeten Schlüssel-
muster und die Vorgabe spezielle Vorlagen zu benutzen.

B EARBEITEN DES F ELDSCHUTZES

Mit dieser Berechtigung ist es dem Benutzer möglich ein aus einer
Vorlage erzeugtes Dokument in einem Modus zu öffnen, der es
erlaubt, die durch die Vorlage vorgegebenen oder versteckten Fel-
der zu editieren oder sichtbar zu machen. Dieser Modus ist über das
Kontextmenü im Navigator und den Unterpunkt Öffnen mit erwei-
terten Rechten zugänglich. Zusätzlich zu dieser Berechtigung wird
die Berechtigung Dokumente editieren benötigt.

GRUPPEN VERWALTEN

Eine neue Gruppe fügen Sie hinzu indem Sie Gruppen und Hinzufü-
gen auswählen.

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PLA 3.0 - Administratorhandbuch

Eine Gruppe bearbeiten Sie indem Sie Gruppen auswählen und

Bearbeiten drücken oder sie in der Navigation eine Gruppe unter
Gruppen selektieren.

Hier können Sie folgende Einstellungen vornehmen:

BESCHREIBUNG
Eine genauere Beschreibung der Funktion dieser Gruppe. Die Be-
schreibung kann durch Übersetzen internationalisiert werden.

GÜLTIG BIS
Hier kann ein Datum ausgewählt werden an dem die Gruppe auto-
matisch deaktiviert wird.

GRUPPE IST DEAKTIVIERT

Diese Einstellung wirkt sich auf alle Gruppenmitglieder aus. Benut-
zer einer deaktivierten Gruppe erhalten nicht die Dokumentrollen,
die sie durch diese Gruppe erhalten würden.

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 Berechtigungen verwalten

AVATAR ÄNDERN

Sie können entweder einen der bestehenden Avatare auswählen,

oder selbst neue Avatare importieren und verwenden.

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PLA 3.0 - Administratorhandbuch

SICHERHEITSKONTEXTE VERWALTEN

Einen neuen Sicherheitskontext fügen Sie hinzu, indem Sie auf Si-
cherheitskontexte gehen und Hinzufügen auswählen.

Sie können einen Sicherheitskontext bearbeiten, indem Sie auf

Sicherheitskontexte gehen und Bearbeiten auswählen oder im Na-
vigator einen Sicherheitskontext unter Sicherheitskontexte selektie-
ren.

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 Berechtigungen verwalten

Mit Hinzufügen können Sie Rollenzuweisungen hinzufügen. Für das

Hinzufügen einer Rollenzuweisung wählen Sie eine Gruppe oder
einen Benutzer aus, dem die Dokumentrolle zugewiesen werden
soll. Anschließend selektieren Sie die Rolle.

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PLA 3.0 - Administratorhandbuch

Auf Reiter Ordner können Sie einsehen welchen Ordnern dieser

Sicherheitskontext zugeordnet ist. Diese Liste ist nicht editierbar, da
Zuweisungen von Sicherheitskontexten direkt am Ordner in dessen
Eigenschaften erfolgen müssen.

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 Berechtigungen verwalten

BENUTZER VERWALTEN

Einen neuen Benutzer fügen Sie hinzu, indem Sie auf Benutzer ge-
hen und Hinzufügen auswählen. Der Benutzername muss eindeutig
sein, es gibt jedoch die Möglichkeit einen Anzeigenamen festzule-
gen.

Sie können Benutzer bearbeiten, indem Sie unter Benutzer gehen

und dann den gewünschten Benutzer selektieren und Bearbeiten
auswählen, oder den gewünschten Benutzer im Navigator unter
Benutzer selektieren.

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PLA 3.0 - Administratorhandbuch

Hier können Sie nun die persönlichen Daten des Benutzers ergänzen
und weitere Einstellungen vornehmen.

ANZEIGENAME
Dieser Name entspricht, sofern nicht anders eingegeben, dem Be-
nutzernamen. Anzeigenamen werden statt des Benutzernamens bei
den meisten Aktionen an der Oberfläche von PLA 3.0 angezeigt und
müssen nicht einzigartig sein. Im Ereignisprotokoll wird daher auf
den Benutzernamen zurückgegriffen um die Eindeutigkeit zu ge-
währleisten.

GÜLTIG BIS
Wenn dieses Datum erreicht ist wird der Benutzer deaktiviert.

BENUTZERKONTO IST DEAKTIVIERT

Mit einem deaktivierten Benutzerkonto kann man sich nicht an der
Datenbank anmelden und der Benutzername erscheint auch nicht
im Anmeldebildschirm.

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 Berechtigungen verwalten

SPERRE
Hier können Sie einsehen, ob der Benutzer zurzeit wegen der Einga-
be eines falschen Kennworts gesperrt ist und können ihn falls nötig
entsperren. Regeln für die Sperre können in den Datenbankrichtli-
nien festgelegt werden.

KENNWORT MUSS BEI DER NÄCHSTEN ANMELDUNG GEÄNDERT

WERDEN
Sie können einen Kennwortwechsel bei der nächsten Anmeldung
erzwingen. Diese Funktion ist vor allem nach dem Zurücksetzen des
Kennworts durch einen Administrator sinnvoll. Es ist nicht notwen-
dig bei Änderung der Kennwortrichtlinien diese Option zu wählen.
PLA 3.0 überprüft bei jedem Anmelden ob das Kennwort den Richt-
linien entspricht und fordert den Benutzer gegebenenfalls auf.

KENNWORT SETZEN
Sie können ein den Kennwortrichtlinien entsprechendes Kennwort
festlegen.

KENNWORT ZURÜCKSETZEN
Diese Funktion ist nur aktiv wenn eine E-Mail-Adresse angegeben
ist. PLA 3.0 erzeugt beim Aufruf der Funktion ein zufälliges Kenn-
wort, das den Richtlinien entspricht und öffnet Ihr standard-E-Mail-
Programm und erstellt eine E-Mail in der der Benutzer das neue
Kennwort mitgeteilt bekommt. Sie müssen die E-Mail selbst abschi-
cken.

AVATAR ÄNDERN
Hier können Sie bestehende Avatare zur Verwendung auswählen
oder selbst einen Avatar importieren, um ihn zu verwenden.

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PLA 3.0 - Administratorhandbuch

DATENBANKEN ÜBERWACHEN

KONZEPTE
SYSTEMEREIGNISPROTOKOLL
Jede Änderung an Dokumenten oder Datenbankeinstellungen so
wie auch jedes An- oder Abmelden wird vom Ereignisprotokoll auf-
gezeichnet. Das Ereignisprotokoll enthält daher eine vollständige
Liste aller Änderungen, die innerhalb einer Datenbank geschehen,
mit dem entsprechenden Zeitstempel und den veränderten Werten.
Weiterhin ist das Ereignisprotokoll nach Benutzern, Zeitspannen,
Aktionen und Objekten filterbar, um möglichst effizient die ge-
wünschten Einträge zu finden.

DOKUMENTEREIGNISPROTOKOLL
Das Dokumentereignisprotokoll ist ein Unterteil des Systemereig-
nisprotokolls und im Dokumenteditor aufrufbar. Es enthält alle
Einträge für das im Editor geöffnete Dokument. Es enthält dieselben
Funktionen wie das Systemereignisprotokoll.

SITZUNGSVERWALTUNG
Beim Anmelden auf der Datenbank erhält ein Benutzer eine Sitzung
mit einer eindeutigen ID, welche in die Datenbank geschrieben
wird. Anhand dieser Sitzungs-ID werden Dokumente für andere
Benutzer gesperrt, wenn ein Benutzer auf sie zugreift. Beim Abmel-
den eines Benutzers wird die Sitzung beendet und alle Dokumente,
die durch dessen Sitzungs-ID gesperrt wurden wieder entsperrt,
sodass andere Benutzer Zugriff erhalten können.

Sitzungen werden in regelmäßigen Abständen auf Ihre Aktivität

überprüft. Falls die Verbindung unterbrochen wurde wird die Sit-
zung automatisch beendet und entfernt.

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 Datenbanken überwachen

Um Einsicht zu erhalten wer momentan auf der Datenbank ange-

meldet ist, kann man in der Sitzungsverwaltung nachsehen welche
Sitzungen bestehen. Dies ist vor allem nützlich um nach dem Sper-
ren der Datenbank zu sehen welche Benutzer sich noch nicht abge-
meldet haben.

EREIGNISPROTOKOLLE
Das Ereignisprotokoll können sie über Ereignisprotokoll im System-
Menü ansehen. Das Dokumentereignisprotokoll ist im Editor des
jeweiligen Dokuments auf der Ereignisprotokoll-Seite verfügbar.
Beide Ereignisprotokolle funktionieren grundlegend gleich, jedoch
kommen einige Aktionen im Dokumentereignisprotokoll nicht vor.
Informationen zur Benutzung des Ereignisprotokolls finden Sie im
Benutzerhandbuch.

AKTIONEN
Hier finden sie eine vollständige Liste der möglichen Ereignisproto-
koll-Aktionen mit Beschreibung

USER_LOGIN
Ein Benutzer meldet sich an der Datenbank an.

USER_LOGOUT
Ein Benutzer meldet sich von der Datenbank ab.

USER_LOGINREJECTED
Ein Benutzer versuchte sich auf der Datenbank anzumelden. Dieser
Versuch ist jedoch gescheitert.

USER_PWCHANGE
Ein Benutzer hat sein Kennwort geändert.

USER_RESETPW

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PLA 3.0 - Administratorhandbuch

Das Kennwort eines Benutzers wurde zurückgesetzt.

DB_INITIALIZED
Die Datenbank wurde initial angelegt. Welche Vorlage dazu ver-
wendet wurde ist als Objekt eingetragen.

DB_ADMINACCESS_ON
Anfang des Administrator-Exklusivzugriffs

DB_ADMINACCESS_OFF
Ende des Administrator-Exklusivzugriffs

DB_ADD_SESSION
Eine Sitzung wurde auf der Datenbank für einen Benutzer angelegt.

DB_DELETE_SESSION
Die Sitzung eines Benutzers wurde von der Datenbank entfernt.

DB_KILL_SESSION
Die Sitzung eines Benutzers wurde über die Sitzungsverwaltung
entfernt.

DB_KILL_LOCK
Die Sperre eines Benutzers auf ein Dokument wurde über die Sit-
zungsverwaltung entfernt.

DB_KILL_ALL_LOCKS
Alle Sperren eines Benutzers auf Dokumente wurden über die Sit-
zungsverwaltung entfernt.

OPTION_MODIFIED
Die Datenbankrichtlinien wurden verändert.

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 Datenbanken überwachen

SYSTEM_ERROR
Ein Systemfehler ist aufgetreten.

IQ_EXECUTED
Eine Installationsqualifizierung wurde durchgeführt.

OQ_EXECUTED
Eine Funktionsqualifizierung wurde durchgeführt.

PQ_EXECUTED
Eine Leistungsqualifizierung wurde durchgeführt.

COMPONENT_INIITIAL
Eine Komponente wurde angelegt.

COMPONENT_SAVED
Eine Komponente wurde gespeichert.

COMPONENT_UPDATED
Eine Komponente wurde aktualisiert.

COMPONENT_IMPORTED
Eine Komponente wurde durch das Installieren eines Pakets impor-
tiert.

COMPONENT_DELETE
Eine Komponente wurde gelöscht.

GROUP_INITIAL
Eine Gruppe wurde angelegt.

GROUP_SAVED
Eine Gruppe wurde gespeichert.

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PLA 3.0 - Administratorhandbuch

GROUP_DELETE
Eine Gruppe wurde gelöscht.

SECURITYCONTEXT_INITIAL
Ein Sicherheitskontext wurde angelegt.

SECURITYCONTEXT_SAVED
Ein Sicherheitskontext wurde gespeichert.

SECURITYCONTEXT_DELETE
Ein Sicherheitskontext wurde gelöscht.

ROLE_INITIAL
Eine Rolle wurde angelegt

ROLE_SAVED
Eine Rolle wurde gespeichert.

ROLE_DELETE
Eine Rolle wurde gelöscht.

HTMLFRAGMENT_INITIAL
Das Datenbank-HTML-Fragment wurde erstellt.

HTMLFRAGMENT_SAVED
Das Datenbank-HTML-Fragment wurde gespeichert.

DATA_ACQUIRED
In das Dokument wurden Daten akquiriert.

DOC_KEY_CHANGED
Der Dokumentschlüssel des Dokuments wurde verändert.

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 Datenbanken überwachen

OBJECT_COPIED_FROM
Das Dokument ist eine Kopie eines anderen Dokuments.

OBJECT_COPIED_TO
Es wurde eine Kopie des Dokuments erstellt.

OBJECT_EXECUTE_TASK
Auf das Dokument wurde eine Aufgaben-Aktion durchgeführt.

OBJECT_EXPORTED
Das Dokument wurde exportiert.

OBJECT_INITIAL
Das Dokument wurde erstellt.

OBJECT_MOVED
Das Dokument wurde verschoben.

OBJECT_REMOVESIGNATURE
Vom Dokument wurde eine Signatur entfernt.

OBJECT_SAVED
Es wurden Änderungen am Dokument gespeichert.

OBJECT_SIGN
Es wurde eine Signatur am Dokument angebracht.

OBJECT_UPGRADE
Die Dokumenttypversion des Dokuments wurde aktualisiert.

OBJECT_DELETE
Das Dokument wurde gelöscht.

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PLA 3.0 - Administratorhandbuch

FOLDER_PROPERTIES_MODIFIED
Die Ordnereinstellungen wurden verändert.

OQ_EXPORTED
Das Dokument oder der Ordner wurde als Funktionsqualifizierungs-
paket exportiert.

PQ_EXPORTED
Das Dokument oder der Ordner wurde als Leistungsqualifizierungs-
paket exportiert.

EXPORTIEREN
Informationen zum Exportieren von Ereignisprotokolleinträgen
finden Sie im Benutzerhandbuch im Kapitel Ereignisprotokoll expor-
tieren.

SITZUNGEN VERWALTEN
Die Sitzungsverwaltung finden Sie im System-Menü unter Sitzungs-
verwaltung.

Hier werden Ihnen die Sitzungen der Benutzer angezeigt, die mo-
mentan mit der Datenbank verbunden sind. Ihre eigene Sitzung ist

74
 Datenbanken überwachen

dabei fett hervorgehoben. Im unteren Bereich können Sie Details zu

den Sperren ansehen, die ein Benutzer auf Dokumente hat.

AKTUALISIERUNGSRATE
Hier können Sie festlegen in welchen Abständen die Liste der Sit-
zungen und Sperren aktualisiert werden soll. Sie können die Ansicht
jederzeit manuell aktualisieren.

AKTUALISIEREN
Diese Funktion aktualisiert die Anzeige der Sitzungen und Sperren
auf den momentanen Stand in der Datenbank.

SITZUNG BEENDEN
Sie können hier die Sitzung eines Benutzers und all seine Sperren
auf Dokumente entfernen. Bitte benutzen Sie diese Funktion nur
um Sitzungen von unsachgemäß geschlossenen PLA 3.0-
Programmen zu entfernen.

ALLE ENTSPERREN
Sie können hiermit alle Sperren, die ein Benutzer auf Dokumente
hat entfernen. Bitte benutzen Sie diese Funktion nur um Sperren
von Dokumenten zu entfernen, die durch auftretende Fehler noch
gesperrt sind obwohl sie nicht in Benutzung sind.

OBJEKT ENTSPERREN
Sie können hiermit die ausgewählte Sperre, die ein Benutzer auf ein
Dokument hat entfernen. Bitte benutzen Sie diese Funktion nur um
Sperren von Dokumenten zu entfernen, die durch auftretende Feh-
ler noch gesperrt sind obwohl sie nicht in Benutzung sind.

75
 PLA 3.0
Installationshandbuch
PLA 3.0 - Installationshandbuch

COPYRIGHT
©2015 by Stegmann Systems GmbH, Rodgau, Germany.
All rights reserved.

KONTAKT
Stegmann Systems GmbH
Raiffeisenstr. 2 // C1, C2
63110 Rodgau
Germany

Telefon: +49 6106 770100

Fax: +49 6106 7701029

www.bioassay.de
[email protected]

2
 Inhalt

INHALT
Copyright ............................................................................................ 2
Kontakt ........................................................................................... 2
Inhalt .................................................................................................. 3
Willkommen ....................................................................................... 6
Installationshandbuch ........................................................................ 7
PLA 3.0 Installieren......................................................................... 7
Systemvoraussetzungen (Lokale Installation) ............................ 7
Systemvoraussetzungen (Terminal Server Installation) ............. 7
Systemvoraussetzungen (SQL Server) ........................................ 8
System vorbereiten .................................................................... 8
Installation ................................................................................. 8
Netzwerk-Schutzschlüssel-Server installieren................................ 9
HASP-Schlüssel ........................................................................... 9
Benötigte TCP/UDP Ports ....................................................... 9
Netzwerk-HASP-Schlüssel-Server ....................................... 9
Netzwerk-HASP-Schlüssel-Clients .................................... 10
Zugriff von Clients erlauben ................................................. 10
Zugriffeinschränkung (serverseitig).................................. 12
Zugriffseinschränkung (clientseitig) ................................. 12
Hardlock-Schlüssel ................................................................... 13
Zugriffseinschränkung (serverseitig) .................................... 16
Zugriffseinschränkung (clientseitig) ..................................... 16
Hardware-Schlüssel an virtuellen Maschinen .......................... 17

3
PLA 3.0 - Installationshandbuch

Deployment Szenarien ................................................................. 17

Konzepte .................................................................................. 17
Datenbanken ........................................................................ 17
Datenbank-Verbindungen .................................................... 17
Testperiode .......................................................................... 18
Lizenzen ................................................................................ 18
Einzelplatzlizenz (Seat License) ........................................ 18
Mehrbenutzerlizenz (Concurrent Use License) ................ 18
Lizenzschlüssel ..................................................................... 18
Systemweite Einstellungen .................................................. 19
Benutzerdefinierte Einstellungen ........................................ 19
Datenbankrichtlinien............................................................ 19
Genutzte Pfade..................................................................... 20
Szenarien .................................................................................. 22
Allgemein ............................................................................. 22
Standalone Umgebung (Seat License) .................................. 22
Mehrbenutzer Umgebung (Seat License) ............................ 23
Mehrbenutzer Umgebung (Concurrent Use License) .......... 23
Terminal-Server Umgebung ................................................. 24
Lizenzschlüssel verwalten ............................................................ 25
Lizenzinformationen ................................................................ 26
Softwareschutz Seriennummer ............................................ 26
Lizenzschlüssel ..................................................................... 27
Herunterladen .................................................................. 27

4
 Inhalt

Hinzufügen ....................................................................... 27
Rollout .............................................................................. 28
Systemweite Einstellungen anpassen .......................................... 28
Properties ................................................................................. 28
Datenbanken verwalten ............................................................... 32
Datenbanken anlegen .......................................................... 33
Vorbereitung (nur MS-SQL) .............................................. 33
Initialisierung ........................................................................ 33
MS-SQL ............................................................................. 34
SQLite ............................................................................... 40
Datenbankverbindungen verwalten .................................... 46
Datenbankverbindung importieren ................................. 47
Datenbankverbindung exportieren .................................. 50
Verteilen von Verbindungsprofilen .................................. 51

5
PLA 3.0 - Installationshandbuch

WILLKOMMEN
Willkommen zum PLA 3.0 Installationshandbuch. Dieses Handbuch
richtet sich vor allem an die Systemadministratoren.

Das PLA 3.0 Installationshandbuch beschreibt die Deployment Sze-

narien für PLA 3.0, die Installation von PLA 3.0 und des Lizenz-
Servers, so wie auch erweiterte Einstellungen für die Verwendung
von PLA 3.0. Es soll Systemadministratoren helfen eine PLA Installa-
tion an die Richtlinien des Unternehmens anzupassen.

6
 Installationshandbuch

INSTALLATIONSHANDBUCH

PLA 3.0 INSTALLIEREN

SYSTEMVORAUSSETZUNGEN (LOKALE INSTALLATION)
Item Minimum Recommended
Betriebssystem Windows 7, Windows 8, Windows 8.1
Prozessor Single-core, 2 GHz Quad-core, 2,4 GHz
oder mehr
Arbeitsspeicher 2 GB RAM 4 GB RAM
Festplatte 500 MB freier 1 GB freier Speicher
Speicher oder mehr
Bildschrim Bildschirm mit Bildschirm mit einer
einer Auflösung Auflösung von 1280
von 1024 x 768 x 1024
Minimale Farbtiefe 16 Bit
Software Installation Internetverbindung oder CD-Rom Lauf-
werk
Software Aktivierung USB 2.0 Anschluss oder Lizenzserver
Speicherplatz für lo- Ca 25 MB
kale Datenbank
Speicherplatz pro Ca 1 MB inklusive Ereignisprotokoll, ab-
Assay hängig von der Komplexität und Anzahl
der Änderungen

SYSTEMVORAUSSETZUNGEN (TERMINAL SERVER INSTALLATION)

Item Minimum Recommended
Betriebssystem Windows Server 2003, Windows Server
2008, Windows Server 2008R2, Windows
Server 2012, Windows Server 2012R2
Festplatte 500 MB freier 1 GB freier Speicher
Speicher oder mehr

7
PLA 3.0 - Installationshandbuch

SYSTEMVORAUSSETZUNGEN (SQL SERVER)

Item Minimum Recommended
Version Microsoft SQL Server 2005, Microsoft SQL
Server 2008
Prozessor *) Single-core, 2 GHz Quad-core, 2,4 GHz
oder mehr
Arbeitsspeicher *) 2 GB RAM 4 GB RAM
Festplatte 500 MB freier 1 GB freier Speicher
Speicher oder mehr
Speicherplatz pro Ca 25 MB
Datenbank
Speicherplatz pro Ca 1 MB inklusive Ereignisprotokoll, abhän-
Assay gig von der Komplexität und Anzahl der
Änderungen
*) Basierend auf Empfehlung von Microsoft.

SYSTEM VORBEREITEN
Stellen Sie sicher, dass genügend freier Speicherplatz auf dem Sys-
tem zur Verfügung steht.

Für das Anzeigen und Drucken von Zertifikaten und Berichten benö-
tigen Sie den Adobe Reader. Diese kostenfreie Software ist un-
ter http://www.adobe.com/de/products/reader.html verfügbar.

INSTALLATION
Starten Sie das Setup als Administrator und folgen Sie den Installa-
tionsanweisungen. Falls zuvor PLA 3.0 in einer älteren Version in-
stalliert wurde, wird dies vom Setup erkannt. Vor dem Installations-
vorgang wird dann zuerst die alte Version deinstalliert.

Wichtig: Nach Beendigung des Installationsprogrammes muss PLA

einmalig als Administrator ausgeführt werden um die Installation
abzuschließen.

8
 Installationshandbuch

Erweiterte Einstellungen werden nach der Installation vorgenom-

men und werden in den folgenden Kapiteln beschrieben.

NETZWERK-SCHUTZSCHLÜSSEL-SERVER INSTALLIEREN
PLA 3.0 unterstützt zusätzlich zu lokalen Schutzschlüsseln auch die
Verwendung von Schutzschlüsseln über das Netzwerk. Diese Netz-
werk-Schutzschlüssel erlauben die Aktivierung von Mehrbenutzerli-
zenzen und dienen der Authentifizierung einer bestimmten Anzahl
von laufenden PLA 3.0-Instanzen. Diese Instanzen zählen nur dann,
wenn sie eine zum Schutzschlüssel passende Aktivierungslizenz,
zusammen mit PLA Lizenzschlüsseln eingetragen und somit ein voll
funktionsfähiges PLA 3.0 haben.

HASP-SCHLÜSSEL
Um einen HASP-Schlüssel zu installieren, müssen Sie zuerst mit den
Treiber installieren, den Sie auf der PLA 3.0 Installations-CD finden
(HASPUserSetup.exe). Falls Sie auf dem PC bereits PLA 3.0 installiert
haben, wurde der Treiber bereits durch das PLA 3.0 Installations-
programm installiert.

B ENÖTIGTE TCP/UDP P ORTS

Um mit Hilfe des Sentinel License Manager Service den Zugriff auf
den HASP-Schlüssel zu erlauben, müssen bestimmte Ports auf dem
Server und auf den Clients geöffnet werden.

N ETZWERK -HASP-S CHLÜSSEL -S ERVER

Der Sentinel License Manager Service benötigt Port 1947 (einge-
hend), für UDP und TCP Pakete. Die IPv4 Ports werden immer benö-
tigt (Der Sentinel License Manager Service ist ohne IPv4 nicht lauf-
fähig). IPv6 Ports werden benötigt, falls IPv6 verfügbar ist.

Diese Ports müssen auch dann geöffnet sein, wenn Sie das Admin
Control Center lokal auf dem Server aufrufen möchten.

9
PLA 3.0 - Installationshandbuch

N ETZWERK -HASP-S CHLÜSSEL -C LIENTS

Der lokale Sentinel License Manager sendet auf Port 1947 UDP
Broadcast Pakete in das lokale Subnetz. Der IPv4 Port wird immer
benötigt (Der Sentinel License Manager Service ist ohne IPv4 nicht
lauffähig). Der IPv6 Port wird benötigt, falls IPv6 verfügbar ist.

Z UGRIFF VON C LIENTS ERLAUBEN

Schließen Sie den Netzwerk HASP-Hardware-Schlüssel an oder akti-
vieren Sie einen HASP-Software-Schlüssel und öffnen Sie im Brow-
ser das Web Admin Control Center unter 127.0.0.1:1947.

10
 Installationshandbuch

Wenn Sie Sentinel Keys anwählen, sehen Sie eine Liste aller HASP-
Schlüssel die zurzeit von dieser Maschine erreichbar sind. Diese
können lokal sein oder auch von anderen Rechnern aus im Netz-
werk bereitgestellt werden. Sie sollten nun den neuen HASP-
Schlüssel sehen können.

Um den HASP-Schlüssel im Netzwerk nutzen zu können, wählen Sie

Configuration aus und selektieren Sie den Reiter Access from Remo-
te Clients. Allow Access from Remote Clients muss aktiviert sein
damit sich PLA 3.0 Instanzen anderer Computer am HASP-Schlüssel
anmelden können.

Wenn Sie diese Einstellungen über Submit speichern, kann es einige

Minuten dauern bevor die Einstellungen umgesetzt werden. Danach
ist der HASP-Schlüssel im Netzwerk verfügbar und kann von PLA 3.0
Instanzen verwendet werden.

11
PLA 3.0 - Installationshandbuch

Z UGRIFFEINSCHRÄNKUNG ( SERVERSEITIG )
Über die Access Restriction Textbox können Sie zusätzlich Ein-
schränkungen vornehmen. Sie können den Zugriff von PLA 3.0 auf
die HASP-Schlüssel einschränken. Die Einträge werden Zeilenweise
vorgenommen und zuerst genannte Einträge werden bei der Aus-
wertung priorisiert. Einträge sehen wie folgt aus:

allow=<IP> oder allow=<Hostname> oder allow=all

deny=<IP> oder deny=<Hostname> oder deny=all

Am Ende der Liste wird automatisch falls nicht bereits vorhanden

ein allow=all angefügt.

Wenn Sie diese Einstellungen über Submit speichern, kann es einige

Minuten dauern bevor die Einstellungen umgesetzt werden.

Z UGRIFFSEINSCHRÄNKUNG (clientseitig)

12
 Installationshandbuch

Zugriffseinschränkungen erfolgen über die pla.properties Datei

(siehe Kapitel Systemweite Einstellungen anpassen und Kapitel
Genutzte Pfade). Durch angeben folgender Properties (siehe Kapitel
Properties in Systemübergreifende Einstellungen) kann Einfluss auf
die Auswahl der HASP-Schlüssel-Server genommen werden:

com.stegmannsystems.edp.license.HaspTargetHostnames

Es ist möglich einen oder mehrere Hostnamen der HASP-Schlüssel-

Server anzugeben indem man sie durch Semikolon trennt. Zuerst
aufgeführte Hostnamen werden priorisiert.

com.stegmannsystems.edp.license.HaspTargetIPs

Es ist möglich eine oder mehrere IP Adressen der HASP-Schlüssel-

Server anzugeben indem man sie durch Semikolon trennt. Zuerst
aufgeführte IP Adressen werden priorisiert.

Die gleichzeitige Verwendung beider Properties ist möglich. In der

Reihenfolge wird zuerst die Liste der Hostnamen verwendet an-
schließend die Liste der IP Adressen.

com.stegmannsystems.edp.license.Providers

Über diese Property können Sie einstellen, welche Art von Schutz-
schlüssel-Server angesprochen werden soll. Mit der Einstellung
HASP werden ausschließlich HASP-Schlüssel-Server verwendet.
Wenn Hardlock eingestellt ist werden nur Hardlock-Schlüssel-Server
genutzt.

HARDLOCK-SCHLÜSSEL
Für die Installation der Hardlock-Server-Software benötigen Sie
administrative Rechte. Starten Sie aksmon32_setup.exe und instal-
lieren Sie den Aladdin Monitor. Dies ist die Software zum Überwa-

13
PLA 3.0 - Installationshandbuch

chen der Sitzungen auf dem Netzwerk-Hardlock-Schlüssel und zum

Verwalten des Hardlock-Server-Dienstes.

Starten Sie den Aladdin Monitor mit Administrativen Rechten.

Wählen Sie Im Services-Menü Hardlock aus und anschließend Install

HL-Server Service. Die Installation ist erfolgreich abgeschlossen
wenn Sie folgende Meldung erhalten.

14
 Installationshandbuch

Starten Sie nun den Hardlock-Server-Dienst im Services-Menü unter

Hardlock mit Start HL-Server Service.

Der Hostname des Rechners sollte nun im Navigator im Ordner

Hardlock angezeigt werden. Falls dies nicht der Fall ist, laden Sie die
Liste erneut über Reload im File-Menü.

Schließen Sie nun den Netzwerk Hardlock-Schlüssel an den Rechner

an. Im Navigator sollte nun unter dem Hostnamen der Unterpunkt
9307 auftauchen. Falls die Änderungen noch nicht angezeigt wer-
den, führen Sie die Funktion Reload erneut aus.

Wenn Sie 9307 selektieren wird eine Liste angezeigt, die die Sitzun-
gen der aktuell verbundenen PLA 3.0 Instanzen enthält.

15
PLA 3.0 - Installationshandbuch

Bitte richten Sie zusätzlich in Ihrer Firewall folgende Regeln ein:

Eingehend: Port 3047 UDP freigeben

Ausgehend: Port 3047 UDP freigeben

Der Netzwerk-Hardlock-Schlüssel ist nun betriebsbereit.

Z UGRIFFSEINSCHRÄNKUNG ( SERVERSEITIG )
Serverseitige Zugriffseinschränkungen sind bei Netzwerk-Hardlock-
Schlüsseln nicht möglich.

Z UGRIFFSEINSCHRÄNKUNG ( CLIENTSEITIG )
Sie können den Zugriff auf Netzwerk-Hardlock-Schlüssel-Server
begrenzen, indem Sie die Umgebungsvariable HLS_IPADDR auf eine
oder mehre IP Adressen oder Hostnamen setzten. Die Werte wer-
den mit Komma getrennt. Der Computer wird nur noch an diesen
Adressen nach Netzwerk-Hardlock-Schlüssel-Servern suchen.

16
 Installationshandbuch

Anmerkung: Diese Einstellung wirkt sich auf alle Programme aus die
einen Hardlock-Schlüssel benutzen. Stellen Sie daher diese Umge-
bungsvariable so ein, dass die Adressen aller Netzwerk-Hardlock-
Schlüssel-Server angegeben sind, die von diesem Computer ver-
wendet werden sollen.

HARDWARE-SCHLÜSSEL AN VIRTUELLEN MASCHINEN

Bei virtuellen Maschinen empfehlen wir den Netzwerk-Hardware-
Schlüssel über ein Netzwerk-USB Gerät mit der virtuellen Maschine
zu verbinden. Je nach Virtualisierungsumgebung ist es aber auch
möglich einen physikalischen USB-Port des Hosts anzusprechen. Die
Installation der Schutzschlüssel-Serversoftware ist abhängig vom
Typ des Schlüssels, jedoch identisch mit der auf einer physikalischen
Maschine. Lesen Sie hierzu bitte das Unterkapitel HASP-Schlüssel
oder Hardlock-Schlüssel dieses Kapitels.

DEPLOYMENT SZENARIEN
KONZEPTE

D ATENBANKEN
PLA unterstützt sowohl Datenbanken mit Client-Server-Modell als
auch lokale oder über das Netzwerk zugänglichgemachte Datenban-
ken. Hiermit soll ermöglicht werden eine Workstation vollkommen
autark mit PLA 3.0 zu betreiben, wie auch mit mehreren Benutzern
an einer gemeinsamen Datenbank zu arbeiten.

D ATENBANK -V ERBINDUNGEN
Datenbankverbindungen werden beim Einrichten einer Datenbank
in PLA 3.0 automatisch angelegt. Sie enthalten die Verbindungsda-
ten wie Pfad, Adresse, Benutzername und das verschlüsselte Kenn-
wort um auf eine Datenbank zuzugreifen. Sie werden in einem Ord-
ner gespeichert und lassen sich exportieren und importieren.

17
PLA 3.0 - Installationshandbuch

Achtung: Datenbankverbindungen sind nicht die Datenbank selbst

sondern lediglich eine Verknüpfung auf eine Datenbank.

T ESTPERIODE
Wenn Sie PLA 3.0 testen möchten, können Sie dies gerne tun. Wenn
Sie PLA 3.0 installieren erhalten Sie automatisch eine 14 Tage Test-
Lizenz. Falls Sie zusätzliche Zeit benötigen treten Sie bitte mit uns in
Verbindung. Während einer Testperiode sind alle Funktionen einer
PLA 3.0 Lizenz verfügbar. Die Funktionen einer PLA 3.0 Validierungs-
lizenz sind nicht verfügbar.

L IZENZEN
Es gibt zwei unterschiedliche Lizenzierungsmodelle für PLA 3.0:

E INZELPLATZLIZENZ (S EAT L ICENSE )

Eine Seat License ist an einen bestimmten Rechner gebunden. Alle
Benutzer auf diesem System können PLA 3.0 verwenden. Es ist je-
doch nicht erlaubt mehrere Instanzen von PLA 3.0 gleichzeitig (z.B.
über Remote Desktop) zu betreiben. Jeder Rechner an dem PLA 3.0
ausgeführt werden soll benötigt einen angeschlossenen Hardware-
Schlüssel.

M EHRBENUTZERLIZENZ (C ONCURRENT U SE L ICENSE )

Ein Netzwerk-Hardware-Schlüssel wird an einem Lizenz-Server an-
geschlossen, welcher überwacht wie viele Lizenzen in Benutzung
sind und wie viele Lizenzen maximal auf dem Hardware-Schlüssel zu
Verfügung stehen.

Eine Concurrrent Use Licence erlaubt es an jedem Rechner inner-

halb des Netzwerks PLA 3.0 zu betreiben. Beim Starten von PLA 3.0
wird automatisch eine Lizenz vom Lizenz-Server bezogen, solange
freie Lizenzen zur Verfügung stehen.

L IZENZSCHLÜSSEL

18
 Installationshandbuch

Das Lizenzierungsverfahren von PLA 3.0 ist dual. Das heißt, es gibt
eine Hardwarelizenzierung durch einen Hardware-Schlüssel und
zusätzlich Lizenzschlüssel, die nur in Verbindung mit dem richtigen
Hardware-Schlüssel aktiviert werden können. Stegmann Systems
verwaltet einen Server von dem Sie Ihre Lizenzschlüssel herunterla-
den können, wenn Sie an dem Gerät eine Internetverbindung haben
und eine Verbindung zum Hardware-Schlüssel besteht. Sie können
ihre Lizenz aber auch ohne Internet aktivieren, indem Sie die Lizenz-
schlüssel manuell hinzufügen.

S YSTEMWEITE E INSTELLUNGEN
In PLA 3.0 werden einige Einstellungen für das ganze System getrof-
fen. Dazu zählen die verwendeten Lizenzdaten, die Einschränkungen
zur Benutzung von Netzwerk-Hardware-Schlüsseln, verwendbare
Datenbanken und Einstellung zur Suche nach Nachrichten und Up-
dates.

Wichtig: Um zu verhindern, dass Anwender systemweite Einstellun-

gen modifizieren können, muss der entsprechenden Benutzergrup-
pe der Schreibzugriff auf die Datei pla.properties entzogen werden.
Den Pfad zur pla.properties Datei finden Sie im Unterkapitel Ge-
nutzte Pfade.

B ENUTZERDEFINIERTE E INSTELLUNGEN
In den Benutzereinstellungen sind die Standardpfade für Aktionen,
Proxy-Einstellungen und weitere UI Einstellungen gespeichert. Jeder
Benutzer kann somit vielbenutzte Pfade als Standardpfad angeben
um schneller auf Ordner und Dokumente zugreifen zu können und
sich den Umgang mit PLA 3.0 zu erleichtern.

D ATENBANKRICHTLINIEN
In den Datenbankrichtlinien werden für die gesamte Datenbank
verbindlich Einstellungen zu den Kennwortrichtlinien, elektroni-

19
PLA 3.0 - Installationshandbuch

schen Signaturen und Änderungsgründen festgelegt. Datenbank-

richtlinien können von Datenbank zu Datenbank unterschiedlich
sein. So können Richtlinien auf der Produktionsdatenbank in vollem
Umfang vorhanden sein während auf einer Testdatenbank nur ein
gewisser Satz an Richtlinien aktiv ist um das Testen nicht unnötig zu
erschweren.

G ENUTZTE P FADE
Systemweite Einstel- Windows 7, 8.x, 2008, 2012:
lungen C:\ProgramData\Stegmann Systems\PLA
3.0\pla.properties

Windows XP:
C:\Dokumente und Einstellungen\All
Users\Anwendungsdaten\Stegmann
Systems\PLA 3.0\pla.properties
Datenbankverbin- Windows 7, 8.x, 2008, 2012:
dungen (allgemein) C:\ProgramData\Stegmann Systems\PLA
3.0\DBConnections

Windows XP:
C:\Dokumente und Einstellungen\All
Users\Anwendungsdaten\Stegmann
Systems\PLA 3.0\ DBConnections
Standard Komponen- Windows 7, 8.x, 2008, 2012:
tenpakete C:\Program Files (x86)\Stegmann Sys-
tems\PLA 3.0\packages

Windows XP:
C:\Programme\Stegmann Systems\PLA
3.0\packages

20
 Installationshandbuch

Erweiternde Kompo- Windows 7, 8.x, 2008, 2012:

nentenpakete C:\Program Files (x86)\Common
Files\Stegmann Systems\PLA
3.0\packages

Windows XP:
C:\Programme\Gemeinsame Datei-
en\Stegmann Systems\PLA 3.0\packages

Benutzerdefinierte Windows 7, 8.x, 2008, 2012:

Einstellungen C:\Users\<Benutzer>\AppData\Local\
Stegmann Systems\PLA
3.0\config\.metadata\.plugins\org.ecli
pse.core.runtime\.settings\com.stegm
annsystems.lims.core.prefs

Windows XP:
C:\Dokumente und Einstellun-
gen\<Benutzer>\Lokale Einstellun-
gen\Anwendungsdaten\Stegmann Sys-
tems\PLA
3.0\config\.metadata\.plugins\org.eclips
e.core.runtime\.settings\com.stegmann
systems.lims.core.prefs

Benuterspezifische Windows 7 Windows 7, 8.x, 2008, 2012:

Datenbankverbin- C:\Users\username\AppData\Local\Steg
dungen mann Systems\PLA 3.0\DBConnections

Windows XP:
C:\Dokumente und Einstellun-
gen\<Benutzer>\Lokale Einstellun-
gen\Anwendungsdaten\Stegmann Sys-
tems\PLA 3.0\DBConnections

21
PLA 3.0 - Installationshandbuch

SZENARIEN

A LLGEMEIN
Für den Terminal Server oder virtuelle Umgebungen ist die Benut-
zung eines Netzwerk-Hardware-Schlüssels über einen Lizenz-Server
verpflichtend. Ansonsten sind sowohl Einzelplatzlizenzen als auch
Mehrbenutzerlizenzen, die über einen Lizenz-Server verteilt wer-
den, verwendbar.

Das ausgewählte Datenbanksystem sollte sich daran orientieren,

wie viele Benutzer gleichzeitig mit PLA 3.0 arbeiten. Genauere In-
formationen finden Sie im Kapitel Datenbanken.

Es gibt viele verschiedene Szenarien für die Verwendung von PLA

3.0 im Folgenden sind die vier meist genutzten Szenarien skizziert
und beschrieben.

S TANDALONE U MGEBUNG (S EAT L ICENSE )

PLA ist auf einer Workstation installiert und wird mit einer dateiba-
sierten lokalen SQLite-Datenbank betrieben. Die Authentifizierung
erfolgt über einen lokal angeschlossenen Hardware-Schlüssel (Seat
License). Diese Lösung ist für sehr kleine Umgebungen oder für die
Dauer der Testperiode geeignet.

Wichtig: Der Kunde ist dafür verantwortlich regelmäßig die Daten-

bankdateien in einem Backup zu sichern.

22
 Installationshandbuch

M EHRBENUTZER U MGEBUNG (S EAT L ICENSE )

PLA 3.0 ist auf einer Workstation installiert und greift gemeinsam
mit anderen Benutzern auf eine MS-SQL Datenbank auf einem Da-
tenbank-Server zu. Die Authentifizierung erfolgt über einen lokal
angeschlossenen Hardware-Schlüssel (Seat License).

M EHRBENUTZER U MGEBUNG (C ONCURRENT U SE L ICENSE )

23
PLA 3.0 - Installationshandbuch

PLA 3.0 ist auf einer Workstation installiert und greift gemeinsam
mit anderen Benutzern auf eine MS-SQL Datenbank auf einem Da-
tenbank-Server zu. Die Authentifizierung erfolgt über einen Lizenz-
Server an den ein Netzwerk-Hardware-Schlüssel angeschlossen ist
(Concurrent Use License).

T ERMINAL -S ERVER U MGEBUNG

PLA 3.0 ist auf einer virtuellen Maschine auf einem Terminal-Server
installiert und greift gemeinsam mit anderen Benutzern auf eine
MS-SQL-Datenbank zu. Die Authentifizierung erfolgt über einen
Lizenz-Server an den ein Netzwerk-Hardware-Schlüssel angeschlos-
sen ist (Concurrent Use License). Über einen Terminal-Client wird
auf die virtuelle Maschine auf dem Terminal-Server zugegriffen.

24
 Installationshandbuch

Lizenzschlüssel verwalten
Lizenzschlüssel können über die Lizenzverwaltung hinzugefügt wer-
den. Zugang zur Lizenzverwaltung erhalten sie über den Anmelde-
bildschirm im Bereich Extras unter Lizenzverwaltung oder über
Lizenzverwaltung im Hilfe-Menü.

25
PLA 3.0 - Installationshandbuch

LIZENZINFORMATIONEN
Hier sehen Sie ihren aktuellen Lizenzstatus. Wenn Sie eine Lizenz
von PLA 3.0 erworben und einen Aktivierungsschlüssel aktiviert
haben wird ihnen angezeigt, dass Sie eine gültige Lizenz für das
Programm verwenden. Falls Sie sich in der Testperiode befinden
werden Ihre verbleibenden Testtage angezeigt.

S OFTWARESCHUTZ S ERIENNUMMER

26
 Installationshandbuch

Dies ist die Seriennummer des Hardware- oder Software-Schlüssels,

der in Kombination mit dem Aktivierungsschlüssel Ihre PLA 3.0-
Lizenzschlüssel verifiziert.

L IZENZSCHLÜSSEL

H ERUNTERLADEN
Stegmann Systems hält den Aktivierungs- und die Lizenzschlüssel zu
jedem Schutzschlüssel auf einem Server zum Abruf bereit. Über
Herunterladen können Sie alle Lizenzen, die Sie für diesen Schutz-
schlüssel erworben haben, herunterladen und somit auf sehr kom-
fortable Art Ihren Schutz- und Ihre Lizenzschlüssel aktivieren.

H INZUFÜGEN
Falls Sie an einem Gerät keinen Internetzugang haben können Sie
die Schlüssel auch manuell hinzufügen

Sie haben die Möglichkeit den Schlüssel manuell einzugeben, oder

ihn per STRG + V oder mit Hilfe des Aus Zwischenablage einfügen
Knopfes einzufügen.

Anmerkung: Sie müssen einen gültigen Aktivierungsschlüssel einge-

ben bevor PLA 3.0 oder das PLA 3.0 Validierungspaket als lizenziert

27
PLA 3.0 - Installationshandbuch

angesehen werden, da ein aktivierter Schutzschlüssel für die Prü-

fung der Gültigkeit der Lizenzschlüssel benötigt wird.

Falls Sie Probleme beim Anmelden haben, überprüfen Sie zunächst

Ihre Lizenzen. Falls ein Schutzschlüssel mit einer anderen Serien-
nummer verwendet wird, müssen Sie die zu diesem Schutzschlüssel
passenden Aktivierungs- und Lizenzschlüssel aktivieren.

R OLLOUT
Der Aktivierungs- und die Lizenzschlüssel werden in der
pla.properties Datei gespeichert. Im Kapitel Systemweite Einstellun-
gen anpassen und im Kapitel Genutzte Pfade finden Sie weitere
Informationen zur pla.properties Datei. Sie können Aktivierungs-
und Lizenzschlüssel durch Kopieren der pla.properties in den ent-
sprechenden Ordner verteilen. Sie werden für diesen Vorgang unter
Umständen administrative Rechte benötigen.

SYSTEMWEITE EINSTELLUNGEN ANPASSEN

Über die systemweiten Einstellungen können Sie gerätespezifische
Vorgaben vornehmen. Während dessen darf keine Instanz von PLA
3.0 geöffnet sein. Die Vorgaben werden in der pla.properties Datei
angegeben. Sie können diese Datei mit einem Textbearbeitungspro-
gramm Ihrer Wahl öffnen. Sie werden für diesen Vorgang unter
Umständen administrative Rechte benötigen.

PROPERTIES
Zur Verwendung dieser Properties tragen Sie bitte pro Zeile einen
Schlüssel und den dazugehörigen Wert durch ein Gleichheitszeichen
getrennt ein.

Schlüssel Wert Beschreibung

com.stegmannsystems. <Zahl der Internetzugang

28
 Installationshandbuch

Schlüssel Wert Beschreibung

edp.internet.Access Option> für die Suche

nach Nachricht
en und Up-
dates.

1 = Automati-
sche Suche

2 = Manuelle
Suche

3 = Keine Su-
che

com.stegmannsystems. true oder Sperren der

edp.system.DisableDat false Datenbankver-
abaseManagement waltung im
Anmelde-
Bildschirm

com.stegmannsystems. true oder Sperren der

edp.system.ExecuteIQ false Installations-
NotAllowed qualifizierung
im Anmelde-
bildschrim

com.stegmannsystems. <GUID der Einschränkung

edp.system.AvailableD Datenbank- der verfügbaren
atabase_0 verbindung. Datenbanken-
Sie finden bankprofile. Nur
com.stegmannsystems. diese in den angegebene
edp.system.AvailableD Verbin- Datenbankpro-
atabase_1

29
PLA 3.0 - Installationshandbuch

Schlüssel Wert Beschreibung

com.stegmannsystems. dungsprofi- file werden im

edp.system.AvailableD len {Link: Anmeldebild-
atabase_2 genutzte schirm ange-
Pfade}> zeigt.
com.stegmannsystems.
edp.system.AvailableD
atabase_3

com.stegmannsystems.
edp.system.AvailableD
atabase_4

com.stegmannsystems.
edp.system.AvailableD
atabase_5

com.stegmannsystems.
edp.system.AvailableD
atabase_6

com.stegmannsystems.
edp.system.AvailableD
atabase_7

com.stegmannsystems.
edp.system.AvailableD
atabase_8

com.stegmannsystems.
edp.system.AvailableD
atabase_9

30
 Installationshandbuch

Schlüssel Wert Beschreibung

com.stegmannsystems. <Zeit in Druckaufträge

edp.system.ReportPrint Sekunden> werden mit
Delay Verzögerung
durchgeführt.
Dies kann bei
Problemen mit
der Druckrei-
henfolge von
Berichten ver-
wenden wer-
den.

com.stegmannsystems. Liste der Li-

edp.license.Keys (Semikolon- zenzschlüssel
getrennte
Liste der
Lizenz-
schlüssel)

com.stegmannsystems. (Semikolon- Schränkt die

edp.license.Providers getrennte vom Lizenzsys-
Liste: gülti- tem berücksich-
ge Werte: tigten Lizenz-
„hasp“ und Server ein.
„hardlock“)

Wenn diese
Property
nicht vor-
handen ist:
hasp;hardlo

31
PLA 3.0 - Installationshandbuch

Schlüssel Wert Beschreibung

ck

com.stegmannsystems. (Semikolon- Schränkt die

edp.license.HaspTarge getrennte vom Lizenzsys-
tHostnames Liste der tem berücksich-
Hostnames) tigten Lizenz-
Server über
Funktionie-
Hostnames ein.
rendes Bei-
spiel:
"WJKA03"

Nicht funkti-
onierendes
Beispiel:
"WJKA03.rs
system.de"

com.stegmannsystems. (Semikolon- Schränkt die

edp.license.HaspTarge getrennte vom Lizenzsys-
tIPs Liste der IP- tem berücksich-
Adressen) tigten Lizenz-
Server über IPs
Beispiel: ein.
"192.168.1.
111"

DATENBANKEN VERWALTEN
Alle Informationen zum Konfigurieren von Datenbankrichtlinien
finden Sie im Administratorenhandbuch im Kapitel Datenbankein-
stellungen verwalten.

32
 Installationshandbuch

D ATENBANKEN ANLEGEN
PLA 3.0 unterstützt zurzeit zwei unterschiedliche Datenbanksyste-
me, die unterschiedliche Anwendungsgebiete abdecken. MS-SQL
sollte die angestrebte Lösung sein, wenn Mehrbenutzerfähigkeit im
Vordergrund steht. SQLite-Datenbanken sind dateibasierte Daten-
banken und für den lokalen Einsatz geeignet. Sie können jedoch
auch über Netzwerkzugriff von kleinen Gruppen bis fünf Benutzer
genutzt werden.

V ORBEREITUNG ( NUR MS-SQL)

Sie benötigen einen MS-SQL-Server 2005 oder höher um eine Da-
tenbank für PLA 3.0 einzurichten.

Sie benötigen eine leere Datenbank, um sie von PLA 3.0 initialisie-
ren zu lassen. Hierfür benötigen Sie einen MS-SQL-Benutzer oder
einen Domänenbenutzer mit db_owner-Rechten.

Nach der Initialisierung der Datenbank durch PLA 3.0 benötigen

Benutzer nur db_datareader- und db_datawriter-Rechte um die
Datenbank zu benutzen.

Initialisierung
Beim ersten Starten von PLA 3.0 nach der Installation öffnet sich der
Dialog zum Anlegen einer neuen Datenbankverbindung. Ansonsten
ist dieser Dialog auch aus dem Anmeldebildschirm heraus über
Extras in der Datenbankverwaltung, oder unter Hinzufügen erreich-
bar.

33
PLA 3.0 - Installationshandbuch

Wählen Sie den Standardmodus aus.

MS-SQL

34
 Installationshandbuch

Um eine MS-SQL-Datenbank zu initialisieren wählen sie Mit beste-

hender Datenbank verbinden aus.

35
PLA 3.0 - Installationshandbuch

Geben Sie den Benutzernamen und das Kennwort des MS-SQL-

Benutzerkontos mit der db_owner Berechtigung an. Wählen Sie
anschließend die Datenbank aus, die initialisiert werden soll.

36
 Installationshandbuch

Überprüfen Sie die Verbindungsdaten und stellen Sie die Verbin-

dung fertig. Sie erhalten folgende Meldung.

37
PLA 3.0 - Installationshandbuch

PLA 3.0 überprüft nun die angegebene Datenbank und öffnet, falls
diese noch nicht initialisiert ist, den Datenbankvorlagen-Dialog.

38
 Installationshandbuch

Wählen Sie eine Vorlage für die Datenbank aus. Default Database
(empty) enthält vordefinierte Rollen, jedoch keine Dokumente.
Default Database with Demo Data enthält sowohl vordefinierte
Rollen als auch Beispieldokumente.

Bestätigen Sie ihre Auswahl und warten Sie bis die Datenbank initia-
lisiert ist. Dies dauert für eine leere Datenbank in etwa eine Minute,
eine Datenbank mit Beispieldokumente in etwa fünf Minuten.

39
PLA 3.0 - Installationshandbuch

Anschließend öffnet sich der Dialog zum Anlegen eines administra-

tiven Benutzerkontos. Ändern Sie bei Bedarf den Benutzernamen
und geben Sie ein Kennwort an, um das Benutzerkonto zu schützen.

Wichtig: Verwahren Sie die Anmeldeinformationen gut, das Kenn-

wort des initialen Administrators kann nicht wiederhergestellt wer-
den.

Bestätigen Sie den Dialog und schließen Sie die Datenbankverwal-

tung falls dies nicht die erste Datenbankverbindung auf diesem
System ist. Die neue Datenbank ist nun verwendbar.

SQL ITE

40
 Installationshandbuch

Um eine SQLite Datenbank zu initialisieren, wählen Sie Neue Daten-

bank erstellen und SQLite aus.

41
PLA 3.0 - Installationshandbuch

Sie können nun die Beschreibung anpassen und falls benötigt den
Speicherort ändern.

42
 Installationshandbuch

Wählen Sie nun die Vorlage aus mit der die Datenbank initialisiert
werden soll. Default Database (empty) enthält nur vorgefertigte
Rollen, Default Database with Demo Data enthält zusätzlich noch
Beispieldokumente.

43
PLA 3.0 - Installationshandbuch

Ändern Sie bei Bedarf den Benutzernamen des administrativen

Benutzerkontos und geben Sie ein Kennwort an, um das Benutzer-
konto zu schützen.

Wichtig: Verwahren Sie die Anmeldeinformationen gut, das Kenn-

wort des initialen Administrators kann nicht wiederhergestellt wer-
den.

44
 Installationshandbuch

Überprüfen Sie die vorgenommenen Einstellungen und bestätigen

Sie anschließend den Dialog mit Fertigstellen. Der Initialisierungs-
vorgang wird gestartet. Dieser Vorgang kann einige Minuten dau-
ern, abhängig von der Anzahl an Dokumenten in der Datenbankvor-
lage und der Leistung des Computers oder Netzwerks. Folgende
Meldung erscheint wenn der Vorgang abgeschlossen ist.

45
PLA 3.0 - Installationshandbuch

Wenn die Meldung bestätigt ist schließen Sie die Datenbankverwal-

tung falls dies nicht die erste erstellte Datenbank auf diesem System
ist. Die Datenbank ist nun benutzbar.

D ATENBANKVERBINDUNGEN VERWALTEN
Um Datenbankverbindungen zu verwalten, öffnen Sie die Daten-
bankverwaltung über Extras im Anmeldebildschirm und wählen Sie
Datenbankverwaltung aus.

46
 Installationshandbuch

D ATENBANKVERBINDUNG IMPORTIEREN
Sie können zuvor mit PLA 3.0 exportierte Datenbankverbindungen
importieren. Wählen Sie hierzu Hinzufügen in der Datenbankver-
waltung aus und gehen Sie in den Standardmodus.

47
PLA 3.0 - Installationshandbuch

Wählen Sie eine .DBConnection-Datei aus, die zuvor mit PLA 3.0
exportiert wurde.

48
 Installationshandbuch

Überprüfen Sie die Einstellungen des zu importierenden Daten-

bankprofils.

Nach dem Fertigstellen des Importvorgangs wird folgende Nachricht

erscheinen.

49
PLA 3.0 - Installationshandbuch

Danach ist die Datenbankverbindung verwendbar.

D ATENBANKVERBINDUNG EXPORTIEREN
Sie können in PLA erstellte Datenbankverbindungen exportieren um
Sie anderen PLA Installationen zur Verfügung zu stellen. Wählen Sie
in der Datenbankverwaltung die Datenbankverbindung aus, die Sie
exportieren möchten und wählen Sie Exportieren.

50
 Installationshandbuch

Sie können nun den Datennamen und Pfad anpassen. Wenn der
Vorgang erfolgreich abgeschlossen ist erhalten Sie folgende Mel-
dung.

Das Verbindungsprofil wurde als .DBConnection-Datei gespeichert.

V ERTEILEN VON V ERBINDUNGSPROFILEN

Verbindungsprofile können durch Kopieren einer zuvor exportierten
.DBConnection-Datei, in den Ordner für benutzerspezifische oder
allgemeine Verbindungsprofile bereitgestellt werden. Die Pfade zu
den jeweiligen Ordnern finden Sie im Kapitel Genutzte Pfade.

51