VERSION 6.0.

1 AND HIGHER

SOFTWARE MANUAL
contents
4.3.1 Import from CSV........................................................22
4.3.2 Add Sample................................................................23
4.3.3 Modify/Create From....................................................24
4.3.4 Delete Sample.................................................. ..........25
4.3.5 Print Sample Database............................................... 25
1 Introduction.................................................................1 4.3.6 Close Sample Database..............................................25
1.1 About..........................................................................1 4.4 Instruments................................................................25
1.2 Technical Support........................................................1 4.4.1 How to Add an Instrument:......................................... 26
1.3 License......................................................... ..............1 4.4.2 Adding a nexgen-PTS™..............................................26
2 Getting Started.............................................................2 4.4.3 Adding a nexgen-MCS™............................................ 28
2.1 PC System Requirements.............................................2 4.4.4 Discover MCS™/PTS™ (100 series)................... .......30
2.2 System Settings...........................................................3 4.4.5 Discover nexgen Instruments Function........................31
2.3 EndoScan-V™ Services Set-Up....................................3 4.4.6 Adding/Modifying BioTek ELx808™............................ 32
2.3.1 Installing EndoScan-V™ Services 4.4.7 BioTek Self-Test Report..............................................33
on a local PC or Central Server Location:......................3
4.5 Global Settings........................................................... 33
2.4 Installation Of EndoScan-V™........................................5
4.5.1 General Tab................................................................33
2.4.1 Installation Method:......................................................5
4.5.2 Security Tab...............................................................35
2.5 Licensing EndoScan-V™..............................................6
4.5.3 Report Tab.................................................................36
3 Navigating the Software ..............................................7
4.5.4 BioTek Layout Settings Tab.........................................36
3.1 Assay Icons ................................................................7
4.5.5 Cartridge Settings Tab................................................39
3.2 Tools/Administration Icons............................................8
4.6 Digital Signature Configuration................................... 39
3.3 Layout.........................................................................8
4.7 Manage Locks............................................................41
3.4 Information Icons.........................................................8
5 Results.......................................................................42
3.5 Account Icon............................................................... 9
5.1 BioTek Results............................................................42
4 Settings ......................................................................9
5.2 Cartridge Results........................................................44
4.1 User Management........................................................9
5.3 Results Options....................................................... ..44
4.1.1 Default User.................................................................9
6 Reports & Applying Digital Signatures........................45
4.1.2 Default Privilege Groups...............................................9
6.1 BioTek Reports...........................................................45
4.1.3 Default Sample Group.................................................15
6.2 Cartridge Reports.................................................... ..47
4.1.4 Users.........................................................................15
7 Import..................................................................... ..51
4.1.5 Privilege Groups......................................................... 16
8 Export..................................................................... ..52
4.1.6 Sample Groups.......................................................... 17
9 Copy from/Create Template(BioTek Mode Only)............53
4.2 Accessory Database.................................................. 18
9.1 Create Template.........................................................53
4.2.1 Manage Accessory Type............................................ 18
9.2 Copy From.................................................................54
4.2.2 Import from CSV........................................................19
10 Setting Up and Running a BioTek Assay......................55
4.2.3 Add Accessory...........................................................20
10.1 Adding Samples and Standard
4.2.4 Modify/Create From....................................................20 to the Template Grid....................................................55
4.2.5 Delete Accessory....................................................... 21 10.2 View List.................................................................. ..56
4.2.6 Print Accessory Database.......................................... 21
10.3 Print Grid....................................................................56
4.2.7 Close Accessory Database.........................................21
10.4 Read Number and Read Time.......................... ...........57
4.3 Sample Database...................................................... 22

P IES V 6 S F T-0 2
10.5 Well/Grid.....................................................................57
10.6 Standards and Samples Lists.................................... ..57
10.7 Properties....................................................................58
10.8 Starting an Assay...................................................... ..62
11 Cartridge MENU (CARTRIDGE MODE ONLY)................63
12 Setting Up and Running a Cartridge Assay...................65
12.1 nexgen-MCS™ Cartridge Panel...................................65
12.2 nexgen-MCS™ Assay Setup.......................................65
12.3 nexgen-MCS™ Cartridge Panel Test Sequence............66
12.4 nexgen-MCS™ Assay Result Screen...........................68
12.5 nexgen-PTS™ Cartridge Panel.................................. ..69
12.6 nexgen-PTS™ Assay Setup Section............................69
12.7 nexgen-PTS™ Cartridge Panel Test Sequence........... ..69
12.8 nexgen-PTS™ Assay Result Section......................... ..69
12.9 nexgen-PTS™ Multiple Bays Display...........................71
12.10 PTS™ Assay Setup................................................. ..71
12.11 MCS100 Assay Set Up.......................................... ....72
12.12 Running PTS™ and MCS™ Cartridge Assays.............72
13 Audit Trail....................................................................74
13.1 Date Range Fields.......................................................74
13.2 Print Button.............................................................. ..74
13.3 Search Criteria Field....................................................75
13.4 Search Keyword Field.................................................75
13.5 Show PC Name/PC Address Checkbox....................... 75
13.6 Show Windows User Name Checkbox........................75
13.7 Display Time in UTC Checkbox...................................75
13.8 Audit Entry Table...................................................... ..76
13.9 Audit Trail Entries - Examples......................................76
14 Back Up and Restore Database....................................78
14.1 Connect to Database...................................................79
14.2 Backup Database........................................................79
14.3 Auto-Backup............................................................ ..80
14.4 Backup Now...............................................................81
14.5 Restore Database.......................................................81

P IES V 6 S F T- 02
1 Introduction 1.3 LICENSE
This section provides a brief introduction to the software, the license Warning: This computer program is protected by copyright law and
agreement, as well as information about obtaining technical support. international treaty. Unauthorized reproduction or distribution of this
software, or any portion of it, may result in severe civil or criminal
1.1 ABOUT penalties and will be prosecuted to the maximum extent under law.
EndoScan-V™ is an endotoxin detection and measuring software utilized to EndoScan-V™ is developed with the following third-party
generate and report quantitative LAL test data. Verified and validated to be software packages:
consistent with global regulatory agency requirements, the software
performs the requisite calculations and creates reports for product release • Bouncy Castle
or incoming testing. For added protection, it generates secure data files and • Entity Framework
audit trails on all actions involving files and raw test data. The program was
• Log4net
designed with flexible
configuration capabilities and performance options for gaining operational • Microsoft.Net
efficiencies. All aspects of the software form the pillars of data integrity • .Net Systems
compliance: fully searchable audit trail, flexible user control and manage- • NPGSQL
ment, and reliable data generation and backup. • SSH.NET
Instrumentation supported by EndoScan-V™ version 6.0 software are: Each of these licenses is listed within the software and can be
• BioTek ELx808IU Microplate Reader provided upon request.
• Endosafe®-MCS™ (Product Code MCS100) Warranty Disclaimer
• Endosafe®-PTS™ (Product Code PTS100) The SOFTWARE is supplied “AS IS”. Charles River
• Endosafe® nexgen-MCS™ (Product Code MCS150) disclaims (to the fullest extent permitted by applicable law) all other
• Endosafe® nexgen-PTS™ (Product Code PTS150) warranties and conditions, expressed or implied, including, without
limitation, warranties of merchantability, fitness for a particular purpose,
non-infringement of third-party intellectual property rights, title, and
those arising by statute or otherwise in law form a course of dealing
1.2 TECHNICAL SUPPORT or use of trade. The user must assume the entire risk of using the
EndoScan-V™ Software.
Charles River
Disclaimer of Damages
1023 Wappoo Rd
Suite 43B Charles River assumes no liability for damages, direct or
consequential, which may result from the use of EndoScan-V™
Charleston SC, 29407
Software even if Charles River has been advised of the possibility of
Phone: (843) 402-4900 such damages. Any liability of Charles River will be limited to refund of
the purchase price. Charles River will not be liable for special,
Email: [email protected]
occasional, non-pecuniary (moral), indirect or inconsequential damage
or loss of profit, business, revenue, goodwill, personnel costs or
anticipated (cost) savings. In purchasing the SOFTWARE, you
expressly release and discharge Charles River from any and all such
causes of action Acceptance of delivery of the SOFTWARE shall be
deemed agreement to these terms and conditions. No document
issued by you attempting to negate or otherwise modify the terms
hereof, including any purchase order or request for proposal, shall be
binding upon Charles River.

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2 Getting Started Recommended:

2.0 GHz 64-bit processor

2.1 PC SYSTEM REQUIREMENTS
PC which meets all minimum requirements for the Windows 7 Compatible with x64 instruction set
operating system or Windows 10 system. 8 GB RAM
Minimum:
60 GB free space for Server OS and 4GB for Installation
I-3 - 2.5 gigahertz (GHz) or more
Screen Resolution Requirements
powerful processor
Recommended resolution scaling is 100% for all supported
64-bit architecture
resolutions.
4 gigabyte (GB) RAM
Resolution scaling set to 125% is only supported for the
Recommended: resolution of 1920x1080
I-5 2.0 (GHz) or faster Supported Languages
64-bit architecture
The software supports English, French, German, Spanish,
8 GB RAM Italian, and Portuguese.
Hard Drive Minimum Requirements • The installed OS language must be one of the 6 languages we
support (English, French, German, Spanish, Italian and
Minimum hard drive space for EndoScan-V™ Portuguese).
Client installation 200 megabyte (MB)
• The Display language can be the language of choice but if a
Minimum hard drive space for EndoScan-V™ Services Sino-Tibetan language (Korean/Japanese/Chinese) is chosen,
installation – 50 MB Minimum hard drive space for Microbial the user must use English in the Window Format (Region and
Solutions Database installation – 200 MB Language-> Format) settings.
• The Windows Format (Region and Language -> Format) must
Windows Server System Requirements
be one of the 6 languages we support (English, French, German,
Spanish, Italian, and Portuguese).
We support Server 2012, Server 2016 and Server 2019
(Server) using the GUI mode only. • Other

Please note – Server Core is not supported. Users may have an older version of EndoScan-V™ software
installed on the PC that has version 6.0 installed. This is
Minimum: acceptable, however they cannot run at the same time.
1.4 GHz 64-bit processor Only one instance of EndoScan-V™ can be run on a PC at a
time. You cannot have 2 different windows users trying to
Compatible with x64 instruction set
run EndoScan-V™ at the same time.
2 GB RAM

32GB free of space for Server OS and 4GB for Installation

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2.2 SYSTEM SETTINGS • Launch the InstallShield wizard for EndoScan-V™ Services.

These settings are found in Control Panel, Power Option. After installing • The following screen will appear identifying the pre-required
on either of the stated Windows systems, make sure the power options software, with the status as pending, to the user.
are set as follows: • If any of the pre-requisites are already installed, EndoScan-V™
• Turn off monitor: Never will skip that installation and proceed to the other
pre-requisites that are not installed.
• Turn off hard disk: Never
• If the EndoScan-V™ Services installer finds all the
• System standby: Never pre-requisites already installed, you can then proceed to install
• Hibernate: Never the EndoScan-V™software.
Windows 7 and Windows 10:
2.3 ENDOSCAN-V™ SERVICES SETUP
Before beginning to install any of the required software, confirm
that you have logged into the operating system as a Windows
Administrator. EndoScan-V™ must be installed in a supported
language Operating System (English, German, French, Spanish, Italian,
and Portuguese).
The software pre-requisites included in the EndoScan-V™ Services
set up are:
• Net Redistributable Version Minimum of version 4.6.1 (If a higher
version than 4.6.1 is already available on the computer, this will
not appear in the list of required pre-requisites).
• Microbial Solutions Database (Custom PostgreSQL).
When the Install button is clicked, the first pre-requisite
• Microsoft Visual C++ 2017 Redistributable Package Minimum
Microsoft Visual C++ 2017 Redistributable Package will be installed
of version 14.14.26405 (If a version higher than 14.14.26405 is
already available on the computer, this will not appear in the list of and the installation status will be shown.
required pre-requisites).
2.3.1 Installing EndoScan-V™ Services on a local PC
or Central Server Location:
The following installation procedure will detail which Windows
operating system the screenshots shown are for. Some differences in
actual screens displayed on the PC during installation, compared to the
screenshots shown in this document, may be seen. This is normal and
should not be taken as a deviation.

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To complete the installation of EndoScan-V™ Services follow the The installation will begin, and its progress will be displayed. Once the
instructions listed below. installation finishes, the below screen will be shown and you can
click on “Finish”.
The EndoScan-V™ Services installation wizard will open. Select Next
on the first panel of the wizard to continue the installation.

On the next screen click “Yes”.

Once the computer restarts log in to Windows using an
On the next screen, read the License Agreement carefully and select administrator account.
“I accept the terms…” and click next
Open the Computer Management Console.

Click “Next” on following screen for user name

and organization.
Expand the “Local Users and Groups” and select “Groups”.
On the next screen click “Install”.
Find the group EndoScan-V™ Users and double click on that group.

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 2.4 INSTALLATION OF ENDOSCAN-V™
Ensure that all required Pre-Requisites have been installed before
installing EndoScan-V™.
Before installing EndoScan-V™, please close all other applications. You may
need to close any virus scanners that are running in the background.

2.4.1 Installation Method:

Double click on EndoScan-V™_Setup.exe and launch the
EndoScan-V™ installer.

Click the “Add” button and enter the Windows user name of a user who will
access Endoscan-V™. (This can be a group or an individual user).

Click “Next” on the first screen shown.

Select “I accept the terms…” and click Next.

Once the user name is typed in click “Check Names” and the user or
group name will be underlined.
Click “OK” and that user/group will be added to the EndoScan-V™
Users group.
Repeat the above steps for the local group named
“EndoscanAdmins”, adding the users who will require access to
perform database administrative tasks such as backup and restore.
Note: If installing EndoScan-V™ Services on a server, the
EndoScan-V™ application must be installed on the server as well.

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 Type the correct database address and click on Connect to Database.
And then OK. See section 14.1 for further information on connecting
to the database.
Click “Next” on following screen for user name and organization.
• If utilizing EndoScan-V™ client manager packages, follow all
On the next screen Click “Install”. instructions in section 6 ‘Installation of EndoScan-V™.
The installation will begin, and its progress will be displayed. Once the
installation finishes the below screen will be shown and you can click
2.5 LICENSING ENDOSCAN-V™
on “Finish”. Double click the EndoScan-V™ icon.

On the main login screen click on ‘Settings’ ‘Add Feature File’

When attempting to login to the software for the first time, the Add
Feature File dialog box will appear.

If the EndoScan-V™ services have been installed on a Server, the main

EndoScan-V™ install will need to be directed to the server location as
follows:
On the main login screen click on ‘Settings’ and then
‘Connect/Restore Database’; the following screen will appear:
The License Feature File will be generated from the Registration Key.
Use the Copy icon next to the Registration Key to copy the Registration
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Key, then paste the Registration Key directly into an email and send it to • Settings Menu:
your local Charles River Laboratories, Inc. Technical Support or
o Connect/Restore Database – see section 14
[email protected]. A license file will then be emailed back to
you; please save this locally on the PC that is going to be licensed. o Add Feature File – as described above
o Help:
If utilizing numerous installs please ensure you detail in the email which  About – Allows the user to review System
registration key is for the Main Install and/or Client/Manager Install. Info and Save EndoScan-V™ logs
 Licenses
 Open User Manual

Into the “User” box type an appropriate user name (if using the default
Software Administrator account, type “admin” (all lower case)). In the
“Password” box type the password for the entered user (if using the
default Software Administrator account, type “password” (again all
lower case)). Click “Login” (See section 4.1 for further information)
The Software Administrator can then proceed to create new users and
Privilege Groups so that the full functions of the software can be set up.

3 Navigating the Software

Below are the listed icons for the main menus both in Biotek Mode and
Cartridge Mode. These icons will not be visible when logged in with the
Click on the explore folder image to the right of the Feature File field and main admin account used for installation.
locate your feature file to import.
3.1 ASSAY ICONS
2.6 LOGGING INTO ENDOSCAN-V™
(BioTek Mode Only) This icon refers to New Assay.
When selected, it will provide options for Copy From
Double-click on the EndoScan-V™ icon.
or Create Template (See Section 9.0 for further
information on these functions).
This icon refers to Results. When selected, users will be
presented with the Results window (See Section 5.0 for
further information on Results).
The Charles River Laboratories, login screen will be displayed. This icon refers to the Reports and will take a user to
the Reports window to enable the printing of reports
(See Section 6.0 for further information on Reports).

This icon refers to Import. When selected,

users can import previous pltx. files
(See Section 7.0 for further information on Import).
This icon refers to Export. When selected, users can
export data as CSV, XML, or CRL (See Section 8.0 for
further information on Export).
(Cartridge Mode Only) This icon refers to Cartridge
menu. When selected, a user will be presented with a
drop down menu of options (See Section 11.0 for further
information on Cartridge Menu).

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3.2 TOOLS/ADMINISTRATION ICONS 3.4 INFORMATION ICONS
This icon refers to Settings. When selected, a user will be This icon refers to Help, if selected, a user will be
presented with a drop down menu of options presented with the Software Manual.
(See Section 4.0 for further information on Settings).
This icon refers to Audit Trail. When selected, a user will be
presented with the Audit Trail window This icon refers to About. See below for screen shot if
(See Section 13.0 for further information on Audit Trail).
selected, by a user.
This icon refers to Edit Password. When selected, a user is
presented with the Change EndoScan-V™ Password Screen
as follows.

To change password the user should enter their old

password, then enter a new password as per the instructions
on the screen.

3.3 LAYOUT
The About screen allows to you view the System
The layout section provides the user with options as to what will be information. This can help Charles River staff when
displayed on the screen in either mode. By checking the boxes those troubleshooting something for the user.
items will display; by unchecking they will be removed from the main
view. Standard Sets and Sample Info display in the left-hand panel and Save EndoScan-V™ Logs – If the user needs to contact
the Accessory DB and Sample DB appear in the bottom window. The Charles River for system issues, Charles River may
ask you to select this button so that you can send your
area they occupy can be adjusted by moving the window edge. system logs for analysis.

BioTek Mode:

Cartridge Mode:

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 3.5 ACCOUNT ICON 4.1 USER MANAGEMENT
This icon refers to Exit. When selected the software will close The User Management functionality allows end users to set up Users,
down. If an assay is running a warning window will appear if a Privilege Groups, and Sample Groups.
user attempts to Exit the Software.
A Privilege Group is a set of privileges assigned to a user group.
A Sample Group is a set of samples from the Sample Database
This icon refers to Lock Software. When selected, a user assigned to a group. Each User will be assigned to a Privilege Group
will lock their account, and this can occur either when the and a Sample Group. Each user can be a member of one privilege
software is dormant or when an assay is running. Locking group. Each user can be a member of multiple
the software prohibits another user from utilizing the software Sample Groups.
or instrument. The user who locked the software or another
user with the appropriate privilege can log back in again. The software will ship with the following Default Users, Default
Privilege Groups, and Default Sample Groups.

4 Settings
When a user with appropriate privileges selects the Global 4.1.1 Default User
Settings icon, a drop down menu appears with the following
options: The software will ship with one user
• Accessory Database
Login Name = “admin”
• Digital Signature Configuration
Full Name = “EndoScanV Installer”
• Global Settings
Password = “password”
• Instruments
• Sample Database The software does not allow any changes to the Full Name for the
default user “admin”. This user cannot be deleted from the software.
• User Management
• Manage Locks 4.1.2 Default Privilege Groups
This section of the software will walk through each of these The following are the default privilege groups:
functions in detail.
“Software Administrator”, “Administrator”, “Manager”, and “User”.

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• The user “admin” will be assigned to the Software Administrator Default
Privilege Group.
Privilege Privilege Name Description
• The Privilege Group “Software Administrator” cannot be edited. This Group
Group can add and modify Privilege Groups and Users. It can also General Assay Settings
enable and disable Users. Global Settings - General
Privileges in Global Settings
• The Privilege Groups “Administrator”, “Manager”, and “User” will Require Comments Allows the user to turn on comments for
have pre-defined privileges (listed in the table below) enabled that can
A for Global Settings Global Settings changes. This checkbox is
be modified. These groups cannot be deleted. Changes in Global Settings -> Security tab.
The table below also details all available privileges available in Allows the user to turn on comments for
Require Comments for
the software. A post assay changes. This checkbox is in
Post Assay Changes
Global Settings -> Security tab.
Default Allows the user to turn on comments for
Privilege Privilege Name Description Require Comment on cancellation of a digital signature. This
A
Group Signature Cancellation checkbox is in Global Settings -> Security
tab.
General Assay Settings
Global Settings - General
Privileges in Global Settings Allows the user to configure the Validation
M/A Validation Terminology Terminology. This field is in Global Settings
Allows the user to turn on auto export and -> General tab.
configure the auto export file path. Also
Allows the user to configure the Sample
Auto Export and allows the user to choose export as CSV or Sample Limit
A M/A Limit Validation Terminology. This field is in
Export File Path XML. This field is a checkbox on the Global Validation Terminology
Global Settings -> General tab.
Settings -> General Tab. Export File Path is
a field on the Global Settings -> General tab. Allows the user to perform an assay. This
U/M Run Assay
privilege includes “Open Template”.
Allows the user to configure Assay Name
M/A Assay Name Prefix Prefix. This field is in Global Settings -> Global Settings - Security Security Privileges in Global Settings
General tab.
Allows the user to configure the number of
Allows the user to configure Assay Name Password Timeout - days before the user’s password expires.
M/A Assay Name Suffix Suffix. This field is in Global Settings -> A
Days This field is in Global Settings -> Security
General tab. tab.
Allows the user to configure lower limit Allows the user to configure the number
M/A Spike Recovery Range for spike recovery. This field is in Global of previously used passwords; these are
Settings -> General tab. A Password History checked when creating a new password.
Include Headers in Allows the user to include the headers for This field is in Global Settings -> Security
M/A the CSV export. This Checkbox is in Global tab.
CSV Settings -> General tab. Allows the user to configure the number of
Login Timeout -
Allows the user to set Auto Print. This field A minutes before the user is locked out. This
U/M/A Auto Print Minutes
is in Global Settings -> General tab. field is in Global Settings -> Security tab.
Allows the user to select the use of expired Allows the user to configure the number
Allow Expired accessories from the accessories of password attempts before being locked
M/A A Password Attempts
Accessories database. This checkbox is in Global out of the software. This field is in Global
Settings -> General tab. Settings -> Security tab.

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Default Default
Privilege Privilege Name Description Privilege Privilege Name Description
Group Group
General Assay Settings General Assay Settings
Global Settings - General Global Settings - General
Privileges in Global Settings Privileges in Global Settings
Allows the user to change how many Allows the user to select ‘Show Accesso-
Password Warning - days before a password expires warning Show Accessories
A M/A ries in Report’. This checkbox is in Global
Days message appears. This field is in Global in Report
Settings -> Report Tab.
Settings -> Security tab.
Allow Login After Allows a user to login when another user Global Settings - BioTek Layout BioTek Layout Settings Privileges in Global
M/A Settings Settings
Software Lockout has locked the software.
Allows a user to reset passwords for all Allows the user to configure the number of
A Password Reset U/M Number of Replicates replicates (BioTek reader only). This field is
users.
in Global Settings -> BioTek tab.
Allows the user the ability to configure
A Server Backup Details server backup information. This field is in Allows the user to select colors for these
Configure STD/SPL/
Global Settings -> Security tab. M/A fields. (BioTek reader only). These fields are
SPK/CTRL Colors
in Global Settings -> BioTek tab.
A Manage Locks Allows the user to remove a record lock.
Allows the user to configure the Reaction
Report Privileges in A Reaction Time Format Time Format for BioTek assays. This field is
Global Settings - Reports
Global Settings in Global Settings -> BioTek tab.
Allows the user to configure logo for reports.
M/A Report Logo Allows the user to configure the direction
This field is in Global Settings -> Report tab.
replicates will set out on the template
Allows the user to configure the position M/A Replication Direction
(BioTek reader only). This field is in Global
M/A Logo Position of logos on reports. This field is in Global Settings -> BioTek tab.
Settings -> Report tab.
Allows the user to configure assay properties
U/M/A View Reports Allows the user to View Reports. (BioTek Reader only). This is the right mouse
U/M Assay Properties
click on the 96 well layout that allows a user
U/M/A Print Report Allows the user to Print Reports. to access Assay Properties.
Allows the user to configure the Laboratory Create/Modify Allows the user to create and modify
M/A Lab Name Name for reports. This field is in Global M
Templates template files (BioTek reader only).
Settings -> Report Tab.
Allows the user to delete template files
Allows the user to select ‘For Invalid Assay M Delete Templates
For Invalid Assay show (BioTek reader only).
M/A show N/A for Sample value’. This checkbox
N/A for Sample Value Allows the user to select Auto Stop (BioTek
is in Global Settings -> Report Tab.
U/M/A Auto Stop reader only). This checkbox is in Global
Allows the user to switch on and add text for
Settings-> BioTek tab
Add Disclaimer to All report disclaimer for summary reports. This
A Allows the user to select automatic creation
Summary Reports checkbox is in Global Settings -> Report Automatic Creation of
Tab. M/A of spikes (BioTek reader only). This checkbox
Spikes
is in Global Settings – BioTek tab.
Allows the user the ability to mask wells
M Change Masked Wells (BioTek reader only). This field is in Global
Settings-> BioTek tab
Allows the user the ability to modify the
M/A Modify Standard Sets
standard sets (BioTek reader only).

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Default Default
Privilege Privilege Name Description Privilege Privilege Name Description
Group Group
General Assay Settings General Assay Settings
Global Settings - General Global Settings - General
Privileges in Global Settings Privileges in Global Settings
Allows the user the ability to modify the Allows the user to configure the Default
Default Spike
sample information in the Assay (BioTek M/A Spike Concentration (BioTek reader only).
Concentration
reader only). Well/Group tab – Sample This field is in Global Settings -> BioTek tab.
Name, Sample Lot number, Sample ID Dil/ Allows the user to select the Enable validation
Modify Assay Sample Conc, Endo Limit, Associate Standards and M/A Enable Validation checkbox (Biotek reader only). This checkbox
U/M/A
Information Sample Comments. It DOES NOT include is in Global Settings -> BioTek tab.
Mask or Spike/Standard Concentration or
Automatic Creation of Spikes.Note none of Allows the user to Disable/Enable Average
these fields are editable when the Standard M/A Average Replicates Replicates (BioTek reader only). This
is selected in the Well Details window. checkbox is in Global Settings -> BioTek tab.

Allows the user to make post assay chang- Allows the user to select the Configure
M/A Post Assay Changes es to settings that can alter the reported Inline spiking checkbox (BioTek reader
M/A Inline Spiking
results. (BioTek Reader only). only). This checkbox is in Global Settings
-> BioTek tab.
Global Settings - BioTek BioTek Calculation Privileges in
Calculations Global Settings Allows the user to select the Show CV prefix
M/A Show CV Prefix (BioTek reader only). This checkbox is in
Allows the user to configure the regression Global Settings -> BioTek tab.
M/A Regression settings (BioTek reader only). This field is in
Global Settings -> BioTek tab. Spike Recovery for Allows the user to select the Spike Recovery
Unreacted Samples - for Unreacted Samples – Use Zero. (BioTek
Allows the user to configure the default M/A
reader only). This checkbox is in Global
M/A Default Collection Type collection type (BioTek reader only). This Use Zero Settings -> BioTek tab.
field is in Global Settings - BioTek tab.
Allows the user to configure the order Global Settings - Cartridge Cartridge Setting Privileges
when using Polynomial Regression (BioTek
M/A Polynomial Order Allows the user to Configure CV limit for
reader only). This field is in Global Settings
-> BioTek tab. M/A CV Limit - Cartridges Cartridges (Cartridge Reader only). This field
is in Global Settings -> Cartridge tab.
Allows the user to configure the number of
# of Points to Use for
A points to use for MaxV used in the PQ. This Allows the user to select Sample Value by
MaxV
field is in Global Settings -> BioTek tab. Display Sample Value Channel (Cartridge Reader Only). This
M/A
Allows the user to configure the Onset OD by Channel checkbox is in Global Settings ->
M/A Onset OD (BioTek reader only). This field is in Global Cartridge tab.
Settings -> BioTek tab.
Cartridge Menu Settings Privileges
Allows the user to configure the num- Cartridge Menu Settings
# of Decimals to and Cog Privileges
Display for ber of decimals reported for Endotoxin Allows the user the ability to download logs
M/A
Value. This field is in Global Settings M/A Download Logs from a cartridge instruments or Save Test
Endotoxin Value.
-> BioTek tab. Reports (Cog) or Save Audit Log (Cog).
Allows the user to configure the Sample CV Allows the user the ability to download
M/A CV Limit - Samples settings (BioTek reader only). This field is in M/A Download Results results from the nexgen cartridge
Global Settings -> BioTek tab. instrument (Cartridge reader only).
Allows the user to configure the Standards
M/A CV Limit - Standards CV settings (BioTek reader only). This field
is in Global Settings -> BioTek tab.
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Default Default
Privilege Privilege Name Description Privilege Privilege Name Description
Group Group
General Assay Settings General Assay Settings
Global Settings - General Global Settings - General
Privileges in Global Settings Privileges in Global Settings
nexgen Instrument Allows the user the ability to update the Sample Database Sample Database Privileges
M/A
Software Update nexgen instrument software.
Allows the user the ability to reconnect a Add/Create From/ Allows the user to add and modify a
U/M/A Reconnect M/A
cartridge instrument (Cartridge reader only). Modify Sample sample in the Sample Database.

Allows the user the ability to shut down or Allows a user to delete samples from
U/M/A Shutdown M/A Delete Sample
Restart the connected cartridge instrument. the Sample Database.

Allows the user to add a sample by Allows a user to print the

M/A Print Sample Database
Modify Cartridge dragging/dropping from Sample Database Sample Database list.
U/M/A
Assay Sample or another panel. They cannot type directly User Management User Management Privileges
into the panel.
M/A/SW Add/Modify Users Allows the user to add and modify users.
Digital Signature Digital Signature Privileges
Allows the user to delete other users if there
M/A Delete Users
Allows the user to configure the meaning is no associated activity for that user.
Digital Signature of a signature or change the name of a
A M/A Archive Users Allows the user to archive other users.
Configuration
signature role. Add/Create From/ Allows the user to create and modify
M/A/SW
Allows the user privilege to cancel a Digital Modify Privilege Group Privilege Groups.
Cancel Digital
M/A Signature. See Cancelation Hierarchy in Sec- M/A Delete Privilege Group Allows the user to delete a Privilege Group.
Signatures
tion 4.6 on Digital Signatures in the manual.
Add/Create From/ Allows the user to add/modify Sample
Associate Digital M/A
Allows the user to associate a digital Modify Sample Group Groups.
SW/A Signature Roles with
signature role with EndoScan-V™ users. M/A Delete Sample Group Allows a user to delete a Sample Group.
EndoScan-V™ Users
SW/M/A Enable/Disable Users Allows a user to enable a disabled user.
Audit Trail Audit Trail Privileges
SW/M/A View Disabled Users Allows a user to view a list of disabled users.
U/M/A View Audit Trail Allows the user to view the audit trail. M/A View Archived Users Allows a user to view a list of archived users.
U/M/A Print Audit Trail Allows the user to print the audit trail. Reinstate User from Allows a user to reinstate a user from the
M/A
Allows the user to select the Display the Archived User List Archived User List.
M/A Display Time in UTC time in UTC time zone checkbox in the
Audit Trail window. Import/Export Import/Export Privileges

Accessory Database Accessory Database Privileges M/A Import Allows a user to import .pltx files.
M/A Export Allows a user to export data.
Manage Accessory Allows the user to create new
M/A
Types Accessory Types. Instrument Instrument Privileges
Add/Create From/ Allows the user the ability to Add and Modify
M/A M/A Add/Modify Instrument Allows a user add and modify instruments.
Modify Accessory Accessories in the Accessory Database.
M/A Delete Instrument Allows a user to delete an instrument.
Allows the user to Delete Accessories from
M/A Delete Accessory
the Accessory Database. Assay Properties Assay Properties privileges (BioTek only)
Print Accessory Allows the user to print Accessory
M/A
Database Database List.

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Default Default
Privilege Privilege Name Description Privilege Privilege Name Description
Group Group
General Assay Settings General Assay Settings
Global Settings - General Global Settings - General
Privileges in Global Settings Privileges in Global Settings
Allows a user to add/delete accessories on a Allows the user to change the Lab Name
U/M Accessories specific assay. Field is available in the Assay setting for a specific assay. This field
U/M Lab Name
tab of Assay Properties. is available in the Assay tab of Assay
Allows a user to select the Auto Stop Properties.
U/M Auto Stop checkbox on a specific assay. Field is Allows the user to change the Mask checkbox
available in the Assay Tab of Assay Properties. U/M Mask for a specific assay. This field is available in
Allows the user to select the Automatic the Well/Group tab of Assay properties.
Automatic Creation Creation of Spikes checkbox on a specific Allows the user to change the Onset OD for
U/M
of Spikes assay. Field is available in the Well/Group tab U/M Onset OD a specific assay. This field is available in
of Assay Properties. the Calculations tab of Assay Properties.
Allows the user to select the Average Allows the user to change the Plate
Replicates checkbox on a specific assay. Temperature Setting on a specific assay.
U/M Average Replicates U/M Plate Temperature
This field is available in the Calculations tab This field is available in the Collection tab
of Assay Properties. of Assay Properties.
Allows the user to change the Collection Allows the user to change the Polynomial
U/M Collection Type Type for the specific assay. Field is available Order on a specific assay. This field is
U/M Polynomial Order
in the Collection tab of Assay Properties. available in the Calculations tab of Assay
Allows the user to change the CV Limit - Properties.
U/M CV Limit - Samples Samples on a specific assay. Field is available Allows the user to select the Regression type
in the Calculations tab of Assay Properties. U/M Regression for a specific assay. This field is available in
the Calculations tab of Assay Properties.
Allows a user to change the CV Limit -
Standards on a specific assay. This field is Allows the user to select the Show CV Prefix
U/M CV Limit – Standards available in the Calculations tab of Assay U/M Show CV Prefix for a specific assay. This field is available in
the Calculations tab of Assay Properties.
Properties.
Allows the user to change the Spike Recovery
Allows the user to change the Enable range for a specific assay. This field is
Validation checkbox for a specific assay. U/M Spike Recovery Range
U/M Enable Validation available in the Calculations tab of Assay
This field is available in the Calculations tab Properties.
of Assay Properties.
Allows the user to change the Spike
Allows the user to change the Endotoxin Spike/Standard Standard Concentration for a specific assay.
U/M
Units setting for a specific assay. This field Concentration This field is available in the Well/Group tab of
U/M Endotoxin Units
is available in the Assay tab of Assay properties.
Assay Properties.
Allows the user to change the Filter Wave-
length setting for a specific assay. This field
U/M Filter Wavelength
is available in the Collection tab of Assay
Properties. 4.1.3 Default Sample Group
Sample Groups allow the end user to add samples set up in the sample
database into specific groups. Users can then be assigned to sample groups,

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therefore allowing them to only view specific samples.
To Add a User, click on ‘Add’ and the following window will appear:
• The Sample Group “All Samples” will be available with the full sample
database as default. The software will add any newly created entries
into this group automatically.
• The Sample Group “All Samples” cannot be deleted.

• The Sample Group “All Samples” will be associated with all users by default.

Field Name Max. of Characters Min. of Characters

Login Name 12 3
Full Name 40 1
4.1.4 Users
Nexgen User Name 12 1
• The Users tab displays Add, Modify, Archive, Delete, and Close buttons.
Password 20 8
• Only authorized users will be able to Add, Modify, Archive,
• Each Login Name and Full Name must be unique.
and Delete Users.
• Nexgen User Name - is automatically generated from the first 12
• Users can only be deleted if they have been created in error and have
characters of the Full Name. Blanks are converted to _ (underscores).
no associated activity (they have never logged into the software).
For example, user = John Quincy Adams will be recorded as nexgen User
The delete button will not be available for any users thathave activity
Name = John_Quincy.
• The Login Name and the Full Name can only contain the following
characters:
1. a-z
2. A-Z
3. 0-9
4. _ (underscore)
5. blanks (spaces)

• The software allows for a default password of “password” this is optional

when a new user is created. To utilize this, select the checkbox next to
“Use default password”.

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• An authorized user can create a password and will be required to type it • Privilege Groups can only be deleted if no users are associated with
twice to confirm the entry. the group.
• Either the default password (password) or a specificpassword must be
provided when a new user is created/edited.
• A user can edit their own Privilege Group if they have the authorized
access, but the changes will not be active until they log out and then log
back in again.
• A checkbox to request a change of password at first login is available for
any new users created. This will force the user to change their password
at first login.
• The software will not allow a user to create another user with the name
“admin”.
• A user will be notified that their account will be disabled prior to the 3rd
(default) or the configured number of failed attempts.
• The button ‘Add’ or ‘Modify’ displays a window to add a Privilege Group
• The Sample Group association is not mandatory. The default is that a user and allows the user to choose the listed privileges. The listed privileges
will be added to the ‘All Samples’ group. Users can be a part of multiple are pre-stored in the database, they cannot be added to, modified or
Sample Groups. deleted. All privileges are listed in the table in section 4.1.2.
• The Status checkbox lets you know about the status of the User, whether
the user is Enabled or Disabled.
o Password expired -> set by the software when the pass-
word expires – passwords will expire at midnight on the day
of expiration.
o Enabled -> set by the software when the user is disabled
after 3 tries (default) or configured number of attempts –
can be reset by a user with the
appropriate privilege (checkbox, checked when enabled,
unchecked when disabled).
• Users can only be a part of one Privilege Group. However, a
user’s Privilege Group can be changed by a user with the
appropriate permission.
• Digital Signatures: A user can be associated with a Digital Signature level • A new Privilege group can be created and a description for the group
as Analyst, Reviewer or Quality Control. They can be assigned to more can
than one Digital Signature be added.

4.1.5 Privilege Groups Field Name Max. of Min. of

characters characters
• The Privilege Group tab displays Add, Modify, Copy, Delete, Privilege Group Name 25 1
and Close buttons.
Description 200 0
• Only authorized Users will be able to Add/Modify/Archive and Delete
Privilege Groups. • Those authorized can enable or disable privileges within a Privilege

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 Group.
• Once a Privilege Group is created, users can be added to the group in one of
two ways. From within the Add/Modify Privilege Group’ screen, highlight the
user from the list and click on ‘Modify Users’; this will take you to the Modify
User Screen where the user’s Privilege Group can be edited. Navigating
directly to the ‘Modify User Screen’ will also allow a User Privilege Group
to be edited.
• The list of privileges for a Privilege Group can be printed; click on the print
button on the screen as shown. The list can be printed or saved as a PDF.
• The button ‘Add’ and ‘Modify’ displays a window to Add/Modify a sample
group.

• Selecting ‘List View’ allows the user to change how the

privileges are viewed. This toggles between a category list and a comprehen- • A group name can be created and a description for the group can be added.
sive list with all privileges listed.
Field Name Max. of characters Min. of characters
• Selecting ‘Set Defaults’ will revert the privileges of the four built-in Privilege
Groups to the original install settings. Sample Group Name 25 1
• When modifying or adding a Privilege Group, select ‘Update’ to save changes. Description 200 0
Selecting ‘Update’ will close the Privilege Group screen. • The software will not allow duplicate Sample Group names.
• Selecting ‘Cancel’ will not save any changes made to the • Those authorized can modify samples within a Sample Group.
Privilege Group.
• Once a Sample Group is created, users can be added to the group in
4.1.6 Sample Groups one of two ways. From within the Add/Modify Sample Group screen,
highlight the user from the list and click on ‘Modify Users’; this will
• The Sample Group tab displays Add, Modify, Copy, Delete, and Close buttons. take you to the Modify User Screen where the user’s Sample Groups
can be edited. Navigating directly to the Modify User Screen will also
• Only authorized Users will be able to Add/Modify/Copy and Delete allow a User’s Sample Groups to be edited.
a Sample Group.
• Sample Groups can only be deleted if no samples are associated with the 4.2 ACCESSORY DATABASE
group. The Accessory Database can be used to add all accessories routinely
• Selecting ‘Copy’ would make a copy of the selected Sample Group. used in the laboratory into EndoScan-V™, allowing for easy addition to
assays and record of all accessories used. Example accessories include
but are not limited to LAL Reagent Water, pipettors, pipette tips, etc.
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The Accessory Database window is divided into 2 sections. The top section is the in the database can then choose from this list. At installation there will
Editor and the bottom section is used to view the already be a list of accessories available as follows:
Accessory Database. You can add and modify Accessories in the Editor.
Both sections have the titles (Accessory Editor and Accessory Database).

Option buttons in the Accessory Database are as follows:

Button Functionality
Manage Accessory Allows you to add an Accessory Type for future use.
Types
Import from CSV Allows you to import Accessories from a .CSV file.
Add Add a new record to the Accessory Editor.
Modify Allows you to modify a record in the Accessory Editor.
Create From Copies a current Accessory(s) from the Database so
that you can use it to create a new Accessory.
Delete Deletes the Accessory(s) that is highlighted in the
Accessory Editor or in the Accessory Database.
Save Saves the current records in the Accessory Editor into
the Accessory Database.
Print Print a report of all the Accessories in the Accessory
database.
Close Closes the Accessory Database window. These accessories are those most frequently used in Bacterial Endotoxin
Testing. The Added By user and Added Date will reflect the installation date.
These accessories can be deleted if not used by the customer and new
ones can be added. The only exception is that Cartridges cannot be
deleted or recreated.
• To Add: Type a new accessory type name in the field and
click Add.
• To Delete: Highlight the required Accessory using the rows
(a small arrow on the left indicates which row is selected)
and press delete. A warning box will appear as follows:

4.2.1 Manage Accessory Type

To ensure consistency of naming conventions, the Manage Accessory Type • Click OK to confirm the deletion.
feature allows those users with the appropriate privileges to name all
accessories used in the facility. Other users just creating accessory entries

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• To exit Manage Accessory Types, click Close. successfully imported Accessories.

4.2.2 Import from CSV

A user can import an Accessory file but the .csv file must abide by the data
rules outlined below.
If a spreadsheet in CSV format is already used to list details of accessories
used in testing which is external to the software, the rules below can be
followed to ensure this file can be imported as a CSV into EndoScan-V™
Version 6.
To successfully import to the Accessory Database within EndoScan-V™, the
CSV file needs to be in the CSV UTF-8 format to ensure all special characters
are imported. In addition, the separation character for a CSV needs to be When you import an Accessory file, EndoScan-V™ creates an Excel
a comma, not a semi-colon. (Note that CSV stands for Comma Separated spreadsheet status file that opens upon completion of the import.
Variable). The Status file will list any files that were not imported.
See example below:
If importing to the Accessory Database via CSV you cannot import from a file
that is open the software will state that 0 of 0 records were imported.

Field Label/Column Valid Range?

Accessory Type Drop down list in software
Accessory Description 1 to 100 characters
Product Code 1 to 40 characters
Lot Number 1 to 40 characters
Calibration Code For cartridges only
Default n/a
4.2.3 Add Accessory
Expiration Date Pop up calendar

Comments 1 to 255 characters To add an accessory, click Add. If multiple accessories are to be creat-
ed a user can click on add multiple times to create multiple rows in the
Added By n/a Editor.
Added Date n/a
Modified By n/a
Modified Date n/a

When importing, the user will receive a message reporting the number of

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 To modify an existing accessory or create a new accessory from an
existing one in the database, the user must highlight the row to be modified
in the database. This is denoted by an arrow to the left of the accessory:

Complete the Accessory details in each row as follows:

• Accessory Type: Choose from the drop down options (this is a unique Click Modify or Create New and this will move the entry into the
identifier field and must be chosen).
Accessory Editor:
• Accessory Description: A further description of the accessory
can be added.
• Product Code: A product code may be added; this may be the
item/order code for that product.
• Lot Number: Is the Lot Number of the accessory (this is a unique
identifier field and must be completed).
• Calibration Code: This field is only used for cartridges; both the lot num-
ber and calibration code need to be completed when adding a cartridge
type accessory (this is a unique identifier field for
cartridges and must be completed).
• Default (BioTek Only): If default is selected these defaulted
accessories will automatically be added to any newly created
assay in BioTek Mode. Modifications to the entry can now be made to the selected row, or if Create
New is selected a duplicate of the selected accessory will appear in the editor.
• Expiration Date: Choose the correct expiration date. Note: If cartridge Select Save to add the entry back into the database.
lots are manually typed into the cartridge panel, the expiration date will
display as N/A on the report. The expiration date can only be edited 4.2.5 Delete Accessory
through the use of the Accessory Database.
To delete an existing accessory, the user must highlight the row to be
• Comments: A comment on the accessory can be added. deleted either in the editor or in the database. This is denoted by an arrow to
the left of the accessory:
Once the information has been completed, select Save to add the entries into
the database.

4.2.4 Modify/Create From

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 Choose Cancel if you wish to return to the Accessory Database to
Select Delete, the following warning will appear: complete edits. Or choose OK if you wish to exit. If you choose OK any
items in the Editor will not be saved.
Accessory Database Notes:
Expired accessories will appear in red in the database. There is a global
setting option to ‘Allow Expired Accessories’; if this is not checked then
a user would not be able to add an expired accessory to an assay. For
further information on this setting please refer to Section 4.5
w(Global Settings).
Select OK to delete the Accessory. The database can be searched by utilizing the search fields at the top of
each column:

4.2.6 Print Accessory Database

To print a list of all accessories listed in the database, select Print. The user
will be directed to a Print Preview page where they can choose to print or
save as a .pdf file.
If a user has searched for a selection of accessories, then when the print
button is selected the Print Preview will display only those
selected accessories.
4.3 SAMPLE DATABASE
4.2.7 Close Accessory Database
The sample database can be used to add all samples routinely tested in
To close the Accessory Database select Close. If items are still in the the laboratory, allowing for easy addition to assays.
Accessory Editor, the following warning will appear:
The Sample Database window is divided into 2 sections. The top
section is the Editor and the bottom section is the Sample Database.
You can add and modify samples in the Editor. Both sections have the
titles (Sample Editor and Sample Database).

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Option buttons in the Sample Database are as follows: When importing to the Sample Database via CSV, the micro sign (μ) is
not acting like a normal character in Excel/CSV. If you attempt to import
Button Functionality it, EndoScan-V™ will not recognize it.
Import from CSV Allows you to import Sample Information from a If importing to the Sample Database via CSV, the Max Dosage needs
.CSV file. have a value (a zero can be added if field not used) or the file will not
Add Add a new record to the Sample Editor. input.
Modify Allows you to modify a record in the Sample Editor. If importing to the Sample Database via CSV you cannot import from a
Create From Copies a current Sample(s) from the Database so file that is open the software will state that 0 of 0 records were imported.
that you can use it to create a new Sample.
Delete Deletes the Sample(s) highlighted in the Sample
Editor or in the Sample Database
Save Saves the current records in the Accessory Editor
into the Accessory Database.
Print Print a report of all the Samples in the Sample
database.
Close Closes the Sample Database window.

4.3.1 Import from CSV

A user can import a Sample file but the .csv file must abide by the data rules
outlined below. Previous versions of EndoScan-V™ do not provide the func-
tionality to export the older product database to a CSV file. Charles River can
provide a tool that allows the product database to be exported to a .CSV and
provide support for this function. Once the CSV file is created this can then
be imported into EndoScan-V™ version 6. If a spreadsheet in CSV format is
already used to list details of samples tested which is external to the software,
the rules below can be followed to ensure this file can be imported as a CSV
into EndoScan-V™ version 6.
To successfully import to the Sample Database Database within Endos-
can-V™, the CSV file needs to be in the CSV UTF-8 format to ensure all spe-
cial characters are imported. In addition, the separation character for a CSV
needs to be a comma, not a semi-colon. (Note that CSV stands for Comma
Separated Variable).

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 Field Label Valid Range
Product Family 40 characters

Sample Name 120 characters

Sample Group(s) N/A

Sample ID 120 characters

Max. Dosage N/A

Units Any of the units listed in the dropdown box.

4.3.2 Add Sample
The Dil/Conc valid range depends on the
Units selected. To add a sample, click Add. If multiple samples are to be created a user
If the units are mL/mL or L/ML or device / can click on Add multiple times to create multiple rows in the Editor.
Dil./Conc. mL then the valid format is X:Y (which is a
Dilution)
If the unit is device/mL then the number to
the left of the colon can be any whole

Endotoxin Limit Greater than 0

EU Criteria Blank, <, or ≤

Alert Limit N/A

Auto Spike Yes or no

Spike Concentration N/A

Comments 60 characters
Complete the Sample details in each row as follows:
Added By N/A
Added Date N/A Product Family: Maximum 40 characters. User can choose to use a
Product Family name for the sample; this would be a grouping of
Modified By N/A similar samples.
Modified Date N/A
Sample Name: Maximum120 characters. User should enter a
Sample Name for the sample (this is a unique identifier field and must
be completed).
When you import a Sample file, EndoScan-V™ creates an Excel spreadsheet
status file that opens upon completion of the import. The Status file will list any
files that were not imported.
See example below: When importing, the user will receive a message If using Charles River Cortex™ software you must restrict
reporting the number of successfully imported Samples. character length for sample name to a maximum of 100 characters.

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 Sample Group A user can choose what Sample Group the Alert Limit User can enter the Alert Limit of the sample.
sample should be a part
of. Default/Blank is All Samples. For further
Auto-Spike (Biotek User can choose if spikes (positive product
information on Sample
Mode only) controls) are automatically created on a new
Groups please see Section 4.1 assay. Default is set to Yes (this is a unique
(User Management). identifier field and must be completed).
Spike Concentration User can choose the spike concentration if
Sample ID Maximum 120 characters. User should enter (Biotek Mode only) Auto-Spike is set to Yes. The default is set to
a Sample ID for the 0.5 EU/mL, this should be evaluated based
on the Standard Set of the assay.
sample (this is a unique identifier field and
must be completed). Comments Maximum of 60 characters. A comment on
the sample can be added.
Max Dosage User can enter the maximum
dosage of the product in dosage units.
Units User should choose the units the sample is Once the information has been completed, select Save to add the
tested in; this will also entries into the database.
denote the units the results are reported in.
Options are: mL/mL, 4.3.3 Modify/Create Form
mg/mL, g/mL, L/mL, device/mL, Unit/mL,
μg/mL, μL/mL and ng/mL To modify an existing sample or create a new sample from an existing
one in the database, the user must highlight the row to be modified in
(this is a unique identifier field and must be
completed). the database. This is denoted by an arrow to the left of the sample:
Dil./Conc The user can enter the Dilution or
Concentration that the sample is
routinely tested at following product
validation. The Dil/Conc valid range depends
on the Units selected. If the units are mL/mL,
L/mL, μL/mL, then the
valid format is X:Y (which is a Dilution). If
the unit is mg/mL, g/mL, Unit/mL, device/
mL, μg/mL, ng/mL then the number does
not require a colon separator (this is a unique
identifier field and must be completed).
Endotoxin Limit User can enter the Endotoxin Limit of the
Sample (this is a unique identifier field and
must be completed). Click Modify or Create New and this will move the entry into the
Sample Editor:
EU Criteria User can choose the EU Criteria to be used in
the Endotoxin Value calculation. The options
are < or ≤. NOTE: ≤ option is only available
for samples added to the sample database
and then dragged/dropped onto the assay. If
sample information is typed directly into an
assay interface only the < criteria will apply.

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Modifications to the entry can now be made to the selected row, or if Create
New is selected a duplicate of the selected sample will appear in the editor.
Select Save to add the entry back into the database.

4.3.4 Delete Sample

To delete an existing sample, the user must highlight the row to be deleted
either in the editor or in the database. This is denoted by an arrow to the
left of the sample: Choose Cancel if you wish to return to the Sample Database to
complete edits. Or choose OK if you wish to exit. If you choose OK, any
items in the Editor will not be saved.
Sample Database Notes:
The database can be searched by utilizing the search fields at the top of
each column:

Select Delete; the following warning will appear:

4.4 INSTRUMENTS
The Instruments function allows users to select which instruments they
would like to use. There are 2 modes in EndoScan-V™: Cartridge and
BioTek. When viewing the Results window, you will see assays depending
Select OK to delete the Sample. the mode you are in. EndoScan-V™ version 6.0 supports the following
instrument types:
4.3.5 Print Sample Database
• BioTek ELx808IU Microplate Reader
To print a list of all samples listed in the database, select print. The user will be
directed to a Print Preview page where they can choose to print or save as a • Endosafe®-MCS™ (Product Code MCS100)
.pdf File. • Endosafe®-PTS™ (Product Code PTS100)
If a user has searched for a selection of samples, then when the print button • Endosafe® nexgen-MCS™ (Product Code MCS150)
is selected the Print Preview will display only those selected accessories. • Endosafe® nexgen-PTS™ (Product Code PTS150)
4.3.6 Close Sample Database All users will have access to the Instruments menu in Settings. Only those
users with the privilege to Add/Modify or Delete will be able to carry out
To Close the Sample Database, select Close. If items are still in the Sample these functions. Those without the privilege will only be able to activate and
Editor, the following warning will appear: deactivate instruments to allow them to switch between different
instruments/modes.

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4.4.1 How to Add an Instrument: Instrument Type EndoScan-V™ 6.0: Number of instruments that can
be connected at one time
nexgen-MCS™ Up to 3 (15 bays total)
nexgen-PTS™ Up to 15
Combination of Up to 15 bays total
nexgen-MCS™ &
nexgen-PTS™
MCS™ Up to 2 (10 bays total)
PTS™ Up to 15
Combination of MCS™ Up to 15 bays total
Navigate to the Settings icon and select ‘Instruments’. On the Instruments and PTS™
window, select Add and choose from one of the pull down options. BioTek Up to 3

4.4.2 Adding a nexgen-PTS™

Select Add, then nexgen-PTS™, and the following window will appear:

Enter the following fields:

IP Address - IP address of the nexgen-PTS™ (If you do not enter an IP
Clicking the Add button presents the following options: address, then there will be a prompt to enter the address.) Example
10.45.3.76. This can be viewed on the nexgen-PTS™ under Network
Please note that only one instrument type can be added at a time and Settings.
the Add function cannot be accessed while an assay is running.
The Modify button will only appear once an instrument has been added. Description - Description of the instrument (optional).
The table below outlines the number of instruments per type that you can Pressing Add on this screen will prompt the software to connect to the
run using EndoScan-V™. instrument. When successful, the confirmation message “Instrument
successfully connected” will be displayed. The software picks up the
serial number of the instrument and the instrument type when it
connects.

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The software will display the nexgen Instrument(s) Bay Settings window. To
add the instrument, check on the Select checkbox and set the Tab and Panel Click Close, and the cartridge panel of the nexgen-PTS™ will appear as below.
numbers to 1. Click Save, and the software will confirm that the instrument
was saved successfully.

Once in the Instrument window, you need to select the nexgen-PTS™ that
you just added to be your Active instrument.
The software will then show the new nexgen-PTS™ in the Instruments main
window. To activate the nexgen-PTS™, check the
Active Instrument box as shown below.

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The top part of the nexgen-PTS™ cartridge panel contains the following: Type in the Base IP (required) and the Instrument Description (optional). Then
select the Add button and the software will connect to the Instrument. Once
• nexgen- PTS™ Icon: icon that portrays the nexgen-PTS™. the connection is complete, the nexgen Instrument(s) Bay Settings window
• Tab number: (1-PTS) is the tab number before starting an assay will appear.
• Eventual tab name is tab: panel number – nexgen-PTS™ serial
number (1-1-16480018) so when this assay runs it will be displayed
in the first tab, in the first panel.
• Status indicator: (green/red/blue circle)
• Assay Name: the assay name is a concatenated combination of:
Suffix
Prefix Sequence
designated
designated in Date in number (3
PTS serial in Global
Global settings - - the format - digits) which is .
number settings
(up to 10 YYYYMMDD reset every day
(up to 10
characters) at 00:00:01 )
characters)

EndoScan-V™ is now ready to run a cartridge using the nexgen-PTS™. The initial setup of a nexgen-MCS™ assumes you would like to run the
instrument in your first tab and that each brick of the MCS™ should be
Up to 5 PTS™ systems can appear in one tab at a time. assigned to panels 1-5 in order. You can change the tab number (to 3)
and the panel numbers.
If the nexgen-MCS™ is the first and only instrument you are connecting to,
you can use the defaults where the nexgen-MCS™ is in tab 1 and the bays
are displayed in panels 1-5 in that tab.

4.4.3 Adding a nexgen-MCS™

Select Add, then select “nexgen-MCS™”, and the following window will appear:

Select Save, and the instrument configuration will be saved into the
database. A notification message will confirm the Instrument was saved.

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 In the example above, the nexgen cartridge panel contains the following:

The software will then present the Instruments main window with the new
nexgen-MCS™ added to the table.

The icon will refresh the instruments connected to EndoScan-V™.

To activate the nexgen-MCS™, check the Active Instrument box,
then press Close.

• nexgen-MCS™ Icon: icon that portrays a nexgen-MCS™.

• Tab number/Bay number: example 2-1 - meaning Tab #2, bay 1.
• To the right of the tab number is the Instruments serial number
followed by the brick serial number.
• Status indicator: (green/blue/red circle)
• Assay Name: the assay name is a concatenated combination of:
Sequence number
Panel (3 digits) which Suffix
Prefix
The nexgen-MCS™ serial number is in the tab of the panel. Number + is reset every day designated
designated Bay
at 00:00:01. The in Global
Once you select Close, the software will load the cartridge panels
in Global - serial - Date in - counter belongs to . settings
settings (up number the format the brick and will
of the nexgen-MCS™. (up to
to 10 chars) YYYYMMDD increment when the 10 chars)
bay has a new assay.

Example:
CRL – 17360016-320190506-001.SUF
When EndoScan-V™ is connected to up to 3 nexgen-MCS™ units, each
instrument can display in its own tab (see below); the tab will be named
with the serial number of the instrument. Multiple nexgen-MCS™ units can
also be displayed in one tab, however, the tab name will be that of the first
instrument connected. Panel numbers should be numbered sequentially,
1-5 for the first nexgen-MCS™ and 6-10 for the second nexgen-MCS™.

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EndoScan-V™ is now ready to run a cartridge using the nexgen-MCS™.

4.4.4 Discover MCS™/PTS™ (100 series)

Select Add, then Discover MCS100/PTS100, and the following window will
appear.

To activate the instrument, check the Active Instrument checkbox.

You must log out anytime you set an instrument to Active.

When the Add button is selected, the software will connect to all COM ports
on the computer, then establish if any 100 series instruments are connected.
The software will determine the instrument serial number(s) and bay serial
number(s), determine if the unit attached is a PTS™ or MCS™, and will
update the information on the screen accordingly.

The top part of the PTS™ cartridge panel contains the following:
• Tab number and instrument type in the tab.
• PTS™ Icon: icon that portrays the PTS™.

Check the box marked Select, then finish adding the instrument by clicking • Tab number, Panel number and Brick serial number.
Add. Once the instrument is added, the Instruments window will display the • Status indicator: (green/red/blue circle).
new instrument. • Assay Name: the assay name is a concatenated combination of:
Prefix
Suffix
designated Sequence
designated
in Global PTS Date in number (3
in Global
settings - serial - the format - digits) which is -
settings (up
(up to 10 number YYYYMMDD reset every day
to 10
charac- at 00:00:01 )
characters)
ters)

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4.4.5 Discover nexgen Instruments Function

Select Add, then Discover nexgen instruments, and the following window
will appear.

Select the bays for use, then fill in the tab and panel number. If you
would like all 5 bays displayed in a single tab, the tab number for each
bay would be 1 and the panel number would be 1 for bay 1, 2 for bay 2,
3 for bay 3, 4 for bay 4 and 5 for bay 5. Each bay can also be displayed
as 5 different tabs. Once all information is completed see below:

Enter the Base IP and a Range for the software to discover the instrument.
(Example: Base IP: 192.168.1.1 and Range 255, means that EndoScan-V™ will
search IP addresses that are in the IP range of 192.168.1.1 to 192.168.1.255)
For the example above, the Discover function will attempt to find MCS™
bays at 192.168.1.101 to 192.168.1.106.
In the Instrument window, activate the instrument you have configured
Select Add, and the software will complete a series of steps to connect to by checking the Activate checkbox.
the instrument.

The Discover function will display any nexgen instruments that

are connected.

Select Close, and the software will display the cartridge panels for the
activated instrument. You need to log out and log back in when you
activate an instrument.

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The software is now ready to run an assay.

4.4.6 Adding/Modifying BioTek ELx808™ If you are unsure of the BioTek COM port, you can use the COM Port field
pull-down menu and choose from the COM ports on your PC.
From the Instruments tab in Global Settings, select Add, then BioTek You can test the connection by clicking on the ‘Test Connection’ button.
ELx808, and the following window will appear:
Once the BioTek reader is added, you will get the following confirmation:

Select the COM port that the BioTek is connected to, then enter the BioTek
serial number. This information can be found under the Windows Device
Manager. It is recommended that one BioTek is added at a time. The serial
number is located on the right-hand side of the instrument.
If you are connecting the BioTek for the first time, please enter 1 in the Tab
Order field. Completing the description field is optional.
Up to 3 BioTek instruments can be active and run at the same time.
Each BioTek instrument connected must have its own tab number, i.e
two BioTek instruments cannot be added to the same tab number.
The software is now ready to run an assay.

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4.4.7 BioTek Self-Test Report
4.5 GLOBAL SETTINGS
By clicking on the ‘Self-Test Report’ button a BioTek System Self-Test
will begin. Global Settings consists of 5 tabs as follows:
• General
• Security
• Report
• BioTek
• Cartridge
4.5.1 General Tab

You will get a confirmation when the test is complete.

The report is generated as .pdf file and stored in the directory specified.
C:/ProgramData/Charles River/EndoScan-V/Documents/Directory with Data
stamp/file name.pdf
Where the file name is BioTek ELx808 Self-Test Report-timestamp.pdf
The Self-Test runs diagnostics of the instrument and diagnoses any
failures. Refer to the BioTek Instrument Manual for details on the
System Self-Test.

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Assay Settings Section: Spike Recovery Range:
EndoScan-V™ calculates spike recovery as a percentage for wells
Field Label Field Type Default Value Valid Range Information containing spiked samples. The range entered into the field, in percent, is the
Export File Path Fill in field from c:\ProgramData\ Any valid folder Used to set an acceptable range for spike recovery and will be included on reports.
Windows Charles River\ accessible by export file
Browse button EndoScan-V\ the PC path for exports. Require Comments:
Export
Assay Name Text input CRL 1-10 characters Used to add Three checkboxes are available for Global Settings, Post Assay Changes, and
Prefix a prefix to the Signature Cancellation. If these boxes are checked, if any authorized user
assay name. attempts to make changes to Global Settings, make changes to assays once
Assay Name Text input Blank 1-10 characters Used to add complete, or Cancels a Digital Signature they will be forced to write a comment.
Suffix a suffix to the
assay name. Comments must be a minimum of 3 characters in length. The comment will
Auto Export Check box with 2 Checked, CSV Checked/ Used if automatic appear on the audit trail line item associated with the activity,
radio buttons unchecked. exports are required. providing the ‘WHY’ to critical audit trail activities.
(CSV and XML) If checked CSV Will export file as
is the default soon For example:
as assay completes.
Spike Whole number 50 0-499 Lower Limit for Spike
Recovery input Recovery, current
Range regulations state 50%.
lower limit See below for
further information.
Spike Whole number 200 0-500 Upper Limit for Spike
Recovery input (upper limit must Recovery, current
Range be larger than the regulations state 200%.
upper limit lower limit) See below for
further information.
Include Check box Unchecked Checked/ Includes column
Headers unchecked headers in a
in CSV CSV export.
Auto Print Check box Unchecked Checked/ Will automatically
unchecked print a report once Validation Terminology Section:
the assay is com-
plete.
Allow Expired Check box Unchecked Checked/ If checked, this will Default
Field Label Field Type Valid Range Information
Accessories unchecked allow users to use Value
expired accessories
from the VALID Pull down VALID VALID, PASS Provides the nomenclature
accessory database. menu on the report when a
Require Check box Unchecked Checked/ See 4.5.2 below result is Valid.
Comment for unchecked table.
Global Settings INVALID Pull down INVALID INVALID, FAIL Provides the nomenclature
menu on the report when a
Require Check box Unchecked Checked/ See 4.5.2 below result is Invalid.
Comments for unchecked table.
Post Assay
Changes UNDEFINED Pull down UNDEFINED UNDEFINED, Provides the nomenclature
menu UNDETERMINED, on the report when a
Require Check box Unchecked Checked/ See 4.5.2 below UNKNOWN, result is Undefined.
Comment unchecked table. UNRESOLVED
on Signature
Cancellation

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Sample Limit Validation Terminology Section: Password Security Section:

Field Default Valid

Field Label Definition Information
Field Label Field Type Default Value Valid Range Information Type Value Range
Password Number 90 0-365 How many days 0 will turn
Sample Pull down VALID VALID, PASS Provides the Timeout-Days input before a use off security
Valid menu nomenclature on the password expires. features.
report when a Sample Limit
result is Valid. Password Number 5 0-10 How many previously 0 will turn off
History input used passwords are security features.
checked when
Sample Pull down INVALID INVALID, FAIL Provides the nomenclature creating a new
Invalid menu on the report when a password.
Sample Limit result is
Invalid. Login Number 15 0-180 How many minutes 0 will turn off
Timeout input before a user is security features
-Minutes locked out
Sample Pull down UNDEFINED UNDEFINED, Provides the nomenclature after inactivity.
Undefined menu UNDETERMINED, on the report when a
UNKNOWN, Sample Limit result Password Pull 3 0-10 How many attempts 0 will turn off
UNRESOLVED is Undefined. Attempts down before a user is security features
menu locked out.

4.5.2 Security Tab Password Pull 14 0-14 How many days 0 will turn off
Warning-Days down before a password security features
menu expiration warning
message appears.

Server Backup Details Section:

Field Label Field Type Default Value Valid Range Information

Backups Pull down No Yes/No Allows user to enable or

Enabled menu disable backup of database.
Backup Pull down 1 1-365 days Allows user to choose
Interval-Days menu the backup interval.

Prefix Text input Blank 0-10 Allows the user to choose

characters a prefix to the backup
file name.
Next Date and Read from Must be in Provides the user the
Backup time stamp database the future information of when the
next backup is scheduled.

Backup File path c:\ Any available Allows the user to choose
Destination ProgramData\ directory on the backup destination file
CharlesRiver\ PC path.
EndoScan-V\
Database\
Backup\

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4.5.3 Report Tab 4.5.4 BioTek Layout Settings Tab

Allows the user to establish settings for the reports. Allows a user to establish certain parameters for a BioTek assay.

Field Label Field Type Default Valid Range Information BioTek Layout Settings Section:
Value
Report Logo File display CRL logo See The Report Logo function can accept Field Field Type Default Value Valid Range Information
Information .JPEG, .JPG, and .PNG images. The Label
column report header section for the logo is
213 by 55 pixels. Any logo with this Number of Pull down menu 2 1-96 Allows the user to
approximate ratio will load into the Replicates choose the number
software correctly and with no of replicates to
distortion. The default CRL logo is be displayed on
300 DPI. Any logo with this DPI or the assay. Can be
higher will render accurately. edited at the assay
level. See further
Logo Posi- Pull down Left Left, Center, Allows the user to choose the information below.
tion menu Right position of the logo on printed
reports. SPL color Color swatch - Blue Any color Allows the user
brings up color to choose the text
Lab Name Text input Blank Text up to Allows the user to choose the palette color for Samples
40 characters Lab Name to be displayed on that will appear in
the reports. the assay grid. See
below for further
For Invalid Checkbox Unchecked Unchecked/ Allows the user to choose if information.
Assay show checked the Sample Value should be
SPK color Color swatch - Black Any color Allows the user
N/A for displayed on a report if other to choose the text
brings up color
Sample parameters are invalid. color for Spikes
palette
Value (Positive Product
Controls) that will
Add Checkbox Unchecked Unchecked/ Allows the user to choose if a appear in the assay
Disclaimer to checked Disclaimer should be added at the grid. See below for
All Summary bottom of all summary reports. further information.
Reports
STD color Color swatch - Black Any color Allows the user
Show Checkbox Checked Unchecked/ Allows the user to choose if the list brings up color to choose the text
Accessories checked of Accessories used in an assay palette color for Standards
in Report should be printed on the report. that will appear in
the assay grid. See
Disclaimer text input N/A 0-300 Allows the user to type a below for further
characters Disclaimer to print on the summary information.
reports if the ‘Add Disclaimer to All
Summary Reports’ is checked.

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 Field Field Type Default Value Valid Range Information
Label
CTRL color Color swatch - Green Any color Allows the user to Field Label Field Default Valid Range Information
brings up color choose the text Type Value
palette color for the
Negative Control Polynomial Order Pull down 4 2, 3, 4 Allows the user to
that will appear in menu choose the
the assay grid. See polynomial order if
below for further Polynomial
information. Regression is being
used. See below for
Reaction Pull down menu SSSS SSSS or Allows the user to
further information.
Time HH:MM:SS choose the reaction
Format time format. See # of Points to Pull down 3 2, 3, 4 This is used for the
below for further Use for MaxV menu Kinetic Noise Test
information. in the Performance
Qualification only.
Replication Pull down menu Left to Right Left to Right Allows the user to
See below for further
Direction or Top to choose the
information.
Bottom replication direction.
See further Onset OD Number 0.1 0-4 Allows the user to
information below. input choose the Optical
Onset OD for the
Wells Text field Blank 0-40 charac- Allows the user to
assay. See below for
Masked ters mask wells. See up to 3
decimal further information.
below for further
information. places
Auto Stop Checkbox Unchecked Unchecked Allows the user to # of Decimals Number 4 2-4 Allows the user to
or checked select auto stop to Display for input choose the numbers
for all assays. Auto Endotoxin Value of decimals to display
stop completes the for Endotoxin Value.
assay once lambda
has reacted. CV Limit-Samples Number 10% 0-100% Allows the user to
input choose the Coefficient
Auto- Checkbox Unchecked Unchecked Allows the user to of Variation for the
mation or checked choose automatic up to 3 Samples. See below
Creation of creation of spikes decimal for further
(positive product information.
Spikes places
controls). Spikes
will then be created CV Limit-Stan- Number 10% 0-100% Allows the user to
for every sample dards input choose the Coefficient
added to the assay of Variation for the
grid. See below for up to 3 Standards. See below
further information. for further
decimal
information.
places
BioTek Calculations Section:
Default Spike Number 0.5 0-100 Allows the user to
Concentration input choose the default
Field Label Field Default Valid Range Information spike concentration
Type Value up to 3 for assays. Can also
decimal be set in Sample
Regression Pull down Linear Linear or Allows the user to
places Database for each
menu Polynomial choose the regression sample. See below
type for analysis. for further informa-
See below for further tion.
information.
Enable Validation Check Checked Checked/ Allows the user to
Default Collection Pull down Kinetic Endpoint, Allows the user to box unchecked enable any validation
Type menu Turbidimetric Kinetic choose the default criteria chosen for the
Turbidimetric collection type for all assay.
or Kinetic assays (can be edited
at the assay level). Average Check Checked Checked/ Allows the user to
Chromo- Replicates box unchecked choose Average
genic Replicates.

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 Field Label Field Default Valid Range Information Inline Spiking
Type Value Sample spikes may be placed in the same row or column as the sample
Inline Spiking Check Checked Checked/ Allows the user to or in an adjacent row or column. When the Inline Spiking Option is on,
box unchecked choose Inline Spik- the sample spikes are placed in the same row or column as the sample
ing. See below for (depending on replicate direction). If Inline Spiking is off, the sample
further information. spikes are placed in the next adjacent row or column (depending on
Show CV Prefix Check Unchecked Checked/ Allows the user to replicate direction).
box unchecked show the Coefficient
of Variation prefix. Default Spike Concentration
Spike Recovery Check Unchecked Checked/ Allows the user to
for Unreacted box unchecked choose. See below for The default concentration in endotoxin units for automatically created
Samples - Use further information. spikes. Any logical concentration may be entered in this box. The units
Zero are designated by the units entered on the Assay Properties. The default
concentration is 0.5.
Replicate Direction Reaction Time Format
The direction for automatic replication can be set for either left to right or The format in which the time values are entered and reported. The
top to bottom. Left to right replication enters the first sample, standard, or possible time formats are: SSSS (integer seconds) or HH:MM:SS
control in a column and the replicate is entered in the next column(s) to the (where HH:MM:SS is the time relative to the start of collection). Select
right until the number of replicates is reached. Top to bottom replication the desired time format from the pull down menu. The default time format
enters the first sample, standard or control in a row and the replicate is is SSSS.
entered in the row(s) immediately beneath until the number of replicates is
reached. If automatic spike creation is selected the spikes will be replicated Wells Masked
in the same direction as the sample. The default replication direction is left
to right. Data in wells can be masked, or hidden, from use in calculations and
reports. Any wells listed in the Wells Masked box are masked for a new
Number of Replicates assay opened in EndoScan-V™. Enter the wells to be masked by typing
the well reference (the letter number combination, such as A3 or G10)
The number of times a sample, spike, standard, or control is separated by a comma (,).
automatically duplicated when entered onto the grid during setup.
The default number of replicates is 2. Colors
Automatic Creation of Spikes Colors may be defined for the text on the well grid for categories of
groups (STD, CTRL, SPL, SPK) using the Colors button on the Biotek
The Automatic Creation of Spikes option directs the software to enter Layout Settings tab. Clicking on the color box for each category
spike information for each sample entered onto the grid. When Automatic
presents a dialog box.
Creation of Spikes is selected, spike values will be placed in the same
number of wells as the sample and its replicates when a sample is added to
the grid. When Automatic Creation of Spikes is not selected, only samples Pick the desired color and select OK.
in the samples database with the auto spike value of “yes” will have spikes
created when placed on the grid. The value of the spike is controlled by the
spike concentration information in the sample database.
The Auto Spike value of any sample added from the Sample database will
override the global Automatic Creation of Spikes. For example: If the global
Automatic Creation of Spikes is set to False and the Auto Spike of a sample
in the Sample Database is set to True then the sample when added to the
grid will also add the spike wells.

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Regression Enable Validation
EndoScan-V™ can perform either Linear or Polynomial regression to Selecting this option directs the program to evaluate the group criteria for
analyze the standard curve. The linear regression option is the default the assay and to determine the validity of the criteria. The status of the
selection for new microplate assays. criteria is reported using the Validation Terminology selected.
Select the default type of regression desired. If Polynomial regression is selected, Spike Recovery Calculation for Unreacted Samples
the Polynomial Order list box will be enabled.
For unreacted samples, EndoScan-V™ calculates spike recovery using
Polynomial Order Option the smallest standard EU or zero, depending on this option. The default
is to use the smallest standard EU.
EndoScan-V™ can perform Polynomial regression of order, or degree, 2, 3, and
4. Select the default order of polynomial regression.
4.5.5 Cartridge Settings Tab
NOTE: For Polynomial Regression to be performed there must be one more data point
than the defined Polynomial Order. If the selected degree of polynomial regression Allows a user to establish certain parameters for a cartridge assay.
cannot be performed due to an inadequate number of standards or points, linear
regression will be used to determine the standard curve

Onset OD Option
The Onset OD option is the default optical density (OD)
reaction-time threshold.

Number of Points to Use for Max V Option

The default number of data points used to calculate the maximum slope or MaxV.
Possible options for the number of data points are 2, 3, or 4 data points. This
function is used for Performance Qualification only.

CV Limit – Samples
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for CV Limit – Cartridges
each sample and spike. The limit entered into this field, in percent, is the default The cartridge reader calculates the coefficient of variation (CV) of the
acceptable limit for sample and spike CV for the limit set. channel results for the sample and spike. The limit entered into this field,
in percent, is the acceptable limit for sample and spike CV. The default is
CV Limit – Standards set to 25% as per the product insert for cartridges.
EndoScan-V™ calculates the coefficient of variation (CV) of the well results for
Display Sample Value by Channel
each standard. The limit entered into this field, in percent, is the default acceptable
limit for each standard CV for the limit set. For cartridge reader assays, sample endotoxin results can be displayed
and reported for each sample channel or for the average reaction time of
Average Replicates both sample channels. Default is off.
Average Replicates determines how the data is used in regression and endotoxin 4.6 DIGITAL SIGNATURE CONFIGURATION
calculations. When this option is selected, the program averages the data from
all the replicates prior to performing the calculations. When this option is not This feature allows the user to configure the Digital Signature Roles.
selected the individual optical density (OD) data values are used in the regression These roles must be configured in order for the Digital Signature
function to work.
and endotoxin calculations.

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Digital Signature Roles
Displays an option for three levels of digital signature: L1, L2, and L3. The levels
cannot be edited, but the Digital Signature Role Name for each level can be edited. A Signature Meaning must be added for each level of signature. Type the
Click into the Name box and type the text required for that level of signature. Signature Meaning and click ‘Add’, this will then add it into the main text box
at the bottom. Multiple meanings can be added for each signature level, these
meaning will then be presented to the user when they sign a record.
Both the digital signature role and meaning will be applied to the record
when signing and will display on the reports.

To delete a digital signature meaning, highlight in the main text box and
click delete.
For further information on applying Digital Signature please refer to
Section 6 – Reports.

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 Once the record is unlocked, other users may access it. Any changes to the
4.7 MANAGE LOCKS record made by the user whose lock was unlocked may or may not (be)
saved. Unlocking should only be used when there is no other way
Manage locks works for those customers using numerous installs but to access the record.
working on the same central database.
The software will allow only one user at a time to modify a record in the
On occasion, an authorized user may have to unlock a record within the database. This feature eliminates the possibility of two users attempting
system. For example, a record may have been locked by a user who to modify a record at the same time. This feature is applicable for certain
has been deleted by the system, or who has left the company or whose records in Global Settings, Assays, Templates, and User Management.
computer may have crashed.
Global Settings
The Manage Locks function is in the Settings menu.
If two or more users attempt to access Global Settings at the same time, the
first user to access the specific setting screen will gain access, or ‘win’, the
ability to edit. The next user(s) who attempt to access the same screen to edit
will get a notification (as below) which states that the Global Settings is locked
by the first user, and to try again later.

Results Database – BioTek Mode

If two users attempt to access Assay/Results at the same time, the first user
will ‘win’ the ability to edit. The next user(s) will get a notification screen (as
below) which states that the Assay is locked by the first user.
Column Name Description

Lock The object that has been locked. It could be an Assay name,
template name, or Global Settings.
Lock Type There are 4 different lock types - Cartridge Assay, BioTek
Assay, Template (BioTek), or Settings.
PC Name The PC name of user that owns the lock.

Login Name The Login of the user that owns the lock.

Last Accessed The timestamp of the creation of the lock.

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 Results Database – Cartridge Mode 5.1 BIOTEK RESULTS
If two users attempt to access a Cartridge Assay/Result at the
same time, the first user will ‘win’ the ability to edit. The next user(s)
will get a notification screen (as below) which states that the Assay
is locked by the first user.

Fields available in Results Window:

Accessing a Template
If two users attempt to access a Template at the same time, the first user
will ‘win’ the ability to edit. The next user(s) will get a notification screen Field Field Default Valid
Mandatory Information
(as below) which states that the Template is locked by the first user. Label Type Value Range
A search field used to find
From Yesterday’s Any date
Date No a particular Assay date
Date date in the past range.
A search field used to find
To Tomorrow’s Any date
Date No a particular Assay date
Date date in the past range.
Assay A search field used to find
Text Blank No a particular Assay name.
Name
A search field used to
Search
Text Blank find a particular string in
Keyword the table.
Will display both
5 Results All
Radio
button All results
One of
Yes
Completed Assays and
imported .pltx files in the
Results the 4
(toggles) table when selected.

Radio Will display Completed

Completed One of Assays in the table when
button All results Yes
Assays the 4 selected.
(toggles)
When the Results icon is selected, the user is presented with their
Will display imported .pltx
BioTek Results window or the Cartridge Results window, depending Radio files in the table when
on what mode they are in. Imported One of selected.
button All results Yes
PLTX files the 4
(toggles)

Radio Will display Template

One of files in the table when
Templates button All results Yes
the 4 selected.
(toggles)

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Column Fields in Results Window:

Table Column
Definition Information
Label
Assay Name Assay Name Unique identifier
Created By Who the assay was
Details the user’s full name
created by
Test Date/Time Assay Date/Time
Collection Type Kinetic Turbidimetric, Kinetic
Collection Type
Chromogenic, End Point.
Instrument Serial Instrument Serial
Number Number
Signature Status Digital Signature
Signed or unsigned
Status
Signature Level If signed, at what
Blank, Analyst, Reviewer, or QC
level?
Auto Export Was the assay
Displays Yes or No.
exported?

Imported Is the file an

Displays Yes or No.
imported one?

A user can search the table by date, Assay Name, keyword or by hovering over
the column header they would like to search on. When the mouse hovers over
the column header, the search arrow appears to the right of the column header if
the field is searchable - see below:

A search column window appears. A user can select the values needed by clicking
the check boxes. The window also allows the user to type
in a specific value (Text Filter). To apply the search criteria select Apply.

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5.2 CARTRIDGE RESULTS Column Fields in Results Window:
Table Column Label Definition Comments
Assay Name Assay Name Unique Identifier
Created By Who the assay was created by N/A
Test Date/Time Assay Date/Time N/A
Sample Name Sample Name N/A
Lot Number Sample Lot Number N/A
Instrument Serial
Instrument Serial Number N/A
Number

Signature Status Digital Signature Status Signed or Unsigned

Blank, Analyst,
Fields available in Results Window: Signature Level If signed, at what level?
Reviewer, or QC
Field Label Field Type Default Value Valid Range Definition Auto Export Was the assay exported? Yes or No

A search field used to Imported Is the file imported Yes or No

Any date in
From Date Date Yesterday’s date find a particular Assay
the past date range. 5.3 Results Options
A search field used to
Any date in
To Date Date Tomorrow’s date
the past
find a particular Assay Selecting Multiple Assays
date range.
A user can select more than one Assay to preview by holding down the
A search field used to
find a particular Assay shift key and selecting each record.
Assay Name Text Blank N/A name.
A user can search the table using the date, assay name, and keyword or
by hovering over the column header they would like to search on. When
Search A search field used to the mouse hovers over the column header, the search arrow appears to
Text Blank N/A find a particular string in
Keyword the Assays. the right of the column header if the field is searchable - see below:

Radio Will display both

completed assays and
All Results button All results One of the 4 imported .pltx files in the
(toggles) table when selected.
Will display Completed
Radio Assays in the table
Completed
button All results One of the 4 when selected.
Assays
(toggles)

Radio Will display imported

Imported .pltx files in the table
button All results One of the 4
PLTX files when selected.
(toggles)
Radio Will display Template
Templates button All results One of the 4 files in the table when
(toggles) selected.

To print preview reports,

digital signatures can be
Print Button N/A N/A applied from in the print
preview window.

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 A search column window appears. A user can select the values needed
by clicking the checkboxes. The window also allows the user to type in a
specific value (Text Filter). To apply the search criteria select Apply.
The user can highlight one or multiple rows. First click on Preview to preview
all the results and then print.

Digital Signature Flow for Cartridge Results

The user can highlight one or multiple rows to select data for digital
signature. Click on preview to preview all the results. The user can then
apply digital signatures from within the print preview. To apply the digital
signature, the user must ensure they choose multiples that are at the same
signature level. For further information on applying digital signatures please
refer to Section 6 – Reports.

6 Reports & Applying

Digital Signatures The report title appears at the top; this can be edited for the report but it
will not edit the assay name in the Results Database.
Report Type:
• Detailed Report: Provides the full details of all the data from
the assay.
Reports are available for both BioTek and Cartridge results. Digital
Signatures can be applied to records and this digital signature will print • Endotoxin Summary Report: Provides a summary of the detailed
on the report. Manual Signatures can also be used. report. If Disclaimer for Summary Reports has been chosen
(Refer to Settings – Section 4.5.3), this will print on the bottom
Note: If Auto-print is selected the assay will print immediately as the assay of all summary report.
completes, before any review or digital signatures are applied. If utilizing
• Kinetic Noise Report: Provides a specific printout when a Kinetic
Digital Signatures it is recommended to not use Auto-Print.
Noise Test is run (for Performance Qualification only).
6.1 BIOTEK REPORTS • Report Footer: A user can choose to have Signature on all pages or
Signature on last page only. This applies for manual signature boxes
To view an assay report, select the Results database icon. In the Results only. If using Digital Signatures, once applied these will appear on
screen, double click the assay desired. This will open the assay in the each page of the report.
BioTek interface mode
• Report Comments: This allows the user to add specific comments
Click on the Reports icon and the Reports screen will be displayed: for the individual report.
• Samples: This allows the user to choose which samples to display
on the report.
• Preview: Once Preview is chosen the software will display the
preview of the report as follows:

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 Apply Signature:

For BioTek Reports:

• If Sample CV limit status, Spike CV limit status, R-Value, or Spike Recovery
To digitally sign a record the user must enter their login name and
Range status are N/A, the Endotoxin Limit Status will always be N/A.
password and click Validate. Once validated as having Digital Signature
• EU Criteria can only be set to < or ≤ when using the Sample database. If Role access the following screen will appear. This screen will then show
typing into the 96 well template directly then < will be applied as the criteria. the user role levels the user has rights to. A user must be logged in to their
• Each report has a unique Page ID so that pages of a long report can be easily own account in order to apply a digital signature.
identified. The Page ID is auto generated and not editable.
• If the Endotoxin Limit has no limit then the Endo Limit status will always be
N/A.
At the top of the screen the following options are available:

Print: By clicking on Print, the report will print to a connected

printer. If not using digital signatures the report can also be
printed and signed manually.

Save: By clicking on Save, the user will have the option to

save the report to a chosen folder as a PDF.

Digital Signature: By clicking on the Digital Signature icon a

user will be presented with a drop down menu; the options to
select are Apply Signature and Cancel Signature. Choose the role to use for the signature. Note that signatures work in level
order as L1, L2, and L3; for example a record cannot be signed at L2
unless it has already been signed at L1. Each level of signature must be
performed by a different user.
Once a user role has been chosen then the signature meaning can be
chosen from the drop down menu:

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 Click Yes to continue with the cancellation of signature.
If ‘Require Comments for Cancellation of Digital Signature’ has been
checked in Global Settings, the following dialogue box will appear:

You will be required to type the reason for cancellation before clicking OK. If
you do not type comments and attempt to click OK, you will not be allowed
to proceed with the signature cancellation.
Once OK is selected the following screen will appear:
Click Sign Assay to apply the signature. Digital Signature roles and
meanings are set up under User Management and Digital Signature
Configuration.
Once the digital signature is applied this will be displayed at the bottom of the
report as shown below:

Click OK to cancel the signature.

6.2 CARTRIDGE REPORTS

Cancel Signature: From the results screen select the records for signing, multiples can be
chosen by utilizing Shift>Up/Down Arrow or by utilizing Ctrl and clicking
When cancel signature is chosen, the following pop up window will appear:
on chosen records.

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Once records are highlighted click the Print button, which will open the following
screen:

At the top of the screen the following options are available:

• For Cartridge Reports: If you print several cartridge reports at a time, the
report title will remain blank, you can type a report title name or leave this
The report title appears at the top; this will detail the assay name if only one assay blank.
has been selected from the Results database. It will remain blank and can be
edited if multiple assays have been selected. Changing the report title will not edit • If Sample CV limit status, Spike CV limit status, or Spike Recovery Range
the assay name in the Results Database. status are N/A, the Endotoxin Limit Status will always be N/A.
• The EU criteria is displayed to the left of the Endotoxin Limit field.
Report Type
• EU Criteria can only be set to ≥ or ≤ when using the Sample database.
Detailed Report: Provides the full details of all the data from the assay.
• Each report has a unique Page ID so that pages of a long report can be
Endotoxin Summary Report: Provides a summary of the detailed report. If Disclaimer easily identified. The Page ID is auto generated and not editable.
for Summary Reports has been chosen (Refer to Settings – Section 4.5.3), this will • If the Endotoxin Limit has No limit then the Endo Limit status will always
print on the bottom of all summary reports. Summary reports are not available for be N/A.
Gram ID, Glucan, and Inhibition/Enhancement Cartridge types. • If cartridge lot number and calibration code are manually typed into the
Report Footer panel, the expiration date for the cartridge lot number will display as N/A.
A user can choose to have Signatures on all pages or Signatures on the last page Print: By clicking Print, the report will print to
only. This applies for manual signature boxes only. If using Digital Signatures, a connected printer. If not using digital
once applied these will appear on each page of the report. signatures the report can also be printed
and signed manually.
Report Comments
This allows the user to add specific comments for the individual report. Save: By clicking on Save, the user will have
the option to save the report to a chosen folder
Preview as a PDF.
Once preview is chosen the software will display the preview of the report as
follows: Digital Signature: By clicking on the Digital
Signature icon a user will be presented with
a drop down menu; the options to select are
Apply Signature and Cancel Signature.

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Apply Signature Click Sign Assay to apply the signature. Digital Signature roles and meanings
are set up under User Management and Digital Signature Configuration.
Once the digital signature is applied this will be displayed at the bottom of the
report as shown below:

Cancelling a Digital Signature

To digitally sign a record the user must enter their login name and password and
click validate. Once validated as having Digital Signature Role access the following Cancelling a digital signature involves both the role hierarchy and the Cancel
screen will appear. This screen will then show the user role levels the user has signature privilege.
rights to. To illustrate how the hierarchy and privilege works:
In the table below ‘privilege’ refers to the ‘Cancel Digital Signature’ privilege in
User Management.
Analyst A – Has the Analyst Digital Signature Role (Level 1)
Analyst B – Has the Analyst Digital Signature Role (Level 1)
Analyst C – Has the Reviewer Digital Signature Role (Level 2)
Analyst D – Has the Reviewer Digital Signature Role (Level 2)
Analyst E – Has the Quality Control Digital Signature Role (Level 3)
Analyst F – Has the Quality Control Digital Signature Role (Level 3)

Choose the role to use for the signature.

Note that signatures work in level order as L1, L2, and L3. For example a record
cannot be signed at L2 unless it has already been signed at L1. Each level of
signature must be performed by a different user.
Once a user role has been chosen then the signature meaning can be chosen from
the drop down menu:

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 Who What can What can What can What can What can What can
signed the Analyst A Analyst B Analyst C Analyst D Analyst E Analyst F
Assay? (L1) do? (L1) do? (L2) do? (L2) do? (L3) do? (L3) do?

Analyst B
Analyst A Analyst D Analyst E
cannot Analyst
cannot can cancel can cancel Analyst F
cancel the C can
Analyst A cancel their the the can cancel
signature cancel the
only has signature signature signature the signature
even if signature if
signed unless they if they if they if they have
they have they have
the assay. have the have the have the the privilege
the the privilege
privilege privilege privilege assigned.
privilege assigned.
assigned. assigned. assigned.
assigned.

Analyst Analyst
Analyst Analyst D Analyst E
A cannot B cannot Analyst F
Assay is C cannot can cancel can cancel
cancel the cancel the can cancel
signed by cancel the the signa- the signa-
signatures signatures the signature
Analyst B signature if ture if they ture if they
even if they even if they if they have
and Analyst they have have the have the
have the have the the privilege
D only. the privilege privilege privilege
privilege privilege assigned.
assigned. assigned. assigned.
assigned. assigned.

Analyst Analyst Analyst Analyst Analyst E Analyst

Assay is A cannot B cannot C cannot D cannot can F cannot The user will then get a confirmation that the digital signature was cancelled.
signed by cancel the cancel the cancel the cancel the cancel the cancel the The Digital Signature History block on the Report will update the new status of
Analyst B, signatures signatures signatures signatures signature signatures the digital signature:
Analyst D, even if they even if they even if they even if they if they even if they
and Analyst have the have the have the have the have the have the
E. privilege privilege privilege privilege privilege privilege
assigned. assigned. assigned. assigned. assigned. assigned.*

*NOTE: This file will be locked and signatures cannot be cancelled if the Level 3
signatory does not have the cancel signature privilege. The Cancel Digital Signa-
ture Privileges is a suggested privilege in the Admin and Manage Privilege groups.
Charles River recommends that all L3 authorized signatories are provided with the
Cancel Digital Signature Privilege. When cancel signature is chosen, the following pop up window will appear:

When the user chooses to Remove signature while in the Report preview window,
they will first get warning:

Click Yes to continue with the cancellation of signature.

If ‘Require Comments for Cancellation of Digital Signature’ has been applied
in Global Settings, the following dialogue box will appear:

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You will be required to type the reason for cancellation before clicking on Ok.
If you do not type comments and attempt to click Ok, you will not be allowed
to proceed with the signature cancellation.

Once Ok is selected the following screen will appear:

For more information on Report Logo, Report Disclaimer, etc. please

refer to section 4.5.3.

7 Import

Click OK to cancel the signature.

Reports General Information:

Failed parameters will highlight in red on the screen when previewing the EndoScan-V™ 6.0 introduces a PostgreSQL database for all data. Data
reports. in previous versions of EndoScan-V™ are stored in flat files - with a file
extension .pltx. These files can be signed or unsigned. EndoScan-V™
Passed parameters will highlight in green on the screen when previewing the version 6.0 and above will provide the customer the ability to import
reports. .pltx files from all prior versions which contain the .pltx file format of
EndoScan-V™. All files and reports generated are read only. The user
will not be able to edit or sign/unsign the imported files.

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Selecting a File or Folder to Import
Click Import and the following screen type will appear:

Once the user has selected the files to import, a status bar should appear
listing the files being imported. The user will be given a chance to cancel
the import.
If the user imports 1200 files and 2 are corrupt and do not import, the
user will be notified which ones did not import.

8 Export
Select the location of the files/folders to be imported. Once the user selects a
folder to import from, the software will check all levels of sub folders for all .pltx
files and automatically import them.
If the user selects a folder without any .pltx files, it will prompt the user to select
a folder that does.
An authorized user can export any record or records in the database to a
.CRL, .CSV or .XML file(s). The user can choose a record in the database,
the file format and then choose the file directory where the exported file will
be stored.

The user can choose to export one file or a group of files. They can select a
group of files by holding down the control and shift keys as they select each
file.

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Once the records are selected, you then can choose what type of export file
you would like by selecting the Export button.
Export as CSV or XML will export in that file type.
9 Copy from/Create Template
(BioTek Mode Only)
Export as CRL will encrypt the file so that it can be emailed to Charles River
for support. Only Charles River licensed employees have the software able
to open a CRL file.

This icon in BioTek Mode will present the user with a drop down box as
follows:

If you choose to Export more than 1 assay, the assay records are concatenated into
one file. The user can choose what folder to place the file into.

9.1 CREATE TEMPLATE

When Create Template is selected the following window will appear:

Templates can be created, edited, and deleted by authorized users. Cre-

ating templates allows the user to control the assay set up so that other
users can create new assays from these templates.
Export File Naming Convention The user can select a name for the Template
The Export file name will be the concatenation of:

EndoScanV-Export Timestamp CSV or XML or CRL

- YYYYMMDDHHMMSS .

Example: EndoScanV-Export -20190222113356.csv

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Click OK to create the template.

The row can be highlighted and Delete can be selected to delete the
template. To modify, double click the template; this will then open the
template in the main interface. Edits can be made and Save selected again.

9.2 COPY FROM

If a user selects Copy From the following window will appear:

A user can then add samples and standards to the plate as required and set plate
properties for the template. Once completed, click the Save icon at the top of the
template:

Templates can be edited and deleted by navigating to Results and

clicking Templates: A user can create a new assay file by choosing the template radio button
and clicking the chosen template or by double clicking a previously run
assay. This action will open a new assay with the details from template/
assay chosen. Note: This action does not overwrite or change the details
of the previous assay or the template.
When the record is selected, if a connected instrument is available, the
following window will appear:

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 • Based on the user’s privileges, the user will be able to delete standards/
samples when an assay is complete.
• Each assay will require the user to add standards to the assay grid be-
fore starting the assay. If the user fails to do so, a dialog box will appear
that states “not enough standards added to the plate, do you wish to
proceed?” Selecting Yes will allow the plate to start without standards
added to the plate.
Select an instrument to assign to the new assay from the drop down. • If an assay is closed while the assay is running, a prompt will
display: “Are you sure you wish to close the assay prior to the assay
If all instruments are in use running other assays, the template grid will
completing?” Selecting Yes will close the assay and save the file. A
be created and the instrument can be assigned when available. note will be made in the audit trail that the assay was closed prior to all
standards/samples reacting.
10 Setting Up and Running a • The minimum number of replicates are 1 and the maximum
replicates is 96.
BioTek Assay • The software has the ability to run multiple standard curves on one
If creating a new assay from a previous assay or template, follow the template and calculate the standard curve reaction times separately.
instructions in Section 9. Icons appear at the top of the 96 well grid as follows:
If BioTek ELx808 IU instruments are connected, when the software is Properties
started a 96 well grid interface will appear for each instrument. The user can
add to the grid directly, or they can follow the instructions from
Section 9 and then assign an instrument.
Cut
10.1 ADDING SAMPLES AND STANDARD TO THE TEMPLATE GRID
• The user can cut Standards and Samples after they have been added to Copy
the template and paste them in another location.
• If the desired well is occupied, the user will receive a notification that
the well is occupied. Paste

• If the desired sample or standard replicate will not fit in the desired
pasted location, the software will notify the user with a message. Undo
• When adding standards to a plate, if the replicates will not fit in the
desired wells, the software will not allow the standards to be added in
that location. The software will notify the user with a message. Redo
• When adding samples to the template in outer wells, the samples and
spikes will not wrap to the other side of the plate. Print Grid
• When cutting samples/standards, the user will be allowed to cut and
paste to open wells, provided there are enough wells to accommodate
the number of replicates needed to paste. Save (for use
• When deleting standards from a template prior to an assay being run, when saving
the standards will be deleted from the plate and the standards list. The Templates)
software will notify the user with a message.
• When deleting samples from a plate prior to an assay being run, all
highlighted fields will be deleted, including the spike wells.
The software will notify the user with a message.

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10.2 VIEW LIST • MaxV View shows the maximum slope (Max V) value for each well. This
view is available after data collection for kinetic collections only.
There are multiple view options on the assay grid as follows: • Reaction Time View shows the time to the Onset OD value for each well.
This view is available after data collection for kinetic collections only.
• EU View shows the Endotoxin Unit (EU) value for each well. This view is
available after data collection.
• Data Values View shows the numeric optical density (OD) values for
each well. For kinetic collections, the operator may step through the
series of values by changing the read number on the menu bar. This
view is available during and after data collection of a kinetic endpoint
assay.

10.3 PRINT GRID

The available views in EndoScan-V™ are Template, OD Graph, Max V,
Reaction Time, EU, and Data Values. Select the desired view from the pull Each of the above views can also be printed. This can be achieved by
down list. selecting the view required as detailed above and clicking on the print grid
icon at the top of the 96 well grid:
• Template View displays the text designators of the well contents.
In the Template View, the menu bar also includes a Replicate
selector. The Replicate selector multiplies the sample, standard, or con-
trol by the number selected when the item is added to the grid area. In
this view, the Properties dialog box can be edited through the properties
icon at the top of the grid, or by using the right mouse button menu on a
well or wells and selecting
properties. Additionally, the right mouse button will allow a user to Undo,
Cut, Copy, Paste, Clear, or Mask; these functions can also be accessed
via the icons at the top of the grid.
• OD Graph View shows a graph of Optical Density (OD) versus time for
each well. This view is available during and after data collection for
kinetic collections only. The Well Zoom feature can be used in this view
to “zoom” into a well, providing an expanded view of the well informa-
tion. To display a Zoom window for the currently selected well, dou-
ble-click a well. Multiple well Zoom windows may be open at An example of these prints is as follows:
one time.

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 10.5 WELL/GRID
Each rectangular area within the Well Area represents one well. The wells are
named using an alphabetic character (A-H) for the row and a numeric
character (1-12) for the column. For example, G3 or C11.
The text options for each well are the sample name or one of the following
designators: SPL# (sample), SPK# (spike), STD# (standard), and CTRL
(control). Sample, spike, and standard have a number associated with the text
to indicate to which group the sample, spike, or standard belongs.
Samples, spikes, standards, and controls are entered onto the plate either by
dragging and dropping from their respective area (including from the sample
and accessory database) or by entering or editing the contents of a well.
Using the drag and drop method, the name of the sample (abbreviated as
necessary) is displayed in the well area. Information from the sample area for
the sample is copied into the well and can be viewed using the well properties
menu. Replicates may be entered either from top to bottom or from left to
right, based on operator preference. Spikes are entered into the wells either
by automatic creation of spikes or by entering or editing the well information.
10.4 READ NUMBER AND READ TIME If automatic spike creation is selected in the global settings, spikes and spike
replicates are automatically added to the plate. The first sample entered on the
The Read Number indicates the number of data reads the program has made plate is designated as SPL1, the next is designated as SPL2, and so on.
during a data collection. In the Data Values View on kinetic collection, the
Read Number can be changed to view the optical density value for each read. Well information can be created using the keyboard or editing by selecting the
text in a well and using the keyboard. Other editing options can be accessed
The Read Time box indicates the time that a data collection has been using the right mouse button on a well.
running. In the Data Values view, the Read Time box indicates the time of the
read corresponding to the Read Number. 10.6 STANDARDS AND SAMPLES LISTS
Standards List
The Standards List of the Main Window provides user access to the
Standards List during assay configuration. The Standards List displays the
general standards available and the standards on each open assay.
Standards for each plate are indicated under the assay name.

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 Items listed in this window can be dragged onto the grid during assay setup
by holding down the right mouse button and dragging and dropping onto
the appropriate well.
New samples, spikes, and controls may be added by entering the group
name in the appropriate blank row. The group name, product name, and lot
number may be edited directly on the Sample Information area. To remove
Standard Sets are entered onto the grid by clicking on the row containing a sample, spike, or control, click into the box and delete using backspace.
the desired standard set and dragging the highlighted standard set onto a It is not necessary to clear the group’s wells before removing it from the
well in the Well Area. If the standard set is not already on the grid, it will be Sample Information Area. When removing a sample and its respective spike
added to the list of standard sets under the assay name. wells, be sure to delete the spike from the Sample Information list first, and
New Standard Sets may be added by entering the Standard Set name, using then remove the sample.
the appropriate naming convention as in the default Standard Sets, and To create a negative control, drag from the Drag for Negative Control area.
Concentrations in the appropriate blank row. Controls will be added into the wells, following the automatic replication set
for the microplate.
Sample Information
The Sample Information Area of the Main Window provides a list of all 10.7 PROPERTIES
samples, spikes, and controls entered onto the grid during the assay setup To enter the assay properties window a user can right click on the grid and
under the assay name. This area provides the group information, the select properties or select the properties icon at the top of the grid.
product name, and the product’s lot number. Lot numbers can be typed
directly into the sample information grid, or added via the Properties
window. Refer to section 10.7 on Properties.

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The properties window will appear as follows: NOTE: If the selected order, or degree, of polynomial regression
cannot be performed due to an inadequate number of standards
or points, linear regression will be used to determine the standard
curve.

• Polynomial Order
Polynomial Order value is established by selecting the value from
the pull-down list. The possible values are 2, 3, and 4.

• Onset OD
The onset optical density (OD) defined for a assay. Enter the
desired onset OD.

• Number of Points to Use for Max V

The number of data points used to calculate the maximum slope
or MaxV. Possible options for the number of data points are 2, 3,
There are four tabs available in properties as follows:
or 4 data points.
Calculations
• CV Limit, Products
EndoScan-V™ calculates the coefficient of variation (CV) of
the well results for each sample and spike. The limit entered
into this field, in percent, is the acceptable limit for sample and
spike CV and will be included on reports.

• CV Limit, Standards
EndoScan-V™ calculates the coefficient of variation (CV) of the
well results for each standard and control. The limit entered into
this field, in percent, is the acceptable limit for standard and
control CV and will be included on reports.

• Enable Validation
Selecting this option directs the program to evaluate the well
criteria (found under the well/group tab) for the assay.
• Regression
• Average Replicates
The EndoScan-V™ software is capable of performing either Linear
or Polynomial Regression to determine the standard curve. Select When Average Replicates is selected, EndoScan-V™ will
the type of regression desired for the assay. If Polynomial average the reaction times of each well in a sample, spike,
Regression is selected, the Polynomial Order option will be enabled. control, or standard group before calculating the grou
endotoxin value. Otherwise, the group endotoxin value is the
For Linear Regression to be performed there must be at least three mean of the well endotoxin values.
data points defined. For Polynomial Regression to be performed
there must be one more data point than the defined Polynomial • Spike Recovery Range
Order. EndoScan-V™ calculates spike recovery as a percentage for
spiked sample groups.

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 Kinetic Chromogenic: Kinetic Chromogenic gathers data from the
• Y Axis Maximum assay over a user specified collection time, measuring the color change
Optical Density is plotted on the Y axis. When a new assay is of the samples, standards, spikes, and controls on the assay.
created, the Y Axis Maximum is set to 3 times the Onset OD. Kinetic Turbidimetric: Kinetic Turbidimetric gathers data from the
assay over a user specified collection time, measuring the change
• X Axis Maximum in turbidity of the samples, standards, spikes, and controls on the
Time is plotted on the X axis. Typically, the X Axis Maximum assay.
should be at least the actual collection time. • Instrument Properties
• Show CV Prefix Collection Time: Collection Time is used for kinetic collections only.
• Selecting this option will add the < or > prefix before the %CV if Entering the desired number of seconds in this box sets the
the calculation criteria warrant it. maximum Collection Time for the entire collection, specified in
seconds.
Read Interval: Read Interval is used for kinetic collections only. The
Collection number of seconds entered in this field defines at what interval data
is gathered during a data collection. Enter the desired Read Interval,
in seconds, into this field. If the selected reader cannot support the
defined Read Interval, it will be adjusted as needed and indicated on
the display.
Plate Temperature: Displays the temperature, in degrees Celsius, of
the assay at the beginning of collection and at the end of collection.
The temperature is not displayed before collection or if the
instrument does not have an incubator. This field is read only unless
the instrument cannot report assay temperature.
Plate Temperature Setting: The temperature entered in this field is the
desired temperature to which the plate should be warmed. Enter the
desired temperature, in degrees Celsius, for the plate, if the
instrument has a heater. The default setting is 37.
Filter Wavelength: Specific filter values supported by the instrument
will be listed in the pull down menu or a numerical value can be
entered by typing directly in the field.
Select the Filter Wavelength value for the current assay. The program
will ensure the selected filter has been installed on the reader.
• Instrument
The Instrument area of the Collection tab displays the information • Shake
for the selected instrument. For instruments with a shaker device attached, the shake intensity
• Collection Type and time can be controlled by the EndoScan-V™ program. This
property will be disabled if it is not supported by the instrument.
Three types of data collection can be performed using the
EndoScan-V™ program for Biotek instruments. These collection Select Shake Enable to have the instrument shake the plate at the
types are Endpoint, Kinetic Chromogenic, and Kinetic Turbidimet- intensity and time indicated in the Shake Intensity and
ric. Select the Collection Type by clicking the radio button by the Shake Time fields.
desired Shake Intensity: Enter the desired Shake Intensity of the assay in
Collection Type. The Filter Wavelength will change depending on the this field.
type of assay that was selected.
Shake Time: Enter the time, in seconds, when the microplate is to be
Endpoint: Endpoint collection gathers data from the assay a single shaken prior to beginning data collection.
time and then automatically stops.

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Assay • Well Details
• Lab Name User can enter the laboratory name. The well details list displays the groups of samples, standards,
spikes and controls entered on the grid. When group identifier in
• Endotoxin Units Determines what unit the assay will be calculated in. Op- this list is selected, it is highlighted and the fields to the right of
tions are EU (Endotoxin Units) or IU (International Units). NOTE: 1EU = 1IU. the list show properties of that item. Information in these fields
• Assay Comments Comments can be added for the assay that will be added to can be edited (see below.)
the report.
To display a list of which wells contain a group, click on the
• Auto Stop Selection of Auto Stop will complete the assay once Lambda has plus sign by the group identifier. To hide the list of wells, click
reacted. on the minus sign by the group identifier.
• Accessories
These are the accessories that have been added to the assay either
by them being listed as default in the accessory database, or by being • Mask
dragged and dropped onto the grid. Accessories can be deleted by those The Mask checkbox indicates whether the selected well is
authorized to do so from the assay on this screen by adding a checkbox masked. It is always unchecked when no well is selected. The
to the delete column as shown below: Mask checkbox is enabled when a well identifier is selected
(highlighted) in the Group/Well list and the user has masking
privileges.

• Sample Name
The Sample Name field identifies the sample name of the
sample or spike selected in the Group/Well list. This will be
pre-populated if added from the sample database.
• Sample Lot Number
A user can add the sample lot number.
• Sample ID
A user can enter a sample ID for the sample. This will be
pre-populated if added from the sample database.

• Dil./Conc.
Well/Group
Enter the Concentration or Dilution for the sample or spike. If
The Well/Group tab allows the user to set the properties for the well and the dosage units are milliliters, this value can be expressed
samples, spikes, controls, and standards (groups of wells) contained in as a Dilution, i.e., a ratio (1:10). If dosage units are other than
the current assay. milliliters, this value must be expressed as a Concentration, i.e.,
a decimal number.
Changing the Concentration/Dilution for a sample changes the
Concentration/Dilution displayed for the sample’s spike, and
vice-versa. This will be pre-populated if added from the sample
database.

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• Endotoxin Limit 10.8 STARTING AN ASSAY
This field contains the Endotoxin Limit for a sample or spike. This Once all samples, standards, and controls have been added to the assay
value is used on reports. and all information is complete, proceed to preparing the assay. Once the
microplate is ready, add to the instrument and then click Start Collection
Changing the Endotoxin Limit for a sample changes the Endotoxin in the grid:
Limit for the sample’s spike, and vice-versa. This will be
pre-populated if added from the sample database.

• Associated Standard Set Start Collection

The Associated Standard Set is the standard set that will be used
to evaluate endotoxin for this group. More than one standard set
can be included on a single assay. Select the standard set from
the pull down list.
Changing the Associated Standard Set for one well/tube in a group
will change the Associated Standard Set for all other wells/tubes
of that group. Changing the Associated Standard Set for a sample
will change the Associated Standard Set for the sample’s spike,
and vice-versa.

• Spike/Standard Concentration
For a sample, enter the amount of endotoxin spike for the sample. The assay will begin collecting data.
For a spike or standard, enter the endotoxin concentration of the The assay can be stopped before it completes via time assigned or auto
spike or standard. This will be pre-populated if added from the stop. This can be done by clicking the Stop Collection icon:
sample database.

• Automatic Creation of Spikes

When selected, the Automatic Creation of Spikes property directs Stop Collection
the program to automatically create a spike group for the sample
when it is entered onto the assay. To select this property, click the The screen below shows when the instrument is connecting:
Automatic Creation of Spikes checkbox. This will be pre-populated
if added from the sample database.
• Sample Comments
The Sample Comments field is available to enter a text
description of a sample or spike. Changing the Sample
Comments of a sample changes the Sample Comments of a
spike, and vice-versa.

• Group Criteria
The Group Criteria are the equations to be evaluated as true or
false for the assay by EndoScan-V™. Criteria entered into the
Group Criteria field will be included on reports for the assay. Enter
all applicable criteria for the plate, connecting criteria
expressions with logical “ AND ” operators. If the instrument does not connect, click the Reconnect Instrument
button.If connection issues continue, refer to section 4.4 on Instruments
in this manual.

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The screen below shows when the instrument is connected and ready:

11 Cartridge Menu
(Cartridge Mode Only)
When in the Cartridge Reader Mode a user can select the Cartridge menu
under the cartridge icon:

When selected a drop down menu will appear:

The screen below shows when the instrument is Running and Collecting
Assay Data:

All functions under this menu can be completed on nexgen instruments.

The function Instrument version is the only available function for MCS™ and
PTS™ instruments. You cannot download results from a 100 series instru-
ment.
The screen below shows when the assay has stopped collecting data: • Download Results (nexgen instruments only)
For nexgen instruments, selecting Download Results will retrieve all
Results from the instrument. When done, a notification will summa-
rize how many assays were downloaded.

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 • nexgen Instrument Software Update
Selecting nexgen Instrument Software Update allows the user to update
the instrument firmware. The user selects the update file.
If a user selects update software, it will update all connected panels from
this menu. The user can update software individually by bay under the
Cartridge panel cog. The software update operation is associated with the
privilege “nexgen Instrument Software Update”.

• Reconnect (nexgen instruments only)

The assay name for a downloaded result is based on the FLT file name on Selecting Reconnect will result in EndoScan-V™ attempting to
the nexgen (e.g., FLT name is FLT20170817071123.txt, so the assay name reconnect to the default instruments.
is 201709171071123). The assay name and the instrument bay serial Reconnect is done when a) the Reconnect menu item is
number make the downloaded test result unique. selected on this screen, b) the default instrument has been changed,
and c) a bay is selected for reconnection within the Manage
Instruments screen. This Reconnect function will prompt the user if
assays are running in any panel to confirm the Reconnection. The
Reconnect operation is associated with the privilege Reconnect.
• Shutdown (nexgen instruments only)
The shutdown function will shut down all bays on the nexgen instru-
ment. The Shutdown operation is associated with the privilege Shut-
down. The shutdown can take several minutes.
The user can shut down individual bays under the “Manage Instrument”
window.
NOTE: The nexgen-MCS™ MUST be shut down using this function.
Utilizing the power button on the rear of the instrument can result in
a power toggle situation or files not being properly written to the bay.
Any assay stopped before completion is not loaded into the results data- Improper shutdown of the nexgen-MCS™ can result in failures within
base. the instrument. It is very important that the proper shutdown procedure
is followed.
• Instrument Version
If the nexgen-MCS™ is shut down via EndoScan-V™, the power button
This command displays serial number and software version
on the back of the instrument must be pressed to turn it back on.
information for connected cartridge instruments.

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12 Setting Up and Running a •
•
nexgen-MCS™ Icon - icon that portrays a nexgen-MCS™.
Tab number/Bay number - example 2-1 - meaning Tab #2, bay 1.
Cartridge Assay • To the right of the tab number is the Instrument serial number
followed by the brick serial number.
When a PTS™ instrument is set as the Active Instrument, the cartridge interface
will be displayed. This can take different forms depending on whether this is a • Status indicator (green/blue/red circle).
nexgen-PTS™, nexgen-MCS™, PTS™ or MCS™ instrument. Assay Name - the assay name is a concatenated combination of:
Sequence
number (3 digits)
Prefix which is reset Suffix
designated every day at designated
Bay Date in
in Global 00:00:01. The in Global
- serial - the format - -
settings counter belongs settings
number YYYYMMDD
(up to 10 to the brick and (up to 10
characters) will increment characters)
when the bay
has a new assay.

12.2 NEXGEN-MCS™ ASSAY SETUP

12.1 NEXGEN-MCS™ CARTRIDGE PANEL
Field Name Requirement Source
The top part of the cartridge panel contains the following: Cartridge Lot Mandatory Pulled from Accessory Database – If global
Number settings option for open fields is chosen
then user can type in.

Cartridge Code Mandatory Pulled from Accessory Database – If global

settings option for open fields is chosen
then user can type in.

Sample Name Optional Pulled from Sample Database or typed in

by user.

Sample Lot Optional Typed in by user.

Dil./Conc. Mandatory Pulled from Sample Database or typed in
by user.
Endotoxin Limit Optional Pulled from Sample Database or typed in
by user.

Sample Information can be filled by dragging and dropping a row from the
Sample Database.

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Accessory information can also be added to the panel. Authorized users can Color chart:
type in the cartridge lot number and calibration code directly onto the panel. If
cartridge lot number is manually typed into the panel, the expiration date for the
cartridge lot number will display as N/A. Red Disconnected or finished
Accessories can be added by dragging and dropping from the Accessory
Database onto the panel.
Accessories can be deleted from the panel by highlighting the accessory and Green Ready to begin test
clicking delete.

Blue Running test

User’s next Status Audible

Order Status Panel
step color cue
1 Enter Assay Enter
Setup Assay data
and insert N/A
Insert Cartridge cartridge

12.3 NEXGEN-MCS™ CARTRIDGE PANEL TEST SEQUENCE

Each panel has a status bar that displays the current activity. For a typical
nexgen-MCS™ assay, the status will move through the following stages:

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 User’s next Status Audible User’s next Status Audible
Order Status Panel Order Status Panel
step color cue step color cue
2 Checking Wait for 5 Add sample User
Cartridge cartridge and click Start selects
check to N/A Start N/A
complete

3 Enter Assay Press Send N/A

Setup Setup
6 Drawing Wait for
Sample step to
complete N/A

4 Sending Assay Beep

Setup

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 User’s next Status Audible User’s next Status Audible
Order Status Panel Order Status Panel
step color cue step color cue
7 Mixing Sample Wait for You can 9 Assay com- View / Print Beep
step to hear the plete results
complete instru-
ment Remove
mixing cartridge if
inserted Remove
cartridge

8 Performing Wait for 10 Enter Assay Select New

Assay step to Setup - Car- Assay
complete N/A N/A
tridge is not button
ready/Remove
cartridge if
inserted.

12.4 NEXGEN-MCS™ ASSAY RESULT SCREEN

See section 12.8, nexgen-PTS™ Assay Result Screen.

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12.5 NEXGEN-PTS™ CARTRIDGE PANEL
A nexgen-PTS™ cartridge test will run similarly to a nexgen-MCS™
cartridge test, only with only one instrument panel per device.

The Cog menu allows you to run cartridge functions on an individual bay.
The functions here are:
• Download Logs
• Save Audit Log
The top part of the nexgen-PTS™ cartridge panel contains the following:
• Restart (see section 11.0 Cartridge Menu for more info)
• nexgen-PTS™ Icon - icon that portrays the nexgen-PTS™ • Shutdown (see section 11.0 Cartridge Menu for more info)
• nexgen-PTS™ serial number • Save Test Reports
• Status indicator (green/red circle) • Download Results (see section 11.0 Cartridge Menu for more info)
• Assay Name - the assay name is a concatenated combination of: • Reconnect (see section 11.0 Cartridge Menu for more info)
Sequence Suffix • Assay Status
Prefix
number (3 designated
designated in PTS Date in Download Logs
digits) which in Global
Global - serial - the format - -
is reset settings
settings (up to number YYYYMMDD This function takes all the logs off the nexgen instrument and saves them in
every day at (up to 10
10 chars) the default directory
00:00:01 ) chars)

12.6 NEXGEN-PTS™ ASSAY SETUP SECTION C:\ProgramData\Charles River\EndoScan-V\Documents\nexgen serial

number\nexgen IP address
Refer to nexgen-MCS™ Assay Setup Section 12.2.

12.7 NEXGEN-PTS™ CARTRIDGE PANEL TEST SEQUENCE

Refer to 12.3 nexgen-MCS™ Cartridge Panel Test Sequence.

12.8 NEXGEN-PTS™ ASSAY RESULT SECTION

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 The cartridge panel will display “Save Audit Log” once the download is complete.

The cartridge panel will display “Save Logs” once the download
is complete.

Save Test Reports

This function takes all the test reports the nexgen instrument and saves them in
the default directory
C:\ProgramData\Charles River\EndoScan-V\Documents\nexgen serial number
Save Audit Trail \nexgen IP address
This function takes all the logs off the nexgen instrument and saves them in the
default directory
C:\ProgramData\Charles River\EndoScan-V\Documents\nexgen serial number
\nexgen IP address
The Audit Trail log shows the audit trail from the panel of each instrument (and it is
not the EndoScan-V™ audit trail). The Audit Log will show the beginning and end of
every test, whether a test was aborted, and if any settings have been changed. The
user will appear as N/A, as EndoScan-V™ only sends down the user name for test
result information.

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This function is used to refresh the assay status, which will update the cartridge
panel to show the current assay status instead of any other text that has been
displayed there.

Multiple nexgen-PTS™ systems are displayed in one tab called 1-PTS

12.10 PTS™ ASSAY SETUP

Before Assay Status, “Save Audit Log” is displayed over the current Assay Status.

After Assay Status, the assay status is now displayed on the cartridge panel.

12.9 NEXGEN-PTS™ MULTIPLE BAYS DISPLAY

Up to 5 nexgen-PTS™ systems can appear in one tab at a time. The tab is to be The top part of the PTS™ cartridge panel contains the following:
labelled as ‘PTS 1’ “PTS 2” “PTS 3” • Tab number and instrument type in the tab
• PTS™ Icon - icon that portrays the nexgen-PTS™
• Tab number, Panel number, and Brick serial number
• Status indicator (green/red/blue circle)

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• Assay Name - the assay name is a concatenated combination of: Order Status Panel User’s Status Audible
Next step color cue
Prefix Sequence Suffix 1 Assay Press
designated number (3 designated Complete the New
PTS Date in
in Global digits) which in Global Assay N/A
- serial - the format - -
settings is reset settings button
number YYYYMMDD
(up to 10 every day at (up to 10
characters) 00:00:01) characters) Do not
insert
cartridge
12.11 MCSTM 100 ASSAY SET UP
The only difference in the setup between the nexgen-MCS™ and the MCS™ is
the MCS™ cartridge panel displays a COM port instead of an IP address.

2 Enter User
Assay inserts
Setup a new N/A
cartridge

Insert
Cartridge User
enters
cartridge
and
12.12 RUNNING PTS™ AND MCS™ CARTRIDGE ASSAYS sample
parame-
• When the cartridge instrument is ready, it will display Insert Cartridge (as ters
displayed in sections above). This indicates that the bay is at the correct
temperature.
• Input cartridge lot number, cartridge calibration code, product name, product lot
number, Conc./Dil (Concentration/Dilution), and the
appropriate units, and finally the Endotoxin Limit (if applicable). Drag and Drop
can be used from the Sample and Accessory Database.
EndoScan-V™ will send this information for each cartridge to the respective
PTS™ or MCS™ bay. Once all information has been entered, select the Send
Setup button.
EndoScan-V™ will display Add sample and click Start when the sample and
cartridge information has been saved. Dispense 25µL into each of the four wells
for each cartridge and select the Start Button.
Each panel has a status bar that displays the current activity. For a typical assay on
the PTS™ or MCS™, the assay will move through the following stages:

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Order Status Panel User’s Status Audible Order Status Panel User’s Status Audible
Next step color cue Next step color cue
3 Enter Press 6 Preparing Wait for You can
Assay Send hear the
to start step to instrument
Setup Setup N/A the assay complete mixing

Please
wait

4 Sending Wait for Beep

Assay step to
7 Performing Wait for
Setup complete Assay step to
complete N/A

5 Add User
sample adds
and click sample N/A
8 Assay View Beep
Start and complete / Print
selects results
Start

Remove
cartridge Remove
if inserted cartridge

Return to
the
beginning
of this
table

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13 Audit Trail 13.2 PRINT BUTTON
The print button will preview a report that lists all the Audit entries in the
The software has a fully searchable audit trail that can be located under the current window. If a user has completed a search and only 5 records match
audit trail icon. that search and then they select Print, only those 5 records will appear in the
report.
The report will have a signature box for manual signing. The order of the
entries listed on the report will be in the same order as shown on the screen.

When this icon is selected the following window will appear:

At the top of the screen the following options are available:

The software audit trail captures all actions within the software. Print: By clicking on Print, the report will print to a
connected printer.
The audit trail will display yesterday’s and today’s entries by default. If any
settings are changed, the next time the screen is accessed, as long as the
software has not been restarted, it will use those settings. If the check box Save: By clicking on Save, the user will have the
next to the “From Date:” is unchecked, then the audit trail will use the oldest option to save the report to a chosen folder as a PDF.
entry as the Starting Date. If the check box next to the “To Date:” is un- If save is chosen, this does not archive any informa-
checked, then the audit trail will use the most recent entry in the Audit Trail as tion from the audit trail.
the Ending Date.
13.1 DATE RANGE FIELDS
From Date: and To Date: fields contain a built-in calendar.

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13.3 Search Criteria Field 13.4 SEARCH KEYWORD FIELD
The Search Criteria list allows the user to search on specially tagged critical The user can type any word into the Search Keyword field and the search
events. function will search all the columns of the Audit Trail.

13.5 SHOW PC NAME/PC ADDRESS CHECKBOX

This checkbox allows the user to add the PC Name and PC Address to the
audit table. The PC Address is the actual network address of the computer
that generated the audit trail entry. This checkbox is unchecked by default.

13.6 SHOW WINDOWS USER NAME CHECKBOX

The Search Criteria field has the following entries: This checkbox allows the user to add the Windows User Name to the audit
table. This information can be useful when troubleshooting database
• Blank – No search criteria selected. connection issues. This checkbox is unchecked by default.
• Add/Modify/Delete/Archive Users - Will search all audit trail entries and
detail when a user has been added/modified, deleted, or archived. 13.7 DISPLAY TIME IN UTC CHECKBOX
• Add/Modify/Delete/Privilege Group - Will search all audit trail entries
and detail when a privilege group has been added, edited, or deleted.
• Add/Modify/Delete Sample - Will search all audit trail entries and detail
when a sample has been added/modified or deleted. This checkbox allows the user to change the Date/Time time zone from
• Add/Modify/Delete Sample Group - Will search all audit trail entries and local time to UTC time. (Universal Time Coordinated). This checkbox is
detail when a sample group has been added/modified or deleted. unchecked by default.
• Changes to Global Settings - Will search all audit trail entries and detail
when global settings have been changed.
• Changes to Global Settings Comments - Will search for all audit trail
entries and detail when comments have been listed when making a
change to a global setting.
• Post Assay Comments - Will search for all audit trail entries and detail when
comments have been listed when making post assay changes.
• Signature Applied - Will search all audit trail entries that show a digital
signature has been applied.
• Signature Cancelled - Will search all audit trail entries that detail a
cancelled signature.

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13.8 AUDIT ENTRY TABLE

Clicking on the sorting arrow toggles it between an up and a down

arrow. The arrow pointing up  sorts the column in Ascending
order. The arrow pointing down sorts the column in
Descending order.

• Table Search and Filter

The user can search the table by hovering over the column header
they would like to search on. When the mouse hovers over the
column header, the search arrow appears to the right of the column
header if the field is searchable.
Table columns are:
A search column window appears. You can select what values you
would like to include by clicking the check boxes. The window also
1. Date/Time – date, time, time zone - example 30-May-2018 08:34:50 AM
allows you to type in a specific value (Text Filter). To apply your
EST. The software will use the system date on the PC. search criteria select Apply.
2. Time Zone (Hidden column) – If display time in UTC is selected, column
1 will display the UTC time and then column 2 will display, the column
header will be Time Zone and will detail the original time zone that the
information was gathered e.g., EST or GMT, etc.
3. Full Name – Full name of user that created the audit entry.
4. Windows User Name – The windows user name of the user (If Show
Windows User Name checkbox is selected).
5. Instrument Serial Number – Serial number of the instrument that
generated the entry.
6. Audit Details – description of the action - If the Global setting ‘Require
Comments for Post Assay Changes’ or ‘Require Comments for Global
Settings Changes’ is enabled; the comments will be appended to the text
in the Audit Details column.

Example: Onset OD changed from 0.03 to 0.1. COMMENT: Incorrect

Onset OD chosen at start of assay.
There is a scroll bar at the bottom of the audit trail page to allow the user to
scroll over to columns on the far right.
7. PC Name – The network or machine name of the user’s PC.
8. PC Address – The machine address of the user’s PC. 13.9 AUDIT TRAIL ENTRIES - EXAMPLES
Here are examples for each major piece of functionality within EndoScan-V™ 6.0.
• Table Sorting
When the user first opens the Audit Trail, all entries will be shown
with the latest entry first.
The user can sort the table by clicking on the column header they
would like to sort on. The sorting arrow appears above the column
header - see below.

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 Delete a Privilege
• Audit Trail Entries - First time Logging In The “Uber User” privilege group was successfully deleted.
Group
Action Audit Trail Entry
Import Feature File Following Feature imported: “c:\Users|cr229404\Desktop\
features.lic, registration key: “A4102ED8-8861-4EAE-82C3-
9BBB9C600A06” type: “Digital Signature”, expiration date:
“N/A” valid: “TRUE”. • Settings - Global Settings
Login Failed because pass-
Login failed. Password is expired. Action Audit Trail Entry
word is expired
Changed Password Changed password. Add a file path Changed Database Backup Destination from C:\
Program Data to C:\Documents
Open software EndoScan-V Version 6.0.0, Build Date: 30-Aug-2019
15:19:44 EDT opened. Check a checkbox Changed “Show Accessories in Report Setting” from
unchecked to ‘checked.
Close software EndoScan-V closed.
Uncheck a checkbox Changed “Show Accessories in Report Setting” from
Incorrect password entered Invalid Password: 2 remaining login attempts until “checked” to “unchecked”.
EndoScan-V™ account “admin” will be disabled.
Change value of a field Changed “Password Timeout - Days” from “80” to
“90”.
• Audit Trail Entries - User Management Add Disclaimer Disclaimer value changed from “N/A” to “Per our NDA”.
Add Logo image Changed logo image from abclogo.png to xyzlogo.png
Action Audit Trail Entry
Change a color value Changed SPL color value from “16711680” to
Add new user Added user “Cheryl” to the system. Full name = “Cheryl Smith”, “65280”.
Active = “checked”, Password Expired = “checked”, User Default
Password = “checked”. Change to Global Setting with Changed Auto Print setting from “Checked” to
Comments “Unchecked”. Comments: Print not required.
Add user to a
Added user “Cheryl” to the privilege group “Administrator”.
privilege group
Add user to sample Added user “Cheryl” to the following sample group(s): “All Sam- • Audit Trail Entries - Instruments
group ples”.
Add privileges to a The following privileges were added to the group Action Audit Trail Entry
privilege group “Administrator”: “Run Assay, Assay Properties, Number of
Replicates, Add Disclaimer to All Reports”. Add Instrument Instrument “nexgen-PTS™” with serial number
247582 was successfully added to the software.
Add new Sample The “CBH Samples” sample group was successfully added with
Group the following sample(s): “SWI”. Users = “N/A”. Description = Activate an instrument Changed instrument from active to inactive.
“my sample group”. Delete an instrument Instrument “2247582” configured using the computer
Add new Privilege The “Testing Staff” privilege group was successfully added with “MAR-L9X6TTT2” was successfully deleted.
Group the following privileges: xxxxxx Deactivate an instrument The active instrument type is changed from
Assign a Signature Building B Lab Manager: privilege group was successfully added BioTekELx808 to nexgen.
Role with the following privilege(s): “Auto Export and Export File Path,
Assay Name Prefix, Assay Name Suffix, Spike Recovery Range,
Include Headers in CSV, Auto Print, Allow Expired Accessories,
Require Comments for Global Settings Changes, Require Com-
ments for Post Assay Changes, Require Comment on Signature
Cancellation, Validation Terminology, Sample Limit Value
Terminology, Run Assay”. Description = “N/A
Delete a User User “TempUser” was successfully deleted.
Delete a Sample
The “CBH Samples” sample group was successfully deleted.
Group

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• Audit Trail Entries - BioTek Assay Modify Accessory Modified Accessory – Accessory Type: “Lysate”, Lot
Number: “K4432E”, Expiration Date: “31-Aug-2020”, Mod-
Action Audit Trail Entry ified Lot Number from “K4432E” to “K4432EEEE”.
Assay started Data collection started for “CRL- Delete Accessory Deleted Accessory - Type: “Cartridge”; Lot Number:
180511A-20190122-002”. “9502168”; Expiration Date: “31-Jan-2020 12: 00:00 AM”.
Assay finished Data collection stopped for “CRL- Add Accessory type Added Accessory Type “Copper tubing”.
180511A-20190122-002”.
Delete Accessory Type Deleted Accessory Type “Copper tubing”.
Added Standard/Spike to Well Changed Well: “Crl-180511A-20190122-001” “B2”
“Group Name” from “N/A” to “STD1”. Modify Accessory Type Modified Accessory Type from “Tubes” to “Tubes 25”.
Added Standard to a Well Changed Well: “CRL-1805111A-20190122-002”
“D7” Group Name” from “N/A” to STD1”.
Added Spike to a Well Changed Well: “Crl-1805111A-20190122-002”
• Audit Trail Entries - Sample Database
“D7” Group Name” from “N/A” to SPK1”.
Post assay change with com- Changed “Standard CV Limit” from “10” to “20” in
ments “CRL-180511A-20190402-002. Post Assay Action Audit Trail Entry
Comments: CV Limit set incorrectly for assay.
Add Sample Added Sample - Product Family: “WFI”, Sample Name: “Insulin 1077”,
Sample ID: “F-099”, Max. Dosage: “5”, Units: “mL/mL”, Dil/Conc.:
• Audit Trail Entries Digital Signatures “1:1”, Endotoxin Limit: “0.125”, EU Criteria: “<”, Alert Limit: N/A”,
Auto Spike: “Yes”, Spike Conc.: “0.5”, Comments: “Batch 44”.
Action Audit Trail Entry Modify Modified Sample Name “Insulin 1077”, Sample ID “F-099” Modified
Sample Comments from “Batch 44” to “Batch 55”.
Added new signature meaning Added New signature meaning (“chocolate”) for the
role “Quality Control”. Delete Deleted Accessory - Type: “Cartridge”; Lot Number: “9502168”;
Sample Expiration Date: “31-Jan-2020 12: 00:00 AM”.
User validated for digital signa- Digital Signature validation was successful for
ture “Cheryl”. Delete Acces-
Deleted Accessory Type “Petri dish”.
sory Type
User signed an assay Assay “CRL-16480018-20190122-001-SUF” was
digitally signed by “Cheryl” with the role “Analyst”. Modify
Accessory Modified Accessory Type from “Tubes” to “Tubes 25”.
User cancelled a signature Digital Signature cancelled for “CRL-7548- Type
20190401”
User cancelled a signature with
comments
Digital Signature cancelled for “CRL-7548-
20190401”. Comments: Post assay changes 14 Back Up and Restore Database
required so signature cancelled.
The Connect/Restore function in the software allows users to connect to a
database, and for specific users or administrators to restore. Most users will
• Audit Trail Entries - Accessory Database not have both privileges. The Restore function will rarely be used, and if so, by a
System Administrator.

Action Audit Trail Entry Connect/Restore Window

Add Accessory Added Accessory - Type: “Cartridge”; Description: The Connect/Restore window can be accessed from the login screen when
“Endotoxin”, Product Code: “% - 0.05”, Lot Number:
“9502168”. Calibration Code:”512739865311”, Expiration the software is started up.
Date:”31-Jan-2020 12:00 AM”.

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Select Connect/Restore Database, and the following screen is displayed.
If an error has been made, the software will display the following error screen:

If the connection is unsuccessful, the Database Address and Database Port will
14.1 CONNECT TO DATABASE not be stored, and the fields will be filled in with the last successful connection
The following fields are required to be filled in correctly in order to successfully Database Address and Database Port or blank if there has not been a successful
connect. connection yet.

Database Address is the IP address of the Database. If the database is on the 14.2 BACKUP DATABASE
local PC, the Database Address will be localhost.
Backups of all the data in the database should be regularly created. This feature
Database Port is used to communicate to the database. By default, it is set to can be set up as a recurring task by using the Auto-backup feature or can also be
the CRL standard of 18083. created in the moment by simply clicking on the Backup Now button.
When these fields are populated, click the Connect to Database button. The Authorized users are granted access to the Global Settings/Security tab.
user should then receive a message saying ‘Successfully connected to
Database’, as below.

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 In the next box, under Backup Interval – Days, enter the number of days you
wish to pass until the next backup is performed.

Then, select the Security tab on the left-hand side, where the Server Backup
Details section is found.

The Prefix field can be used to create an identifier to change the default,
which is discussed in the Naming Convention section below.

The time of the Next Backup can be set by clicking the calendar icon in the
drop down, as below. The date can be selected from the calendar, and once
the date is selected, the time of day can be manually entered.

The backup process will be run using the Computer Account of the system where
EndoScan-V™ Services is installed. If a network share is being used to save the
backup data this Computer Account must be given access to that network share.
If a database error occurs with EndoScan-V™ the software will create offline files
located in “C:\ProgramData\Charles River\EndoScan-V\Offline\Audit Trail and C:\
ProgramData\Charles River\EndoScan-V\Offline\Plate”. Once a database connection
is reestablished the files will then be imported into the database with the correct
timestamps and actions or assays that were performed during the disconnected
period. These files are locked down to the SYSTEM user of the PC and will not be
able to be deleted before or after they are successfully imported. Finally, Backup Destination can be established by using the Browse button
and navigating to a folder. We recommend using a network location and a
14.3 AUTO-BACKUP secure folder where the data is protected.
To enable automatic backups, select Yes from the Backups Enabled drop down
menu.

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Clicking on the Apply button will commit the backup schedule. Click OK to close
the window and return to the main EndoScan-V™ 6.0 window.

14.4 BACKUP NOW

Administrators can choose to make an immediate backup of the database if
required. To do this, simply click the Backup Now button. An immediate backup
will be created to the pre-established Backup Destination, using the filename as in
the Naming Convention section below.

From the next screen, select Browse and the software will open a window
where the user can navigate to the folder where backups are stored.
Select the .tar (backup) file to restore, and click Open.

A message will appear in the lower right-hand corner of the screen which states After Restore is clicked, the software will create a backup of the database
Starting Database Backup. Once completed, a message will appear that states and then populate it with the file that was selected for restore.
Backup Complete.

14.5 Restore Database

The Restore Database function will rarely be used, only if a customer had a cat-
astrophic failure and needed to restore their complete EndoScan-V™ 6.0 database
from a backup.
Restore Database function is only available under the following conditions:

• The Windows user is in the EndoscanAdmins Windows group.

• The Windows user is logged on to the PC where the database is
stored.
• The EndoScan-V™ 6.0.Services software is installed on the PC.

Charles River recommends performing a Backup of the current database before Click Yes to restore the database, the following confirmation screen will
performing the Restore function. Once a backup is done, proceed with the display.
Restore as below.
The Restore function is found from the login screen of the software.
Click Settings, then select Connect/Restore Database.

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 If the user has the Scheduled Backup feature turned on, the file name will be
created as:
Prefix_EndoScan-VScheduledBackupYYYY-MM-DD_HH-MM-SS
Example: Prefix_EndoscanVSchduledBackup2019-04-10_15-23-56.tar
If the user initiates a Backup Now function, the file name will be created as:
Prefix_EndoScan-VImmediateBackupYYYY-MM-DD_HH-MM-SS
Example: Prefix_EndoscanVImmediateBackup2019-04-10_15-23-56.tar
If the user initiated a Restore database call, the file name will be created as:
Prefix_EndoScan-VRestoreBackupYYYY-MM-DD_HH-MM-SS
Choose No to abort the restore, the following screen will display.
Example: Prefix_EndoscanVRestoreBackup2019-04-10_15-23-56.tar

Any Backup or Restore functions will be noted in the audit trail, as below.

File Naming Conventions for Backup Files

Different naming conventions will be used to make the backup file type easier
to identify by the filename.

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