FERRING INTERNATIONAL CENTER

Document ID Document Name Page

Computer System Design Specification 1 of 20

Equipment/System

Pentasa Manufacturing Automation (406)

Author Reviewer System Owner QA Approver

Name

Role

Date

Signature
 FERRING
BM2 automation Retrofit

Computer System Design Specification

File Reference
Version
Business Number Document Number
17119010 A03-006 05.00

Ingénierie Industrielle Automation Ingénierie Tertiaire

Document : EKIUM :774402109.docx

 PC

APPROVALS

NAME POSITION DATE VISA

NAME POSITION DATE VISA

NAME POSITION DATE VISA

Change History
Revision Date Object of the Version Redaction Verification
01 09/10/2018 Original version MONTERYMARD N. PONSIN E.
Update with the licences of
02 11/12/2018 MONTERYMARD N. PONSIN E.
the test platform
03 27/05/2019 For signature BOHLY J. PONSIN E.
04 07/06/2019 For Signature BOHLY J. PONSIN E.
Update for iFix 2023 / Coaters
retrofit
05 13/11/2023 JOUBERT S. LY J.
Separation between iFix 2023
and iFix 5.9

Document : EKIUM : 774402109.docx

EQS 034 3 / 20
 PC

Table of Contents

1 Purpose...........................................................................................................5
2 References......................................................................................................5
3 Abbreviations................................................................................................6
4 Overview........................................................................................................7
5 Detailed Description......................................................................................7
5.1 General......................................................................................................................................7
5.2 Virtual infrastructure..............................................................................................................8
5.3 Dataflow....................................................................................................................................8
5.3.1 Dataflow between PLC and Runtime Server....................................................................................8
5.3.2 Dataflow between Runtime Server and Historian Server.................................................................8
5.4 Software....................................................................................................................................9
5.4.1 Operating System Windows..............................................................................................................9
5.4.2 Automation......................................................................................................................................10

6 Licenses Production....................................................................................15
6.1 Licenses HISTORIAN...........................................................................................................15
6.2 Licenses iFIX Clients.............................................................................................................16
6.3 Licenses SCADA....................................................................................................................16
6.4 License Development Server.................................................................................................17
6.5 Licenses IGS Drivers.............................................................................................................17
6.6 License Dream Report...........................................................................................................18
7 Licenses not used / not activated................................................................18
7.1 Licenses HISTORIAN...........................................................................................................18
7.2 Licenses SCADA....................................................................................................................19
7.3 Licenses IGS Drivers.............................................................................................................19

Document : EKIUM : 774402109.docx

EQS 034 4 / 20
 PC

1 Purpose
The purpose of this detailed software design specification is to define all the software implemented in
relation to the functional specification for the FERRING "BM2 Automation Retrofit Project" project of
the Saint Prex site.

This document describes the rules put in place and the technical software specifications for 013 Coater
1, 313 Coater 2, 304 Coating Solution and 305 Granulation Solution.
The hardware and network design documents complement this document to fully meet the functional
specification of the project.

2 References
This document is based on the following elements :

Description EKIUM’s reference

Detailed Network Architecture 17119010A03-008-Detailed Network
Architecture
Computer System Design Specification 17119010A03-006-CSDS-Computer System
Design Specification
Network Design Specification 17119010A03-005-NDS-Network Design
Specification
Hardware Design Specification 17119010A03-003-HDS-Hardware Design
Specification
Functional Analysis of supervision - Solution 17119010A03-021-Functional Analysis of
Systems -v04.00 supervision - Solution Systems -v04.00
Functional Analysis Report of 304 - 940 - Solution 17119010A03-025-Functional Analysis Report
Systems -v03.00 of 304 - 940 - Solution Systems -v03.00
Functional Analysis Report of 305 - Solution 17119010A03-024-Functional Analysis Report
Systems -v03.00 of 305 - Solution Systems -v03.00
Functional Analysis of supervision – Coater To be created
Systems -
Functional Analysis Report of 013 - Coater To be created
Systems
Functional Analysis Report of 313 - Coater To be created
Systems

Document : EKIUM : 774402109.docx

EQS 034 5 / 20
 PC

3 Abbreviations
Automation
DFS : Detailed Functional Specification
AI : Analog Input
PLC : Programmable Logic Controller
AO : Analog Output
DI : Digital Input
DO : Digital Output
I/O : Input / Output
FAT : Factory Acceptance Test
HMI: Human-Machine Interface
SAT : Site Acceptance Test
CCS : Command Control System
SCADA : Supervisory Control and Data Acquisition
SNMP : Simple Network Management Protocol
A&E: Alarm and Events
S&F: Store and Forward

Qualification
CSDS: Computer System Design Specification
HDS : Hardware Design Specification
NDS : Network Design System
DQ : Design Qualification
IQ : Installation Qualification
OQ : Operational Qualification
QP : Performance Qualification
SMDS : Software Module Design Specification
URS : User Requirement Specification

Document : EKIUM : 774402109.docx

EQS 034 6 / 20
 PC

4 Overview
The CCS system consists of different standard hardware components of the market. No material was
specifically designed for this project.

The CCS system allows the visualization of all system variables, the management of environments, the
management of configuration and development tools.

The configuration of all these pieces of software and their implementations are described in the
following chapters.

It is planned to install two platforms :

- A test platform for training and testing,
- A platform for environment production.
But only the environment production platforms exist for Solution (in iFix 5.9), Granulation (in iFix 5.8)
and Solution (in iFix 2023)

5 Detailed Description
5.1 General
The CCS system consists of a set of software running on different types of hardware.

In GAMP 5 software categories are defined. The table below lists these :

Category Description Comment

Infrastructure software
These are the recognized operating systems available
1 including operating
commercially.
systems
2 Removed Removed (see below)
Non-configurable These are the software packages offering a solution
3
software available in the state, to the industrial process
These are the software packages specifically configured
4 Configured software
to define the process (SCADA, LIMS, …).
These are software packages developed to meet the
5 Bespoke software
specific needs of the company or process.

Category 2 from GAMP 4 has been removed. This is related to firmware.

At the time when GAMP4 was issued firmware was mainly considered to be used for simple
instruments.
However, as technology has advanced it has been recognized that complex software can be
embedded (firmware) within systems.

For configurable software packages of category 4, only the configuration necessary for the definition
of the architecture is detailed.
The specific configuration for defining the method is defined in the design specification document
related to the integration.

The various pieces of software are classified and analyzed according to the predefined categories, this
also makes it possible to optimize the validation approach for the whole system.

Document : EKIUM : 774402109.docx

EQS 034 7 / 20
 PC

Document : EKIUM : 774402109.docx

EQS 034 8 / 20
 PC

5.2 Virtual infrastructure

All virtual servers are installed on a virtualization infrastructure.

This infrastructure is provided by Ferring's IT services.

GE recommends to use VMware for the virtualization because their software is tested on VMware
Platform. However, it’s possible to use others solution like HyperV which is the FERRING standard.
Only VirtualBox is not supported.

5.3 Dataflow
5.3.1 Dataflow between PLC and Runtime Server
The figure below summarizes the data exchanges between a PLC and a Runtime server.

5.3.2 Dataflow between Runtime Server and Historian Server

The figure below summarizes the data exchanges between a Runtime server and the Historian server.
The A&E Collector has Store and Forward (S&F) functionality that allows data to be stored locally on
the Runtime server in the event of a network problem.

Document : EKIUM : 774402109.docx

EQS 034 9 / 20
 PC

5.4 Software
5.4.1 Operating System Windows

Concerning the update of Windows operating systems, a note is specified by General Electric in the
document "Getting started" of iFIX:

Concerning the time setting of the servers, a recommendation is specified in the document "Getting
started" of iFIX:

The name of the servers and workstations must respect the naming conventions in Active Directory for
computers, domains, sites provided by Microsoft. It does not use “FIX32” as machine’s name (keyword
for IFIX).

5.4.1.1 Runtime & Historian Server for iFix 2023 (Coater)

Application Machine name Designation Windows Quantity

Supervision server Coater I&II Server 1 FECH3736VS Windows Server 2019 Standard 1
Supervision server Coater I&II
FECH3740VS Windows Server 2019 Standard 1
Server2
Historian, SQL & Dream Report Server
FECH3734VS Windows Server 2019 Standard 1
Coater
Terminal Servers 1 Coater I & II FECH3735VS Windows Server 2019 Standard 1

Terminal Servers 2 Coater I & II FECH3737VS Windows Server 2019 Standard 1

Total 5

5.4.1.2 Runtime & Historian Server for iFix 5.9 (Solution)

Application Machine name Designation Windows Quantity
Supervision server Solution System
FECH3584VS Windows Server 2012R2 Standard 1
Server 1
Supervision server Solution System
FECH3585VS Windows Server 2012R2 Standard 1
Server 2
Historian & Dream Report Server FECH3583VS Windows Server 2012R2 Standard 1

Terminal Servers 1 FECH3597VS Windows Server 2012R2 Standard 1

Terminal Servers 2 FECH3598VS Windows Server 2012R2 Standard 1

Total 5

Document : EKIUM : 774402109.docx

EQS 034 10 / 20
 PC

5.4.1.3 Development Workstation for iFix 2023 (Coater)

Application Machine name Designation Windows Quantity

Development workstation iFix 2023 FECH3DTP0625 Windows 10 64 bits Enterprise 1

Total 1

5.4.1.4 Development Workstation for iFix 5.9 (Solution)

Application Machine name Designation Windows Quantity

Development workstation iFix 5.9 FECH3DTP0602 Windows 10 64 bits Enterprise 1

Total 1

Windows 10 version should be used with Thin client.

5.4.1.5 Client iFix 5.9

For the thin clients, it’s necessary to be connected on each Runtime server using a remote desktop
session.
For this, the client computer must have at least Windows XP SP3.
In the future, it is recommended to use Windows 10 64 bits Enterprise as the operating system.

To connect to the Runtime server, it is necessary to have a user account that will automatically launch
the IFIX application at the start of the session without running Windows.

5.4.1.6 Client iFix 2023

For the thin clients, it’s necessary to be connected on each Runtime server using a remote desktop
session.
For this, the client computer must have at least Windows 10 64 bits Enterprise as the operating system.

To connect to the Runtime server, it is necessary to have a user account that will automatically launch
the IFIX application at the start of the session without running Windows.

5.4.1.7 Client Antivirus

GE Digital encourages customers to use third-party anti-virus software of their choice and to keep it
up-to-date with the latest updated versions.
GE Digital does not specifically certify or recommend any particular anti-virus vendor's software.
Following this, the same McAfee antivirus implemented on the Ferring site will be used for the project
servers.

5.4.2 Automation
5.4.2.1 General Electrics (Supervision)
The different software must be installed in the same language as the Operating System.

5.4.2.1.1 License Management

All IFIX licenses are installed on the Historian server.
At installation, for each server and workstation, the license is transferred from the Historian server.
Thereafter, the server (or workstation) connects to the "License Server" tool every day at midnight to
verify that its license is still valid. After 21 days (configurable duration) without verification, the
application is no longer functional.

Document : EKIUM : 774402109.docx

EQS 034 11 / 20
 PC

5.4.2.1.2 Licenses for iFix 2023 (Coater)

The table below lists all licenses required to install all servers :

Coater 1 & 2

Coater 1 & 2

Dev. Station
Servers 1
Historian

Terminal

Terminal
Server 1

Server 2

Server 2
Designation Reference Quantity

iFix v2023 Plus Development Unlimited Points English

Electronic Signature IF2023PDUNLEN-E 1 1
+ Microsoft® VBA 6.5
iFix v2023 Plus Runtime Unlimited Points English SCADA
Synchronization Electronic Signature IF2023PRUNLEN-SE
1 1 2
+ Historian v2023 Standard 400 Points 2500 HS20230S000042500-A
Addditionnals CALs Alarms and events
iClient v2023 Thin-Terminal Services Runtime English 1 2
IC2023TSREN-C001E 1 1
Client Electronic Signature (2*1 clients)
Historian Enterprise v2023 1000 points 2500 Addditionnals
CALs eSignature HS2023E0000102500-E 1 1
1 x Collector Historian Server to Server
Legacy Collector
History of local SCADA data on the local Historian supplied Not Applicable 1 1 1 3
with Historian
Collector Server to Server
History of local SCADA data on the Historian server Not Applicable 1 1 1 3
supplied with Historian
Collector Historian Alarm&Events
History of local SCADA alarm and event data on Historian Not Applicable 1 1 2
server supplied with Historian
Siemens communication driver (IGS) supplied with iFIX DR-G00P253V0 1 1 1 3
Dream Report for Proficy v2023 GE 1000 Additional Tags
DE2023GA01000N005E 1 1
5 Additional CALS Life Science (ESig)
Adobe Acrobat Reader Version 2018 1 1 1 3

Document : EKIUM : 774402109.docx

EQS 034 12 / 20
 PC

Coater 1 & 2

Coater 1 & 2

Dev. Station
Servers 1
Historian

Terminal

Terminal
Server 1

Server 2

Server 2
Designation Reference Quantity

General Electric License Server (for the distribution of the

20.6.2341.0 1 1
licence to the different servers)
Windows Client Access License (CAL) for Remote Desktop
CAL-RDP 2 2 4
Services
SQL Server standard 2019 2019 1 1

5.4.2.1.3 Licenses for iFix 5.9 (Solutions)

The table below lists all licenses required to install all servers :

Dev. station
Solutions

Solutions

Servers 1
Historian

Terminal

Terminal
Server 1

Server 2

Server 2
Designation Reference Quantity

iFix v5.9 Plus Development Unlimited Points English Electronic

Signature IF59PDUNLEN-E 1 1
+ Microsoft® VBA 6.5
iFix v5.9 Plus Runtime Unlimited Points English SCADA
IF59PRUNLEN-SE
Synchronization Electronic Signature + Historian v7.0 Standard 1 1 2
HS70S000042500-A
400 Points Alarms and events
2
iClient v5.9 Thin-Terminal Services Runtime English 4 Clients
IC59TSREN-C004E 1 1 (2*4 clients pour
Electronic Signature
solution)
Historian Enterprise v7.0 1000 points Two Mirror
HS70E0000100000-EM2 1 1
1 x Collector Historian Software to Software
Legacy Collector
History of local SCADA data on the local Historian Not Applicable 1 1 1 3
supplied with Historian DVD

Document : EKIUM : 774402109.docx

EQS 034 13 / 20
 PC

Dev. station
Solutions

Solutions

Servers 1
Historian

Terminal

Terminal
Server 1

Server 2

Server 2
Designation Reference Quantity

Collector Server to Server

History of local SCADA data on the Historian server Not Applicable 1 1 1 3
supplied with Historian DVD
Collector Historian Alarm&Events
History of local SCADA alarm and event data on Historian
Not Applicable 1 1 2
server
supplied with Historian DVD
Siemens communication driver (IGS) supplied with iFIX DVD DR-G00P253V0 1 1 1 3
Dream Report for Proficy v4.8 Standard 1000 Additional Tags
DE48ST01000C006-E 1 1
6+2 Additional CALS Electronic Signature
Adobe Acrobat Reader Version 2018 1 1 1 3
General Electric License Server (for the distribution of the
18.2.1361.0 1 1
licence to the different servers)
Windows Client Access License (CAL) for Remote Desktop
CAL-RDP 4 4 8
Services
SQL Server standard 2012 2012 1 1

Additional Requirements for the Historian server

- NET Framework 3.5 and .NET Framework 4.61,
- IIS (Internet Information Services) feature,
- The current Windows user must have administrator rights on the machine to install the different products,
- A user needs to have local administrative rights to run and use Dream Report,
- The following components of Dream Reports must be unblocked on the firewall :
o Logger RT.exe,
o USC.exe,
o Generator.exe

Document : EKIUM : 774402109.docx

EQS 034 14 / 20
 PC

5.4.2.2 Siemens
5.4.2.2.1 SIEMENS STEP7 (development software)
Designation Quantity
Step7 v5.6
1
Without Service Pack

5.4.2.2.2 SIEMENS TIA PORTAL (development software)

Designation Quantity
TIA PORTAL Professional V15
1
Without Service Pack

Document : EKIUM : 774402109.docx

EQS 034 15 / 20
 PC

6 Licenses Production
6.1 Licenses HISTORIAN

Legacy Serial Contract Contract Activation

Qty Description Serial Number Activate ON
Number Level End Code
1 Historian v2023 Enterprise 1000 Points 2500 3-26058101-040- 200124405, AP 7/24/2024 E15D-35C4- FECH3583VS
Additional CALs eSignature 001 200124405-01, Premier 6DE1-CFED
200124405-02,
200124405-03
1 Historian v2023 Enterprise Additional Server Add-on En attente N/A AP 7/24/2024 En attente FECH3734VS
Premier

Historian v7.0 Standard 400 Points Alarms and 3-26058101-070- N/A AP 7/24/2024 C296-C197- FECH3585VS
1
Events 001 Premier 7403-932E
Historian v7.0 Standard 400 Points Alarms and 3-26058101-049- N/A AP 7/24/2024 13F6-3EC5- FECH3584VS
1
Events 001 Premier 0EDD-A098
Historian v2023 Standard 400 Points Alarms and 3-26058101-027- N/A AP 7/24/2024 2AAE-BAE9- En attente
1
Events 001 Premier 3505-627E
Historian v2023 Standard 400 Points Alarms and 3-26058101-132- N/A AP 7/24/2024 1106-44C0- En attente
1
Events 001 Premier 8448-FCBD

Document : EKIUM : 774402109.docx

EQS 034 16 / 20
 PC

6.2 Licenses iFIX Clients

Legacy Serial Contrac Contract Activation

Qty Description Serial Number Activate ON
Number t Level End Code

1 iClient v5.9 Thin-Terminal Services Runtime English 4 3-26058101- 100153194, AP 7/24/2024 D660-81C9- FECH3598VS
Client Electronic Signature 055-001 100153194-01 Premier C31A-6C29

1 iClient v5.9 Thin-Terminal Services Runtime English 4 3-26058101- 100148374, AP 7/24/2024 17DD-228A- FECH3597VS
Client Electronic Signature 052-001 100148374-01 Premier E8D6-65A9

1 iClient v2023 Thin-Terminal Services Runtime English 1 En attente En attente AP 7/24/2024 En attente En attente
Client Electronic Signature Premier

1 iClient v2023 Thin-Terminal Services Runtime English 1 En attente En attente AP 7/24/2024 En attente En attente
Client Electronic Signature Premier

6.3 Licenses SCADA

Legacy Serial Contract Contract Activation
Qty Description Serial Number Activate ON
Number Level End Code
1 iFix v5.9 Plus Runtime Unlimited Points English SCADA 3-14479801- 100149648 AP 8/21/2024 6D9F-7974- FECH3534VS
Synchronization Electronic Signature 003-001 Premier 70FB-B316
1 iFix v5.9 Plus Runtime Unlimited Points English SCADA 3-14479801- 100253671,2 AP 8/21/2024 19AF-5A86- FECH3536VS
Synchronization Electronic Signature 005-002 Premier 52C8-A82B
1 iFix v2023 Plus Runtime Unlimited Points English 3-14479801- 100253671,2 AP 8/21/2024 C141-3AEF- FECH3735VS
SCADA Synchronization Electronic Signature 005-001 Premier 6DA8-6348
1 iFix v2023 Plus Runtime Unlimited Points English 3-26058101- 100148373, AP 6/27/2024 AD0C-EFE9- FECH3735VS
SCADA Synchronization Electronic Signature 011-001 100148373-01 Premier 7CA8-42B6

Document : EKIUM : 774402109.docx

EQS 034 17 / 20
 PC

6.4 License Development Server

Legacy Serial Contract Contract Activation

Qty Description Serial Number Activate ON
Number Level End Code
1 iFix v5.9 Plus Development Unlimited Points English 3-26058101-141- N/A AP 8/21/2024 A683-0EA1- FECH3DTP0602
Electronic Signature 001 Premier 3B82-EC1E
iFix v2023 Plus Development Unlimited Points English En attente N/A AP En En attente En attente
Electronic Signature Premier attente

6.5 Licenses IGS Drivers

Legacy Serial Contract Contract Activation

Qty Description Serial Number Activate ON
Number Level End Code
1 Drivers IGS- Industrial Gateway Server for Basic Points 3-26058101-108- N/A AP 8/21/2024 6ECD-9F8F- FECH3585VS
253 Additional IGS Protocols IOT Gateway plug in No 001 Premier 6627-0EFA
Tags
1 Drivers IGS- Industrial Gateway Server for Basic Points 3-26058101-105- N/A AP 8/21/2024 2DBC-1D9D- FECH3584VS
253 Additional IGS Protocols IOT Gateway plug in No 001 Premier C1A5-7044
Tags
1 Drivers IGS- Industrial Gateway Server for Basic Points 3-26058101-102- N/A AP 8/21/2024 4DCD-2D40- En attente
253 Additional IGS Protocols IOT Gateway plug in No 001 Premier B3A6-2AE6
Tags
1 Drivers IGS- Industrial Gateway Server for Basic Points 3-26058101-120- N/A AP 8/21/2024 4CB5-4264- En attente
253 Additional IGS Protocols IOT Gateway plug in No 001 Premier B639-7B1F
Tags
1 Drivers IGS- Industrial Gateway Server for Basic Points 3-26058101-111- N/A AP 8/21/2024 E74D-35A8- En attente
253 Additional IGS Protocols IOT Gateway plug in No 001 Premier D993-43B9
Tags

Document : EKIUM : 774402109.docx

EQS 034 18 / 20
 PC

6.6 License Dream Report

Legacy Serial Contrac Contract Activation

Qty Description Serial Number Activate ON
Number t Level End Code
1 Dream Report for Proficy v4.8 Standard 1000 3-26058101-123- N/A AP 8/21/2024 CDA4-F852- FECH3583VS
Additional Tags 6 Additional CALS Electronic Signature 001 Premier 97A2-B10E
1 Dream Report for Proficy v2023 GE 1000 Additional En attente N/A AP 8/21/2024 En attente En attente
Tags 5 Additional CALS Life Science (ESig) Premier

7 Licenses not used / not activated

7.1 Licenses HISTORIAN

Contract Contrac
Qty Description Serial Number Legacy Serial Number Activation Code
Level t End
E24A-01BD-
1 Historian v7.0 Standard 400 Points Alarms and Events 3-26058101-012-001 N/A None N/A
0473-A4A5
55F2-036B-76DA-
1 Historian v7.0 Standard 400 Points Alarms and Events 3-26058101-022-001 N/A None N/A
5C7D
1 Historian v7.0 Essential 1000 Points 3-26058101-142-001 6A31-F0BF-97B3-
N/A None N/A
8013

Document : EKIUM : 774402109.docx

EQS 034 19 / 20
 PC

7.2 Licenses SCADA

Contract Contract Activation

Qty Description Serial Number Legacy Serial Number
Level End Code
1 iFix v5.9 Plus Runtime Unlimited Points English SCADA E009-19DE-
Synchronization Electronic Signature 3-038193-003-001 N/A None N/A 998F-BF90
1 iFix v5.9 Plus Runtime Unlimited Points English SCADA 0E2D-0579-
Synchronization Electronic Signature 3-038193-003-002 N/A None N/A 3ED7-934D

7.3 Licenses IGS Drivers

Qt Contract Contract Activation

Description Serial Number Legacy Serial Number
y Level End Code
1 Drivers IGS- Industrial Gateway Server for Basic Points 253 3-26058101-117- 1596-C24C-
Additional IGS Protocols IOT Gateway plug in No Tags N/A None N/A E5C1-2261
001
1 Drivers IGS- Industrial Gateway Server for Basic Points 253 3-26058101-114- F63B-C13F-
Additional IGS Protocols IOT Gateway plug in No Tags N/A None N/A 8C6B-2257
001

Document : EKIUM : 774402109.docx

EQS 034 20 / 20