This talk was presented by Tanja Picker (Adesso) at Intland Connect: Annual User Conference 2020 on 21 Oct 2020. To learn more, visit: https://intland.com/intland-connect-annual-user-conference-2020/

1. - using codeBeamer ALM
Principles of Tool Validation and Infrastructure Qualification
Intland Annual
User Conference
2020
Tanja Picker
adesso SE
+49 152 380 973 18
Tanja.Picker@adesso.de
www.adesso.de
Intland Annual
User Conference
2020
Tanja Picker
adesso SE
+49 152 380 973 18
Tanja.Picker@adesso.de
www.adesso.de

2. 10/21/2020 adesso SE2
“… you should accept the current
regulations as representing the
distilled wisdom of past
experience."
John J. Tobin and Gary Walsh 2008
Medical Product Regulatory Affairs: Pharmaceuticals, Diagnostics, Medical
Devices
DOI:10.1002/9783527623037

3. 10/21/2020 adesso SE3
HAMBURG
BASEL
BERN
ZURICH
STRALSUND
HANNOVER BERLIN
DORTMUND
JENAAACHEN
COLOGNE
FRANKFURT
NUREMBERGKARLSRUHE
STUTTGART
MUNICH VIENNA
BARCELONA
SOFIA
ISTANBUL
EUR 449,70 million
Group sales 2019
More than 4.200 employees
adesso Group | as at 30 June 2020
LUGANO
ROSTOCK

4. adesso AG10/21/20204
Principles of Tool Validation and Infrastructure Qualification
- using codeBeamer ALM
• Compliance in Software Development
• codeBeamer configurations
• Project learnings
Agenda

5. adesso AG10/21/20205
Principles of Tool Validation and Infrastructure Qualification
- using codeBeamer ALM
• Compliance in Software Development
• codeBeamer configurations
• Project learnings
Agenda
Verification Validation Evaluation Qualification

6. 10/21/2020 adesso SE6
Computer-
System-
Validation
(CSV)
Verification &
Validation
of MD/IVD
SOUP-
Evaluation
Tool-
Validation
Infrastructure
Qualification
Compliance in medical software development
MDR/IVDR
IEC 62304
ISO 14971
(MDR/IVDR)
IEC 62304
ISO 13485
GAMP 5
ISO TR 80002 – 2
GxP
GAMP BPG
GxP
GAMP 5
GMP Annex 11

7. adesso AG21.10.20207
Projects
Principles of Tool Validation and Infrastructure Qualification
- using codeBeamer ALM
• Compliance in Software Development
• codeBeamer configurations
• Project learnings
Agenda
Tracker Fields Traceability

8. Every product is represented as project in codeBeamer
10/21/2020 adesso SE8
Computerized
System
Medical
Device
Invitro-
Diagnostic

9. Content of validation documents is stored in tracker
10/21/2020 adesso SE9
Medical Solution Example Company
2015-05-28
Titelblatt.v04.doc
VERTRAULICH
1 von 8
SYSTEM
REQUIREMENTS
Aktuelle Version: 4
Freigabe: Von:
Letzte Änderung: 28.05.2015 Von: tw
Erstellungsdatum: 06.11.2014 Von: tw
Historie:
Datum Name Version Bemerkung
28.05.2015 tw 4 Korrekturen Zeichnungen / Wording
10.11.2014 tw 3 RFID und 3D-Printing rein
09.11.2014 tw/nw 2 Überarbeitet und ergänzt
06.11.2014 tw 1 Neu
Medical Solution Example Company
2015-05-28
Titelblatt.v04.doc
VERTRAULICH
5 von 8
ARCHITECTURE
Aktuelle Version: 1
Freigabe: Von:
Letzte Änderung: 28.05.2015 Von: tw
Erstellungsdatum: 06.11.2014 Von: tw
Historie:
Datum Name Version Bemerkung
06.11.2014 tw 1 Neu
Medical Solution Example Company
2015-05-28
Titelblatt.v04.doc
VERTRAULICH
6 von 8
DETAIL
DESIGN
Aktuelle Version: 4
Freigabe: Von:
Letzte Änderung: 28.05.2015 Von: tw
Erstellungsdatum: 06.11.2014 Von: tw
Historie:
Datum Name Version Bemerkung
28.05.2015 tw 4 Korrekturen Zeichnungen / Wording
10.11.2014 tw 3 RFID und 3D-Printing rein
09.11.2014 tw/nw 2 Überarbeitet und ergänzt
06.11.2014 tw 1 Neu
Medical Solution Example Company
2015-05-28
Titelblatt.v04.doc
VERTRAULICH
4 von 8
FMEA
Aktuelle Version: 4
Freigabe: Von:
Letzte Änderung: 28.05.2015 Von: tw
Erstellungsdatum: 06.11.2014 Von: tw
Historie:
Datum Name Version Bemerkung
28.05.2015 tw 4 Korrekturen Zeichnungen / Wording
10.11.2014 tw 3 RFID und 3D-Printing rein
09.11.2014 tw/nw 2 Überarbeitet und ergänzt
06.11.2014 tw 1 Neu

10. IT Infrastructure and Tools as support project
10/21/2020 adesso SE10
PRODUCTS
SUPPORT

11. IT Infrastructure used for regulated systems (CS and IVD)
10/21/2020 adesso SE11

12. Infrastructure items analysis and documentation in codeBeamer
10/21/2020 adesso SE12
Documentation (Tracker)
Risk
Test Case (OQ)
Operation &
Maintenance
Product
Infrastructure
Element
Supplier
Qualification
Instance
Qualification Plan

13. Infrastructure project in codeBeamer
10/21/2020 adesso SE13
Documentation (Tracker)
Risk
Test Case (OQ)
Product
Infrastructure
Element
Supplier
Qualification

14. Infrastructure Elements – views in codeBeamer
21.10.2020 adesso SE14

15. Support project Tool-Validation in codeBeamer
10/21/2020 adesso AG15
Documentation (Tracker)
Risk
Test Case
Project Tool
Supplier
Qualification
Specification
Requirement

16. Alternative – Tools as part of product project
21.10.2020 adesso SE16

17. Example: Tool validation in one tracker
10/21/2020 adesso SE17

18. Support projects vs. combined tracker in product project
Support Projects Tracker in Product Projects
Simple tools with low risks
Existing ITSM solution
Few managed products
10/21/2020 adesso SE18
Complex tools
Infrastructure
Several managed products

19. adesso AG10/21/202019
Principles of Tool Validation and Infrastructure Qualification
- using codeBeamer ALM
• Compliance in Software Development
• codeBeamer configurations
• Project learnings
Agenda

20. Pitfalls and Recommendations
21.10.2020 adesso SE20
Support your team in starting phase
• Playgrounds
• Project and tracker inherence
• Views and links
Tracker Configuration
• Keep permissions simple
• Start with few fields and sort them in tracker configuration
• CustomFields: Do not use Property Names for different content
Versioning of items
• Baselining for important project steps/stages
• Tracker item for document history

21. Thank you
adesso SE21 Tanja Picker
adesso SE
+49 152 380 973 18
Tanja.Picker@adesso.de
www.adesso.de
Life Sciences @ adesso SE
• Regulated Environment
• FDA 21 CFR Part 11
• CSV
• DIN EN ISO 13485 14971
• IEC 62304 62366
• Medical SPICE
GAMP 5 | MDR IVDR
REGULATORY
V-MODEL | AGILE
• PMI / PRINCE2
• Agile Methods
• Usability Engineering (UX)
• IREB (RE), Design Thinking
• ISTQB (Test)
• iSAQB (Architecture)
METHODSPROJECT EXAMPLES
• codeBeamer Implementation and Configuration
using adesso Templates for GAMP, MD/IVD, SPICE
• Development Medical Device Software
• ERP Validation Pharmaceutical Wholesale
• Design & Development of mobile Apps in MedTec
• Implementation of Quality Management Systems
• Computer System Validation (CSV)