Computerised System Validation eBooklet

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice and the application of risk management in Computerised System Validation. The Principles are applicable to all regulated computerised systems, particularly those used within the pharmaceutical industry.

Much of the information within this booklet has been developed concurrently with the RQA Professional Development Course on 'Auditing Computerised Systems' and 'Computerised System Validation'.

Contents

1. Introduction
2. The Validation Process
3. The Regulations
4. Risk Management
5. Project Deliverables
6. Validation Process
7. Qualifications
8. Validation Strategy
9. Appendix A - Example User Requirements Specification
10. Appendix B - Example Functional Design Specification
11. Appendix C - Example System Design Specification
12. Appendix D - Example Traceability Matrix
13. Appendix E - Example Test Script
14. Appendix F - References
15. Appendix G - Example Architecture Diagram
16. Appendix H - The Iterative or Prototyping CSV Model

Authors

Chris Montgomery and the RQA Computing Committee

ISBN

978-1-904610-20-5

Published

First printed December 2008

Reviewed January 2013