Jump to content

Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability

Hard Copy:

Computerised System Validation (CSV) Buy Now

Get it instantly by purchasing the PDF eBooklet:

Buy this on Selz Selz powering ecommerce websites

 

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

Price

Normal Price £10.00 

(save up to 50% if purchasing over 10 booklets, click here for more information)

ISBN

978-1-904610-20-5

Published

First printed December 2008

Reviewed January 2013

 


We also recommend

Booklets

Auditing Computerised Systems
Management of the training and competency of personnel in GxP and research environments - Part 1: An introduction to training systems

Professional Development Courses

Auditing Computerised Systems
Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability