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Auditing Computerised Systems Booklet

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice in the auditing of computerised systems. The principles are applicable to all computerised systems audits, but particularly those used within the pharmaceutical industry.


  1. Foreword
  2. Acknowledgement
  3. Introduction
  4. Objective
  5. The System Life Cycle (SLC)
  6. Risk Management
  7. Validation Deliverables
  8. Change Control 
  9. Planning an Audit 
  10. Audit Types 
  11. The Principles of Data Integrity 
  12. Archiving Principles 
  13. Regulations and Guidance 
  14. References 
  15. Appendix I – Computerised System Audit Checklists 
  16. Appendix II – Definitions and Acronyms


Christopher Montgomery and the RQA Computing Committee




January 2013

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

  • 266236BOOK10 for orders of 10 - 19 copies - 25% discount
  • BOOK20 for orders of 20 - 49 copies - 33% discount
  • BOOK50 for orders over 50 copies - 50% discount

This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.

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