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Auditing Computerised Systems

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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.   Acknowledgment
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



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January 2013



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