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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'.
Chris Montgomery and the RQA Computing Committee
First printed December 2008
Reviewed January 2013
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