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GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems was launched on 28th February 2008.
The release of GAMP 5 aims to provide guidance on regulatory compliance through cost and time effective methods and signifies a period of transition of new ideas with a more innovative approach to compliant systems.
GAMP 5 relies heavily on Risk Assessments and to put it in to context, ICH Q8, ICH Q9 and ICH Q10 as well as ASTM 2500 must be read and understood.
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