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.

 

 

Write Your Own Review
You're reviewing:PLC Validation
Your Rating