Changes to the GAMP 5 Main Sections

The main updates by Section:

Section 3 and 4: The lifecycle methodology in Gamp 4 has been developed to include the complete computerized lifecycle , with wide ranging guidance on all phases from concept to retirement in the lifecycle. Real life examples have been added for clarity.

Section 5: Risk Management guidance has been enhanced.

Section 6: System specific activities and attaining compliance through regulated company activities are described here.

Section 7: Supplier activities are targeted here. The advice given is that GAMP 5 is not selective to certain systems it is developed for all types of systems.

Section 8: Advice for efficiency improvements is presented in this section. The importance of Supplier activities has been emphasised by adding a whole section in to the guide.

Section 9: This section does not give separate guidance only relevant to process control systems.

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