According to the complexity and configurability, computer systems are divided into five categories, and the verification work will be different.
GAMP 5 introduces risk assessment, and assigns different proportions of verification work according to the risk levels of different functions.
Electronic records and electronic signatures are not necessary in the sense of laws and regulations, but if they are used, they must conform to Part 1 1.
According to different systems, corresponding templates are needed, and a set of documents (from verification plan, functional specifications and design specifications to test scripts and verification reports) are developed based on the templates.
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