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[better] | Gamp Standards
GAMP is a set of guidelines designed to help manufacturers meet regulatory requirements, such as the U.S. FDA’s 21 CFR Part 11 and EU GMP Annex 11. While it is not a legally mandatory "standard" in the same way a law is, it is the acknowledged "best practice" used by industry experts and referenced by regulatory inspectors worldwide.
A Category 4 system (e.g., SAP) might require 200 test scripts. A Category 1 system (Windows) requires none. This saves millions of dollars in wasted effort. gamp standards
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