ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd edition)

ISPE · Industry guide

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Summary

Industry good-practice guide for the lifecycle of GxP computerised systems, widely referenced by regulators and companies. Proprietary: cite and link only.

Dated events

1. 29 Jul 2022 Second edition published (29 Jul 2022) Source for Second edition published (29 Jul 2022)

Official source

Official text

Summary in our own words. See the official text from ISPE.