Compare GAMP AI guide and ISPE GAMP 5, 2nd ed.

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GAMP AI guideISPE GAMP 5, 2nd ed.
AuthorityISPEISPE
Legal weightIndustry good practiceIndustry good practice
StatusIndustry guideIndustry guide
Last verifiedNot yetNot yet
Summary

ISPE industry guide on AI-enabled computerised systems in GxP work. Link only: ISPE guides are not reproduced here.

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

Lifecycle
  • ~1 Jul 2025 Published (July 2025, month only on ISPE's public page)
  • 29 Jul 2022 Second edition published (29 Jul 2022)
SourceOfficial text
Summary in our own words. See the official text from ISPE.
Official text
Summary in our own words. See the official text from ISPE.

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