GAMP AI guide and its 1 linked instrument

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	GAMP AI guide	ISPE GAMP 5, 2nd ed.
Authority	ISPE	ISPE
Legal weight	Industry good practice	Industry good practice
Status	Industry guide	Industry guide
Last verified	Not yet	Not 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)
Source	Official 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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