ISPE GAMP 5, 2nd ed. and its 2 linked instruments

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	ISPE GAMP 5, 2nd ed.	FDA CSA guidance	GAMP AI guide
Authority	ISPE	FDA	ISPE
Legal weight	Industry good practice	Guidance & Q&A	Industry good practice
Status	Industry guide	Final	Industry guide
Last verified	Not yet	Not yet	Not yet
Summary	Industry good-practice guide for the lifecycle of GxP computerised systems, widely referenced by regulators and companies. Proprietary: cite and link only.	FDA's risk-based approach to assuring software used in production and quality systems, favouring critical thinking and unscripted testing where risk is lower. Final since September 2025 and updated in February 2026 to align with the QMSR.	ISPE industry guide on AI-enabled computerised systems in GxP work. Link only: ISPE guides are not reproduced here.
Lifecycle	29 Jul 2022 Second edition published (29 Jul 2022)	13 Sep 2022 Draft guidance published 24 Sep 2025 Final guidance published 3 Feb 2026 Updated and retitled for QMS software	~1 Jul 2025 Published (July 2025, month only on ISPE's public page)
Source	Official text Summary in our own words. See the official text from ISPE.	Official text Source: FDA. Public domain.	Official text Summary in our own words. See the official text from ISPE.

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