Compare FDA CSA guidance and ISPE GAMP 5, 2nd ed.

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FDA CSA guidance is related to ISPE GAMP 5, 2nd ed. · Source Unverified link

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	FDA CSA guidance	ISPE GAMP 5, 2nd ed.
Authority	FDA	ISPE
Legal weight	Guidance & Q&A	Industry good practice
Status	Final	Industry guide
Last verified	Not yet	Not yet
Summary	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.	Industry good-practice guide for the lifecycle of GxP computerised systems, widely referenced by regulators and companies. Proprietary: cite and link only.
Lifecycle	13 Sep 2022 Draft guidance published 24 Sep 2025 Final guidance published 3 Feb 2026 Updated and retitled for QMS software	29 Jul 2022 Second edition published (29 Jul 2022)
Source	Official text Source: FDA. Public domain.	Official text Summary in our own words. See the official text from ISPE.

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