Compare FDA CSA guidance and Part 11 scope guidance

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How they are linked

FDA CSA guidance is related to Part 11 scope guidance · Source Unverified link

Side by side

	FDA CSA guidance	Part 11 scope guidance
Authority	FDA	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
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.	FDA guidance on how it applies Part 11. FDA says it will not enforce certain requirements on validation, audit trails, record retention and record copying, and sets criteria for legacy systems. Part 11 remains in effect, and predicate rule requirements still apply.
Lifecycle	13 Sep 2022 Draft guidance published 24 Sep 2025 Final guidance published 3 Feb 2026 Updated and retitled for QMS software	5 Sep 2003 Final guidance issued
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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