FDA software validation and its 3 linked instruments

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First column: FDA software validation. The others are every document linked to it.
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Details: Guide Definitions: every term and label explained

	FDA software validation	FDA CSA guidance	Part 11 scope guidance	FDA blood system validation
Authority	FDA	FDA	FDA	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Final	Final	Final	Final
Last verified	Not yet	Not yet	Not yet	Not yet
Summary	FDA guidance setting out the validation principles it considers applicable to medical device software, and to software used to design, develop or manufacture medical devices.	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.	FDA guidance on how a blood establishment validates its computer system, including blood establishment computer software, in its own facility.
Lifecycle	9 Jun 1997 Draft version 1.1 dated 9 Jun 1997 11 Jan 2002 Version 2.0 issued, superseding the 1997 draft	13 Sep 2022 Draft guidance published 24 Sep 2025 Final guidance published 3 Feb 2026 Updated and retitled for QMS software	5 Sep 2003 Final guidance issued	~1 Apr 2013 Final guidance issued (April 2013)
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.