Compare Part 11 scope guidance and FDA software validation

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How they are linked

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

Side by side

	Part 11 scope guidance	FDA software validation
Authority	FDA	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	Not yet	Not yet
Summary	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 setting out the validation principles it considers applicable to medical device software, and to software used to design, develop or manufacture medical devices.
Lifecycle	5 Sep 2003 Final guidance issued	9 Jun 1997 Draft version 1.1 dated 9 Jun 1997 11 Jan 2002 Version 2.0 issued, superseding the 1997 draft
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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