FDA blood system validation and its 1 linked instrument

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	FDA blood system validation	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 a blood establishment validates its computer system, including blood establishment computer software, in its own facility.	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	~1 Apr 2013 Final guidance issued (April 2013)	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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