FDA guidance

Blood Establishment Computer System Validation in the User's Facility: Guidance for…

FDA guidance · Final · issued Apr 1, 2013

Key facts

Title Blood Establishment Computer System Validation in the User's Facility: Guidance for Industry
Status Final
Issue date Apr 1, 2013
Center Center for Biologics Evaluation and Research
Issuing office Center for Biologics Evaluation and Research
Communication type Guidance Document
Regulated product Biologics
Docket number FDA-2007-D-0069
Open for comment No
Document on fda.gov fda.gov

At a glance

  • None Product codes referenced
  • None Recognized standards referenced

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About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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