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FDA Guidance for Industry; Blood Establishment Computer Systems Validation in the User's Facility

Origin/Publisher:

Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm078815.pdf

Document Type:
Guidance for Industry
Content:
FDA, is issuing this guidance to assist you, blood establishments, in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.

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