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GUIDANCE DOCUMENT

Blood Establishment Computer System Validation in the User's Facility Guidance for Industry April 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2007-D-0069
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are 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. This guidance addresses a blood establishment's validation of its Blood Establishment Computer System (system) which incorporates Blood Establishment Computer Software (BECS). In the context of this guidance, the term “user's facility” means the blood establishment.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2007-D-0069.

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