Blood Establishment Computer System Validation in the User’s Facility: Guidance for Industry

Issue Date: April 1, 2013
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood Products
Status: Final

Blood Establishment Computer System Validation in the User’s Facility: Guidance for Industry

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.

Download the Guidance Document

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