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FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility DRAFT GUIDANCE


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This guidance addresses a blood establishment's validation of its Blood Establishment Computer System which incorporates Blood Establishment Computer Software (BECS). The BECS that is incorporated into a Blood Establishment Computer System may be manufactured either in-house or by a software manufacturer/vendor.

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