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