FDA Guidance for Industry Blood Establishment Computer System Validation in the User’s Facility
Title:
FDA Guidance for Industry
Blood Establishment Computer System Validation in the User’s Facility
Origin/Publisher:
FDA, http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM078815.pdf
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