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Resources FDA U.S. Food and Drug Administration / U.S. Department of Health & Human Services Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility (October 2007; UCM078815): http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072560.htm General Principles of Software Validation; Final Guidance for Industry and FDA Staff (CDRH, January 11, 2002; UCM085371): http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices (September 9, 1999; UCM73779): http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm073778.htm Guidance for Industry Process Validation: General Principles and Practices (January 2011, Revision 1; UCM070336): http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf International Society of Blood Transfusion (ISBT) ISBT Guidelines for Validation of Automated Systems in Blood Establishments (Volume 98, Supplement 1, February 2010): http://www.isbtweb.org/fileadmin/user_upload/guidelines-Validation-Automated-Systems-in-Blood-Establishments.pdf |
