A) General Principles of Software Validation; Final Guidance
for Industry and FDA Staff
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm
Sec 2.4 - REGULATORY REQUIREMENTS FOR SOFTWARE VALIDATION
“Software validation is a requirement of the Quality System regulation”
Sec 3.1.2 – DEFINITIONS AND TERMINOLOGY, Verification and Validation
“…confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”
“…developing a level of confidence that the device meets all requirements and user expectations for the software automated functions and features of the device.”
Sec 3.4 - “Benefits Of Software Validation
“Software validation is a critical tool used to assure the quality of device software and software automated operations. Software validation can increase the usability and reliability of the device, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users…”
5.2.6 - TYPICAL TASKS SUPPORTING VALIDATION, User Site Testing
User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance. Documented evidence of all testing procedures, test input data, and test results should be retained. There should be evidence that hardware and software are installed and configured as specified. Measures should ensure that all system components are exercised during the testing and that the versions of these components are those specified. The testing plan should specify testing throughout the full range of operating conditions and should specify continuation for a sufficient time to allow the system to encounter a wide spectrum of conditions and events in an effort to detect any latent faults that are not apparent during more normal activities.
B) CGMP, 21 CFR 211.68
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.68
“Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy.”
C) Bar Code Label Requirements for Blood and Blood Components
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/BarCodeLabelRequirements/default.htm
“…container label must bear encoded information in a format that is machine-readable and approved for use…”
D) Blood Guidances
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm
“Blood guidance documents - Division of Communications and Consumer Affairs”
E) Background Information Regarding the ISBT Label
http://www.fda.gov/downloads/BiologicsBloodVaccines/DevelopmentApprovalProcess/AdvertisingLabelingPromotionalMaterials/InternationalSocietyofBloodTransfusionISBT/UCM154879.pdf
“…correct ISBT label information to expedite the review process where we anticipate potential errors in labeling submissions.”
F) Guidance for Industry - Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073362.htm
“We, FDA, recognize as acceptable, except where inconsistent with the regulations,1 the standard for blood and blood component container labels, "United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128," version 2.0.0, dated November 2005 (the Version 2.0.0 Standard).”
G) Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility
“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.”
H) Blood & Blood Products
"The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion...CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.”
I) 7342.001 - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors - Requirements for Blood Bank Computer Software
“The actual use of blood bank computer software by blood establishments is subject to the CGMPs for Blood and Blood Components and the CGMPs for Finished Pharmaceuticals. Blood establishments who use vendor supplied software are required to perform user validation to ensure the software is meeting its intended use.”
