21 CFR Part 11: Validation - Food and Drug Administration

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Draft Guidance for Industry - Not For ImplementationGuidance For Industry21 CFR Part 11; Electronic Records;Electronic SignaturesValidationAdditional copies of this draft guidance document are available from the Office ofEnforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857; Internethttp://www.fda.gov/ora/compliance_ref/part11.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationOffice of Regulatory Affairs (ORA)Center for Biologics Evaluation and Research (CBER)Center for Drug Evaluation and Research (CDER)Center for Devices and Radiological Health (CDRH)Center for Food Safety and Applied Nutrition (CFSAN)Center for Veterinary Medicine (CVM)August 2001ii
Draft Guidance for Industry - Not For ImplementationGuidance For Industry21 CFR Part 11; Electronic Records; Electronic SignaturesValidationTable of Contents1. Purpose .........................................................................................................12. Scope ............................................................................................................12.1 Applicability ................................................................................................22.2 Audience ....................................................................................................33. Definitions and Terminology ..........................................................................34. Regulatory Requirements; What Does Part 11 Require? ..............................35. Key Principles ................................................................................................45.1 System Requirements Specifications.........................................................45.2 Documentation of Validation Activity ..........................................................65.2.1 Validation Plan.....................................................................................65.2.2 Validation Procedures..........................................................................65.2.3 Validation Report ................................................................................65.3 Equipment Installation ................................................................................75.4 Dynamic Testing.........................................................................................75.4.1 Key Testing Considerations .................................................................75.4.2 Software testing should include: ..........................................................85.4.3 How test results should be expressed. ................................................85.5 Static Verification Techniques ....................................................................95.6 Extent of Validation ....................................................................................95.7 Independence of Review..........................................................................105.8 Change Control (Configuration Management)..........................................106. Special Considerations ................................................................................116.1 Commercial, Off-The-Shelf Software........................................................116.1.1 End User Requirements Specifications..............................................126.1.2 Software Structural Integrity...............................................................126.1.3 Functional Testing of Software ..........................................................136.2 The Internet..............................................................................................136.2.1 Internet Validation..............................................................................13Appendix A - References .................................................................................15iii
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21 CFR Part 11: Validation - Food and Drug Administration

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