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Draft Guidance For Industry; Part 11; Validation

Draft Guidance for industry - Not For ImplementationGuidance for Industry21 CFR Part 11; ElectronicRecords; electronic SignaturesValidationDraft GuidanceThis Guidance document is being distributed for comment purposes and suggestions regarding this Draft document should be submittedwithin 90 days of publication in the Federal Register of the notice announcing theavailability of the Draft Guidance . Submit comments to Dockets ManagementBranch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room1061, Rockville, MD 20852. All comments should be identified with the docketnumber questions regarding this Draft document contact Paul J. Motise, Office ofEnforcement, Office of Regulatory Affairs, 301-827-0383, 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Health (CDRH)Center for Food Safety and Applied Nutrition (CFSAN)Center for Veterinary Medicine (CVM)August 2001 Draft Guidance for industry - Not For ImplementationiiGuidance For Industry21 CFR Part 11; electronic Records; electronic SignaturesValidationAdditional copies of this Draft Guidance do

Draft Guidance for Industry - Not For Implementation 2 requirements to ensure that electronic records and electronic signatures are trustworthy,

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March 20, 1997 federal register - labcompliance.de

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13430 Federal Register/Vol. 62, No. 54/Thursday, March 20, 1997/Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 11 [Docket No. 92N–0251] RIN 0910–AA29 Electronic Records; Electronic

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