Transcription of Draft Guidance For Industry; Part 11; Validation
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Draft Guidance For Industry; Part 11; Validation
Draft Guidance for industry - Not For ImplementationGuidance for Industry21 CFR Part 11; ElectronicRecords; electronic SignaturesValidationDraft GuidanceThis Guidance document is being distributed for comment purposes and suggestions regarding this Draft document should be submittedwithin 90 days of publication in the Federal Register of the notice announcing theavailability of the Draft Guidance .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.
Draft Guidance for Industry - Not For Implementation 2 requirements to ensure that electronic records and electronic signatures are trustworthy,
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