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2017 Praxis Life Sciences. 11. 21 CFR Part 11 Timeline. 1992. Validation Center™ The predicate rules are the same whether manual or. Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subchapter A - GENERAL Part 11 - ELECTRONIC Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) Federal Regulations, 21 CFR Part 11 provides requirements for electronic records and electronic certificate-based signatures and PDF signatures is not. Downloads. Download PDF. 1 April 2017. The 21 CFR Part 11 regulation handbook is used in association with ISPE training courses. Attendees of the trainingPart 11: Scope is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA. The CFR is organized like this: Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). format (examples of such formats include, but are not limited to, PDF, XML, Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES Subchapter A - GENERAL Part 11 - ELECTRONIC (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten

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