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Compliance to 21 CFR Part 11 Electronic Records & Signature Verification: Electronic Records & Signature Verification
This eBook reviews the regulatory requirements of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).
It is written in a step by step format to assist those working with electronic records and electronic information electronically subject to part 11.
Part 11 of CFR is relevant to “records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.” This first section of the book is provides background information and explanations of each section and requirement of the regulation. The second half of this eBook provides a clear and transferrable verification process for each requirement of 21 CFR Part 11, with suggested verification methods included.
It is written in a step by step format to assist those working with electronic records and electronic information electronically subject to part 11.
Part 11 of CFR is relevant to “records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.” This first section of the book is provides background information and explanations of each section and requirement of the regulation. The second half of this eBook provides a clear and transferrable verification process for each requirement of 21 CFR Part 11, with suggested verification methods included.
50 pages, Kindle Edition
Published June 16, 2016
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