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 21 CFR 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.” The first section of the book provides background information and explanations for each section and requirement of the regulation. The second half of this eBook provides a clear and transferable verification process for each requirement of 21 CFR Part 11 with suggested verification methods included.

 

(Page Count 56 pages)