Compact Regs Part 11: CFR 21 Part 11 Electronic Records

Presents verbatim reproductions of key US FDA regulations. This text is suitable for: employees as part of documented GMP training programs, for suppliers/vendors to provide components, labels, and parts with an understanding of FDA requirements, and for various clinical investigators to help assure compliance to clinical trial protocols.

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The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. A keyword index can be found at the end of each booklet.