21 CFR Part 11 and systems assessment: key to complying with the FDA's electronic record-keeping regulation and reaping the associated benefits is understanding regulation requirements and the software to support compliant operations.(INSIDE PHARMA)

Control Engineering, April, 2005 by Bowden, Nigel

By establishing the criteria under which electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures executed on paper, 21 CFR Part 11 has given the pharmaceutical industry a universally accepted, industry standard for paperless record keeping. Included in the regulation are electronic records that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in U.S. Food and Drug Administration regulations and/or submitted to the FDA.

For process operators to comply with 21 CFR Part 11, they must meet stringent requirements on the authenticity, integrity, and confidentiality of electronic records and signatures. In addition, software used to comply with the...

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