Nigel Bowden

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Industrial Networking April 1, 2005

21 CFR Part 11 and Systems Assessment

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, archive...

By Nigel Bowden
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