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1 bobnadler commented Permalink

21 CFR Part 11 deals with authentication and auditing of electronic records and is mostly used in the pharma industry. It is not a "life-critical regulation". You're thinking of medical device development which is regulated by the FDA QSRs (Part 820). For more information see: <div>&nbsp;</div> <a href="http://rdn-consulting.com/blog/2007/07/22/agile-development-in-a-fda-regulated-setting/">Agile development in a FDA regulated setting</a>

2 ScottAmbler commented Permalink

Thanks. I just updated accordingly.

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