Re: 21 CFR Part 11

On Thursday 19 April 2007 16:45, Steve Chapel wrote: > I'm looking for the document from the FDA called the "21 CFR Part 11," 21 CFR = Title 21, code of federal regulations, of which Parts 1 - 1300 seem to cover FDA, 1300-1400 cover DEA/DoJ, and 1400-1500 Cover other drugs. Of course, there are at least 20 other CFR's, as well... It's mostly about electronic signatures, data, and audit trails for data and processes. Depending on your local legal department/advisor, it might not pertain at all to data analysis processing (except as far as "audit trails" might be relevant). So in a sense, it's off-topic for this list. But still amusing. best, -tony blindglobe Muttenz, Switzerland. "Commit early,commit often, and commit in a repository from which we can easily roll-back your mistakes" (AJR, 4Jan05). application/pgp-signature attachment: stored