NONMEM Users Network Archive

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Re: 21 CFR Part 11

From: AJ Rossini <blindglobe>
Date: Thu, 19 Apr 2007 20:38:50 +0200

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 s=
eem
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 an=
d
processes.

Depending on your local legal department/advisor, it might not pertain at a=
ll
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).

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Received on Thu Apr 19 2007 - 14:38:50 EDT

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