NONMEM Users Network Archive

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RE: 21 CFR Part 11

From: Mike Davenport <Mike.Davenport>
Date: Thu, 19 Apr 2007 14:06:42 -0400

Here is the link to the FDA guidance. Note that it does not differenti=
ate between SAS files or any other software. Nor does exclude analyses=
 that are not predefined. I think this is something we will all need t=
o deal with. thanks mike www.fda.gov/cder/=
guidance/5505dft.pdf ________________________________ =


:57 PM To: Steve Chapel Cc: nmusers
Re: [NMusers] 21 CFR Part 11 Hello Steve, =
   It seems like NONMEM jobs are not part 11 compliant, are they? Al=
so, PK analyses are exploratory and cannot be predefined. The FDA ask=
s for SAS files and NONMEM works with text files. This also makes Par=
t 11 less related. Thank you, Pavel -----=
 Original Message ----- From: Steve Chapel Date: Thursday, Apr=
il 19, 2007 12:07 pm Subject: [NMusers] 21 CFR Part 11 To: nmuser=
s
led the "21 CFR > Part 11," > which are the regulations for=
 the handling of electronic records > and > signatures requ=
ired by the FDA. I've found numerous references > to this >=
 document, but I cannot seem to locate where I can obtain a copy > =
of that > document itself. It is available on the web? If so, cou=
ld > someone > provide a direct link to the document itself=
? Do I need to order > a copy? > If so, can someone pro=
vide the details of ordering it? > > On a related note, wher=
e can I find the FDA regulations on > software > validation=
 for drug development? I found a very useful document > from the =

regulations > themselves, and they apply to medical devices instead=
 of drug > development. > I'm a software engineer relatively n=
ew to the field of drug > development, > and I find many in=
stances of people referring to "validation" > and "audit > =
trails", but mysteriously I cannot find the actual FDA > regulation=
s I'm > supposed to be following. Any help would be greatly appreci=
ated! > > Thanks, > Steve > __________=
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Received on Thu Apr 19 2007 - 14:06:42 EDT

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