Date: Wed, 1 Aug 2001 09:58:06 -0500
Reply-To: Rodney Sparapani <rsparapa@MCW.EDU>
Sender: "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From: Rodney Sparapani <rsparapa@MCW.EDU>
Organization: Medical College of Wisconsin, Milwaukee
Subject: Re: SAS datasets and CFR 21 part 11
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Susanne:
It would be difficult to find a pharmaceutical company or a CRO that has
not had a debate on what these regulations mean and how to comply with
them. And there are vastly different opinions. I assume that you are
interested in SAS programming. I found Paul Gill's "The Next Step:
Integrating the Software Life-cycle with SAS Programming" to be very
helpful, but certainly not the last word on the subject.
Rodney
Susanne Sardella wrote:
> Hello all,
>
> Does anyone have an understanding how the FDA CFR 21, part 11
> regulations on electronic documents influence the creation and
> manipulation of SAS datasets for analysis purposes?
>
> What are companies doing to comply with these regulations?
>
> Thanks,
>
> --
> Susanne M. Sardella
> Cognigen Corp.
> Voice: 716-633-3463 x226 Fax: 716-633-7404
> http://www.cognigencorp.com
>
>
--
Rodney Sparapani Medical College of Wisconsin
Sr. Biostatistician Patient Care & Outcomes Research (PCOR)
rsparapa@mcw.edu 8701 Watertown Plank Rd., Rm. H2775
(414) 456-8786 (FAX: 6689) PO Box 26509, Milwaukee, WI 53226-0509
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Susanne:
<p>It would be difficult to find a pharmaceutical company or a CRO that
has not had a debate on what these regulations mean and how to comply with
them. And there are vastly different opinions. I assume that
you are interested in SAS programming. I found Paul Gill's "The
Next Step: Integrating the Software Life-cycle with SAS Programming"
to be very helpful, but certainly not the last word on the subject.
<p>Rodney
<p>Susanne Sardella wrote:
<blockquote TYPE=CITE>Hello all,
<p>Does anyone have an understanding how the FDA CFR 21, part 11 regulations
on electronic documents influence the creation and manipulation of SAS
datasets for analysis purposes?
<p>What are companies doing to comply with these regulations?
<p><font face="Arial,Helvetica">Thanks,</font>
<pre><font face="Arial,Helvetica">--
Susanne M. Sardella
Cognigen Corp.
Voice: 716-633-3463 x226 Fax: 716-633-7404
<a href="http://www.cognigencorp.com">http://www.cognigencorp.com</a></font></pre>
</blockquote>
<pre>--
Rodney Sparapani Medical College of Wisconsin
Sr. Biostatistician Patient Care & Outcomes Research (PCOR)
rsparapa@mcw.edu 8701 Watertown Plank Rd., Rm. H2775
(414) 456-8786 (FAX: 6689) PO Box 26509, Milwaukee, WI 53226-0509</pre>
</html>
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