Date:         Wed, 28 Aug 2002 01:11:19 +0100
Reply-To:     Kevin <k_kane@BLUEYONDER.CO.UK>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Kevin <k_kane@BLUEYONDER.CO.UK>
Organization: blueyonder (post doesn't reflect views of blueyonder)
Subject:      SAS programs and FDA 21 CFR Part 11

Hi,

After reading the regulations from the FDA on electronic records and
electronic signatures
(http://www.fda.gov/ora/compliance_ref/part11/FRs/background/pt11finr.pdf)
I have been considering what are the implications for SAS programmers and
statisticians in the pharmaceutical industry.  These are my questions:-

1) Are SAS programs written to analyse clinical trial data considered
"electronic records" according to the FDA guidelines?
2) If I have a system that calls SAS macros and stores a list of parameter
values for a variety of tables would this be considered an "electronic
record" according to these guidelines?
3) Is anyone attempting to electronically or digitally sign their programs,
perhaps to say they are the creator or they have been validated?

I would be grateful for any thoughts or ideas...

Kevin Kane
http://www.phastar.co.uk