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Date:   Tue, 27 May 2003 07:33:11 +0100
Reply-To:   Roland <roland@RASHLEIGH-BERRY.FSNET.CO.UK>
Sender:   "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:   Roland <roland@RASHLEIGH-BERRY.FSNET.CO.UK>
Subject:   Re: Stats programming and 21 CFR Part 11

"Shane Hornibrook" <shane_sasl_nospam1@SHANEHORNIBROOK.COM> wrote in message news:Pine.LNX.4.44.0305261727020.32103-100000@ensim.lncare.com... > On Sat, 24 May 2003, Jay Cunington wrote: > > > >Are you saying that that is not the SOP at all SAS shops? Why would you > > >not save the .LOG and .LIS files as a matter of course? > > > > Lack of space? > > > > I've worked in half a dozen different SAS shops. None saved the lists or > > the logs. The feeling was identical input and programs means identical > > output. We programmers know that isn't true in the real world, of > > course. > > Lack of space? That's brutal! I would think that disk space would be > cheaper than programmer time e.g if there was an audit. I don't think the > FDA would take the programmer's word. What about using 'options nomprint' > and the like, or gzipping the .log and .lis?

gzip would have to be "validated" software first, I think. And you wouldn't be allowed to validate it in any case because it hasn't been validated. That's the sort of thinking I have come across in the industry.

> --Shane > Shane Hornibrook > Mobile: (902)441-4158 > shane_sasl_nospam1@shanehornibrook.com > http://www.shanehornibrook.com/


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