Date:         Tue, 15 Jan 2002 07:44:31 -0000
Reply-To:     Roland <roland.rashleigh-berry@VIRGIN.NET>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Roland <roland.rashleigh-berry@VIRGIN.NET>
Organization: Virgin Net Usenet Service
Subject:      Re: SAS validation for FDA submissions-Help

It's easier than you think. I assume youl have a set of standard operating
procedures in place that detail what must be done. You do this, provide
documentation that you have done this, and your job is done.

I would imagine that you would have to at least duplicate program any
efficacy results.


"NewSTATPharma" <johnsebastianfigglewortdathird@yahoo.com> wrote in message
news:464e394e.0201111134.5858e862@posting.google.com...
> I am currently working at a biotech and we are using SAS.  The
> question is how much work do we have to do to validate SAS.  SAS has a
> procedure that runs modules on test data sets and generates output
> which can then be checked to what it is suppose to be.  Do we have to
> provide documents from SAS to show that SAS is okay?  I have some
> validation guys telling me it is going to cost between 100 and 200
> thousand dollars to validate SAS for FDA submissions.  If this were
> true then I would guess that most small biotechs would not be using
> SAS and they are using it.  Can anyone out there give me some advice?