You may be confusing two issues here.

For submissions, you have to validate that your SAS programs correctly present the clinical data that has been collected. You can use PROC PRINTs, PROC FREQs, PROC CHARTs, whatever and keep that in a central filing place.

SAS software is already validated. There is a very good white paper on their web site that is about the validation of SAS. SAS is an off-the-shelf software that end users do not have to validate. Do you validate Word every time you send a memo?????

When you install a new version of SAS, eg., from V6.12 to V8.2, then you have to validate that your programs that worked in the older version give the same results in the new version. Most people have a written validation plan and then run a study that was done in the older version in the new version and then do some PROC COMPAREs to show that things worked fine.

Susan ---------------------- Forwarded by Susan Fehrer/BDI on 11/01/2002 02:53 PM ---------------------------

NewSTATPharma <johnsebastianfigglewortdathird@YAHOO.COM> on 11/01/2002 02:34:50 PM

Please respond to NewSTATPharma <johnsebastianfigglewortdathird@YAHOO.COM>

To: SAS-L@LISTSERV.UGA.EDU cc: (bcc: Susan Fehrer/BDI) Subject: SAS validation for FDA submissions-Help

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?

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