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?