Bioequivalence and Bioavailability Forum

Dear All,

There is no end to discussions on validation of computer systems. SAS is a very large system and validation requires a great deal of time and efforts. Yes, as told by HS there are some buttons which will give you IQ/OQ aspects after you install the SAS on your computer. PQ, the wise thing is to do it as per the task requirements. If you are using SAS for any task, it is better to validate that part and use it. If you are using SAS for ANOVA and CI calculation, it is easy to validate SAS for this process. As I mentioned earlier, SAS is very big, it calculates mean and also manages credit card transaction in banks. It's up to you what you want to do with SAS. Remember SAS is a off-the-shelf software and need different approach for validation. This is one area where there is a confusion in the minds of people. Confusion between 21 CFR Part 11 and validation of computer systems for clincial use. Both are not same, but they are inter-related.

Dr. Shiv