Vendor Assessment

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Funny and serious question i am asking really. We have been implemented softwate and it has been running and using since 2005.

Now our management decided to implement validate the software. So how can we performa the vendotr assessment activity.

Initially we purchaged and implemented to update the financial purpose. Now it is slowely and fully implemented in all OPM transactions without any validation.

How can we DO THE VENDOR ASSESSMENT IN THIS CASE, PLEASE SEND ME ANY ONE HAVING WITH SAME PROBLEM OR IF KNOWS.

Thanking YOu

Tarakam

2

Doesn’t seem logical at this stage to do the vendor assessment, the whole point of a vendor assessment is to assess the vendor before the software or system is purchased.

I would be more concerned at this stage in retrospectively validating the software to ensure that it is functioning correctly and consistently.

Is the vendor assessment critical to your documentation lifecycle?