Validation Plan/IQ/OQ/PQ template for purchased software validation for CDMS


I am engaged in CSV for a purchased software for clinical data management. can anyone please provide me all the template documents required to suffice the validation. I would greatly appreciate your kind help.

Best regards

First of all you need to develop a validation plan. This plan should detail all of the documents you need in order to bring this system into a state of compliance.

I would also ask the software vendor about documentation they have generated for the system and try and leverage off them aswell (GAMP 5).

There are also many CSV templates on this site in the kits section that would help you greatly with your project.


Graham gives good advise, but you also need to define your (user) requirements. These will be the basis for your validation efforts.