My company is in the process of developing a customer application for the manufacturing of drugs. Knowing that the application is going into regulated environments, the application will require IQs, OQs, and PQs, which are being developed. But, what about the computer systems that this application is running on? Do these require IQ\OQ\PD validation?
Currently the application requires three computers:
A Citrix server
A database server
Looking at the Citrix server, do I need to have IOQs for everything that is on the computer, ie; Operating system, backup software, anti-virus software etc? Does the hardware need to be validated?
Thanks in advance.