URS for COTS

COMPUTER SYSTEM VALIDATION (CSV)
1

Hi,
for pharmaceutical industries, is it required that we must have URS for COTS computer systems, like Dell, HP, Acer etc?
if so then what are we suppose to write in it?

Also, does anyone know if even the office computers require validation? these computers have no affect on the quality of product. And how detailed is it suppose to be?

could anyone please provide a sample for qualification?

Any help will be appreciated

Thank you

2

Besides GAMP 5, you might also want to see GAMP® Good Practice Guide: IT Infrastructure Control and Compliance. For a URS you might want to specify the platform and the standard configuration of the system. With a risk assessment the actual validation testing may be minimal.

3

Thank you for reply,
for URS, your saying that I should just list its hardware specification along with factory installed software such as OS and MS-Office, or do i need to explain in detail as to what exactly will this computer be used for?

Thank you

4

Well somewhere the reason for the computer system will be documented. Is there a Risk Assessment? Is there anything in it that details if the system is used for any GxP purpose? For Software I would put in the specification the Operating System and all Application software to be used including the version and service pack. For the Hardware I would put in the specification the make and model, processor(s), type and size of memory, type and size of hard drive(s), disk controller and any peripherals attached. I would also spec the security and user settings, and the network settings. If it is a system for a secretary in a front office that has no GxP purposes, then the Risk Assessment will detail that and the appropriate level of testing and documentation required.