Non-Conformances to the URS

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hi,
Just a question about how best to deal with non-conformances to the URS when outsoucing systems.
For example if my URS contains a requirement -all product contact parts must be constructed of 316 stainless steel however the only two systems on the market both have aluminium product contact parts. Say this is brought to management attention and deemed acceptable as chosen system has proven market history in GMP manufacturing. How do I document this decision?
Do I explain the non-conformance in the Trace Matrix and update the URS?
Do I need a formal sign-off on non-conformances by project manager and quality etc. ?
Should I update risk assessment with non-conformances and approve there?
Should I just remove requirement from URS (but does this leave us open to questions in audit about system selection - Why did ye go with an aluminium system? Will this impact product quality? - No - Where have ye documented this assessment?)

2

I think the normal method would be to receive a response from your supplier (functional and / or design specification) which would state their inability to meet your requirement.

You then conduct a (documented) design qualification step (whatever you choose to call it) in which you compare your requirements to the supplier resopnse and decide (and document) what you will do about any differences.

So if you need 316SS and the supplier can only offer aluminium, you note the difference and decide that it is acceptable. You then document why it is acceptable to you.

Hope that helps

Cat

3

Thanks for your help Cat

4

:)Dear…,
I do agree with the CAT as a the preliminary DQ will help us to take immediate desicion. However, we can think of updating the requirements also as changes are controlled and with the help of your engineering and quality you can raise change control and will be signed by them. In this case the problem is clear and it is always better to clear it from URS stage instead of going to impact assessment and again coming back to URS. This is a very common problem, and we faced these in our project. At that time we have not yet started DQ, so we immediately updated in URS by raising change control.