Hi… I have a long history of CSV work, but little exposure to PLC validation. My assumptions which may make an a… of me, are that much of the same documentation is required, e.g. URS, Risk Assessment, FRS, SDS, Validation Plan, Test Plan, IQ, OQ, PQ, Validation Summary Report. I would probably add FEMA for each controller. Am I on the right track? Can anyone provide some guidance in difference in documentation of each system? Thanks.
I’ll jump on the train, as I would like to get some more information as well. 
So far we are not validating the PLC by itself, always in context with the machine/system or whatever is “behind” the PLC.
So basically we are using the standard approach for validation. The PLC-software is versioned and can only be changed within the formal change control process. But I don’t know if this is the “best” way to do it.
So I’m curious about further opinions.
Cheers,
Alex
In my experience it’s the same. However, I’ve usually validate the PLC as part of a system.
The only thing to consider would be the amount of testing performed on the PLC and whether or not you can leverage the vendors Quality plan to have a risk-based approach to testing the code in the PLC.
Let me know if you have other specific questions and I’d be happy to help.