Process Validation vs. Software Validation

I am in a Quality group that is responsible for reviewing all validation documents from stem to stern from our Engineering groups. Recently we have had quite a discussion around the need to do software validation when a process that’s being validated uses a computer system to control an automatic process step such a a rinse cycle. My opinion is that a process validation is done on the process taking into account the computerized system as part of that process. The vendor writing the code to control the automatic process is responsible for validating the software which is being written to our URS and FRS. Am I off base here?

I’m afraid its not the vendors job to do this, unless you have stated this in your SLA, and even if you have would you trust a third party like a vendor to perform the validation properly.

This is a critical part of the overall process so I would advise that this is performed in house to ensure that everything is within compliance.

To make your job easier when the URS is written you should make sure that the vendor satisfies all of your requirements.

Get them to explain in detail any FS statements that you dont understand just in-case it leads to a requirements that cannot be satisfied at the validation stage.

In my experience very few vendors actually care about the validation process so its up to you to make sure everything is verified

Hope this helps