Medical Device Validation Protocols and Reports - Acceptance Criteria

P

patricky15

#1
We recently completed a validation at work and a question came up. We had an approved and released protocol. Once the testing was completed, someone realized one of the acceptance criteria was not relevant to the testing.
The proposal was to remove the acceptance criteria, in essence revise the protocol once it had been executed and address the mistake through the change order process.
I did not approve the change and the issue was addressed in the report but I was asked to provide a document where this is the correct approach.
Does anyone know where I could find this guidance?
thank you!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We recently completed a validation at work and a question came up. We had an approved and released protocol. Once the testing was completed, someone realized one of the acceptance criteria was not relevant to the testing.
The proposal was to remove the acceptance criteria, in essence revise the protocol once it had been executed and address the mistake through the change order process.
I did not approve the change and the issue was addressed in the report but I was asked to provide a document where this is the correct approach.
Does anyone know where I could find this guidance?
thank you!
Hi,

If it's a major thing the Design Input needs to be changed, formally. Otherwise I would just address the mistake in the validation reprot's discussion and conclusions sections, and call it a day.

I can't point out a specific official guidance that this approach is taken from.

Cheers,
Ronen.
 

Candi1024

Quite Involved in Discussions
#3
I would not revise an approved protocol. Mark the change as a deviation in the report and explain, then go back and revise the protocol for next time.
 

yodon

Staff member
Super Moderator
#4
A deviation on acceptance criteria will get the most scrutiny if anyone looks. As others have pointed out, you do need to provide detailed documentation about the situation. For deviations on acceptance criteria, we take extra measures to provide assurance that the test was not modified to meet the actual results (which is the typical knee-jerk response from an auditor / inspector). We generally have copious documentation AND an independent reviewer (QA) to approve the deviation.
 
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