P
patricky15
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!
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!