From prior experience, when a verification/validation had failed I was obligated to redo the verification and validation per the updated specification. Yes, this is time consuming and can be costly, but it is the cleanest way to reroute the protocols. By redoing the protocol and validation the acceptance criteria will change, but within the documentation one should state the reasoning for new acceptance criteria. A justification for the failure must be documented along with the new expected output. Therefore, it is critical to spend time brainstorming the test and failures that can occur well in advance to the execution of the protocol. Based on the type of failure, one should decide whether they want to complete a regression test or re-evaluation. It is also based on upper managements decision on whether they want to fund a re-evaluation or to just move on to a different project.