We are currently resource planning for several upcoming validation projects. The question being debated is in regards to who is allowed to execute testing/test scripts required for IQ, OQ, PQ.
The current SOP states that the system developer can not execute testing/test scripts. I intepret this to mean the code writer can’t test their own system (makes sense…possible conflict of interest). The debate we are currently having is around the testing/test script writer. Can the person who writes the testing/test script also execute the testing? Obviously a different person must 2nd person review the testing.
Any input based on your experiences would be appreciated.
This does come up frequently but I’ve never seen any regulation, standard, or guidance that would prohibit the test developer from also executing. So the only reason, I think, would be if your internal procedures prohibit it for some reason.
Taking a step back, what bias could be introduced if a test developer executed the script? One might argue that test protocol deviations / anomalies might be hidden away for fear of exposing faults introduced by the tester. I don’t see this as a strong argument. Hopefully there’s a defined, rational approach to handling protocol deviations in the procedures.
On the other hand, if resources are available, it’s not necessarily a bad idea to have someone else execute. Script developers may make some assumptions that are not valid and may only be exposed if someone else executed.
The bottom line is that, unless internal procedures dictate, I don’t believe there’s a (regulatory / standards-based) reason a test developer shouldn’t execute. Having someone else execute, though, can be beneficial.
although there is no requirement that the developer cannot execute the test scripts, Verification or Validation must be performed in accordance with the previously approved procedures/protocols. These must be reviewed and approved by an independent person. The results and the report of the activity must also be reviewed by an independent individual.
It is also generally known and accepted by the regulators and industry that one cannot effectively review his or her own work.
Thanks Mike…I appreciate your input.
I also agree with your input.
In your experience have you ever been aware of a regulator having issues with a test developer executing their own tests?
I have not heard of any inspector or auditor make an issue, but then I don’t think i’ve ever witnessed an auditor checking the role or credentials of individuals writing or executing test scripts. It would typically end with an auditor making sure that the document was reviewed and approved by more than one person.
I have not been around for that long, so take it with a grain of salt.
Thanks yodon. Your response validates my position on the question. Thanks for taking the time to share your opinion.