Software test automation in the regulated environment

Dear All,

Have you ever done software test automation within a regulated environment (OQ and PQ for instance)? If so, how do you submit the “document evidence” of test execution to FDA? Any specific examples of using HP Quality Center and QTP together with Genilogix’s eSignature would be of great help.


Greetings…did you ever get a response or find this information elsewhere. We are running into the same questions.



Has the FDA requested this information?

I would make a copy of the test execution i.e the OQ or PQ and submit this, obviously you need to keep the originals for your own records.

I would also submit the test step instructions and pre-requisite information with the executed OQ and PQ to make it crystal clear to the FDA person how the execution happened.

Also attach any deviations or discrepancies with the test execution with all relevant close-out information for each deviation or discrepancy.

Hope this helps

Assuming this question relates to premarket submissions, the requirement is that you provide all test protocols, test results and test reports, in support of your Software Verification & Validation Plan (Major Level Of Concern). Whether you used automated test tools or not, this documentation must be hard copy and include approval signatures (ink) to establish the objective evidence that planned v&v activities were executed. If your automated tool features e-signatures, you must state that in a side letter, generate a test results summary (most tools have the capability to run a report) and endorse it, and include a copy of the validation summary report of the automated tool.