jmolny

Please do not advertise on the forum

I believe it is a major conflict of interest to have a software manufacturer validate its own software. They will not test the software as the facility will use it. They will test it the way they know it will work. I know that it is frustrating that a company that you have not had a chance to interview the vendor who will be doing your validation. I find that the reason that it is written into the contract usually is because the facility wants to only pay one bill for the project. Unfortunately I don’t believe that this will change unless the FDA does more than frown on the practice. If you cannot do the validation yourself, there are third parties that can do a thorough job. It’s not that you cannot do a good job but with all the tech shortages you probably do not have the time. And I agree that reviewing someone else’s validation is not exciting but it takes less time than the planning, creation of test cases and test case execution and review that needs to be done by the site itself.