Software validation has become an integral part of the overall software lifecycle when it comes to using a software application in a regulated environment. If the application is defined as being GxP system or critical to quality the end result means that a high degree of testing is required in order to allow the application to be used in the manufacturing process.
What should happen is that a comprehensive Vendor Audit needs to be carried out, to ensure that the system has been developed to the highest of quality standards. This approach is essential so that you have a high degree of assurance that the system is sound, and can be leveraged from later in at the validation stage.
Before a software validation script is drafted in anger, it is essential to perform a robust risk assessment to ensure that you don’t end up testing every single mouse click that occurs, in reality what happens is that people who have little experience of the system get together and come to the conclusion:
“Hey, everything is critical in this system, we have to test anything that moves!”
Does this sound like a familiar situation to you?
Anyway I am getting off the point slightly, one of my major gripe’s with software validation testing is the constant call for screenshots to prove that a certain value appears on the screen, when a certain calculation or button click is performed.
What I don’t understand is, why is this necessary?
Surely when you have highly qualified people developing these scripts and testing these scripts, if someone signs off that the acceptance criteria has been met, or records the actual value this should be sufficient.
Are we saying that validation people cannot be trusted, and you need a screenshot for everything?
Is there a requirement out there that states screenshots are the preferred form of documented evidence?
I think it’s time to open up this debate and see what the general feeling is out on the front line. If we are ever to get to a point where we have a lean validation approach these are the issues that need to be addressed.
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