I am curious if there are any other people on the forum that work for FDA regulated companies? The reason I ask is that we are, and being such, we are required to do a large amount of paper work. I have been given the task to complete a Validation of some Off the Shelf Software. While I have done Software Validation Protocols and Reports for Embedded Software, Off the Shelf is new for me. I am just looking for some insight on how to set Test Cases and a general layout for the process. Any information would be greatly appreciated.
Thanks, Micheal
Thanks, Micheal