OT....FDA Software Validation

[XtremeIN]

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

 

[Oakley]

Is COTS software not tested by the vendor? If so, then do a vendor audit and call it done.

 

[XtremeIN]

I know nothing about vendor audits.... Any other helpful insight? Also, what about Validating a Server? I read a little bit about it, but what I was able to find is so vague.

Thanks,
Micheal

 

[unsunghippie]

I would start asking questions of your quality department. They have been a great resource for me. I agree with you that the FDA regs regarding this sort of thing are quite vague, and reading the regs tends to leave me with more questions than answers. Sorry, not very helpful, but I feel your pain.

 

[Oakley]

Surely this isn't the first time this has been done in your company (or the company you are contracted to).

Leverage the IT department, the Quality departments, Corporate policies and procedures, etc.