FDA Software Validation for SW
FDA Software Validation for SW
(OP)
Has anyone had to make sure that SW was a "FDA Approved" software package. The FDA regulates software used in or for the manufacturing of medical devices. Such as any CAD program used to create drawings for said devices.
Our "IT" department has informed us that the program needs to be validated before we upgrade. Personnaly I think it's a load of bull. I've been using SWX since 98 and never had a problem with the FDA.
Thanks,
CADShark
Our "IT" department has informed us that the program needs to be validated before we upgrade. Personnaly I think it's a load of bull. I've been using SWX since 98 and never had a problem with the FDA.
Thanks,
CADShark






RE: FDA Software Validation for SW
RE: FDA Software Validation for SW
RE: FDA Software Validation for SW
I know that this regulation has been around for a few years so I'm not worrying about it to much.
Thanks a bunch!