does anyone know who the source of software verification standards for pharmaceutical applications is. i understand there is a GAMP standard but need info on it
The short answer to your questions is "no."
The FDA governs pharmaceuticals, medical devices, blood products, foods and other systems and products directly affecting health. Their "Predicate Rule" clarification states that, if the FDA does not have interest in the application, the chances are excellent that they will have only a limited interest in the software applying to that system. Therefore, if your AutoCAD does not actually go into the pharmaceutical or biological product or service, and if the safety or efficacy or quality do not depend upon AutoCAD (or Excel or Word or LotusNotes), the FDA probably will not have an active interest in this regard.
The FDA has recently clarified their requirements for software cGMP compliance, I encourage you to visit their website early and often. As taxpayers, it is our privilege and right.
The long answer is that the International Society of Pharmaceutical Engineers has drafted GAMP guidelines covering this area. This is a minority opinion, but I'm a bit old-fashioned in this regard: if FDA is licensing and governing, I prefer to comply with their requirements.
When ISPE licenses your facility or product, we can talk about using their method. Personally, I've got a list of better uses for my US$145.
