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SOFTWARE VERIFICATION - "GAMP" STANDARDS
- Thread starter atg3145
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Try <A HREF=" TARGET="_new">
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To obtain the GAMP guide, visit
They are the publishers of GAMP.
I am a GAMP consultant and have successfully implemented GAMP at 4 different companies.
ray mckinney
They are the publishers of GAMP.
I am a GAMP consultant and have successfully implemented GAMP at 4 different companies.
ray mckinney
To learn about software verification try
WingTipHsu
Chemical
Hello, manojkn
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.
Specifically the part of software compliance which applies to your question is found under "Part 11"
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.
Let me know if this helps
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.
Specifically the part of software compliance which applies to your question is found under "Part 11"
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.
Let me know if this helps
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