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jr377 replied to the topic It's the Right Thing To Do in the forum Project Management Process and Medical Device Development 6 years ago
I don’t know what company you’re talking about and I’m not sure if I’m looking in the right place (all I can find is avengers stuff). That’s good that they’re checking each step. There’s a lot of aspects of cGMP but I’m not sure you can narrow it down to just one. Maintaining data integrity and ensuring only certain people get access to certain things are some aspects. These ISOs are fine as well. I think a good question is what else would you like to see? There may be gaps that you think need to be filled, what are they?