I can imagine an FDA auditor coming for a visit, asking for the Quality System documents, loading them up to an AI and simply asking: "what's wrong with these procedures?"
This is gonna happen.
Discussion
AI will not be a kangaroo court like the Chevron doctrine was. That ship sailed.
Also, Couldn’t the company getting audited have done the same and adjusted the procedures say 90 days before the audit?
Or better yet couldn’t the company getting audited ask AI why the governments concerns are wrong?
AI is a tool and I can’t imagine the government official will be able to out use it vs the private sector, without a chevron doctrine that they won’t get.
#AI #law #chevrondoctrine
I was an auditor myself for certification and regulations of medical products, including medical software applications. Believe me, a good auditor has a certain instinct when procedures do not interact well inside the system. You could literally smell it. No AI can do this.
Wanna help us figure out how to put medical data on Nostr? We need regulatory help.
Hi, sounds interesting. My knowledge is maybe not up to date, I am out of the business for some years now. But we could start like this: Provide me with your basic ideas, after this we adjust the definitions and define the procedure, if needed a risk assessment and validation. Depending what the project will need.
I am German and living in Italy.