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Another day, another "revolutionary" AI tool claiming to bypass the need for human oversight in GxP.
Before you hit the 'buy' button, think again.
I've spent the last week reviewing the latest draft guidance, and the message from the regulators is loud and clear: technology is not a substitute for accountability. (For those not in the know, check out the recent updates to Annex 11).
Interestingly, the loudest voices complaining about "innovation being stifled" are often the ones who haven't actually read the requirements. My question is: Seriously? Do you really want to bet your manufacturing license on an LLM that thinks 2+2 is 5?
Because here is the reality: the agencies aren't trying to stop you from using AI. They are trying to stop you from being reckless. By insisting on the Human-In-The-Loop, they ensure that when the technology inevitably trips up, a person is there to catch the fall before it reaches the patient. (And trust me, it will trip up).
A really cool point: the most effective compliance strategies I'm seeing right now aren't using new, flashy tools. They are sticking to the fundamentals of Data Integrity and applying them to new tech.
To those who still think "the old rules don't apply to us", read Sarah Moeller's latest breakdown here: https://lnkd.in/example and then tell me how "stifled" you feel.
Stick to the basics. It's cheaper than a Warning Letter.
Highly recommended!
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