Can I use an AI first draft in a regulated document?
For framing and a running start, yes. As the submission, no. The draft clears the blank page; the human writing, review, and quality process is untouched, and the author of record stays human.
Yes, for the right part of the job, and it is a bright line worth stating plainly.
Use an AI first draft as scaffolding: a running start on structure and language that clears the blank page, which is the most expensive part of regulated writing. That is a legitimate, valuable use, and it is where the backlog actually lives.
What you do not do is treat that draft as the submission. Everything that reaches a regulator, the sourcing, the argument, the precision, the review, is the decisive work, and it stays human. AI-drafted content goes through your full, normal writing, review, and quality process, unchanged. No AI-generated text should go to an agency as-is, and the author of record stays a human being from the first draft to the final filing. A machine producing the first version does not move accountability by an inch.
The precise controls, what your review must include, what has to be documented, how validation applies, are not a question for a case study. They are a question for your own quality and regulatory function, and nothing here is a substitute for their judgment or for the controlling guidance. The worked example is in The Blank Page Is the Expensive Part. The rule it lives by: escape the blank page, never skip the work.
Cheers,
-Titus
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