LLM Use in GMP-Regulated Work
Version 22Oct2026
Scratch, Draft, Decision: how to use AI tools with human review built in, anchored to FDA’s first AI warning letter.
There’s a lot of talk about new compliance topics and very few documents to work from. These are free, adaptable, and explain why every control is there.
Version 22Oct2026
Scratch, Draft, Decision: how to use AI tools with human review built in, anchored to FDA’s first AI warning letter.
Licensed CC BY 4.0. Templates, not advice: adapt and validate them for your own operation.
More are coming. If there’s a topic you’d like to see, tell me.