How Ordo finds the deviations nobody wrote up
A late sample or an unplanned dilution often has no record calling it a deviation. How Ordo checks the data against the plan, and who decides.
Notes on AI in regulated labs, from Ordo
Using AI under 21 CFR Part 11: what the rule actually asks
Part 11 never mentions AI. Here is what it does require of records an AI model touches, who signs them, and what an inspector will ask your lab to show.