Glossary
What 21 CFR Part 11 means for AI
The FDA rule on electronic records and signatures, read for the day an LLM is the thing that drafted the record.
21 CFR Part 11 is the FDA rule that governs electronic records and electronic signatures in regulated work. For AI, it means any record an AI or LLM creates or signs must be attributable, complete, time-stamped, audit-trailed, and secured, with a named person accountable for the output.
21 CFR Part 11 is the FDA rule that governs electronic records and electronic signatures in regulated work. For AI, it means any record an AI or LLM creates or signs must be attributable, complete, time-stamped, audit-trailed, and secured, with a named person accountable for the output.
The rule predates large language models, and it does not need an update to cover them. Part 11 asks who did this, when, and on what record. An LLM that drafts a deviation report or a regulatory response is doing exactly the kind of work Part 11 watches. The model writing well in a demo does not answer the auditor's question.
The model is the easy part. The harder part is the record around it: an audit trail of what the agent did, version control on each output, access scoped to the task, and a named reviewer who signs. That is the point of agentic systems built to be audited, and it is why Lama runs them inside the client's own Claude Enterprise tenancy rather than a shared tool. The same Part 11 thinking carries into regulatory affairs work and the security controls underneath it.
Common questions
Does 21 CFR Part 11 apply to AI-generated content?
Yes, when the AI creates or modifies an electronic record the FDA can ask for. The rule does not care that a model wrote the draft. It cares that the final record is attributable, audit-trailed, and signed by a named person.
Can an AI provide the electronic signature under Part 11?
No. A Part 11 electronic signature is a legal act tied to a human. The AI can prepare the record and remove the blank page. A named person reviews it and signs for it.
15 min. 5-day written diagnosis. No deck.