Blog
Governed knowledge, in writing.
Written for the people who have to defend an AI answer. Every post cites its primary sources, and lists them at the end.
The most recent piece.
21 CFR Part 11 and AI-generated answers: what an inspector will ask
An inspector who finds an AI assistant answering from controlled documents asks the questions Part 11 has always framed: who approved this, where is the audit trail, was it current. What a defensible answer trail looks like, mechanism by mechanism.
Life sciences ยท 7 min read
Read the piece →Everything else.
Everything else we have published.
Compliance officers, regulatory affairs leads, quality teams, and the engineers who build for them.
Standards
ISO 30401 for AI governance: a clause-level walkthrough
ISO 30401:2018 is the certifiable management system standard for knowledge management. Its clauses map onto what a review board asks about AI: who approved this, when, and is it still current. A clause-by-clause walkthrough of what each requires and the evidence that satisfies it.
Read →Financial services
SEC 17a-4, FINRA supervision, and AI-generated answers
Neither SEC Rule 17a-4 nor FINRA Rule 3110 mentions AI. Both still apply to it. This piece shows where an AI answer creates records and supervision risk, and what an evidence trail looks like: who approved it, when, from what source, at which version, and how long it is kept.
Read →System of record
What is a knowledge management system of record?
It is the one place that holds the approved version itself, not a link to wherever the file happens to sit. This piece defines the term, shows how it differs from tools that only point at content, and says why AI raises the bar.
Read →AI governance
Why your AI initiative stalled at governance review
The mandate was real and the pilot worked, yet the deployment stalled the moment governance asked who approved what the assistant says. The objection is to the knowledge it reads, not the model, and it has a mechanical fix.
Read →Knowledge governed. Intelligence everywhere.
See it on your own content, in your own environment.