The engine, in six parts
What it enforces while the agent runs, not in a policy document.
Before an agent takes a high-consequence action, it is held to the separation any serious operation puts on people: a defined role, deny-by-default access, a required second sign-off on the irreversible step, and a log that breaks if any line is changed. This is domain-neutral, the same whether the action moves money or changes a patient record. These six hold whether or not anyone remembers a procedure, and each one writes its own proof as the action runs.
Agents as employees
An AI agent is modeled the way a regulated company models a person: it is an identity that holds exactly one role at a time. The role is the unit of authority. Nothing an agent does is anonymous, and nothing it can do is implicit, capability flows only through the role it wears.
Maps toAttributability, the ALCOA “Attributable” principle.
Versioned skill grants
A role is a key ring. Each grant opens one specific door, a tool, a connector, a skill, and everything not granted is denied. Grants are versioned, so you can reconstruct exactly what any agent was permitted to do on any past date. This is the difference between a control and a fence: a tool list hard-coded by the developers who built the agent has no record of who approved it, no history, and no revocation trail.
Maps toAccess limited to what is explicitly granted; authority checks (e.g. 21 CFR §11.10(d)/(g)).
Structural segregation of duties
If an agent prepared the work, it is impossible, not discouraged, impossible, for that agent’s role to approve it. The separation is enforced structurally inside the run, at runtime, by construction. The attempt is refused and the refusal lands in the log. No tracker, content filter, or scoped credential can express “may prepare or approve, but never both on the same item.”
Maps toMaker-checker; quality-unit independence (e.g. 21 CFR §211.22).
Human approval gates
A gate is a step in the workflow, not a notification bolted on afterward. It demands a quorum, n of m named approvers, and the human who requested the action can never be one of them. When a person signs, their reason is captured verbatim and bound to the decision, so the signature carries its meaning.
Maps toSignature with recorded meaning (e.g. 21 CFR §11.50).
Role limits
A role carries the limits of its authority: a monetary threshold above which a human must sign, a cap on how many times a skill may fire, a budget on tokens. Limits are set and owned by the compliance side, not the developers who build the agent, and when a limit is reached, the system fails closed.
Maps toDelegated-authority limits.
Signed audit ledger
Every action, every model call, every approval lands in a sealed, append-only chain. Change one record and the chain breaks at that record. You can export a signed evidence bundle that an outside inspector verifies offline, with no access to your systems or ours, against a published, open formula anyone can reimplement. The record stands on its own math, not on our word.
Maps toAudit trails and signature linking (e.g. 21 CFR §11.10(e), §11.70).