Life sciences
Agents handle the complaint and adverse-event volume no team can staff. The reportability and release decision stays a named officer’s — with 21 CFR Part 11-grade signed evidence an inspector verifies offline. AI drafts, a qualified human signs, every time.
The pain
The volume forces AI into the queue. The clocks and the personal accountability mean efficiency was never the thing keeping you up at night.
Volume no team can staff
Adverse-event and device-complaint volumes have grown far faster than reviewer headcount — more than any team can clear by hand. Caseloads already exceed reviewer capacity, which is why AI is already inside PV and complaint queues. The agents are coming whether or not you govern them.
Clocks that start on awareness
A 30-day MDR clock starts the moment anyone becomes aware; serious-unexpected ICSRs are due in 15 days. A late expedited report is a per-case, dated, inspectable failure — and an agent triaging the queue is exactly where the awareness moment now happens.
Recalls at the Philips scale
Philips Respironics entered a federal consent decree in 2024 after years of device-safety reporting failures. Under-reporting, not over-reporting, is what ends companies — and the gap between intake and the reportability decision is where the liability concentrates.
Your name on the system
The QPPV is personally responsible for the entire PV system; a named designated-unit reviewer signs every reportability call. When litigation asks “who — or what — decided,” the buyer is not protecting the company first. They are protecting themselves.
How it works
The shape every flow shares: free on the reading and drafting, structurally stopped at the one decision the statute reserves for a named human.
An agent ingests the complaint or adverse-event queue, proposes seriousness and expectedness, and moves toward safety on its own — quarantining a temperature-excursion pallet, because holding is reversible. It can only do what its role explicitly allows. Fast on the safe direction, with no gate.
The run parks at the one-way door — reportability, medical review, release-or-destroy. The agent that triaged the case is structurally barred from deciding it: §211.22-style independence enforced by the system, not promised in an SOP. A named officer signs, and the meaning of that signature is recorded word for word.
Every prompt, response, grant state, and decision lands in an append-only hash chain — a tamper-evident record where altering one entry breaks the whole chain — bound to the awareness timestamp that started the clock. Each case exports as an Ed25519-signed bundle (a tamper-proof digital seal) a BSI or FDA investigator verifies with zero access to your systems, against a published spec.
Gate
cold-chain · pallet VX-4471 · excursion 41 min
Excursion caught live · pallet quarantinedsafe direction · agent acted alone
Stability data pulled · disposition case assembled
One-way door
The agent cannot decide this. A named QA person signs — recorded reason required.
“Excursion within validated stability range for this product. Releasing pallet VX-4471.”
See it work
Working software your validation team can read and run. Each demo plants the exact cases that force the human moment.
Demo · MDR reportability triage
A complaint analyst agent triages ten complaints and flags two against their statutory clocks: an insulin-pump injury (InsuFlow MX, on the 30-day MDR clock) and a ventilator malfunction (VentAssist 300, recurrence-reportable). The agent can never decide reportability — the regulatory officer does, then the MDR skeletons are drafted.
Demo · PV ICSR processing
A case-processor agent intakes ten adverse-event cases, proposes seriousness and expectedness, and routes the two serious-unexpected ones (acute liver failure; anaphylaxis from a foreign source) to the 15-day expedited track. Medical review gates the submission — the processor who triaged a case may not review it. Blocked at runtime, not flagged.
Demo · cold-chain release / destroy
A cold-chain agent catches a temperature excursion live, pulls the validated stability limits, and quarantines the affected lots itself. Then it stops. Publishing the flow without the gate is rejected: high-risk steps force an approval gate by construction. The release-or-destroy call belongs to a named qualified person.
Evidence for
We never say “compliant” or “validated for you.” We say this: MakerChecker is designed against the requirements of the rules your inspectors already enforce — and it produces the signed artifact each one asks for.
Structurally prevented, cryptographically evidenced. The grants and SoD prevent; the chain and signature prove it happened.
Keep reading
See it for yourself
One command starts the demo: an agent stopped from signing off its own work, and the signed evidence file an inspector can check for themselves.
Designed against the rules your auditors already enforce.