The design-partner pilot
One workflow, in production, with proof, in twelve weeks.
A fixed-fee pilot run self-hosted in your own environment on synthetic or minimized data. An agent does the triage and the drafting, your named person signs the calls that carry legal weight, and you walk away with a signed audit a regulator can verify offline. Forward this page to your team; the sample evidence file below is real.
The offer, plainly.
- Eight to twelve weeks, self-hosted in your environment, on synthetic or minimized data. No patient data leaves you.
- A fixed fee, US$25,000 to $75,000. Scope sets the point in the band: intake channels, product lines, and whether we run one gate or two. We quote one number after a single scoping call. No per-seat licensing and no usage metering during the pilot.
- The agent runs deny-by-default. It performs only the skills you grant, inside fail-closed limits. Your named person signs every decision that carries legal weight, and the software blocks the agent from signing its own work.
- You keep a signed, offline-verifiable audit. Every action, agent and human, on a hash-chained record your regulator checks without trusting our software, your database, or us.
What you get, week by week
By week 4
Running in your environment
Deployed self-hosted on your infrastructure. Your decision tree encoded as the agent policy, skill grants and fail-closed limits configured and signed off by your workflow owner. First cases flowing through, your designated reviewer signing at the gate, and the first signed audit checked offline by your own team.
By week 8
The workflow at volume
Your full pilot case set processed on synthetic or minimized data you select. A side-by-side of agent triage against your team's historical adjudication, including every disagreement and how the gate caught it. Segregation-of-duties and limit-breach scenarios tested on purpose and shown failing closed.
By week 12
The evidence pack and the decision
A signed, offline-verifiable audit covering the whole pilot, plus a one-page summary you can put in front of your quality council or an inspector: what the agent was allowed to do, what it was denied, who signed each reportable call, and how to verify all of it. A production-readiness assessment and a joint go or no-go.
What we need from you
- A workflow owner
- One person with authority over the decision tree, about two hours a week.
- Case data
- Synthetic cases, or a minimized historical sample with identifiers stripped. No patient data is required at any point.
- Named signers
- One to three people authorized to adjudicate in the pilot. In drug safety that is your safety physician or QPPV; in devices your quality reviewer, with the PRRC standing behind it.
- An environment
- A VM or container host inside your network. Your security team keeps the keys. Nothing leaves your infrastructure.
What it is not
- Not a data-sharing deal
- Self-hosted, in your environment, synthetic or minimized data. We never hold your case files.
- Not a QMS or safety-database replacement
- Your system of record stays yours. We govern the agent and produce the evidence layer.
- Not autonomous filing
- The agent drafts. Your named person decides. That is the design, not a setting.
- Not a multi-year services deal
- Fixed fee, fixed window, a defined exit. You keep the evidence either way.
Take these to your team
A real signed audit, to download and check yourself.
This is a real MakerChecker audit bundle from a governed run: an agent was blocked from approving its own work and a named human signed instead. Download it, then drop it into the verifier and watch it re-check itself. Change one row and it breaks. This is the kind of file your pilot produces.
Want the two-page pilot brief for your quality council, or the commercial terms? Email hello@makerchecker.ai. See also how we clear a security and procurement review.
See it for yourself
Pick one workflow. We will get it into production.
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.