Industry solution
Automation an auditor can trust.
In regulated manufacturing, every action needs a reason and a record. Tokoaido is built around human approval and an audit log of who decided what, and why. It is not validated for GxP use, and it has no 21 CFR Part 11 electronic signatures.
How Tokoaido helps
What changes.
Every consequential action is written to the audit log with the actor, target, risk and reason. Energy setpoint decisions also carry hash-chained lineage from source data to action.
High-risk actions wait for a named person, who records a reason; nothing high-risk executes silently.
MES, LIMS and QMS remain the systems of record. Tokoaido governs on top; those connectors are built for your stack in a pilot.
No GxP validation package and no 21 CFR Part 11 electronic signatures yet. Controls are mapped to the EU AI Act, NIST AI RMF and GDPR as a self-assessment.
Sound familiar?
The work nobody signed up for.
If you have said one of these this month, the rest of this page is for you.
Audit week means three people pulling batch records, emails and sign-offs into a binder.
A deviation takes two weeks to close, and most of that is waiting for the right signature.
The inspector asks who changed the parameter and why. Too often the answer is in someone's inbox.
We would like to use AI, but nobody can tell me how it fits our validation approach.
The LIMS, the MES and the QMS each tell a different part of the same batch's story.
Every time a line stops for a quality problem, the shortage team is on the phone to me within the hour.
Use cases
What you would use it for, first.
Each one starts from a problem you can name, and ends with something a person can see has changed. Live means it runs in the product today; pilot means we build it with you.
- 01
Process drift triaged to a named approver
Live todayTodayA batch parameter drifts, the alert goes to a shared inbox, and the deviation is opened days later from memory.
With the platformThe platform flags the drift against the designed process, proposes the next step with the evidence, and waits for a named person to approve it with a written reason.
What changesTriage starts the day the drift starts, and the decision is recorded at the moment it is made. It supports your quality process; it is not a validated GxP system.
- 02
A decision history you can hand to QA
Live todayTodayBefore an inspection, people reconstruct who approved what from five systems and a shared drive.
With the platformEvery consequential action is written to one audit log with the actor, the target, the risk and the reason, viewable in the product and exported on request.
What changesDecision history comes from one record. It does not replace your QMS, and the platform has no 21 CFR Part 11 electronic signatures.
- 03
AI that drafts while people decide
Live todayTodayTeams want AI help with triage and drafting, but cannot risk patient data or a GMP decision reaching an external model.
With the platformThe model gate refuses to send PHI or payment data to any external model and falls back to deterministic logic. Agents only propose; a person decides.
What changesAI does the reading and drafting while qualified staff keep the decisions, in line with the direction of the draft EU GMP Annex 22.
- 04
MES, LIMS and QMS in one batch view
Built in a pilotTodayOne batch's story is split across the MES, the LIMS and the QMS, and stitched together by hand for every investigation.
With the platformIn a pilot we connect your MES, LIMS and QMS read-only through the REST/OAuth connector, so a batch's events sit in one model.
What changesInvestigations start from one timeline instead of three exports.
Business value
Where the return comes from.
The levers, and the range other organizations have published for each. Ranges are typical of the category, not a promise and not our customers' results.
Exposure in inspections
The FDA increasingly cites data-integrity failures in drug GMP inspections, with warning letters, import alerts and consent decrees behind them. A clear decision record is the first defence.
US Food and Drug Administration, Data Integrity and Compliance With Drug CGMP: Questions and Answers (Guidance for Industry) (2018)Supply lost to quality problems
62% of shortages studiedMost US drug shortages studied followed a manufacturing or quality problem. Catching drift early protects supply, not just compliance.
US Food and Drug Administration, Drug Shortages: Root Causes and Potential Solutions (2019)Hours spent preparing for audits
Decision history comes from one record instead of a binder. Put your own audit hours into the estimate below.
Deviation cycle time
The approval reaches a named person with the evidence attached, instead of waiting in a shared inbox.
Run your numbers
Evidence gathering you stop doing by hand.
Every input is yours to change, and the arithmetic is shown in full. Nothing is hidden in a multiplier.
6 × 160 × €85 × 40% = €32,640
An estimate on the numbers above, not a measurement and not a customer result. In an Operations X-Ray we replace the assumptions with figures measured on your own systems.
Before and after
The same week, run differently.
Audit week is three people building a binder.
Decision history is pulled from one record.
A drift alert waits in a shared inbox.
The drift reaches a named approver with the evidence the same day.
Who changed a parameter, and why, lives in someone's email.
Every decision carries its approver and a written reason.
AI is banned outright because nobody can say where the data goes.
Patient data never reaches an external model, and people keep every decision.
In practice · Example scenario
Deviation triage → governed workflow
A batch parameter drifts. The platform triages, proposes a documented next step, requires sign-off with a reason, and records who approved it and why.
Other industries
Operations X-Ray
Start outside the GMP-critical path.
We begin with a non-GMP-critical process, so your quality team can see the decision record before anything else.