Example processhealthcareFDA/EMA

Pharmacovigilance automation software

An example of pharmacovigilance as a governed process: agents do the 8 steps, and a person signs the gate before anything irreversible happens. Download it, import it into your workspace, and adapt it to your systems.

Download example · JSONImport into Minctrl →

minctrl.process/v1 · hash 5fe5eb84269d…20f8

The graph8 agent steps1 human gatesigns: QPPV / drug-safety physician

Pharmacovigilance autopilot

Pharmacovigilance is high-volume ICSR processing under a 15-day expedited clock, where a named QPPV is legally accountable for every causality and seriousness call. Cases coded, de-duplicated and causality-assessed straight-through; the QPPV signs before any safety report is submitted.

The governed flow · branches, parallel work & a human on the irreversible step
invalid / incompletevalid casenon-seriousserious / expeditedrejected — re-assesssigned
Start
agent · low risk
Intake the adverse-event case (ICSR) from the source and capture reporter, product and event fields
decision
Case valid & complete (identifiable patient, reporter, product, event)?
agent · low risk
Request follow-up from the source to obtain the missing minimum criteria, then re-intake
parallel · fan-out / join
Run coding, causality and seriousness assessment concurrently on the valid case
agent · low risk
MedDRA-code the terms and de-duplicate against the safety database
agent · low risk
Assess drug-event causality
agent · medium risk
Triage seriousness / expectedness and start the 15-day expedited-reporting clock
parallel · fan-out / join
Join the parallel assessment branches into a single case assessment
decision
Serious / expedited-reportable case?
agent · low risk
Auto-log the non-serious case to the safety database for periodic (PSUR) aggregation; no expedited report
gate · human sign-off
Review the causality, seriousness and E2B report; sign or reject the case assessmentsigns: QPPV / drug-safety physician
agent · high riskirreversible
Submit the safety report (E2B) to FAERS / EudraVigilance
agent · low risk
Run signal detection and maintain the safety database
Done
low riskmedium riskhigh riskbranch / reworkgate · human sign-off
Use this example
01

Download the file

A minctrl.process/v1 document: the graph and the hash of the process it becomes.

02

Import it in Processes

Import into Minctrl opens this example in your workspace; one click stores it as your first version. Import JSON does the same with the file, and a file changed after download is refused.

03

Connect your systems

Every connector starts in shadow: steps run, nothing leaves Minctrl until you configure a connector and switch it live.

04

Adapt it

Change signers, time limits and steps on the canvas. Each save is a new version; a running case stays on the version it started with.

Questions
How do I automate pharmacovigilance with Minctrl?

Start from this example. Import the file in Processes, connect your own systems, and adapt the steps on the canvas. Agents run the reversible steps; every irreversible step waits at a gate for the role you choose. The example has 8 steps and 1 gate; you can change any of them.

Is pharmacovigilance in Minctrl auditable?

Every run start, signature and change to the process is written to a hash-chained audit log your auditor can verify and export. The example is modelled on FDA/EMA; whether your process meets it is a decision for your compliance team.

Does the AI decide everything?

No. Minctrl will not make a process runnable while an irreversible step can be reached without a human gate, and one person cannot sign two gates of the same run.

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