A 13-step governed process, not a black box.
The Pharmacovigilance workflow breaks pharmacovigilance into 13 discrete, ordered steps. Specialist AI agents execute each one; a gate resolver scores every step by blast radius and reversibility, parking the 1 riskiest, irreversible step for a human to sign off. Because pharmacovigilance is governed by FDA/EMA, the flow emits FDA/EMA evidence as it runs and records every decision with a tamper-evident audit hash.
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.
Why teams choose Minctrl to automate pharmacovigilance.
Most tools that promise pharmacovigilance automation software either fully automate and lose the audit trail, or bolt AI onto a form and still route every case to a human. Minctrl is different: it's an AI-native workflow builder for regulated operations. You design pharmacovigilance once as the Pharmacovigilance flow, AI agents run it, and a governance layer keeps a human on the steps where a mistake is irreversible.
The Pharmacovigilance agent handles pharmacovigilance the way an experienced operator would — gathering inputs, applying policy, and drafting the decision — while the governance layer decides, step by step, whether it can clear automatically or needs a human. This is what makes pharmacovigilance automation with human sign-off practical rather than a slogan: the AI does the 13-step work; the person owns the1 decision that actually carry risk.
Whether you want to automate pharmacovigilance, deploy an AI pharmacovigilance agent, or roll out full pharmacovigilance workflow automation under FDA/EMA compliance, the flow ships with the governance, the human gates and the tamper-evident audit trail already wired in. Advisory first — a tier only earns autonomy after it's calibrated — so you can adopt pharmacovigilance automation software without changing the human sign-off until you're ready.
Questions about pharmacovigilance automation.
How do you automate pharmacovigilance?
Minctrl models pharmacovigilance as a governed workflow of 13 steps. Specialist AI agents run each step; a governance layer scores every step by blast radius and reversibility and parks the risky, irreversible ones for a human at 1 sign-off gate. Build the Pharmacovigilance flow once, agents run it, and governance keeps a human on the steps that count.
Is Pharmacovigilance automation FDA/EMA-compliant?
Every gate decision in the Pharmacovigilance flow is recorded with its tier, resolver, confidence and an audit hash, and runs are deterministic — an auditor re-running the flow gets the same result. FDA/EMA evidence is emitted as the process runs, not reconstructed afterward.
Does the AI decide everything, or is there human sign-off?
There is always human sign-off on the risky steps. The default is SAFE: any irreversible or high-blast-radius step in pharmacovigilance parks for a human. The AI clears the reversible, low-risk volume; a person signs off exactly where it matters — that's pharmacovigilance automation with human sign-off.
Build your Pharmacovigilance flow.
Governed automation with human sign-off on the risky steps and a tamper-evident audit trail. Free tier — bring your own LLM key.
Launch dashboard →