At Ultragenic, we see AI fundamentally reshaping pharmacovigilance — from automated case intake to intelligent intake/reporting workflows and modern safety systems. However, in GxP ‑regulated environments, innovation can never stand alone.
It must be firmly anchored in patient safety, data integrity, and regulatory compliance.
For us, Responsible AI in pharmacovigilance goes far beyond deploying algorithms. It requires robust AI governance that is fully aligned with QMS, CAPA, and change control frameworks, ensuring AI remains inspection‑ready throughout its lifecycle.
At Ultragenic, this translates into:
- Risk‑based validation proportionate to GxP impact
- Continuous lifecycle monitoring to proactively manage model drift
- Transparency and explainability to support regulatory inspections
- Human oversight, ensuring expert judgment remains central to all critical decisions
Industry guidance consistently reinforces what we practice at Ultragenic: trust in AI is earned through disciplined governance and validation — not speed of adoption.
