Pharma & Life Sciences

Pharmacovigilance is where AI evidence gets real.

If you want to see the future of AI evidence requirements, don’t read the think pieces — read pharmacovigilance regulation. Nowhere else is the duty this concrete: when AI touches safety signals, the record must show what the algorithm was, what it decided, and how sure it was.

Good pharmacovigilance practice expects that where automated systems support signal detection and case processing, the audit trail captures the classification, the algorithm and its version, and the confidence of the output — per case, reconstructable. Not a model card. Not a validation binder. A per-decision record.

21 CFR Part 11 sets the general rule pharma has lived with for decades: electronic records require secure, computer-generated, time-stamped audit trails — who, what, when, why — and a record whose trail is incomplete effectively does not exist for the regulator. EU GMP Annex 11 carries the same expectation in Europe, and the new Annex 22 extends the logic explicitly to AI in GxP environments.

Every regulator converging on AI is converging on the same primitives pharma already enforces: per-decision records, version and provenance, human accountability, immutability. Healthcare, banking and government are being walked toward the standard pharmacovigilance already lives. Institutions that build the evidence layer once are ready everywhere.

AI in pharmacovigilance is deployable — and defensible — when every output is checked against verified clinical and pharmaceutical reference data, bound to the exact rule, signed, and sealed into an immutable trail with the algorithm’s identity attached. That is not an aspiration; it is the regulation, read carefully. It is what we build.

― basis: GVP (signal management, audit trail expectations) · 21 CFR Part 11 §11.10(e) · EU GMP Annex 11 · Annex 22 (AI in GxP) · EU AI Act Art. 12