Good Pharmacovigilance Practice is on the Verixa roadmap
Pharmacovigilance — case processing, signal management, and periodic reporting — carries some of the heaviest AI-governance stakes in pharma. It is on the Verixa roadmap, not in Phase 1.
GVP is a roadmap commitment, not a current module. Verixa Phase 1 focuses on GMP Core today; GVP is planned for 2028+ and built on customer pull, not founder push.
Marketing authorization holders and PV service providers — teams working under the strictest clocks in the industry, where AI is already creeping into case processing faster than anyone can document who decided what. If any GxP domain needs a provable line between “the AI suggested” and “a qualified person decided,” it’s this one.
The regulatory context we are designing for
PV teams face rising case volumes and AI-assisted triage under tightening EU GVP and FDA expectations — exactly where advisory-only, human-in-the-loop AI matters most. Verixa Phase 1 focuses on GMP Core; GVP is planned for Phase 3 (2028+), built on customer pull.
EU GVP Modules
Good Pharmacovigilance Practice modules governing the EU safety system.
ICH E2E
Pharmacovigilance planning and risk management.
FDA 21 CFR 314.80
Post-marketing adverse drug experience reporting.
EMA EudraVigilance
Adverse-reaction data management and signal detection.
What this demands of a quality system
Case intake and processing within regulatory clocks — with quality events raised, investigated and closed when the process misses.
Signal management with documented human medical judgement — a signal assessment is a medical decision; the record must show whose.
PSMF currency — the pharmacovigilance system master file describing the system you actually run, not the one written down two years ago.
Oversight of PV vendors and partners — quality agreements, audits and corrective actions with the same rigour as any supplier.
The Phase 1 foundations GVP will build on
The Phase 1 GMP Core architecture — schema-level audit trail, MIRA advisory + HITL, and Evidence & Validation — is designed to extend into GVP. None of it claims GVP coverage today.
Planned · not yet built
Good Pharmacovigilance Practice
Schema-level audit trail
The schema-level audit trail extends to safety-case records — logging model version, prompt hash, retrieved evidence, and the human decision.
MIRA advisory + HITL
MIRA’s advisory + human-in-the-loop pattern fits case triage and narrative drafting, with a qualified human accepting before any safety-relevant action.
Evidence & Validation
The Evidence & Validation structure generalises from a GMP workflow to a pharmacovigilance workflow.
Per-tenant isolation & e-sign
Per-tenant data isolation and e-signature audit objects (controls under verification) apply to safety records unchanged.
In Phase 1
GMP Core foundation
Every foundation above is already live and load-bearing in GMP Core. GVP reuses this architecture — it adds no GVP coverage today.
On the GVP roadmap — planned, not yet built
These are design intentions for the GVP roadmap, phrased as intent — not capability claims. Nothing here is available today; each is built only when design-partner pull justifies the engineering.
PV quality event workflows on the governed spine.
Signal-governance records preserving the AI suggestion and the human medical judgement side by side, each attributed.
PSMF-supporting evidence on the sealed-pack model.
Vendor and partner oversight with the same audit-trail guarantees.
Express interest in the GVP roadmap
GVP is targeted for Phase 3 (2028+), pending customer pull. Subscribe to roadmap updates to help shape the GVP cohort and to hear first when it opens.
Expressing interest is lead capture for a future phase — it is not an order, a demo request, or a claim that GVP is available.