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 live module. Verixa Phase 1 ships GMP Core today; GVP is planned for 2028+ and built on customer pull, not founder push.
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.
The Phase 1 foundations GVP will build on
The GMP Core architecture — schema-level audit trail, MIRA advisory + HITL, and the G-7 evidence pack — 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.
G-7 evidence pack
The G-7 evidence-pack structure generalises from a GMP workflow to a pharmacovigilance workflow.
Per-tenant isolation & e-sign
Per-tenant data isolation and e-signature audit objects apply to safety records unchanged.
Live 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.
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.