The Validated AI
Operating System
for Pharmacovigilance
AI in pharmacovigilance and quality management without compromising GxP compliance — architecture-first, validated by design.
Core Tension Resolved
"Speed and provability usually pull against each other. VAIO-PV is built to do both."
Stages
Compliant
Access Roles
Audit Records
See VAIO-PV in action
Watch how VAIO-PV handles end-to-end pharmacovigilance — from safety intake to audit-ready compliance, all in one validated workspace.
GxP Validated
Every workflow meets ICH & EU standards
AI-Accelerated
Faster case processing, zero compliance risk
Append-Only Log
Nothing editable — by design, not by policy
Move faster on case intake, signal detection and CAPA management — and prove every decision is traceable.
VAIO-PV is not an AI layer bolted onto legacy PV tooling. It is a platform where compliance is the foundation the AI runs on top of — not an afterthought bolted on after launch.
"Compliance is the foundation the AI runs on, not a layer added after launch."
Speed Without Compromise
AI-powered intake and processing reduces cycle times without sacrificing regulatory defensibility.
Validated by Design
Every module is validated under a documented IQ/OQ/PQ lifecycle — inspection-ready from day one.
Full Traceability
Every AI suggestion, human decision, and system action is permanently logged and cryptographically signed.
One workspace.
All six stages.
AI co-pilot at every stage
· human reviewer at every decision
Safety Intake
Reports from HCPs, patients, studies, literature and mobile apps, captured by AI extraction — OCR, email parsing, voice-to-text.
Case Processing
Automated duplicate detection and case validation run before a processor is ever assigned.
Medical Review
Coding and causality assessment are proposed with a confidence score; a qualified person signs off.
Signal Detection
Disproportionality analysis and signal evaluation, grounded in your own case history and documents.
Risk Management
Benefit-risk assessment and RMP impact review, so a detected signal has a documented path to regulatory action.
Quality & Compliance
Deviations, CAPAs, root-cause analysis and SOP lifecycle on the same audit trail and RBAC model as the safety side.
One workspace across all six stages. AI co-pilot at every stage, human reviewer at every decision.
Designed around the frameworks PV and quality teams are measured against.
Compliance Frameworks
Role-Based Access — 6 Defined Roles
Role-Based Access Control
Six defined roles — from safety reviewer to auditor — so the people who need to see a record can, and the people who don't, can't.
Append-Only Audit Log
Every record, AI query and human decision is logged append-only. Nothing in the audit log can be edited or deleted — by design, not by policy.
SHA-256 + HMAC Signing
Every entry is SHA-256 checksummed and HMAC-signed. Tamper evidence is cryptographic, not procedural.
Inspection-Ready from Day One
These are the frameworks PV and QA teams are actually measured against. Six roles, append-only log — always audit-ready.
A platform your next inspection won't be afraid of.
Accelerate and strengthen AI into your pharmacovigilance operations without putting your compliance posture at risk.