AI that speeds up pharmacovigilance and still passes your audit
VAIO-PV brings AI to case intake, signal detection and CAPA without breaking GxP: every step validated, every record locked, every decision traceable.
Move faster on case intake, signal detection and CAPA management, and prove every decision is traceable.
VAIO-PV is not an AI layer added to legacy PV tools. Validation, role-based access and an immutable audit trail are the foundation of the platform, and the AI works within them.
- ICH E2B
- EU Annex 11
- 21 CFR Part 11
- EU AI Act
- GAMP 5
“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 access 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.
- ICH E2B(R3) & E2A
- EU Annex 11
- 21 CFR Part 11
- EU AI Act (high-risk)
- ISO 9001:2015
- GDPR
Role-based access: 6 defined roles
- SRSafety Reviewer
- PVPV Processor
- MRMedical Reviewer
- QPQualified Person
- AUAuditor
- ADAdministrator
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
Validation documentation, role-based access and the append-only audit trail are in place from the first day of use, so evidence is ready whenever inspectors ask.
Ready for your next inspection.
See how VAIO-PV brings AI into your pharmacovigilance operations without putting your compliance posture at risk. We will walk you through the platform with your own use cases.
- GxP validated
- ICH E2B compliant
- EU AI Act ready
- Append-only audit trail