Inspection triggers
- Routine inspection scheduling
- For-cause triggers based on intelligence, complaints, or emerging safety concerns
- QPPV changes or governance gaps
- Vendor / partner failures
- Licence transfers, M&A, or organisational change affecting PV responsibilities
What inspectors verify
- Timely, accurate ICSR processing and reconciliation
- Documented signal detection, evaluation, and governance decisions
- Risk management system upkeep and effectiveness evidence
- Oversight of outsourced PV activities
- PV QMS controls (deviations, CAPAs, change control)
- Training and competence evidence
- Data integrity across PV systems and interfaces
Evidence map
ICSR processing SOP
- Case intake/assessment/submission records
- Timeliness KPIs and reconciliation evidence
Signal management SOP
- Signal tracking log
- Evaluation reports
- Governance decisions with documented rationale
Vendor oversight evidence
- Technical agreements
- Oversight KPIs
- Issue tracking and CAPA evidence
Common failure patterns
SOPs exist but records don’t match practice
Why it happens: Procedures are written once but workflows change; teams work around systems under time pressure.
What inspectors do: Inspectors trace transactions end-to-end and compare audit trails to SOP claims; inconsistencies often drive major findings.
Outsourcing without retained oversight
Why it happens: The MAH assumes the vendor is responsible and fails to evidence ongoing monitoring and governance.
What inspectors do: Inspectors test oversight cadence, KPIs, escalation evidence, and governance decisions; findings focus on the MAH’s control, not outsourcing itself.
What good looks like
- Clear ownership of every PV activity and evidence object
- SOPs that mirror system reality and are followed in practice
- Decisions recorded with rationale and traceability
- Oversight evidenced routinely (not only before inspection)
Operationalisation
- Maintain a controlled PV evidence library aligned to GVP obligations
- Run monthly PV governance with recorded actions and follow-up
- Track reconciliations and trend metrics routinely
- Treat inspection readiness as BAU
Mapped toolkits
These toolkits operationalise the evidence expectations above. Masters remain immutable; customers edit their own copies.
Pharmacovigilance Core System Toolkit
Operationalises system-level evidence for case processing, signal governance, and oversight.