Stage 9 · Toolkit 9.8
PV Audit, Deviation & CAPA
Manage PV audit schedule, findings, deviations, CAPAs, effectiveness, and inspection readiness.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for PV Audit, Deviation & CAPA.
How it helps your team
Connect day-to-day safety operations with visible ownership, evidence, and inspection readiness.
Designed for
QPPVs, Heads of Pharmacovigilance, Drug Safety, PV Operations, Medical Safety, Quality, and affiliate teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- PV Deviation & CAPA SOP
- PV Audit SOP
- PV CAPA Plan Template
- PV Effectiveness Check Template
- PV Audit Report Template
Excel workbooks
- PV Audit Tracker
- PV Deviation Log
- PV CAPA Tracker
- PV Inspection Finding Tracker
- PV Audit Evidence Matrix
Related toolkits
Continue within stage 9
ICSR Case Management
Manage adverse event case intake, processing, QC, medical review, reporting, follow-up, and closure.
9.2Literature Surveillance & Review
Manage literature search, screening, medical review, reportability, and evidence of surveillance.
9.3Signal Management
Detect, validate, prioritise, assess, escalate, document, and close safety signals.