Inspection & Compliance
Explore all topics, guides, and frameworks related to Inspection & Compliance.
Articles in this section
2- What is CAPA in Pharmacovigilance? A comprehensive, inspection-focused Corrective and Preventive Actions (CAPA) procedure tailored to pharmacovigilance (PV). Includes regulatory context, step-by-step CAPA lifecycle with timelines and KPIs, root cause analysis (RCA) methods, governance and inspection considerations, an implementable RACI matrix, templates for CAPA records and investigations, and a practical checklist to make CAPAs inspection-ready. Read Article →
- What is a QPPV Inspection? Explains pharmacovigilance inspections: their purpose, common areas reviewed (QPPV oversight, PSMF, case processing, signal management), typical triggers, and practical steps to maintain continuous inspection readiness such as mock inspections, CAPA and vendor oversight. Read Article →