Pharmacovigilance Audits

Pharmacovigilance Audits & Inspection readiness Services

Yashfin supports organizations in designing and implementing robust Pharmacovigilance Quality Assurance (PV-QA) frameworks through a risk-based, inspection-focused approach.

Our audit services strengthen compliance, enhance oversight, and promote continuous improvement across PV systems and processes.

Audits Performed
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Risk-Based Internal Audit Strategies
Establishment of risk-based audit programs focusing on high-impact PV processes, vendors, systems, and products.
Inspection Preparedness & Regulatory Support
We support Marketing Authorisation Holders (MAHs) throughout the inspection lifecycle, from readiness activities to post-inspection follow-up.
  • ✔ Inspection readiness assessments and mock audits
  • 🛡 Support during regulatory inspections
  • 📄 Drafting of clear, compliant, and regulator-ready responses to inspection findings
  • 📋 CAPA definition, prioritisation, and effectiveness monitoring
Digital Audit & CAPA Tools
Our technology-enabled audit and CAPA solutions streamline PV quality oversight and ensure full traceability.
  • ✔ Digital audit planning and scheduling
  • 🔍 Inspection and observation tracking
  • 📋 CAPA management with ownership, timelines, and effectiveness checks
  • 📊 Centralised documentation and compliance dashboards

A transparent, inspection-ready PV Quality System supported by risk-based audits, effective CAPA management, and digital quality oversight.