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Pharmacovigilance audits
Pharmacovigilance audits
  • Global Pharmacovigilance audit
  • MAH audit
  • QPPV audit
  • Company affiliates audit
  • Business partner/Marketing partner audit
  • Vendor/Service provider audit (Literature search, Case processing Unit, Translations, Vendor (PSUR/PABER/RMP/ADCO, etc.)
  • Inspection/audit readiness
Audit Scope
  • PV System Overview - Organisation Structure and responsibilities
  • Management and oversight of PV Operations globally.
  • Quality Management System - CAPA Management, KPIs and Metrics, Oversight of Quality Organisation,
  • Training Management – On boarding, Training, Mentoring, Documentation - JDs and CVs, Off boarding)
  • Business Continuity Planning
  • Information Security and Data Privacy
  • Pharmacovigilance System Master File
  • Individual Case Safety Reports - SOPs, Processes and Case reviews, Systems and Tools
  • Aggregate Reports - PSUR, PBRER, PADERs - SOPs, Processes and Reports review, Systems and Tools
  • Outsourcing, Vendor Oversight / Governance, Vendor Contracts
  • Contractual Documents
  • Governance Meetings
  • Oversight and communications between CRO-MAH: Compliance Dashboards/Metrices their Frequency/Periodicity
  • Management of Late Cases and USR
  • PADER Processes
  • Process to Manage HA requests and regulatory enquiries
  • Documents Archival process
  • Signal Management
What's New
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
CRQA is looking for
qualified and Independent
Pharmacvovigilance Auditor
- experience essential in
Pharmacovigilance Audits.
Interested Professionals
may apply to bd@crqa.in
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