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Pharmacovigilance audits

Pharmacovigilance audits

CRQA provide wide range of solutions for pharma and clinical research regulatory issues. Our team is well equipped to provide turnkey solutions for the regulatory issues in India for drugs and devices. Some of our key services are:

  • 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