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