Strengthen pharmacovigilance audit readiness
Cencora delivers pharmacovigilance audit services that help you assess compliance, strengthen oversight, and prepare for inspections. Our team supports the design and implementation of audit systems, risk-based planning, audit execution, reporting, and follow-up activities.
We tailor support to your organizational structure, portfolio, legal requirements, and agreements, with on-site and remote audit options to fit your needs.
We tailor support to your organizational structure, portfolio, legal requirements, and agreements, with on-site and remote audit options to fit your needs.
Address complex pharmacovigilance audit demands
Pharmacovigilance audit programs must satisfy global regulations, fit diverse partner models, and lead to corrective actions that hold up under inspection.
Global regulatory alignment
Maintain audit activities in line with GVP requirements and global regulations across company entities, partners, and service providers.
Risk-based audit planning
Prioritize affiliates, partners, and vendors through risk assessment to shape strategic audit plans and annual audit schedules.
CAPA and inspection follow-up
Turn audit findings into managed CAPA follow-up and inspection support that strengthens ongoing pharmacovigilance system effectiveness.
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Comprehensive audit support
You receive support across the full pharmacovigilance audit lifecycle, including audit system design, risk analysis, audit planning, execution, reporting, and follow-up.
Cencora can also tailor vendor qualification, due diligence, and inspection support to your pharmacovigilance and quality system needs.
Cencora can also tailor vendor qualification, due diligence, and inspection support to your pharmacovigilance and quality system needs.
What we offer
Audit system design
Define and implement risk-based pharmacovigilance audit strategy, including audit risk analysis and supporting audit system setup.
Audit program management
Prepare and manage audit programs, questionnaires, plans, and agendas for internal teams, partners, and service providers.
Audit execution
Conduct pharmacovigilance system, affiliate, distributor, qualification, and process audits on site or remotely, based on your needs.
Reporting and communication
Prepare audit reports and communicate findings clearly to support alignment, accountability, and timely next steps.
CAPA follow-up
Review proposed corrective and preventive actions and support follow-up activities tied to pharmacovigilance audits or inspections.
Inspection readiness support
Support due diligence and pharmacovigilance inspections while helping verify the effectiveness of pharmacovigilance and quality systems.
Why choose Cencora for pharmacovigilance audits
Qualified auditors across regions
Highly qualified auditors deliver pharmacovigilance audit support worldwide with strong communication skills and cultural awareness.
Flexible delivery models
On-site and remote audit options adapt to your structure, portfolio, legal requirements, and working preferences.
End-to-end oversight
Support spans audit strategy, execution, reporting, CAPA follow-up, and inspection readiness across the audit lifecycle.
Expert insight
Intensifying regulatory oversight of local pharmacovigilance is leading to more demanding audits. In tandem, biopharmaceutical companies are requiring tighter Service Level Agreement (SLA) adherence from outsourced service providers.
— Iain Barnden
How automation increases efficiency and accuracy of local PV monitoring and KPI tracking
Related solutions
Qualified person for pharmacovigilance (QPPV)
Appoint an experienced EU QPPV or deputy, supported by a network of specialists across Europe and by round-the-clock availability to regulators.
Local affiliate pharmacovigilance management
Navigate complex local pharmacovigilance (PV) requirements with in-market expertise and centralized routine activities that improve efficiency, scalability, and compliance.
PharmaLex is now Cencora
Pharmacovigilance audits is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about pharmacovigilance audits?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.