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Understanding the Pharmacovigilance Audit Process

The Pharmacovigilance Audit Process is an independent, objective assurance activity designed to add value and improve an organization’s safety operations. Whether it is an internal audit or a partner audit, understanding the scope is vital for compliance.

The Scope of a PV Audit

A standard Pharmacovigilance Audit Process evaluates your adherence to GVP modules and internal SOPs. The auditor will look for:

• Data Integrity: Can the safety data be traced from the source to the final report?

• Training Records: Are the staff qualified to perform their safety roles?

• CAPA Management: How does the company handle previous errors?

For more on maintaining the documents required for this process, read our guide on PSMF Management.