Pharmacovigilance audits – part of quality management and inspection preparation

The regular auditing of the company’s own pharmacovigilance systems (including subsidiaries) as well as those of the commissioned partners (including distributors and pharmacovigilance service providers) required by the Medicinal Products Act and Module IV “Audit” of the Good Pharmacovigilance Practices Guideline, among others, represents a growing challenge for many MAHs.


This is where our long-standing pharmacovigilance expertise comes in. We have developed a specific audit program that focuses on regulatory requirements as well as the requirements of the medium-sized pharmaceutical industry.


As a component of your in-house quality management or in preparation for an official inspection, we carry out pharmacovigilance-specific audits throughout Europe. We systematically review and evaluate the pharmacovigilance system of your company and/or your commissioned partner companies – in particular, with regard to the functionality of the pharmacovigilance system and compliance with regulatory requirements.


Our on-site pharmacovigilance audits focus on the following analysis areas, among others:

    • Existing documentation (e.g. SOPs, organisational charts, work flows)
    • The documentation and handling of notifications (e.g. ICSRs, SUSARs) and reports (e.g. PSURs, annual reports)
    • Database systems
    • Internal and external interfaces
    • Employee interviews


In addition to a detailed audit report, the results include specific analyses of improvement opportunities and optimisation potential as well as an action plan for eliminating findings, which is drawn up in close consultation with you.


Would you like to know more?

We are pleased that you are interested in our pharmacovigilance audit services. We would be happy to present our services in detail – just contact us.