Audits

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

This is precisely where we come in with our long-standing pharmacovigilance expertise, and we have developed a specific audit programme that keeps the regulatory requirements in view just as much as the needs of the medium-sized pharmaceutical industry.

As a building block of your company's own quality management, in preparation for an official inspection, as an internal training measure or as a consulting measure on the occasion of regulatory changes, our qualified auditors conduct pharmacovigilance-specific audits Europe-wide. This involves a systematic examination and assessment of the pharmacovigilance system of your company and/or your contracted partner companies, in particular with regard to the operability of the pharmacovigilance system and the fulfilment of the regulatory requirements.

The analysis focuses of our on-site pharmacovigilance audits include, among others:

• existing documentation (SOPs, organisation charts, workflows, etc.)
• documentation and handling of reports (ICSRs, SUSARs, etc.) and reports (PSURs, Annual Reports, etc.)
• database systems
• internal and external interfaces
• staff interviews

As results, in addition to a detailed audit report, you receive, among others, specific analyses of possibilities for improvement and optimisation potential as well as, if required, an action plan for remedying findings, which is prepared in close coordination with you.