The Audit Methodology

The approach followed is directly based on experience of Regulatory Authorities Inspections. This includes the comprehensive and structured review of all relevant processes in a limited amount of time. This is made possible through collection of audit information mainly during interview of relevant personnel, complemented by the review of a limited sample of documented evidence supporting the processes under evaluation. Through this approach, the key objectives are to verify whether appropriate arrangements are in place for each process, and whether it is adequately and consistently implemented and documented.

The objectives of the approach followed are to review all components of the Pharmacovigilance System in a minimum amount of time on site. In addition to achieving optimum cost-effectiveness, this guarantees a contained disruption of the activities in the organisation audited.

The expectations of Pharmacovigilance Inspectors are monitored on a continuous basis and reflected in the audits performed by PV Focus. As a result, our Pharmacovigilance Audits are not only a tool for compliance monitoring and process improvement, it also provides an opportunity to prepare the organization to potential inspections as they are conducted by leading Regulatory Authorities in the field of Pharmacovigilance.