Friendly Audit
We offer on-site pharmacovigilance-specific "friendly audits" as part of a company’s quality management system.
A systematic analysis of the in-house pharmacovigilance system (structure, processes etc.) in the context of regulatory requirements is performed.
Analysis focus
- Existing documentation (SOPs, Organigrams, Workflows etc.)
- Documentation and handling of adverse reaction reports (ICSRs, SUSARs etc.) and other reports (PSURs, Annual Reports etc.)
- Database handling
- Analysis of external and internal interfaces (e.g. SOPs, service provider and consultant contracts, consumer and health professional information)
- Staff interviews
Audit Result
- Generation of an audit report
- Identification of areas for improvement and potential optimization
- Action plan for rectification of possible findings
For further information please contact info@bpi-service.de.
You can find a collection of relevant regulative pharmacovigilance documents in our pharmacovigilance document library.