Quality Management and Quality Assurance
Quality assurance guarantees that quality standards are applied and documentation is maintained. These processes need to be validated through ongoing monitoring and auditing.
- The implementation of a Quality Management System including quality assurance measures is a necessary prerequisite for compliance and risk limitation.
- All employees have to be trained with regard to basic PV issues. Personnel actively involved in PV processes have to be trained with respect to relevant processes, SOPs and documentation. We provide in-house training adapted to your individual needs.
- In the Pharmacovigilance System Master File (PSMF) the performance of several key processes is illustrated using so-called performance indicators. These comprise, for example, timeliness of ICSR reporting and PSUR submission, timeliness of variation implementation as well as adherence to RMP and safety commitments. Consult us for advice in the presentation and assessment of performance indicators.