Challenges in practice
Medical technology and pharmaceuticals - the Qualified Person has a wide range of responsibilities in your company.
Starting with technical documentation, conformity of medical devices, reporting of incidents to the notified bodies through to product monitoring: the competences and areas of responsibility of the Qualified Person considerably extend conventional QA/QM processes.
Solution QS1
QP-relevant processes are displayed transparently for effective processing in the form of dedicated dashboards. Whether batch releases, authority notifications based on CAPAs or associated risk analyses - your qualified person receives the tasks to be processed in a compact format. The workflow-based control system enables effective processing, which of course includes electronic signatures and documentation in the audit trail.
- System-wide process logic in the GxP environment for the Qualified Person
- Different role authorisations
- Workflow-based planning and control of the QP's processing activities
- Digital signatures
- ‘4/6 eyes’ principle
