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.
- Systemweite Prozesslogiken im GxP-Umfeld für die Qualified Person
- Unterschiedliche Rollenberechtigungen
- Workflowbasierte Planung und Steuerung der Bearbeitungstätigkeiten der QP
- Digitale Signaturen
- „4/6-Augen“-Prinzip
