Challenges in practice
Medical technology and pharmaceuticals, chemistry and food, in your industry you are subject to different regulations and guidelines. Guidelines in the GxP environment are laid down by the European Medicines Agency and the US Food and Drug Administration (FDA), for example. Compliance with the established guidelines is regularly checked by the supervisory authorities of the respective countries. When using your ERP system and, of course, your QA/QM solution, all processes must be designed with these regulatory requirements in mind. This applies in particular to the requirements of ISO13485 2016 EN and the regulations 21 CFR Part 11. Common procedures for validating software are usually a considerable burden due to their complexity, effort, the amount of paper, the lack of practical benefits, etc. For this reason, small and medium-sized companies in particular shy away from the urgently needed introduction of software requiring validation.
Lösung QS1
In der GxP-Branchenlösung bietet Ihnen QS1 beginnend mit der Produktentwicklung bis hin zum CAPA-Management eine Vielzahl von Modulen/Funktionen, welche es Ihnen erlauben, diese Abläufe effizient und normengerecht zu gestalten.
Wir unterstützen Sie nicht nur bei der eigentlichen Systemeinführung, sondern auch im Kontext Software-Validierung und Auditvorbereitung mit Bezug auf QS1 und Ihrem ERP-System.
- Qualification matrix:
Management and documentary evidence of your employees' qualifications as the basis for PDC feedback and various authorisations for transactions. - CAPA management:
Preconfigured process module for managing CAPA, integrated with the customer/authority complaint processes and QS1 measure management. - Batch tracking:
Interactive batch network for end-to-end traceability and tracking from raw material to delivery of the end product for batches and serial numbers with integrated analysis and statistics functions for root cause analysis. - DashBoard-Qualified Person:
Control centre for the responsible person to assess the conformity and release (also automated) of batches. - Electronic signatures and workflows for DMR data:
Versioning of DMR data such as part specifications and inspection plans with workflow-based inspection and release processes and associated audit trail. - Application software validation (based on GAMP5):
Success factors of our methodology for the validation of application software QS1 / ERP
