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.
Solution QS1
We support you not only with the actual system implementation, but also in the context of software validation and audit preparation in relation to QS1 and your ERP system.
QSC has a tried-and-tested methodology based on GAMP5 that is specifically geared towards the introduction of standard application software. Our process-based approach is combined with an innovative, risk-based approach and, despite validation, enables you to implement QS1 quickly, easily and cost-effectively.
In the context of QS1, configurable standard software means no customisation of interfaces and functions. Compared to conventional validation procedures, our risk-based approach reduces the effort required for test planning and execution by more than 50%.
The validation methodology is customised to your specific operational context during the project and integrated into existing QM processes such as your change control procedure. With our validation repository, release changes are easy for you to manage and can be carried out promptly based on changes with little effort.
- System-wide process logic for GxP regulations
- Implementation of validation with QS1 introduction
- Establishment of software validation as a component of the QM system
- Modern, tried-and-tested, risk-based procedure for test planning and execution (CSV / CSA), based on GAMP5
- Extensive catalogues and best practices for test plan and test case creation in an operational context
- Validation repository; risk-based approach to processes/use cases
