Challenges in practice
Different regulations, particularly in the medical technology / pharmaceutical and chemical / food sectors, require a validation-capable process for the individual subtasks in the QA / QM area in the course of your product and process developments.
Throughout the entire product life cycle, from product development to market release and utilisation, all process steps must be documented, versioned and, in some cases, run through the corresponding testing and approval processes via electronic signatures.
Solution QS1
The development projects in QS1 offer you a convenient, workflow-controlled process for planning, controlling and executing the individual subtasks in the course of product and process development. All areas of change management are documented in QS1 in a validation-compliant manner and linked to the elements of document control.
The development project is seen as a ‘bracket’ that encompasses all data elements to be handled, such as test plans, initial sampling and all associated processes that belong to a logically related project. The relevant QA data is released via the development project; digitally signed in accordance with the required audit trail.
- System-wide process logic in the GxP environment for processing and releasing new or changed QA/QM data
- Different role authorisations
- Document control
- Workflow-based planning and control of processing activities
- Versioning of DMR data such as part specifications and inspection plans with workflow-based inspection and approval processes and associated audit trail
- Digital signatures
- ‘4/6 eyes’ principle
- Integration of the competences and tasks of the Qualified Person (QP) for medical devices
