Challenges in practice
Medical technology and pharmaceuticals, chemistry and food - you are subject to different regulations and guidelines in your industry. Both the FDA and MDR guidelines in the GxP environment prescribe the audit trail as a mandatory quality assurance tool.
Audit trails are used to monitor and record changes that are made to processes. In contrast to conventional monitoring systems, which continuously monitor certain processes, audit trails focus on monitoring changes and deletions made by users. This means that interventions in processes are comprehensible, controllable and fully visible for downstream levels in supply and value chains.
Solution QS1
QS1 offers you a secure, computer-generated and time-stamped electronic record with the system-wide audit trails. This enables you to trace the history of events based on the creation, modification or deletion of electronic records.
Both at master data and transaction data level, QS1 offers you the possibility of traceability at all times:
- Who
- What
- When
- Why did what.
In the regulatory environment, audit trail information is of course closely linked to the possibilities of electronic signatures, development projects and document control elements.
- System-wide change history for reconstructing your GxP-relevant data
- Change notes and development projects
- Digital signatures
- Multi-stage review and approval scenarios (‘4/6 eyes’ principle)
- Regular review via SOPs from a risk management perspective