Task:
An electronic risk management system needed to be implemented at three international locations to comply with the requirements of ISO 14971.
**Objective:**
Deployment of the system at three international locations.
Milestones:
- Implementation of the system at the Germany location
- Implementation of the system at the USA location
- Implementation of the system at the Singapore location
Approach:
First, the available software systems on the market were evaluated based on usability, functionality, and cost criteria. The selected system met the VDA criteria but had gaps in relation to ISO 14971. These gaps were addressed through adjustments made by the supplier to meet the requirements.
The system was successfully integrated into the IT infrastructure and validated according to GAMP 5 guidelines.
Critical Quality Parameters (CTQs) were defined, linked to potential causes, and required actions. These causes and actions were then evaluated using the FMEA method.
At the second location, the advantage of existing information and data was utilized. This data needed only to be supplemented with new information and partially translated into English. It was then decided to conduct further processing exclusively in English.
The implementation process was similar to the first location: installing the system into the IT infrastructure, performing computer system validation (CSV), and training employees.
At the third location, the procedure from the second location was repeated, with additional information and data integrated into the system.
Conclusion:
At the first location, many challenges had to be overcome, but the experiences gained were successfully transferred to the subsequent locations. Employees embraced the new digital system enthusiastically and quickly recognized that it facilitated their work. The individuals responsible for system maintenance were initially very motivated. However, this enthusiasm waned as they became more involved in the maintenance process and had to provide more information and data.
During the implementation phase, the system provided the necessary information for handling complaints, implementing CAPA measures, and communicating with regulatory authorities and notified bodies.