Serialization Equipment Qualification and Validation
- Project location: Basel (CH), International Sites (IT, US, ES).
- Project time frame: 7 years.
- Test protocol development.
- Test execution.
- Engineering support tracking system.
Vesdo’s support enabled one of the top international research-based pharma enterprises to implement serialization technology for secondary packaging items. This Serialization Equipment Qualification support activities extended across all project phases. At a time when serialization technology was still relatively new the extensive research and in-depth assesssment of the available systems and technologies performed by Vesdo paved the way to the User Requirements Specification (URS).
Vesdo developed the test protocols for FAT/SAT/IQ/OQ/E2E tests in cooperation with experts from the client and vendors and monitored the test execution to help bring the equipment into a validated state.
Furthermore, Vesdo provided engineering support for the implementation of the product tracking system. The project was completed on time and in budget.