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.