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Like many companies preparing for EU FMD, this mid-size French pharma company invested in a new line management system (LMS) to handle the upcoming serialization requirements for its own business and for the pharma customers it had taken on in a CMO capacity. The company had also diversified its own manufacturing in recent years, building a network of over 30 CMOs for its product portfolio.
Key criteria: cost control and time constraints
The pharma company evaluated a number of serialization solution providers to integrate with its new technology and help it achieve compliance with EU FMD.
- Given their significant investment in the new LMS, the company wanted to control its initial cost outlay. However, they soon discovered that the seemingly lowest cost solutions could not offer a proven integration to their new LMS. If the LMS and serialization solution could not talk to one another, the pharma company would not be able to apply the serialized data to its products and, subsequently, upload it to the European Hub. Not only would this mean a complex, labor-intensive integration effort and potential business disruption, it also jeopardized their chances of being compliant by the deadline.
- The company realized that the resources required to create, test and maintain individual connections to its growing network of CMOs and manufacturing customers would also impact their budget. More important, the time needed to onboard their partners also put the company at risk of not being ready by February 2019.
Efficient data exchange would be crucial, not just between the company’s internal systems but also with its trade partners. For those reasons, the company decided it could not take a risk on an unproven solution.
Decision driver: on-time implementation and low connectivity costs
To control implementation costs through out-of-the-box integration and streamlined partner onboarding—and ensure that its LMS investment would be producing serialized product by the deadline—the company turned to TraceLink for:
- Seamless integration to line management systems
TraceLink offered a ready-to-use integration to the pharma company’s new LMS. Because this integration had already been tested in real-world production environments, the pharma company would benefit from a shortened implementation and user acceptance timeline. In addition to achieving compliance by the deadline, the company would more quickly begin to realize the business efficiencies it sought when it purchased the new LMS. - A network approach to streamline partner connections
For EU FMD compliance, the pharma company needed to exchange product data with its network of over 30 CMOs, plus an additional 20 pharma companies who outsourced their manufacturing to the company. It discovered that 65% of their 50 partners were already on the TraceLink network, so all it needed was one connection to TraceLink in order to exchange data with them. In addition, TraceLink would onboard the remaining partners, meaning that the pharma company did not need to invest in developing point-to-point connections to its growing partner network.
TraceLink helps companies achieve efficiencies in addition to compliance
With the selection of TraceLink as its serialization solution provider, the pharma company is not only on track to achieve EU FMD compliance by the deadline, but to do so in a way that minimizes the impact on its day-to-day operations. While many solution providers charge for additional partner onboarding and service requests, TraceLink’s all-inclusive subscription model will insulate the pharma company from unexpected development costs in the future. The pharma company saw the benefits of a proven solution, and will continue to benefit from being part of the TraceLink network as it continues to grow and diversify in the future. Contact us to learn how we can help your business.