A mid-size pharma company in Italy that also acted as a CMO needed an EU FMD solution that allowed it to connect to the EU Hub to upload product data, and connect to pharma customers to exchange serial numbers and other compliance data.
Critical shortcoming: Lack of connectivity
The company had two false starts, selecting providers who claimed they could help but didn’t have
- Their line equipment provider, Atlantic-Zeiser, committed to also provide the Level 5 serialization functionality needed to exchange data with customers and the EU Hub. However, they specialize in printing and packaging, not data exchange—a primary challenge of EU FMD—and the pharma company’s project stalled as Atlantic Zeiser did not have the network technology to connect the company to its numerous customers by the deadline.
- The company was in discussions about an ERP system with Infor, who claimed they could also offer a Level 3 – 5 solution. However, they had not previously developed a connection to the EU Hub, and ultimately couldn’t develop a solution to do so according to EMVO’s strict specifications.
At this point, the company realized that if it were to meet the EU FMD deadline in just seven months, it needed to stop taking risks on unproven providers.
Decision drivers: Proven technology and local support
The company spoke to TraceLink,
- Proven ability to connect companies to their partners and the EU Hub. Of the 154 organizations connected to the EU Hub, 52% of them connected via TraceLink*. The company also discovered that 50% of its partners were among the 270,000 entities already on the TraceLink network, which would allow them to seamlessly connect after one integration with the TraceLink network.
- Support to meet the company’s needs as a CMO. The company needed to exchange product data with its increasing number of customers in the many different data formats each customer required. TraceLink’s network technology allowed for custom design and integration, all via one connection, at much less time, cost, and risk than traditional point-to-point connections.
- Local language support. TraceLink was the only one of the three solution providers that could provide Italian native speaking consultants and product documentation.
TraceLink: Enabling success with a best-in-class solution
After just two months with TraceLink, the company was on track to ship its first serialized batch by the end of the year. By partnering with TraceLink, not only is the company going to achieve compliance in advance of the deadline, but it will also be in prime position to win new business from the other 650 pharma companies on the TraceLink network.
Contact us to find out how we can help your organization meet the EU FMD deadline.
* As of September 1, 2018.