For a small Spanish pharma company, the potentially high investment required to comply with EU FMD represented a huge hurdle. The company operated a manufacturing site for its own products and to provide CMO services for its affiliate companies, and also outsourced manufacturing services to five CMO partners.
The pharma company needed an EU FMD compliance solution that would:
- Connect current and future supply chain partners
The company needed a Level 4 – 5 serialization solution that would be able to exchange data seamlessly between its partners. Although they had a relatively small network, its future plans required a solution that could scale easily to add new partners as the company continued to expand.
- Integrate with its existing Level 3 serialization solution
As a small company with fewer resources than its larger peers, the pharma company needed a solution that would work well with its existing systems and processes, without compromising operational efficiency. As they evaluated Level 4 – 5 solution providers, they realized that the time required to develop an untested solution put them at risk of missing the February 2019 EU FMD deadline, and focused on companies with an existing interface to its Level 3 provider.
- Maintain customer satisfaction and loyalty
The pharma company needed to control costs but it also understood that taking a risk on an unproven compliance solution could jeopardize its ability to meet its obligations to customers and partners. The company viewed the solution as an important business investment in its brand and reputation.
Decision drivers: network model reduces time, risk and total cost of ownership
As the pharma company evaluated solution providers who competed solely on price but could not offer proven results or references from similar pharma companies, it saw the benefits of selecting TraceLink:
- All of its supply chain partners were already on the TraceLink network
By joining the largest digital supply chain network, all the pharma company needed was one connection to TraceLink to be able to start exchanging data with all of its partners immediately. This meant the pharma company had no need to develop custom connections or workflows, which would have added time, risk, and complexity for the small business.
- Proven integration to Level 3 solution for efficient operations
TraceLink’s unmatched number of out-of-the box integrations with leading business systems included the pharma company’s existing Level 3 solution, eliminating the time and cost of development and testing.
- Lower total cost of ownership (TCO) through all-inclusive subscription
The TraceLink network’s all-inclusive subscription model allowed the pharma company to eliminate many of the unpredictable costs of integration, customization, and service that they would have risked by basing their decision on low initial cost.
TraceLink network: a platform for growing companies
By choosing the TraceLink Life Sciences Cloud, the company is on track to achieve EU FMD compliance while minimizing the disruption to its business operations. And being part of the TraceLink network will simplify the onboarding of future partners as the company continues to expand. The network-tenant approach to software validation and upgrades will allow the growing company to respond to evolving regulations, and TraceLink’s compliance modules for other regions give them the ability to manage all of their serialization needs on one platform, with one proven vendor.
Contact us to learn how we could support your company’s serialization and compliance needs, enabling you to stay focused on your business.