Like many companies, this European pharma needed an EU FMD compliance solution that would integrate seamlessly with the existing ERP and line management systems critical to its daily business operations. Given that its ERP provider also offered a serialization solution, the pharma company believed it would be the logical choice. However, with limited time to implement a compliance solution by the February 2019 deadline, the choice of provider would come down to who could offer proven serialization data exchange capabilities and streamlined partner onboarding.
The company needed a solution that would:
- Interoperate with its existing business systems
The pharma company had a strong relationship with its ERP solution provider, who also offered a serialization solution. In order to be considered, any alternative solution provider would have to demonstrate working Level 4 – 5 capabilities as well as seamless integration with the pharma company’s ERP and other business systems.
- Onboard its 25 CMOs by the deadline
In addition to its internal manufacturing plants, the pharma company had a network of 25 CMO partners producing its medicines. The chosen provider would have to demonstrate an efficient connectivity solution between the pharma company and all of its partners, in order to exchange the product data required by EU FMD.
- Enable compliance in other markets
As it operated across 80 markets worldwide, the pharma company needed a provider that could help it navigate the complexities of regulations for individual countries—in addition to EU FMD—and stay current with evolving compliance requirements in each market.
Decision driver: live demo shows integration capabilities, network connectivity, and onboarding programs
To help it make an informed decision, the pharma company requested a live demo from all shortlisted solution providers. During those demonstrations, TraceLink was the only provider able to showcase proven Level 4 – 5 expertise. The pharma company selected TraceLink based on their ability to demonstrate:
- Seamless ERP and line management system integration
TraceLink had pre-existing integrations to the pharma company’s ERP solution and LMS, tested and optimized for a quick integration and smooth day-to-day operations, ensuring business continuity.
- A global network with over 267,000 entities exchanging data
TraceLink was able to show that pharma companies around the world were already exchanging data with their CMOs and other supply chain partners via the TraceLink Life Sciences Cloud. The pharma company’s most important CMO partner was already on the network, and TraceLink presented an onboarding plan to show how it would streamline connections to any CMO partners not on the network in advance of the EU FMD deadline.
- A single platform for future growth
With its cloud technology and proven expertise in compliance solutions for the life sciences industry, TraceLink had the ability to offer the pharma company one platform to manage all of its track and trace needs in the future. This meant the pharma company would not need to develop new connections or purchase new systems, as it could all be managed through its one connection to TraceLink.
TraceLink’s network ensures compliance today, adaptability for future growth
By selecting TraceLink for EU FMD, the pharma company can easily onboard its CMO partners, and is on track to achieve compliance by February 2019. TraceLink’s proven integration with its existing ERP and line management systems means minimal impact on the pharma company’s existing workflows and business efficiencies, and its suite of compliance offerings provide flexibility to adapt to evolving business requirements. Contact us to learn how we can help your organization.