Case Study: German Biotech Company achieves EU FMD compliance with TraceLink

German Biotech Chooses TraceLink Network Over Point-to-Point Approach

A German biotech company preparing for EU FMD compliance needed a reliable way to connect to the European Hub and exchange product data with its contract manufacturing partners. Instead of building and maintaining multiple point-to-point links, the company evaluated options and chose TraceLink’s cloud-based, multi-tenant Life Sciences Cloud with automated validation support.

TraceLink implemented a single network connection to onboard all 10 CMOs, already supported by the TraceLink network, and provided a proven live connection to the EU Hub ahead of the 2019 deadline. With Automated Validation Manager (AVM) helping maintain GMP/GxP compliance and a lower total cost of ownership than on-premise or single-tenant alternatives, the German biotech company gained a scalable compliance platform and can also extend the same vendor approach to Brazil and South Korea.