Visit Praxis Packaging Solutions’ website and you’ll see the “Serialization: Countdown to Compliance,” clock identifying the time until FDA’s Nov. 27, 2017 deadline, along with the question, “We’re ready now, are you?”
The Grand Rapids, MI-based contract packaging firm is ready to meet this year’s U.S. Drug Supply Chain Security Act (DSCSA) deadline—despite the enforcement delay to late 2018—thanks to its partnership with TraceLink Inc., a global track-and-trace network for connecting the life sciences supply chain and provider of real-time information sharing for better patient outcomes.
After experiencing connectivity challenges with another vendor's serialization solution, Praxis turned to TraceLink to eliminate point-to-point integration complexities, meet the DSCSA serialization deadline, and reduce business risk for its pharmaceutical customers. The previous serialization vendor provided both hardware and software, but Praxis experienced challenges when the software was unable to connect with the contract packager’s customers. As a result, the company selected TraceLink for its integration expertise, data exchange and partner connections.
"Praxis ensures that product quality and consumer safety are at the forefront of everything we do. We needed a cost-effective serialization provider that was proven in providing an end-to-end digital supply chain network, with the agility to quickly connect and validate the brands within our infrastructure," says Scott Hanmer, the company’s Senior Vice President. "Now that TraceLink is integrated into our overall serialization program, we can provide our customers with the highest levels of product control and tracking throughout our part of the supply chain, from our receipt of incoming product until the time we ship the finished goods."
"We are pleased that Praxis chose TraceLink as its long-term serialization partner for DSCSA compliance. By quickly recognizing the critical need to migrate from its former point-to-point serialization system to TraceLink's interoperable, integrate-once network platform, Praxis is raising the bar with their serialization strategy," says Shabbir Dahod, the vendor’s President and CEO.