In the lead up to and after the Food and Drug Administration’s enactment of the Drug Supply Chain Security Act (DSCSA) in 2013, serialization solution providers have been focused on meeting the numerous requirements to assist healthcare trading partners build a more secure and transparent drug supply chain.
Many of the serialization providers naturally leveraged their existing manufacturing software/hardware solutions and merely integrated new serialization modules. Like all strategies, this created trade-offs for both the solution provider and the customer. For the serialization provider, it required the customer to utilize proprietary systems; thus, increasing its control and raising the switching costs. For customers, it resulted in serialization API’s that are unnecessarily complex as they were developed and designed to conform with existing production processes.
At Covectra, we developed our AuthentiTrack Line and Site (ATLAS) solution from the ground up with a sharp focus on simplicity and interoperability, leveraging off-the-shelf equipment to integrate across product handling, vision, and printing systems. All of which reduces line maintenance challenges, enables customers to integrate and benefit from the newest, most advanced available equipment, all while keeping costs down. Options that prevent customers from being at the mercy of the proprietary equipment development schedules and often enable our engineers to eliminate manual processes that reduce throughput and increase costs. The ATLAS Prime and Enterprise solutions also provide customers with scalability alternatives that allow operations to maintain validated processes and enable the addition of new lines to adapt to growing and evolving needs.
Today, ATLAS is supporting customers that initially needed a DSCSA serialization solution for the healthcare supply chain who are now offering services to new partners like Amazon, which require non-serialized Fulfillment Network Stock Keeping Unit (FNSKU) numbers. ATLAS’ interoperable foundation and data structure can manage many diverse types of information, including the China Ministry of Agriculture and Rural Affairs (MARA) requirements for the animal health market that use Chinese characters. This demonstrates Covectra’s commitment to providing solutions that not only meet regulatory compliance, but also support business growth and expansion into new markets.
Covectra’s market strategy will continue to focus not only on addressing the immediate needs of a business or industry, but also fostering growth and opening new commercial and revenue opportunities by designing and delivering interoperable, scalable, and flexible solutions for customers.
