When DSCSA was enacted in 2013, manufacturers’ immediate focus was enabling serialized packaging internally and externally. As the deadline draws close, and just 60 percent of all manufacturers have embarked on or are some ways down the path of serialized packaging, concerns have shifted to logistics, both in-house and outsourced. According to the HDA 2016 Factbook, only 2.6 percent of all products in the U.S. supply chain are serialized. That equates to approximately 70 million serialized units. With more and more serialized products in the supply chain, how do manufacturers move them downstream through the supply chain, and how do they exchange serialized information with trading partners?
3PLs Get a Bigger Role
Manufacturers that run in-house distribution operations are actively working on solutions to enable serialized shipping and data exchanges. Many more manufacturers that outsource their logistics to third-party logistics (3PL) providers lean on those 3PLs for solutions.
Traditionally, 3PLs follow the lead of manufacturers in terms of guidance, directions, and business requirements. Serialization was not an expectation when DSCSA was enacted in 2013. Over the last three years, I’ve seen 3PLs taking on incredible growth, in both the breadth and depth of their serialization capabilities. Many of them are proactively assisting their manufacturer customers. The 3PLs that took on the challenges early had the opportunity to learn from their real-world experience of solving problems and creating solutions. They have now emerged as enabling partners who help their manufacturer customers achieve serialization compliance.
At the recent HDA Traceability Seminar, Tim Bishop of UPS, Maryann Nelson of Cardinal, and Heather Zenk of AmerisourceBergen took the stage as panelists representing their companies’ 3PL business, advising the industry on their perspectives of data exchange, data ownership, and how to ensure compliance collaboration with manufacturers. Their 3PL business presents a shortcut for manufacturers to meet the fast approaching serialization deadline. Building out internal capability and infrastructure is time and capital intensive. The idea of partnering with someone who has done it already is both viable and appealing.
Making the Most of Your 3PL Partner
To successfully engage a 3PL and leverage their serialization capabilities, a manufacturer can take the following steps:
- Define project scope, roles, and responsibilities: Clearly state goals, objectives, and activities involved in the partnership. Lay out the rules that both have agreed to: Identify roles, responsibilities, and accountabilities.
- Provide master data: The master data is your single source of truth. In the world of serialization, they are GTINs, GLNs, and their associated attributes. A well-defined process with governance standards should be in place to ensure the integrity and accuracy of master data when it is initiated, maintained, and updated over time.
- Define data requirement: Serialized data exchange is far from mature. The industry has adopted GS1 standards so all trading partners can send and receive data in a uniformly defined manner. However, standards change from time to time to meet shifting market demands. GS1 EPCIS, the serialized exchange standard, its 1.0 version was released in 2007, 1.1 in 2014, and EPCIS 1.2 was newly released in October 2016. This leaves the industry with three active versions of EPCIS format. Defining the data requirement down to the version of EPCIS is necessary to enable data exchange.
- Build system integration: 3PL operations are in the middle of the order-to-cash cycle. Their shipments directly impact manufacturers’ inventory, costing, and revenue. Without such data, manufacturers can’t send ASNs or invoices. Integrating to 3PLs systems brings supply chain visibility that enables the manufacturers to act on alerts and notifications when issues arise, therefore eliminating wait times and speeding up resolutions. Fortunately, newer technologies are API enabled, which means one system can interoperate the data from another system through data mapping. No old-style hard coding and intrusive programming are necessary.
Serialization does not run in silos. Everyone throughout the supply chain is responsible for part of the requirement. Manufacturers and 3PLs need to collaborate to get there. When partners collaborate, it’s good business.
Serialization Help Is Here – with LSPediA
To get your business on the road to DSCSA compliance, contact LSPediA. We can ensure you understand and successfully implement a DSCSA strategy using our industry-tested serialization toolkits and our new, innovative traceability solution, Rx Chain.
About LSPediA – Life Sciences Solutions
LSPediA is a leading provider of enterprise software and services designed for pharmaceutical manufacturers, wholesale distributors, and dispensers. With help from LSPediA, customers can better implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.
For additional information, contact: Julianne Jahn [email protected]