Key Requirements for Transitioning from Non-Serialized T3 to Serialized T2

Going from exchanging non-serialized T3 data (Transaction History, Transaction Information, and Transaction Statement) to serialized T2 data (TI and TS) is a major operational shift. And yet many life sciences and healthcare companies still haven’t started this transition—and some may not even be aware they are required to do so.

To be clear: the Drug Supply Chain Security Act (DSCSA) 2023 mandates that all health industry companies—from drug manufacturers and wholesalers to hospitals and retail pharmacies—are able to exchange serialized TI and TS information for pharmaceutical products through an interoperable, electronic method at the package level. The deadline for compliance is November 27, 2023, although companies should aim to complete this transition well in advance, so they have time to properly establish and test their SOPs.

With the transition from T3 to serialized T2, not only are the components of the data changing, but the form of the data is also changing from Electronic Data Interchange (EDI) to Electronic Product Code Information Services (EPCIS), a global GS1 Standard for creating and sharing this serialized data. This necessitates a major shift in how trading partners connect their enterprise systems with each other.

So, how can you achieve compliance before the deadline without the need for prohibitively expensive point-to-point integrations? And what are the key capabilities and requirements you need in order to accomplish this goal and make the transition to serialized T2?

Our recent webinar, “DSCSA 2023 Compliance on the TraceLink Opus Platform,” looked to answer those questions. A new approach to integrating with trading partners across your end-to-end supply chain may be required to simplify this transition—and Opus Digital Network Platform offers a unique network architecture that does just that, giving you the capabilities you need to address serialization requirements in a quick and cost-efficient manner.

The big takeaways from the session were:

• Connectivity is a major barrier to receiving and reconciling serialized T2 data. From direct purchases to repackaged products, exchanging data requires seamless system integration with your trading partners. TraceLink’s network-based approach enables you to integrate with the platform once and then interoperate with everyone else connected, so you don’t have to create costly point-to-point integrations with every trading partner.
• Many organizations underestimate how involved they’ll need to be with compliance activities. Even routine tasks like searching and retrieving serialized T2 data have a lot of different operational touchpoints. The Opus platform was designed with this in mind, based on the feedback of real-world users, with dashboards that enable users to quickly identify how many shipments were received and sent, whether there were any exceptions, and more.
• Managing serialization requires a number of key capabilities. From managing the status of serialized inventory and exceptions to accessing information about products, there are a lot of serialization requirements. Further, the precise requirements are going to differ depending on role within the supply chain. TraceLink serialization solutions offer all the capabilities needed for serialization activities and then some, and it’s all available via the web user interface, mobile app, or even via real-time web service APIs so can be fully integrated.
• Every business has different requirements, which is why flexibility and customizability are important. TraceLink Opus Solution Designer supports tailoring solutions to match their requirements, including customizations to the user interface, data model, workflows, and roles, so you can ensure your compliance solution accommodates the specific needs of your unique supply chain.

Interested in learning more about DSCSA 2023 from a panel subject matter experts and your industry peers? Sign up for our DSCSA webinar series today—there are tracks for both manufacturers and distributors or pharmacies and dispensers.

You can also watch the webinar for a complete tour of the TraceLink Opus Network Platform, including a firsthand look at its newly revamped and easy-to-navigate user interface, and see how Opus interfaces and workflows can be tailored to meet the needs of health systems and retail pharmacies.