HDA 2025 Traceability Seminar: Data Quality and EPCIS Standards Take Center Stage

In a video interview with Pharma Commerce, Ullrich Mayeski, community engagement director of health with GS1 US, discussed how last month’s HDA Traceability Seminar received positive feedback from attendees, who emphasized both the quality of its organization and the timeliness of its content. The event, held annually, was noted for effectively addressing the current challenges facing the pharmaceutical supply chain. One of the greatest strengths of the seminar lies in its diverse audience, which brings together manufacturers, distributors, dispensers, solution providers, and professionals from varying organizational levels. This diversity facilitates meaningful conversations, both within sessions and informally, helping stakeholders compare challenges, share strategies, and build valuable relationships across the industry.

This year’s seminar differed from previous ones in tone, shifting toward a stronger sense of confidence and readiness. Manufacturers, in particular, appear to have made significant progress in providing data and resolving technical issues. Distributors also displayed greater assurance in their preparedness for the approaching regulatory requirements. While inbound processes seem relatively stable, outbound operations continue to present challenges, particularly in ensuring compliance on the dispenser side. Attendees observed that dispensers still benefit from certain exemptions, especially regarding the receiving of electronic data, which provides them additional time and flexibility.

The broader industry discussion is now less about uncertainty and more about refining readiness for enforcement. Attendees pointed to three major themes gaining traction: exception management, governance, and compliance execution. Exception management focuses on how companies will address inevitable discrepancies or system errors. Governance relates to setting consistent policies and practices across supply chain partners to ensure compliance. Overall, the event reflected an encouraging trend: the pharmaceutical supply chain is moving closer to readiness for the upcoming traceability enforcement deadlines, with conversations now centered on fine-tuning systems rather than questioning their feasibility.

In separate conversations, Mayeski also dives into panels they participated in at the conference; industry’s preparedness for DSCSA enforcement; best practices stakeholders should adopt to ensure secure, end-to-end traceability and interoperability; and much more.

A transcript of his conversation with PC can be found below.

PC: Your roundtable discussion was centered around data quality and management, along with EPCIS standards and guidelines. Could you elaborate on what was specifically discussed, while further explaining what EPCIS is, along with its value in the supply chain?

Mayeski: EPCIS means electronic product code information services, which is kind of a mouthful, but really, it's the GS1 standard for what the industry has generally adopted for the exchange of data between trading partners to meet the DSCSA requirements for transactions involving prescription drugs. If you think about GS1 standards being organized into three categories, we've got identification, parties, and location, for example. Then we've got capture, which is barcodes, that's what GS1 is known for (the kind of the barcode entity), and then there's the share part.

We've identified the information we've captured into the barcode, and then we're sharing that information between trading partners. Well, EPCIS is for DSCSA, the venue with which trading partners exchange that data. Does that make sense?

The session that we had was very well attended. We had two sessions. We had about 50 people in each session, which was really good from an attendance perspective. The audience really wanted to focus less about EPCIS itself—the standard—and they really wanted to delve into the discussion about data quality, which is, of course, I don't want to say an overused term in the industry, but from a general perspective, everyone would say, well, I want to have good data.

But beyond that, how do you get into the weeds of what that actually means? There was a really good discussion where folks talked about inconsistencies with identifiers—like addresses, for example—in the system, how they're using master data, duplicate records, issues that prevent systems from being able to accept the appropriate data, so that transactions can't go through.

Why this session was really timely, is that we’re getting to a period of time like I mentioned, where we're kind of post-exemption, and the data quality elements really, really important. One of the big themes that came out of the discussion was the need to have the procedures in place for your organization around how you're going to handle master data and other data attributes, and to make sure that team members understand not just how to do their normal job, but if there's an issue, how to raise their hand and get the appropriate guidance so that there's not an issue at the back end. At the end of the day, there's a patient at the end of all this that's expecting to get their medication. They deserve to get their medication, and so issues with data quality shouldn't be something that prevent that from happening.