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By Joe Lipari, Director, Global Traceability Solutions, Systech
After another productive HDA Traceability Seminar, one thing is clear: the pharmaceutical traceability conversation is evolving.
For years, much of the industry’s attention has understandably centered on achieving Drug Supply Chain Security Act (DSCSA) compliance. At this year’s event, the discussion increasingly turned toward what comes next: operating effectively in a serialized supply chain, preparing for NDC-12, improving interoperability and finding greater operational value in the infrastructure the industry has built.
The HDA agenda reflected that shift, with discussions spanning NDC and barcode modernization, EPCIS migration, transaction errors and exceptions, DSCSA enforcement and emerging technologies such as artificial intelligence.
NDC-12 is becoming a business readiness conversation
Not surprisingly, NDC-12 was one of the most prominent topics throughout the event.
What stood out to me was the breadth of the conversation. Preparing for a 12-digit NDC isn’t simply a matter of changing a label or updating a barcode. The identifier can touch packaging, Electronic Data Interchange (EDI), back-office and DSCSA systems—and ultimately the business processes that rely on them. HDA devoted sessions specifically to these cross-functional implications and to operating through the three-year transition period.
Organizations should be thinking now about where NDCs are consumed, shared and displayed and understanding how changes could affect master data, inventory, trading partners and other downstream processes.
That kind of preparation requires looking beyond individual systems to understand the complete flow of data and dependencies across the organization.
From compliance to operations
Another recurring theme was what happens after compliant systems are in place. Barcode scanning and EDI transaction errors, EPCIS migration, 340B and drop-ship scenarios, enforcement and exception management all appeared on the agenda.
These are reminders that successful traceability isn’t simply about generating compliant data. Organizations need to identify issues, understand their cause and move them toward resolution without unnecessarily interrupting product movement.
The question is increasingly shifting from “Are we compliant?” to “How effectively are we operating while remaining compliant?”
Getting more value from traceability
Perhaps the most forward-looking conversation at HDA was about what organizations can do with the traceability infrastructure and data they already have.
One session specifically explored moving beyond basic DSCSA compliance by using emerging technologies, including AI, to strengthen visibility, streamline transactions and improve business processes.
That’s an important evolution for our industry.
Traceability environments generate tremendous amounts of information. The next opportunity is making that information easier to understand and act on—helping teams surface patterns, prioritize issues and shorten the distance between an event and a decision.
Preparing for whatever comes next
The conversations at HDA reinforced something we’ve long believed at Systech: traceability can’t be approached in silos.
Changes at the product and packaging level can ultimately affect site operations, enterprise systems, regulatory processes, trading partner transactions and downstream supply chain activity.
As NDC-12 approaches and standards, regulations and technology continue to evolve, organizations need a foundation capable of evolving with them.
At Systech, we’re staying closely engaged with these developments and working with pharmaceutical organizations to understand not only what changes mean technically, but what they mean operationally—from the packaging line through the enterprise and across the supply chain.
Being ready isn’t simply about meeting the next requirement. It’s about being prepared for what comes after it. We can help. Contact us to speak with an expert.