What Sets True DSCSA Readiness Apart?

In a recent discussion with Pharmaceutical Commerce, Dan Walles, VP & GM, traceability and compliance solutions, TraceLink, explains that with the Drug Supply Chain Security Act (DSCSA) dispenser deadline fast approaching (Nov. 27), the divide between organizations that have fully operationalized serialized data exchange and those that are only minimally compliant is becoming increasingly clear. The strongest indicator of true readiness, he notes, is the ability to treat DSCSA processes as routine business operations rather than one-off implementation tasks.

Organizations that are well prepared have been working toward compliance for years, building DSCSA requirements directly into their standard workflows. For these companies, serialized data exchange is embedded into daily receiving procedures, supported by documented standard operating procedures (SOPs), robust training programs, and clearly defined exception-management pathways. Rather than treating exceptions as unusual events, these organizations expect them as part of normal operations and have established cross-functional awareness to ensure issues are resolved efficiently.

This level of integration, often referred to as “operationalization,” is the key differentiator. Mature organizations have moved beyond simply establishing system connectivity and instead, have focused on how people, processes, and technology work together to support DSCSA compliance at scale. Their teams are aligned, trained, and prepared for the day-to-day realities of serialized data exchange.

In contrast, companies that are only minimally compliant tend to focus almost exclusively on the technical connections required for DSCSA data transfer. Many of these organizations have only recently begun preparing, leaving little time to build the broader operational infrastructure needed for ongoing compliance. Without established SOPs, cross-functional training, or workflows for exception management, they risk facing significant disruptions when serialized data exchange becomes a daily expectation.

As the deadline draws near, the organizations that will succeed under DSCSA are those that understand compliance is not a checkbox, but rather, a fully integrated operational discipline.

He also shares the lessons he observed across thousands of dispenser go-lives,the definition of “true readiness;” and much more.

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

PC: As the DSCSA dispenser deadline approaches, what indicators distinguish organizations that have fully operationalized serialized data exchange from those that are only minimally compliant?

Walles: I think you hit the nail on the head with the term ‘operationalize.’ I think for the folks that we see that are well on their way, they've obviously been working at it for a number of years, are really looking at DSCSA as getting to business as usual, as they would say. What that really means is it's fully integrated into their processes, whether it be their receiving processes, they've established SOPs and processes around exception management.

I think we'll start to see exceptions just being a normal course of action that happen on a daily basis. Having the SOPs in place, the training in place, the cross-function awareness within organizations is really important. That’s really the biggest difference that we see compared to those that may just be getting started, which obviously there's not much time left, or we're really just focusing on the connectivity aspect of it. That’s probably the largest distinguishing factor.