On August 18th and 23rd, LSPediA teamed up with Jennason to share crucial information on how manufacturers and other trading partners should be preparing for DSCSA’s November 2023 implementation deadline, focusing on the challenges presented by serialization and interoperability.
Michael Ventura, LSPediA’s Vice President of Solutions and Innovations, emphasized that time is of the essence, and that manufacturers and suppliers must execute much of the work this year. Ventura clarified the FDA deadline as well as the industry deadline for DSCSA. As well, he warned that without preparation, EPCIS data issues will halt product movement and send it to quarantine.
LSPediA CEO Riya Cao noted that serialization will impact every part of the industry. Accurate data supports product movement at every level — and numerous issues can surface if data is inconsistent between partners.. Additionally, it’s not possible for any company to work their own data to perfection without interaction with their trading partners. Many factors are out of one’s individual control: trading partners may not have up-to-date master data; a pharmacy may not have a GLN number; syntax and semantic errors can easily occur; files can be sent late. Cao highlighted the direct connection of data to physical business outcomes: where data is stuck, a shipment is stuck.
A webinar poll asked the audience if they feel DSCSA is “Easy”, “Hard,” “Super Complex,” or “Over my Head.” Just 18% felt that DSCSA was “Easy.” The rest expected a significant challenge in compliance, with 45% finding it “Super Complex.”
While trading partners may never find serialization “easy,” Cao said LSPediA is leading the industry in making DSCSA implementation easier. Its Compliance Guarantee includes training, technology, and resources for serialization. As well, LSPediA will review a customer’s compliance position and create a customized plan to resolve gaps. Further, LSPediA seeks to ensure that customers benefit from serialization rather than simply meeting compliance targets.
Scott Pugh, Principal at Jennason, picked up the presentation to review key facts about how the 2023 DSCSA deadline will affect manufacturers, including the potential misstep of assuming that compliance solely requires establishing connections with downstream customers. Rather, manufacturers must manage serialization as a dependent process throughout packaging and distribution. They also need to be ready to handle a significant increase in exceptions for their operations to continue smoothly.
Pugh presented how trading partners can evaluate their existing capabilities and systems, and advised that they ensure that their planning for 2023 covers extensive testing, business process development, and efforts to identify automated tools and procedures for exceptions management.
Before signing off, Pugh presented a second poll, where attendees could give their view of their own serialization process. The options were “100% DSCSA compliant, “Mostly compliant, with some gaps,” “Has major gaps,” “How do I know?” and “I need help.”
Only 22% felt secure that their serialization efforts were DSCSA compliant, while the rest either felt they were somewhat compliant, were feeling pressure from compliance gaps, or were simply unsure.
The data suggests that 78% of companies have more to do with DSCSA implementation. LSPediA can help you take the next steps. Join us for future webinars, available on our Upcoming Events page, or contact us today.