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Cardinal Health and Manufacturers Collaborate for FDA DSCSA Compliance  

Cardinal Health is ready and willing to ramp up EPCIS onboarding of its many suppliers. That message was strongly conveyed by Manager of Pharmaceutical Information Technology Jeff Falardeau during Wednesday’s Investigator Workshop, the final event in a series of monthly events that started in November 2021. The Workshops featured how Cardinal Health was using LSPediA’s Investigator to streamline EPCIS data transfer for a more efficient workplace.  

“We are currently knee-deep in supplier onboarding, but we still have a ways to go,” said Falardeau. “We want supplier onboarding to wrap-up by November 27 of this year. In 2023 we want to pivot to our customer base and pivot to outbound for dispensers.” 

EPCIS Onboarding

Cardinal Health went live with LSPediA’s Investigator, an automated DSCSA exceptions management solution from LSPediA, on February 19, 2022. Aiming to complete manufacturer supplier onboarding by November 2022, Falardeau impressed a sense of urgency that there are only six months to go to meet Cardinal Health’s EPCIS data exchange goal. “As it currently stands, we would need 13 suppliers to begin the onboarding process every week,” said Falardeau. “If they take an average of 4-6 weeks to onboard, that means concurrently we would have anywhere between 50-90 suppliers onboarding at any given time.” 

Cardinal Health plans to shift internal resources to outbound EPCIS operations to meet the next DSCSA deadline. Starting Nov. 27, 2023, all trading partners must be interoperable by exchanging Product Information data on the packaging level according to the FDA.  

The good news is that the attendees to this Cardinal Workshop indicated that their timeline to onboard has accelerated. LSPediA repeated a poll from the initial workshop in November 2021. The new poll results showed the number of attendees already sending EPCIS data increased from 21 to 26%. Also, 26% of attendees now plan to onboard in the third quarter of 2022, up from 14%, and 33% indicated they would onboard in quarter 4 of 2022, up from 23%.  

Investigator to the Rescue

Falardeau mentioned that having Investigator would compress that time down significantly and ease what would otherwise be an arduous process. He effused praise on having Investigator as a key DSCSA software solution to manage EPCIS exceptions rather than relying on additional staffing and a human eye for the solution.  

“Some of the primary reasons for going with LSPediA and Investigator is if we have late, failed, or incorrect documents it can create a severe impact to our receiving operations, and we want to minimize any of those situations as much as possible,” Falardeau said. “The goal of automation is to provide error feedback in the shortest amount of time possible and create an opportunity to remediate any data issues before receiving is impacted.” 

Likewise, Cardinal Health Software Engineer David Mikesell went so far as to say Investigator represented a leap forward from a traditional EPCIS system.  

“Previously we would trip on the first error in the EPCIS file and send it back. Investigator now immediately notifies the manufacturer of everything that is wrong with the EPCIS file top to bottom. The sender gets a real time email alert which enables them to initiate the issue resolution process in a timely manner,” said Mikesell. “Investigator is the digital bouncer that keeps the bad data out and good data in.” 

Onboarding Runway is Open

In closing out the Investigator Workshop series, Falardeau repeated that Cardinal Health was fully engaged in getting suppliers onboarded and this is the time to do it.  

“Our systems are ready and waiting for suppliers to reach out to us,” he said. “Since 2014 we’ve had the trace website for DSCSA and drug tracing, and you’ll find our onboarding guide there, current with information about Investigator for EPCIS.”  

Smart and Scalable

Cardinal Health brings scaled solutions that help their customers thrive in a changing world. Through innovation and technology, Investigator is in perfect alignment to Cardinal Health’s vision. What works for Cardinal Health serves as a great example for other pharmaceutical companies to follow. After all, delivering safe and secure medicine to patients in the complex healthcare industry demands a smart and scalable solution. If this speaks to your aspirations of growing your business, please click the links to learn more about Investigator or OneScan – LSPediA’s flagship suite of cloud-based DSCSA serialization solutions. For further questions, send us an email at [email protected] and one of our in-house experts will connect with you promptly.