The Drug Supply Chain Security Act (DSCSA) represents a transformation of the U.S. drug supply chain, such that any trading partner will be able to track, trace, and verify the status of any prescription drug product at the package level, from initial production to final sale.
Amid a phased 10-year rollout ending November 27, 2023, pharmaceutical trading partners must -- among other requirements -- be authorized for product traceability, have formed interoperable connections with their trading partners, and carry out EPCIS transactions with serialized data.
Importantly, DSCSA requires pharma trading partners to exchange transaction data before, or at the time of, a physical product transaction. If the data is missing, unreadable, or doesn't match the product as delivered, an exception occurs, and product must stop movement and go into quarantine while the matter is investigated.
So, if a company cannot deliver or accept EPCIS files properly -- or lacks the means to quickly process and correct them -- their operations can be vulnerable to disruptions, and doing business with them will also be difficult.
That's why many companies are seeking solutions like LSPedia's Investigator, which can automatically find exceptions and guide the resolution process.
Genetco Inc. is one of the largest privately owned generic pharmaceutical distributors in the U.S., with a 24,000-square-foot facility in Ronkonkoma, NY and licenses covering 48 states. Genetco buys from 120 manufacturers, and serves pharmacies, hospitals, and other facilities.
Since erroneous transaction data will stop product movement, Genetco sought to avert disruptive outcomes from data errors rooted in their DSCSA solution. However, its legacy provider couldn’t consistently provide complete shipment data, and – critically – didn’t integrate at all with Genetco’s ERP system.
These issues resulted in recurring processing errors, which increasingly pulled personnel away from their jobs to deal with missing or incorrect 3Ts data. The legacy system also potentially posed a problem for future audits, adding unforeseeable business exposure.
Genetco’s Bill Carney, Vice President of Operations, began the search for a new provider rather than continue to divert time, attention, and resources away from the activities that support and grow Genetco’s business. Carney prioritized providers who could:
Genetco selected LSPedia’s OneScan suite, including its EDI Track, EPCIS, VRS, Investigator, Portal, and API Connector modules. The implementation of OneScan enhanced transaction data integrity and removed duplicative manual entry, which streamlined distribution, prevented errors, and minimized product quarantine.
To address exceptions, Genetco used LSPedia’s Investigator, which is built with hundreds of GS1 data rules and complex business algorithms. Investigator detects all errors in an inbound EPCIS file in seconds, and sends real-time alerts to the data sender as well as a live link where they can review issues and apply a resolution.
Genetco saw immediate improvements to its DSCSA operations and ASN quality, with operational problems declining 70%. Its Perfect Order Rating also jumped, as shipments consistently had correct tracing data at the lot and package level.
The improvement saved time for Genetco personnel, who could again fully focus on making on-time shipments to pharmacies and their customers, rather than spending time dealing with data problems.
The companies are now taking the vital step of jointly supporting Genetco customers for DSCSA compliance. Under DSCSA, it’s in every company’s best interest to ensure that their partners have an efficient and compliant way to exchange data with them.
Make sure your team is equipped to prevent disruptions under DSCSA! Find out more about LSPedia's Investigator, or get hands-on experience by joining our Exceptions Pilot.
And watch our full case study video here: