LSPedia Launches DSCSA Exceptions Pilot
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WEST BLOOMFIELD, Mich., Dec. 7, 2022 /PRNewswire/ -- LSPedia Inc., a leading cloud solutions provider for the pharmaceutical industry, announced its Exceptions Pilot, a program designed to help the industry manage an explosion in data errors within the prescription drug supply chain. The pilot will run from January through May of 2023, and will produce a final report as well as three interim progress reports.
The FDA's final deadline for enforcement of the Drug Supply Chain Security Act is November 27, 2023. After that date, data will need to accompany prescription drug products whenever they change hands. This will trigger a hundredfold increase in data exchanges, with three billion serialized products expected annually. Consequently, there will be a massive rise in the number and variety of data errors – known as exceptions – that occur, exposing up to 15% of transactions to friction in the supply chain. Incomplete or mismatched data can stop product movement and increase staff workloads, in turn raising costs and preventing medicines from reaching patients. Complicating the problem, many trading partners have not yet upgraded their systems to handle DSCSA-compliant data.
The pilot, which includes more than a dozen participants, will provide agnostic exceptions for the entire supply chain. The scope of the pilot includes EPCIS data, data exchange, and logistics, covering product without data, data without product, and discrepancies between them, incorporating the Healthcare Distribution Alliance's "Exceptions Guidelines for the DSCSA."
The pilot will compile a comprehensive list of error scenarios, design resolutions and develop metrics to evaluate them, recommend best practices, and reach consensus on application.
"We process hundreds of orders inbound and thousands outbound. As long as humans are picking and shipping, overship and undership will happen," said Jeff Primeau, VP Business Solutions, Integrated Commercialization Solutions, a division of AmerisourceBergen. "How do we manage these exceptions and reconcile the data to meet the Interoperability Requirement? Our capability at managing exceptions keeps me awake at night."
Qualified participants are manufacturers, wholesale distributors, dispensers, and healthcare providers, including both LSPedia customers and non-customers.
LSPedia is a leading SaaS solution provider in the pharmaceutical industry, serving CMOs, manufacturers, 3PLs, wholesale distributors, dispensers, and healthcare providers. Customers use LSPedia's OneScan solution to make, move, track, verify, and ship serialized products at every point in the supply chain.
LSPedia is different because our solution's potential is limitless. Our OneScan software delivers flexible CMO integration, high-performance product verification, and state-of-the-art EPCIS data exchange; our Investigator software is the gold standard for serialization exceptions management, leading the industry as the first collaborative platform for trading partners to resolve EPCIS errors and supply chain issues in real time.
LSPedia is the go-to solution provider for serialization, traceability, and interoperability with turnkey DSCSA compliance. For more information, call +1 (248) 973-2008, email [email protected] or visit our website at www.lspedia.com.
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