Two-Year Error-Free Shipping: The Value of Serialization Beyond Compliance

“We had a two-year span where we didn’t have any shipping discrepancies. That’s huge. In the years before we implemented RxChain for serialization it was common to have one a month, sometimes more than that. Serialization and LSPediA’s serialization solution helped improve our accuracy drastically.”

– Bryan Brassell, Warehouse and Facilities Manager at Kowa Pharmaceuticals

The Challenge

The Drug Supply Chain Security Act (DSCSA)’s serialization requirement meant big changes in pharmaceutical manufacturing and distribution. Like every change, it adds complexity and cost to every manufacturer and distributor’s business operations.

“For DSCSA, we needed various systems for EDI, CMO integration, warehouse automation, EPCIS data exchange, and data analytics. We also needed new scanners, new printers, new policies and new procedures,” said Ken Riester, VP Trade and Supply Chain.

“The biggest challenge with the act is its complexity. And for a company of our size with limited personnel and resources, the question was – where do we start?” That’s how Joseph Barna, Chief Financial Officer at Kowa Pharmaceuticals, summed up the organization’s feelings about the DSCSA and serialization.

The Solution

“We looked at LSPediA’s Serialization Solution RxChain in 2017, and it offered everything we needed for EPCIS, CMO integration, EDI integration, and warehouse automation, including the plug and play mobile smart scanners. It’s also easy to implement and easy to use. We are really happy we made that call,” added Ken Riester.

Kowa implemented the full suite of LSPediA’s RxChain solutions:

  • RxChain Standard Edition as the L4/L5 EPCIS solution integrated with CMOs
  • RxChain Mobile as the Edge solution for warehouse distribution integrated with ERP and EDI

Two years after implementation, Kowa sees that their DSCSA compliance initiative has transformed the company’s supply chain operations for greater value and Return on Investment (ROI).

Business Outcome

The warehouse operators scan every serialized package, bundle, or case to fill orders. RxChain ensures that inventory picked for each order is accurate down to the individual serialized product.  Outbound shipments are completed serialized as well, eliminating any errors and establishing the highest level of data integrity.

“We had a two-year span where we didn’t have any shipping discrepancies. That’s huge. In the years before we implemented RxChain for serialization, it was common to have one a month, sometimes more than that. Serialization and LSPediA’s serialization solution helped improve our accuracy drastically.” Said Bryan Brassell, Warehouse and Facilities Manager.

In addition, RxChain provided end to end serialization capability, enabling visibility, accountability, and traceability in the entire supply chain.

Verification and Interoperability

Another important milestone of the DSCSA is the serial verification requirement starting on November 2019. Kowa implemented LSPediA’s OneScan as the Verification Router Service solution. With OneScan, Kowa gains comprehensive verification capabilities:

  • Verification, investigation, exception management
  • 3911 reporting to the FDA

Kowa also actively participates in HDA and FDA pilots, collaborating with key industry stake holders from other manufacturer and distributor companies on establishing the path to effective interoperability by 2023.

“We feel really positive and confident moving forward, without a doubt, because of LSPediA,” said Ken Riester.

Trusted Provider and Advisor

LSPediA is well positioned to be a trusted provider and advisor in providing serialization solutions with full compliance today and into the future. LSPediA is committed to provide value to customers and will continue to perform at the highest level for solution delivery and customer service.

LSPediA customers, including manufacturers, wholesale distributors, and dispensers, leverage our traceability product RxChain to manage serial data, serialized warehouse, and pharmacy shelves for both FDA compliance and operational efficiency. For more information about LSPediA, call +1-248-973-2008, email info@lspedia.com, or visit www.lspedia.com.