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Systech, the global technology leader in connected brand protection and a Markem-Imaje solutions brand, has partnered with Spherity to offer a first-class solution to facilitate compliance with the US Drug Supply Chain Security Act (DSCSA), part of which requires the verification of trading partners.
Both organizations are members of the Open Credentialing Initiative (OCI), a collaborative, non-profit initiative formed by a group of trading partners, solution providers and standard organizations to support the pharmaceutical industry in adopting credentialing and digital wallet technologies to enhance supply chain security. Integrating an electronic system to trace prescription drug products is the final phase in the DSCSA program, with compliance mandatory by November 2023. Together with Spherity, Systech is introducing an Authorized Trading Partner (ATP) solution which provides efficient and error-free accreditation of partners within the pharmaceutical supply chain, following manufacture. Verifying supply chain partners between the point of creation and point of dispensation is an additional layer in protecting the end consumer.
“Our goal always, is to partner with our pharmaceutical customers on their compliance journey,” said David DeJean, Vice President of Customer Success and Business Development, Systech solutions by Markem-Imaje. “By combining Spherity’s subject expertise with our leadership in traceability, we provide a swift and easy to integrate route to best practice compliance for our customers.”
DeJean added, “Data is the key ingredient for almost all aspects of DSCSA compliance. Our role is to provide a solution for secure and reliable capture, use and storage of that data—so that our customers can focus on their core operations.”
The introduction of an ATP solution provides an additional layer of security in Systech’s traceability portfolio, which includes their Verifizierungs-Router-Dienst (VRS). Launched in partnership with Chronicled in 2019, to meet the saleable returns requirements of the DSCSA which mandates that wholesalers must verify returned products before they can be redistributed.
Additionally, last week Systech participated in a DSCSA pilot and workshop to provide an environment where FDA, government and industry participants can engage in tabletop data simulations to better understand, and identify gaps in, systems being developed in preparation for the 2023 DSCSA requirements.
As a pioneer in pharmaceutical serialization, Systech has protected the pharmaceutical supply chain for decades helping to ensure the safety of tens of billions of products annually.
About Spherity
Spherity is a German software provider bringing secure and decentralized identity management solutions to enterprises, machines, products, data and even algorithms. Spherity provides the enabling technology to digitalize and automate compliance processes in highly regulated sectors. Spherity’s products empower cyber security, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.
