Spherity is Partnering with Legisym Offering Joint Compliance Product for the U.S. Life Sciences Market.
Legisym, LLC is a trusted expert in the U.S. Life Sciences Market, providing services to pharmaceutical companies around the world since 2009
Legisym and Spherity have worked closely together to bring to maturity a joint offering that meets the security requirements of the U.S. Life Sciences Market. As part of the joint development, both companies have collaborated with SAP and Novartis, which have already subjected the product to extensive quality testing and functional validation. Spherity and Legisym are pleased to officially announce their partnership as of today.
In November 2013, the U.S. congress enacted the Drug Supply Chain Security Act (DSCSA) in order to protect patients’ health. To ensure that only legitimate actors are part of the supply chain, the regulation requires U.S. pharmaceutical trading partners to ensure that they only interact with other trading partners that are authorized. Authorized is every trading partner holding a valid state-issued license or a current registration with the Food and Drug Administration (FDA).
Today in 2022, U.S. pharmaceutical supply chain actors have no interoperable, electronic mechanism to validate each other´s authorized status. With more than 60,000 interacting trading partners involved in the U.S. Life Sciences Industry and a FDA recommendation to respond to data requests in under one minute, a solution that provides compliance with the regulations by 2023 is in high demand. Legisym and Spherity have decided to cooperate and offer an interoperable highly secure service to enable pharmaceutical supply chain actors to become an Authorized Trading Partner (ATP) according to U.S. DSCSA.
Legisym, as a trusted identity and license verification service provider, perfectly complements Spherity’s digital wallet technology for managing verifiable credentials. The verifiable credential technology is used to represent the authorized status of interacting trading partners in an highly efficient, secure and DSCSA-compliant way. To use credentialing for Authorized Trading Partner (ATP) requirements under DSCSA, trading partners need to go through a one-time due diligence onboarding process with Legisym. Once the verifiable credentials are issued, they are stored in a secure digital wallet which comes embedded with the Credentialing Service, CARO provided by Spherity. Using this technology enables U.S. pharmaceutical supply chain actors to interact with digital trust, as they now can digitally verify their ATP status in every interaction.
Georg Jürgens, Manager Industry Solutions at Spherity says, “together with our partner Legisym we focused on making the adoption of credentialing for trading partners as simple as possible. Manufacturers, wholesalers and dispensers can all acquire a digital wallet and ATP credentials within minutes without integration effort and use this innovative solution for DSCSA-regulated interactions.”
“Legisym is thrilled to be working alongside Spherity to bring the first production-level ATP Credentialing solution to the industry,” said Legisym President & Co-Owner David Kessler. “With the successful completion of the ATP Credentialing Pilot in 2020 and the joint founding of the Open Credentialing Initiative in early 2021, the Spherity-Legisym partnership is already proving successful in collaboration and forward thinking.”
Legisym and Spherity founded along with other adopters, the Open Credentialing Initiative (OCI). This newly formed organization incubates and standardizes the architecture using Digital Wallets and Verifiable Credentials for DSCSA compliance for Authorized Trading Partner requirements. Besides U.S pharmaceutical manufacturers, wholesalers, and dispensers, the OCI is open for solution providers integrating the ATP solution.
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About Legisym, LLC
For over a decade, Legisym, LLC has successfully provided the pharmaceutical industry with affordable and effective regulatory compliance technologies. In early 2020, driven by the 2023 authorized trading partner (ATP) requirements, Legisym began leveraging their existing Controlled Substance Ordering System (CSOS) and license verification technologies and experience, to engage as a credential issuer. By performing thorough credential issuer due diligence processes, first to establish a root of trust, Legisym promotes confidence in the trading partner’s digital identity prior to the issuance of all ATP credentials.
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 technical 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.
