One-Button Trusted Release for Medical Products with Verifiable Credentials

The existing regulations in the EU specify that no batch of medicinal product can be released for sale or supply prior to certification by a Qualified Person. Hence, a Qualified Person needs to deal with multiple production documentations to approve a batch for release in a Trusted Release process.

Imagine a digitalized Trusted Release process on a batch with instant access to all the relevant information in verifiable form, rather than dealing with multiple distributed paper documents. Digitized and pre-validated data allows the Qualified Person to dig deeper or double-check any input with a minimum friction of effort.

To trust the presented data, the Qualified Person needs a digital audit trail of all value chain events upstream. All actors, whether they are employees, machines or enterprises, get a digital identity that allows them to issue credentials about production events. At the end of the digital audit trail, the Qualified Person can evaluate whether the batch of a medicinal product or drug can be released for sale or supply.

To have a complete picture of a batch, we create a digital twin of a batch of a medicinal product or drug. This allows every actor in the production process of a given batch to get access to the digital twin and register their events as another verifiable credential to the digital twin. At the end of the production process, the Qualified Person gets access to all the value-chain credentials of the batch, to evaluate them in the Trusted Release process.

Benefits

  • Infrastructure for one-button trusted release
  • Digital audit trail saves documentation and audit costs
  • No process information from suppliers is disclosed to other suppliers
  • Digital exception-handling and deviation analysis

Features

  • Issue, store and verify production events as Verifiable Credentials
  • Verifiable data chain of production events as audit trail for Qualified Person
  • Access control credentials can also be managed using the same identity wallets

Client Testimonial

“Based on our successful collaboration with Spherity, the industry agreed to further investigate the usage of W3C Decentralized Identifiers and Verifiable Credentials technology to electronically verify Authorized Trading Partners in the saleable returns verification process in an industry-wide pilot.”

oliver-nuernberg-sap-life-sciences

Dr. Oliver Nuernberg
Chief Product Owner, SAP Life Sciences

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