FDA Invites Systech and Solution Partners to Participate in DSCSA Pilot
PRINCETON, NJ – (April 24, 2019) Systech, a global leader in supply chain security and brand protection, along with key strategic partners, has been confirmed to participate in a Food and Drug Administration (FDA) pilot program under the Drug Supply Chain Security Act (DSCSA).
The program is intended to assist drug supply chain stakeholders in developing the future DSCSA electronic, interoperable system to identify and trace prescription drugs as they are distributed within the United States.
Systech partners comprising the Optimal Solution pilot team include RxTransparent, FarmaTrust, T-Systems, Cryptowerk and CalQLogic. Systech CEO, Ara Ohanian, says “The DSCSA is the shield that protects Americans from counterfeit and suspect drugs. By leveraging our advanced technologies, this pilot approach addresses product safety and trust issues beyond compliance. We believe we are creating a unique comprehensive solution with an unmatched combination of partners.”
The collective approach meets regulatory requirements and delivers additional benefit including:
- Utilizing a digital e-Fingerprint® layer of security to create an immutable track and trace ledger that improves visibility and enhances counterfeiting detection at the product level
- Capturing the Internet of Things (IOT) and Cold Chain information to leverage data for additional consumer insight and analytics
- Deploying blockchain as the infrastructure to enable interoperability providing a reliable foundation for trust in data that has been elusive with other technologies
“No single company provides an end to end solution that meets every DSCSA requirement while providing enhanced security and safety for pharmaceutical products. The pilot team intends to demonstrate what is possible using innovative technologies and showcasing capabilities that could ensure the U.S. drug supply chain is the safest in the world,” says Jim Lee, SVP Product Management at Systech. The pilot duration is proposed as six months with the final FDA presentation anticipated for Fall 2019.