FDA Forms The Optimal Solution with Six Companies Teaming Up to Assist with DSCSA Compliance


Recently, six institutions were selected to take part in a Food and Drug Administration (FDA) pilot program that assists pharmaceutical companies to comply with the Drug Supply Chain Security Act (DSCSA). The six are CalQLogic, Cryptowerk, FarmaTrust, RXTransparent, Systech, and T-Systems. These six companies are collectively known as the ‘Optimal Solution.’

According to Dwight deVera, the CEO and founder of RXTransparent, the DSCSA prevents the circulation of counterfeit drugs in the American market. He added that when the act was first implemented, the vision was to create a fully interoperable drug supply chain. Dwight is confident that the Optimal Solution will transform that dream into reality.

Prior to the introduction of the pilot program, the six firms work with a non-profit research and educational organization called the Center For Supply Chain Studies. Together, they created a solution that allows for the identification, tracing and tracking of prescription drugs being distributed across the United States.

Achieving interoperability in the pharmaceutical supply chain is no mean feat. In this regard, Ara Ohanian, the CEO of Systech, said that the Optimal Solution will leverage several technologies with them the aim of actualizing the dream of interoperability. The group will also infuse new techniques to increase the safety standards in America’s drug supply chain.

Jim Sabogal, the head of healthcare and life sciences at T-Systems, mentioned that the Optimal Solution is the only company that provides a comprehensive solution that is compliant to the DSCSA and assures the safety of drugs. He added that the group will show Americans what a pool of vendors with a common goal can achieve.

Speaking on the impact of interoperability on the key players on the drug supply chain, Shahnawaz Aziz, the CTO of FarmaTrust, asserted that it would improve the quality of healthcare received by US residents. This is the main reason why the Optimal Solution is emphasizing interoperability.

On his part, Peter Ebert, the senior VP at Cryptowerk, stated that they will rely on advanced technologies to ensure that drugs are compliant, safe and trusted by their consumers. Peter further said that they are creating a unique solution that other participants in the pharmaceutical industry will seek to emulate.

Lastly, Swamy Narayanaswamy, the CTO of CalQLogic, said that the Optimal Solution consists of leading companies that have been working together for years to asset supply chain firms to comply with DSCSA.

The pilot program is scheduled to last for six months ending in autumn this year. The main features of the solution include;

  • A digital fingerprint recorded on an immutable blockchain ledger to prevent the production and circulation of counterfeits.
  • Using the Internet of Things for data analytics.
  • Using blockchain technology to enable interoperability.

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