Global traceability regulation is increasingly becoming a focus area for pharmaceutical manufacturers and supply chain partners across the world. The key markets around the world are the USA, EU, Russia, India, China, Turkey, Australia, Saudi Arabia, Egypt, South Korea, Brazil and Argentina. The regulation is going to be in 40 countries soon.


The USA pharmaceutical market

 

The need to end-to-end traceability of prescription drugs arises when the Drug Supply Chain Security Act (DSCSA) signed into law in 2013 that outlines steps to build the electronic, interoperable system to be established by the pharmaceutical manufactures and distribution supply chain members by 2023, setting regulatory milestones and compliance requirements over the 10-year timeline, to identify and trace prescription drugs as they are distributed within the United States.

 

The existing system which is getting evolved in a phased implementation process to qualify regulatory milestones and compliance requirements established under the Drug Supply Chain Security Act (DSCSA) has been identified with several issues broadly classified as follows-

 

  1. Performance issues (e.g. time to response, reconcile difference etc.) causing productivity loss
  2. Interoperability issues causing delays
  3. Master data redundancy causing errors in retrieving information.

 



We have built the world’s only one-integrated enterprise SaaS platform for the US pharmaceutical manufacturers and members of distribution supply chain with a centralized configuration of distributed members’ database, helping pharmaceutical companies and ecosystem members comply with regulations on traceability of prescription drugs at the industry best performance levels.


Its concept is based on a revolutionary cryptography creating Navigation Identifiers for point-to-point database navigation system resulting technically best achievable performance benchmarks and a patent pending system mechanism for interlocked transaction records to a temper-proof transaction-chain.


To implementing requirements established under the Drug Supply Chain Security Act (DSCSA) as follows:

Overview of capabilities:

 

1.    Serialization at unit-level and aggregates

 

2.    Performance standards

           a.  Time to response

                The world’s only technology, demonstrating standardized time to response at full or partially loaded with data


           b.  100% accuracy level, zero error rate

                zero data redundancy by having centralized configuration of ecosystem members database

 

3.   Error free and efficient repackaging of product returns

 

4.   Speedy product recall data

 

5.    Real time reconciliation

 

6.    Customization to country-specific requirements