The Drug Supply Chain Security Act (DSCSA) has become a law in the U.S. since November 27, 2013 and its statutory requirements were enforced beginning January 1, 2015, non-compliance to which could result in penalties. Compliance is not just necessary to avoid fines or penalties but it will generate a compliance driven ROI which will increase the speed and accuracy of inventory flow, improve tracking and traceability of orders and returns, and result in optimized business processes that will favorably impact the bottom line. The legislation will eliminate spurious, illegal or hazardous drugs from entering the market and will eventually enable tracking down to the individual item level.
In the current compliance requirements, pharmaceutical sector firms are required to have the ability to share transaction information, history, and statements at the lot or batch level of identification so that when the drug is sold in the U.S. market- manufacturers, contract packagers, and wholesale distributors can provide the purchaser with product tracing information at the batch level.
Each player in the supply chain must pass along a document that contains transaction details for each item and the packaging-lot number combination, the transaction history of the product, as well as statements related to the authenticity of the product. All companies must capture, record this information for six years, and companies must be able to provide data upon request from federal or state officials.
It aims to standardize and streamline the exchange of information about the path a drug takes through the drug supply chain. It impacts drug manufacturers, wholesale drug distributors, drug re-packagers, pharmacies and other stakeholders in the drug supply chain.
As per the law, Lot Level Management requirements have come into effect from January 1, 2015, Item Serialization will be required by 2019 and Serialized Item-Level Traceability will be required by 2023.
Companies in the pharmaceutical business will need to upgrade their ERP for DSCSA compliance or migrate to another one.
Pharmaceutical manufacturers are finding that the most efficient means of reporting on this information comes from the same ERP software that is used at the formulation, QC, and production levels. This type of single-system is able to report on production history quickly and efficiently, and provides the granular level of detail that the transaction documents are required to report. This approach to accessing data and generating reports directly from the single source ERP system is proven to be very effective when dealing with product recalls as well.
An ERP that is on the cloud is almost like a plug play device with minimal launch times and with much lower cost than a legacy solution that uses an on-premise model. Any solution that is adopted must be flexible and ready to any changes in future laws that cannot be predicted even in the present. They must also be upgradable to future DSCSA regulation requirements.
We at Versa offer you all this with the advantages of a cloud platform that is easier on the pocket without compromising on top-of-the-line functionalities. Small businesses too can now be free of the hassle of figuring out DSCSA, the Versa ERP is DSCSA ready and offers a comprehensive business solution with issues of migration, portability, mobility etc all taken care of to ensure that you have the least amount of discomfort and changeover time. We can help you migrate from virtually any ERP platform with all your concerns addressed across time zones and business functions with a single window and a one stop shop solution.
