US Drug Supply Chain Security Act

How the US Drug Supply Chain Security Act Impacts Manufacturers Catering to American Markets

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The Big Data Issue

These new regulatory requirements will have profound impact on the pharmaceutical industry. Given the differences between FMD and DSCSA, compliance represents a major challenge requiring flexibility, effort and investment for companies producing prescription medicines for both markets.

Serialization affects more than just the packaging lines. What many companies fail to understand or understand too late is that, in fact, serialization is a complex data management issue that impacts multiple departments within the organization. Serialization and track&trace processes generate an immense amount of data: serialization data for hundreds of thousands of units per year, plus event reporting in different formats for different authorities. Pharmaceutical companies therefore need a system that is designed for big data, to safely store, manage, exchange and report huge quantities of data. Only enterprise-level solutions can offer this type of data management capabilities.

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Today, there are solutions that open up new horizons beyond regulatory compliance in terms of data analysis and machine learning that improve supply chain visibility and help optimize processes. With the right solution, pharma companies and CMOs will be able to accelerate the digital transformation of the pharmaceutical supply chain for increased patient safety and ROI.

* * The Author is Founding Partner & CEO at Adents

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