Combatting Counterfeit Med Devices And Pharmaceuticals: Serialization, Validation, And A Case For Digital Transformation

By Brian Freymann

The manufacture, sales, and distribution of counterfeit medications and medical devices is a persistent and growing problem worldwide. The financial loss to manufacturers to develop compliant products and adhere to FDA software validation and regulated GxP standards is significant, but the resulting risks to patient health from counterfeit pharmaceuticals and medical devices that neglect software validation for medical device manufacturing can cause adverse long-term consequences or even death.

As regulators continue to align, pharma and medical manufacturers have a unique opportunity to adopt serialization compliance while positioning themselves for improved operational value by linking their serialization program to a modern ERP system. Continue reading to learn how an enterprise-grade system manages the needs of a serialization effort both internally within the operational confines of the manufacturer and the broader big data networks and supply chain ecosystems.