Countering the challenge of counterfeit medical devices and pharmaceuticals with compliance and serialization

October 4, 2022

The recurrent challenge of counterfeit medical devices & pharmaceuticals and the need to combat it, has never been more imminent.Brian Freymann, Director, Health and Life Sciences at Microexcel, talks about these challenges and ways to overcome them, in his Thought Leadership article, “Combatting Counterfeit Medical Devices and Pharmaceuticals”.

From negligence in compliance, to rampant production of counterfeit medicines that put patients’ health at risk, the article reiterates the need for GxP validation. The GxP protocols along with data integrity help streamline the end-to-end drug manufacturing cycle. Furthermore, it helps to create an integrated value chain that drives patient-safety.

Bringing in the serialization solution through a centralized regulatory database, the author substantiates its effectiveness in many areas. Firstly, it helps to establish a common international standard, while reinforcing data integrity linking the back office with the entire supply chain. Secondly, a serialization solution also provides regulatory compliance at all phases of drug development. Most importantly, this solution helps to trace the product, substances, or devices’ validity along the value chain.

Aligning the different stakeholders with serialization compliance, the article throws the onus on a modern enterprise resource planning system. The core functions of the ERP will be to drive quality, operational efficiency, and traceability by covering all levels in the serialization process. Additionally, the ERP will improve visibility and coordination within the organization and supply chain, while unifying the separate value chains.

Driving digital transformation through data, compliance, centralized serialization, and unified systems; Microexcel’s SAP solutions bring in new opportunities for sustained growth.

Overcome the challenges of counterfeit medicines and pharmaceuticals through serialization solution,
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