Serialization & Traceability


Serialization & Traceability

General lot and expiration date traceability have always been important elements of both the pharmaceutical, and food & beverage manufacturing industries. However, in today’s ever-restrictive regulatory environment and with the increased possibility of counterfeiting, tampering, and adulterated products, tracking by batches isn’t enough anymore. According to the World Health Organization, substandard, spurious, falsely labeled, falsified and counterfeit (SSFFC) medical products are by their very nature difficult to detect. They are often designed to appear identical to the genuine product and may not cause an obvious adverse reaction; however, they often will fail to properly treat the disease or condition for which they were intended. Since 2013, nearly 1,000 medical products have reported negative impacts, and the numbers continue to grow.

Clarke Solutions has always focused upon brand quality and protection including proper product identification and authenticity. It was a natural evolution to pioneer and support our clients through successful programs that provide item-level serialization, authenticity, and comprehensive chain-of-custody.

Every manufacturing company worries about losing control of its supply chain. Regulatory bodies share these concerns as well. Although supply chain risks can’t be avoided completely, E-pedigree type mandates are becoming the norm, demanding that you maintain meticulous records for every single aspect of your products. For example, California’s E-mandate requires item-level serialization with comprehensive chain-of-custody documentation for every single unit of sale.

Clarke can assist you in providing a complete, robust manufacturing solution to validate your products, maintain goodwill and loyalty, and prevent expansion of the counterfeiting market. Our subject matter experts are knowledgeable in pharmaceutical serialization (aggregation and end-to-end methods) as well as medical device UDI (unique device identification); additionally, our experts are supporting proactive clients in other industries including nutrition and general industrial manufacturing who are seeking to further protect their brand. Our engineers can support every step of the process, from the first planning meeting through final implementation.

Why should your pharmaceutical, medical device, or food & beverage company invest that kind of money in the hope of managing risk when Clarke Solutions already offers comprehensive serialization and traceability solutions? Clarke Solutions has already mastered the art of performance optimization and risk management, meeting regulations that can vary from each region of the globe and client market.

Clarke Solutions is the solution to your serialization challenges and will provide quality, a drastically lowered risk of recall, regulatory compliance, and optimized performance that is unparalleled in food & beverage, medical device, and pharmaceutical manufacturing industries. Clarke has specific solutions to fit your serialization needs:

If you need a fully integrated, item-level serialization system to protect your company, contact us here or call 317.849.0330 today for a free, no-obligation impact assessment.