Ensuring Quality Management Amidst Regulatory and Design Technology Changes

A regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.