'Labeling Challenges' Blog Series, Issue #6 The 3 Cs of Label Production

Recent UDI requirements have persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and market drivers, has led to a growing number of companies issuing Requests for Proposals (RFPs) to labeling solution vendors to address this key operational activity. However, many organizations still overlook the strategic importance of labeling and underestimate its impact right across the supply chain.

Companies need to take an enterprise-level approach to determine the impact a label lifecycle management system can have in terms of operational efficiency, risk management, regulatory compliance, consolidation and in some cases expansion.

All instances of production label prints across manufacturing lines, distribution centers, as well as by 3rd party manufacturers must Consolidate, Control, and Capture the entire process.

The three C’s enable companies to manage electronic reconciliation across all printing operations within the system to satisfy regulatory auditors and management accountability, ensuring a “single version of the truth” to meet current and evolving regulatory requirements including UDI.

By incorporating the three C’s in label lifecycle management software, medical device manufacturers can manage and document labels through design, approval, print and inspection. This end-to-end approach gives greater visibility and control of the entire process, and supports FDA compliance.