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June 7, 2016


A Beginner's Guide to Global Labeling Regulations

by Maureen Perroni

The global marketplace is full of opportunity. Never before have firms had so many opportunities to work with partners around the world to manufacturer and sell products. But the market is also a veritable minefield of potential challenges. Competition is fierce, and firms may struggle to get ahead if they do not achieve supply chain efficiency. On top of that, numerous new and existing regulations are presenting further difficulties that must be overcome.

"The market is a veritable minefield of potential challenges."

Loftware's Enterprise Labeling Solutions can help your business reach its full potential in the global marketplace. Our browser-based label design and unbounded printing capabilities allow firms to be nimble as they adjust their labeling to meet changing standards. If you're curious about some of the regulatory requirements that Loftware solutions can address, the following are some helpful links to get you started:

  • Electronics manufacturers that operate in or do business with Europe may be familiar with the Restriction of Hazardous Substances. Previously, the electronics industry relied on minerals that were later found to pose a danger to human health. Here's a list of the materials covered under the regulation.
  • Advances in medicine have improved living standards for millions of people around the world. This would not be possible without strict track and trace standards for pharmaceuticals and medical devices. The U.S. Food and Drug Administration's Universal Device Identification (UDI) system is designed to make it easier to identify specific complex devices, and has a lengthy, staged rollout that will take effect over a period of years. In addition, the Drug Supply Chain Security Act (DSCSA) places a number of labeling requirements on drug manufacturers and distributors. 
  • Accurate electronic records are also important. Title 21, Part 11 of the Code of Federal Regulations requires drugmakers and medical device manufacturers preserve auditable electronic records of production. This will help improve tracking standards.

And, there are many more evolving standards and regulations that impact lableling, that businesses across a wide range of industries need to consider.  For more information on how Enterprise Labeling can help companies stay compliant, check out Regulatory Standards and Compliance page on our website or call a Loftware expert at labelingsolutions@loftware.com.