How Can You Successfully Navigate Industry Regulatory Issues?

by Maureen Perroni, on July 24, 2018

Regulations are a double-edged sword: they help assure consumers that the products they purchase are safe and meet a standard of quality. On the other hand, regulations create challenges for companies as they add costs and complexity to supply chain operations. In addition, regulations change frequently (both domestically and in foreign markets), testing companies' agility to remain compliant. 

As organizations strive to achieve efficiency and maintain profitability, they must also remain in compliance with regulations that govern various processes. An Enterprise Labeling Solution can play a key role in accomplishing just that. The right solution will standardize and centralize labeling so information is consistent, accurate and complies with an array of customer and regulatory requirements. 

The Most Well-Known Industry Regulatory Issues 

There are four industries in particular that must navigate some of the strictest manufacturing regulations: chemical, pharmaceutical, medical devices, and food and beverage. 

Chemical manufacturers must comply with the Globally Harmonized System (GHS) of classifying and labeling chemicals. Container and pallet labels must contain certain information as well as images or pictograms in order to comply with GHS. In addition, many countries have their own specific labeling regulations for shipping chemicals. 

Pharmaceutical companies face regulations across the globe. The FDA (Food and Drug Administration) has its Drug Supply Chain Security Act (DSCSA), which mandates serialized product labeling to ensure traceability and visibility throughout the supply chain. In 2019, the EU will enact its Falsified Medicines Directive (FMD), a similar piece of legislation to protect consumers.

Medical device manufacturers that sell their devices in the US have to submit to the FDA’s Unique Device Identification (UDI) system for registering and labeling products. The EU has its Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), adding another regulatory burden.

The food and beverage industry must also comply with national and international regulations. The FDA’s Food Safety Modernization Act (FSMA) demands complete transparency of how products are made and where they are in the supply chain at all times. Shipping labels must support that. 

Woman with a test tube drawing fluids.

How Do Enterprise Labeling Solutions Help?

When you’re dealing with numerous regulations, you can’t have a number of disparate labeling systems. They don’t ensure accuracy, consistency and, most importantly, compliance - not to mention multiple systems are more difficult to maintain and scale with company growth. An Enterprise Labeling Solution, conversely, allows you to accurately and consistently manage the design, review and printing of labels across all of your facilities and even with your trade partners.

We’ll use a real-life example to show how Enterprise Labeling Solutions work. The Eaton Corporation is a multinational power management company that uses Loftware's Enterprise Labeling Solution. 

"Eaton Corporation recognized savings from correcting mislabeling, reducing labeling delays and downtime, avoiding costly maintenance, and meeting regulatory compliance with Loftware." 

Eaton Corporation was not only able to remain in compliance with regulations, the organization also benefited from cost savings. Moreover, complying with regulations is simpler because its Enterprise Labeling Solution centralizes label creation, enabling companies to deal with complex variability in labeling and to limit the number of label templates.

The double-edged sword of regulations will always hang over your head. However, you can alleviate the pressure by making it easier to comply. With an Enterprise Labeling Solution, your labels are always consistent, accurate and compliant. To learn more, download our report: Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance.


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