Industries of all types face ever-evolving labeling regulations and standard practices. With that, it can be challenging for organizations to keep up with changing regulations while also developing products, entering new markets and meeting customer demand.
End-to-end labeling compliance — the process of making labels that meet regulatory requirements — is vital to an organization’s ability to maintain credibility, produce and distribute safe products, operate efficiently and avoid costly errors or penalties associated with mislabeling.
Yet, with a vast global supply chain (manufacturers, suppliers, logistics), many organizations still struggle to manage labeling regulations. And these regulations affect nearly every industry from food and beverage to chemical and aerospace.
A 2018 Recall Index study found that 14.3% of pharmaceutical recalls were attributed to mislabeling. In the medical device industry, mislabeling was the second highest cause of product recalls behind software problems. And in the food and beverage industry, undeclared allergens lead to the most food recalls, which may be a function of not meeting food labeling requirements.
Considering the staggering number of recalls directly related to labeling, it’s all the more important that organizations in highly regulated industries find comprehensive, proven labeling solutions.
This chapter will walk you through the primary challenges facing specific industries and offer insight for choosing the right labeling software for your organization.
Different industries face different label regulations
Labeling is subject to a vast set of regulatory requirements in various industries across the globe, which often makes managing compliance a challenge for organizations and their compliance departments. They are tasked with carefully considering how various aspects of their supply chain are affected by each regulatory standard.
While each industry faces different labeling challenges and regulatory requirements, some industries are more regulated than others. According to the 2014 McLaughlin-Sherouse List, petroleum and coal were the most regulated industries in the US, followed by motor vehicle manufacturing, credit, air transportation, fishing and pharmaceuticals.
On a global scale, many industries are heavily regulated due to their distribution in so many different countries. Since each market maintains different regulations, creating a streamlined, accurate process for meeting each regulation to maintain labeling compliance is crucial.
Medical device industry
Elements like medical device labels are highly regulated to ensure accuracy and consistency, which ultimately protects the consumer. Medical device companies are subject to several standards set forth by regulatory bodies like the US Food and Drug Administration (FDA), European Commission (EC), such as the FDA’s unique device identification (UDI) system.
Localization is also an important component of medical device labeling, which includes printing labels with proper regional translations, colors and dialect, and correctly placing the labels on packaging. But this gets complicated when medical devices are being manufactured, sold and distributed in countries around the world.
According to a survey from 2015-2016, 58% of World Health Organization (WHO) member states (194 total member states at the time of the study) maintain regulations for medical devices. If a medical device manufacturer operates in each of those member states, they are subject to each set of regulations, increasing the potential for costly, or dangerous labeling errors.
Furthermore, medical device barcode labels need to be accurately preserved to drive FDA 21 CFR Part 11 labeling compliance. This standard calls for medical device and pharmaceutical manufacturers to capture and record activity of any electronic systems used to identify and track their products.
Considering this diverse set of medical device regulations, companies need to find a labeling solution that is fully scalable and able to meet the ever-evolving demands of the regulatory industry, including medical device labels.
The chemical industry is known for its complex supply chains that are subject to several industry regulations set by regulatory bodies like the Environmental Protection Agency (EPA), including requirements like the Globally Harmonized System (GHS label requirements). Chemical manufacturers also have to manage variable data that includes branding elements, transport and hazard information.
But when these manufacturers are managing data for various organizations in the chemical industry, like lubricants, cleaners, and sanitizers, chemical labeling becomes an even bigger challenge.
BarTender®, a labeling software for enterprise business, worked with a specialty chemical manufacturer who had recently acquired nine different chemical companies that each had their own labeling requirements, printers and processes. The companies they acquired each had their own set of labeling software and processes, which needed to be integrated into one, consistent company-wide system.
The company had previously implemented enterprise labeling solutions but found it to be inefficient and unable to comply with OSHA’s GHS mandate. Simplifying the labeling process was paramount to ensuring label compliance across each of the companies, regardless of where they operated and which industry they were in.
The company’s print methodology was complex. For every single product and SKU, there was a file, with over 9,000 label files in the system. Due to how label formats and product data were stored, print operators had to access multiple software systems just to print labels for a single product, making for a terribly inefficient and potentially inaccurate labeling process.
A BarTender partner created a labeling system that relied on Intelligent Templates™ to manage variable data by integrating images, regulatory and product information that was stored in several different systems across their supply chain. Using a new labeling system with BarTender’s features, the company has reduced the number of label formats it requires from more than 9,000 — that’s before integrating newly acquired companies into its system — to 24 across all of its current facilities.
In addition to the drastic reduction in label formats, the new labeling system was created to be scalable and agile to quickly align with changing business needs, regulations and standards. As a result, the company increased the accuracy of their labels, reduced waste and implemented efficient processes.
Food and beverage industry
Food and beverage companies face a complex set of regulations and standards related to food labeling and traceability that span across the global food supply chain, which includes producers, processors, logistics providers and manufacturers.
Data can be located in numerous places for various markets and information must be correct for consumer safety, particularly food allergen labeling. But what happens when there’s a new vendor, a new warehouse management system (WMS), new pricing, third-party logistics provider (3PL) or processing facility?
Instant global change management becomes essential. This can be done with labeling software like BarTender, which implements new label data, pricing, format and regulatory changes across the supply chain using Intelligent Templates. This helps avoid errors and ensures accuracy and label compliance.
An example of how labeling software can help manage label compliance and efficiency was an organic dairy farm who implemented a BarTender-driven system to enable compliance with the data capture and retrieval conditions of FSMA.
This organic dairy farm manually marked and tracked thousands of batches each year, but this process was time-consuming and created a high potential for human error.
With BarTender, a labeling system was developed to print a complete set of product labels for each batch, which includes barcodes for automated data management and capture. This ensured consistency, accuracy and ultimately, safety for consumers. It also dramatically reduced the hours spent manually processing and recording data saving the dairy farm money, time and stress of meeting FDA labeling requirements and other standards.
Emerging markets present additional regulatory challenges
Expansion into new markets around the world is a key component of enterprise organization growth. Whether they are acquiring new companies or introducing a product in a new location, they will need to adhere to label compliance in each market they enter.
Growth may also necessitate the introduction of new supply chain partners who will need to comply with label regulations, making it important to streamline the labeling and printing process.
As growth occurs, labeling compliance can become more complex, especially if an organization relies on outdated labeling software or even manual processes that increase the chance for human error. For example, if a food product contains an allergen but it isn’t listed on the label (per food labeling requirements in that market), it’s not only in violation of regulations, but could present safety risks to consumers.
Additional challenges when entering new markets include:
- Lack of centralized traceability and serialization, which can lead to regulatory violations
- Noncompliant with global security standards for electronic signature, data logging and audit trail, like those associated with FDA 21 CFR Part 11
- Lack of supply chain visibility
- Slow response to changing standards, new products and localization (language, symbology, color label placement, etc.)
- Siloed systems that don’t integrate with WMS, enterprise resource planning (ERP) and other systems
Choosing a dynamic, compliant labeling system that can grow with your organization and each new market it enters will help avoid these challenges and potential consequences. Labeling software that centralizes data can help with global change management, so you’re never left wondering if labels are correct.
Additionally, with a system like BarTender, you can easily configure complex printing scenarios by telling templates, layers and individual objects when to print based on specific web triggers, a single data source or database field or even using multiple conditions. You don’t need to worry about coding, which helps simplify the labeling process so that your organization can scale with ease.
Risks of non-compliance
There are numerous risks that companies face with poor barcoding standards and non-compliant labeling and processes that go beyond a simple violation.
Mislabeling can lead to many costs associated with fixing the error including:
- Fines from regulatory agencies
- Relabeling costs
- Recalling products
- Legal fees
- Manufacturing new product
Damage to brand reputation
Customer loyalty and trust is an important part of a company’s success, but if there is a product recall or regulatory violation, consumers may begin to lose trust. This can result in lost business or negative media attention, which may affect other parts of the company’s supply chain. With damage to a brand’s reputation it can be challenging to reestablish consumer confidence.
Interruptions to supply chain
If a company is found violating regulations, they may need to pause production and reconsider processes that consume time, money and resources, which affects the entire supply chain. If a supplier in one country isn’t compliant, it may cause delays for each stakeholder, even if it isn’t the company itself.
How the right labeling solution helps you navigate compliance
Choosing a comprehensive labeling and barcode software will help organizations maintain safety, security, efficiency and compliance by offering a number of specific benefits.
Integrate with sources of truth
While labeling software can aid with the proper creation of barcodes, RFID tags and labels, there is a wealth of data from other systems that needs to be integrated to facilitate streamlined, compliant labeling. A few of these important systems include:
- Remotely located printers
- Spreadsheets and databases
- Operating systems, web browsers and devices
- Human resources systems
An example of proper integration can be found in hospitals that use barcoding systems for:
- Inventory of equipment
- Monitoring different types of devices
- Tracking the age of devices
- Updating equipment
- Managing compliance
Barcoding software is integrated with other automated hospital and healthcare systems, such as an ordering system, to ensure that the hospital always has the supplies it needs and is using equipment that is safe, compliant and fully functional. This helps reduce chances for human error, fosters accountability and helps protects patient safety.
Centralized labeling processes
If enterprise organizations have minimal supply chain visibility, siloed processes and labeling that occurs from multiple locations, it can lead to errors and inefficiencies. By centralizing data, traceability and serialization, organizations know that every label is consistent and accurate, no matter where it’s being printed.
An example is a large apparel retailer that struggled to maintain consistent labels across its global supply chain. Goods from suppliers were often mislabeled and it was challenging to keep up with the pace of business across their eCommerce, catalog sales and brick-and-mortar stores.
With BarTender, they were able to centralize and standardize labeling so suppliers could quickly access templates through the Print Portal. Regardless of printer type or location, suppliers could choose from a selection of label formats and appropriate data to include on the labels, eliminating time-consuming and costly homemade labels.
Centralization also helps organizations trace the following in regard to barcodes and labels, which aids with label compliance and consistency:
- Part numbers
- Manufacturer ID
- Transaction codes
- Location codes
- Expiration dates
- Personal information
- Product type
- Lot number
Additionally, small businesses may not have the time and resources to manage their inventory and warehouses in the same way as a large organization. Tools like barcode inventory software can help streamline processes so that even with fewer resources, small organizations can be successful and grow.
Improve workflow efficiencies
Complicated workflows and processes can hinder productivity and be costly. With the right labeling software, organizations can streamline workflows to remove unnecessary steps in the label creation and printing process.
If organizations rely on manual processes or legacy labeling software, they may greatly benefit from a dynamic, automated system that removes the need for manual adjustments or a person continuously monitoring the labeling process. The benefits of BarTender’s software with improved document management and labeling workflow include:
- Improved QA with easy design, approval, tracking and deployment
- Fast approval with web-based Print Portal and email configuration for label approval anywhere
- Licensing backup server to keep printing operations moving
- Printing from any browser, device or connected printer
- Simple label system control
Growth is inevitable, but what happens when an organization grows into a new market or introduces a new product? How can they ensure that label compliance is followed and that production will continue without issues?
Implementing labeling software that integrates with multiple systems and can align with evolving regulatory standards will help organizations scale with ease.
- Centralized data management
- Integration with other business systems, processes and devices
- Label compliance across global governing agencies
- Global change management
- Total security with label monitoring at all printing locations
- Superior customer service