In industries where accuracy, safety, and adherence to regulatory standards are paramount, effective labeling isn’t just about clear communication. It’s about maintaining trust, meeting legal obligations, and safeguarding consumer welfare.
Keeping on top of labeling compliance as regulations continue to evolve poses an increasingly difficult challenge for businesses. Navigating these shifting requirements while managing a large, diverse product line can feel like an overwhelming task. Yet, this is where advanced labeling software proves invaluable.
By automating workflows, tracking changes, and managing compliance documentation, labeling software solutions transform labeling into a streamlined process that supports precision, transparency, and efficiency.
Below we explore how the right software solutions are essential for organizations looking to meet and exceed labeling compliance standards across a range of industries.
The labeling compliance challenge
As well as posing serious health and safety risks, inaccurate labels can lead to a number of issues for businesses, including costly recalls, a loss of consumer trust, and potentially legal fines for non-compliance.
Those working in highly regulated industries will know that rules and regulations can change frequently – leading to changes in distribution, design, ingredients and labeling requirements.
In a fast-paced environment, where efficient manufacturing can be the difference between your product hitting the shelves on time or not, you can often be left feeling like you’re on the back foot when it comes to updating and re-distributing your products. Sometimes, resulting in mistakes.
Recalls, due to error, can leave all-important products off the shelves, costing a business thousands, and those who need urgent healthcare, for example, are left without the medicine they need.
Remaining compliant is one of the most challenging, yet crucial, components in the labeling and artwork journey, but each market has its own unique challenges.
Medical devices
In 2025 alone, we’ll see a handful of new regulations come into play that will affect medical device manufacturers, including the Windsor Framework, EU MDR and IVDR.
Keeping track of all these regulatory changes, and those likely to come through in the months and years that follow, is no easy task. That’s why it’s no surprise that recalls of medical devices, due to labeling issues, continue to grow year-on-year.
With automated workflows, approvals and version control at your fingertips, our software can help you maintain traceability of each stage of a label’s lifecycle, preventing error and improving safety, while also storing and keeping a record of the stringent documentation, and strict standards, that comes with each regulation’s certification.
Pharmaceuticals
Much like the medical device sector, pharmaceutical businesses have to face the challenge of dealing with regulation changes. Changes that can affect the labeling and artwork on hundreds – or even thousands – of products, that could each span multiple geographies.
According to the FDA, labeling and artwork errors are one of the most common reasons for recall – likely as a result of relying on legacy, siloed systems or manual processes. Interoperability in a sector that relies on consumer trust and accuracy, is vitally important.
Kallik provides pharmaceutical manufacturers with a competitive advantage by offering an end-to-end labeling and artwork management solution that guarantees compliance and reduces errors, helping you get your products to market quickly, safely and with minimal recalls.
Chemicals, Oil and Lubricants
Counterfeit threats are one of the most common challenges that chemical, oil and lubricant enterprises face today. In fact, as recently as last year, one of the industry’s main trade bodies reported that there would be an expected rise in related counterfeit products, with criminals looking to sell cheaper – and dangerous – alternatives.
Taking advantage of global economic downturn, black market dealers have been known to sell fake products, like oil for example, without key components, including the correct precautionary statements, hazard warnings and ingredients to ensure your vehicle runs properly and that you remain safe while in use. In fact, many of these fake products are missing important additives, are either reused and re-packaged as new, or are a lesser-spec oil than the premium one being sold.
Yet, one of the most complex hurdles to overcome is their genuine-looking branding, and the speed at which they are able to update and redistribute their products under cover. To avoid consumers falling victim to black market deals, brand consistency is paramount.
We’ve worked with a number of global giants in the industry, from P&G and Kenvue to ExxonMobil and Mary Kay, using our cloud-based, end-to-end labeling and artwork platform, Veraciti, to help them tackle the increase in counterfeit threats through automated labeling and artwork management – solutions which have enabled them to speed up time to market, guarantee compliance, traceability and minimize the chances of counterfeiting.
Food and beverage
Food and drink labels are a legal requirement and they are important for many reasons. As well as helping us to make informed choices about what we’re putting in our bodies, they also provide important guidance on cooking and storing food safely, the origin of the produce and prevent people consuming ingredients, of a certain level, that they could be allergic to. The ramifications of a poorly labeled product could be disastrous.
With regulations like the Windsor Framework and ISO 9001 coming into effect in 2025 – rules that focus on quality management, including consistency and traceability, and require products to clearly declare their origin - it’s now more important than ever for manufacturers to consider how software could help them remain compliant and, above all, keep consumers safe.
Why software is key to labeling compliance
In these highly regulated industries, labeling, precision and compliance are paramount. The smallest error or short-cut from industry regulations can have far-reaching consequences that not only affect a brand’s reputation, but also put the end-user at risk.
Despite regulatory changes and supply chain disruptions being a common challenge in these markets, many firms continue to operate a patchwork of disparate systems with little to no integration with one another. Some use outdated, legacy systems, while others rely entirely on manual processes.
One lesson learned during the Covid-19 pandemic was the important role that digital technologies can play and their ability to combat disruption, from improving interoperability between departments, boosting efficiencies and maintaining accuracy.
An end-to-end labeling and artwork management software, like Veraciti, will act as your single source of truth, holding up-to-date, approved digital assets in one auditable cloud-based labeling solution, ensuring that your business remains completely compliant.
A typical manufacturer can have thousands of products to manage at one time, across a number of territories. With version control, you have complete traceability over your product’s life cycle, from initial creation, where you can ensure consistency and accuracy across each product thanks to pre-approved templates, right through to getting it on shelves.
Content management
Automation is the future. Not only is it fundamental for helping fast-paced businesses reduce manual errors and minimize recalls, but it also drastically reduces the time taken to identify the number of labels or artworks impacted by a change and implement those changes—from months to days. This, in turn, accelerates the entire content management process.
Those yet to deploy automated labeling and artwork solutions will likely waste a significant amount of time rifling through files for the latest artwork or liaising with external artwork designers, going back and forth with approvals, and updating them with each change made to the product or the brand’s logo and messaging.
Now, thanks to automated workflows, repetitive tasks are a thing of the past as automated labeling and artwork solutions can handle tasks like generating artwork, applying changes and searching for content. Coupled with version control management and audit trail features, you’ll have complete visibility over any changes made to your label components, so you can reduce errors.
Accelerating approval processes
Labels are always subject to stringent reviews and approvals. Take the medical device sector, for example, with a label destined for the EU market. That one label must pass through extensive review and approval processes to ensure medical, marketing and regulatory information – including symbols and markings – are all accounted for, accurate and consistent.
Then, you’ve got the challenge of it being translated into more than a dozen languages; a process which can often result in human error, leading to lengthy delays. Manufacturers will know that time-to-market is everything. Delays cost money, and can leave retailers without important stock on their shelves.
Significant errors occur though, when incorrect symbols or medical information hasn’t been properly updated, then not updated in the other translated versions. Without the right tools to spot the error, your non-compliant products could end up on the shelves with incorrect information on their labels, resulting in hefty recalls.
Without a fully integrated workflow, a thorough audit trail and a robust approval process that helps you monitor the performance of your process, and ensure you deliver correct labels each time, you could be opening yourself, and your customers, up to serious risk.
Case study: Össur
Global leader in non-invasive orthopedics, Össur, approached us when new regulations (EU MDR) were due to come in. Its team were stuck using disparate, non-standardized legacy systems; solutions that meant its IFU labels were stored in separate documents with only a master spreadsheet to chronicle them. While sufficient to create individual IFUs at one time, the requirements to keep costs low and the demands from this latest regulation meant that a more efficient process was needed.
As well as slow approval times on its IFUs, thanks to mismatched data and disparate documents, Össur's team were also contending with fragmented data and limited visibility across its hundreds of global product lines. They were also faced with a lack of consistency in tracking and managing information, which led to further challenges when trying to translate each IFU. This called for an overhaul of its legacy system, which saw the introduction of Veraciti.
Implementing the solution meant that Össur could consolidate all of its IFU phrases into one single system, finally giving them enhanced visibility of all its IFU assets. This streamlining of product information also enabled them to identify key phrases that could then be reused in multiple product IFUs, while ensuring that each label was accurate and completed in quick time.
Added to this, the changes made from Veraciti’s implementation illustrated the scale of the MDR compliance project that was required, giving them a clear vision of the steps needed to be taken to ensure their operations were fully compliant.
Streamline labeling compliance with Kallik
As we’ve showcased, labeling and artwork is fundamental to our everyday lives. Without it, we’d lack the guidance and clarity to eat our food and fill up our cars, take our medicine or seek treatment at a nearby hospital. Failure to comply with regulations could leave your business in hot water.
Our labeling and artwork management expert, Liam Conlin, adds: “The saying is true, ‘first impressions count’, and labels are often that first impression a consumer gets when they see a product on the shelf. But, with compliance at the very heart of these highly-regulated industries, when safety, accuracy and trust are compromised by missing labels, guidance or misinformation, non-compliance can put everyone in danger. Not to mention hamper your brand’s reputation.
“Making the switch from manual procedures to automated labeling and artwork software is guaranteed to make sure manufacturers remain in the compliant to all legislation ensuring 100% levels of safety and brand trust for consumers. Thanks to fully traceable version control and automated workflows that improve efficiencies, to a robust audit trail and reliable approvals platform that minimize risk and error, manufacturer’s are in safe hands.”
Safety is the backbone of each of these highly-regulated industries, backed by the accuracy and consistency that automated labeling and artwork solutions provide. If you’re looking to boost efficiencies, streamline your approvals process and ensure brand consistency, Kallik’s tried and tested software could be for you.
Book a demo to discuss how Kallik can benefit your labeling and artwork management process.