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. 
 

View our brochure 

As industries grow increasingly global, the challenges of managing labeling and artwork processes have never been more complex. Whether you're juggling regulatory requirements, cultural preferences, or supply chain logistics, navigating these waters effectively requires a strategic and modern approach. That’s where our new ebook, Mastering Labeling and Artwork Technology in 2025: A Best Practice Guide, steps in as your essential roadmap.  

This guide is packed with actionable insights and proven strategies from industry experts to help enterprise organizations streamline their processes from design to distribution. Here’s a sneak peek into what you’ll discover—and why this ebook is a must-read for industry leaders.  

What’s You'll Learn?  

Managing global artwork design comes with its share of hurdles. The ebook explores key pain points, such as:  

- Language and cultural localization: How to streamline translation workflows and ensure cultural relevance.  
- Regulatory compliance: Integrating automated validation checks for a hassle-free approval process.  
- Supply chain logistics: Aligning designs with distribution requirements for maximum efficiency.  
- Brand consistency: Using centralized systems to maintain a cohesive global image while adapting to regional needs.  

Each challenge is paired with practical solutions to reduce inefficiencies and foster innovation.  

Introducing the Global Design Master 

A standout feature of the ebook is the introduction of the Global Design Master, a transformative framework for managing artwork across diverse markets. Key components include:  

- Centralized design standards to unify branding.  
- Modular design approaches for adaptability.  
- Advanced digital asset management systems (DAM) to streamline storage and collaboration.  
- Localization capabilities that resonate with regional consumers.  

This approach not only enhances consistency and compliance but also drives faster time-to-market and strengthens brand recognition worldwide. 

Why Download This Ebook?  

If you’re ready to modernize your labeling and artwork processes, this guide provides the tools and insights to help you:  

- Enhance efficiency and adaptability.  
- Stay ahead of compliance regulations.  
- Strengthen your brand’s global presence.  

 
Don’t miss this opportunity to revolutionize your approach to labeling and artwork management. Download the ebook here to discover how you can optimize your processes, improve speed-to-market, and ensure compliance—all while reducing costs in 2025 and beyond.  

Stay ahead of the curve and empower your organization to thrive in an increasingly complex global market. Let this guide be your stepping stone to a smarter, streamlined future.  
 

The future of labeling and artwork is digital — that’s no secret. Legacy systems trapped in silos are becoming relics of the past, while cloud-based solutions are defining the industry’s future. If your business hasn’t embraced digital transformation yet, it’s time to rethink your approach. Check out our 2024 Top Tips Guide for an in-depth look at why going digital is essential, with input from some of Kallik’s experts and Gartner Senior Analyst, John Blake.  

But what’s next? In 2025, staying ahead in the labeling and artwork game means focusing on three critical areas: innovative technology, sustainability, and supply chain traceability. Let’s dive in.
 

1. Innovative Tech: The Power of Cloud, Automation & AI  

Advancements in cloud-based platforms, automation, and artificial intelligence (AI) are completely transforming how labels and artwork are created, managed, and updated. We've already seen them become a major hot topic over the last couple of years, but as they continue to develop, we're expecting them to become even more crucial in 2025. 

That's right, they aren’t just buzzwords on LinkedIn — they’re revolutionizing the labeling and artwork process, and ignoring them could mean your organization gets left behind quite quickly. Let's look at some of the key ways they're already transforming label and artwork management.

Cloud-Based Platforms

Cloud-based platforms allow teams across different locations to collaborate in real time, ensuring that everyone works from a single source of truth. This eliminates version control issues and reduces costly delays caused by miscommunication. For global businesses, cloud solutions mean instant access to data, regardless of location.

Still unsure about whether the move to cloud software is worthwhile? Check out our blog, Cloud-Based vs On-Premis Labeling Software: Choosing the Right Solution for Your Organization. Our recent case study, summarizing our work with personal and beauty care leader, House of Cheatham, also covers the benefits of utilizing cloud-based technology to eliminate bottlenecks and reduce time to market. Read the full case study here. 

Automation

Automation streamlines repetitive and time-consuming tasks, such as data entry, label generation, and compliance checks. This reduces the risk of human error, enabling faster, more accurate label creation. It also allows staff to focus on higher-value tasks like strategy and creative design.

Artificial Intelligence (AI)

AI-driven tools can identify inconsistencies, suggest corrections, and even predict future needs based on historical data. For instance, AI can detect regulatory changes and adjust label templates automatically, ensuring compliance without manual intervention.

Benefits:

• Faster time-to-market
• Reduced errors and rework costs
• Enhanced operational efficiency

To understand more about the advantages and capabilities of automation and AI in labeling and artwork software, you can read our recent blog here. 

2. Sustainability: Green Packaging for a Greener Planet  

Sustainability is no longer a “nice-to-have” — it’s a competitive and regulatory necessity. Looking for new ways to improve the sustainability of your product? We're expecting eIFUs (electronic Instructions for Use) and connected packaging to dominate in 2025. For those unfamiliar with the terms, let's go over what they are and their key benefits.

What Are eIFUs?

Electronic Instructions for Use (eIFUs) are digital versions of printed product instructions. Common in industries like medical devices and electronics, they allow businesses to provide detailed product information online rather than in bulky paper inserts.

Benefits:

• Reduced paper waste and environmental impact
• Cost savings on printing and packaging
• Easier updates to product information, ensuring compliance without costly recalls

To learn more about eIFUs and their benefits, our recent blog looks closely at how we expect them to transform the labeling and artwork process in 2025. Read the blog here.

What Is Connected Packaging?

Connected packaging uses technologies like QR codes, NFC tags, or RFID chips on product packaging to link consumers to digital content. By scanning a code with their smartphone, customers can access a wealth of information such as product origins, sustainability certifications, or recycling instructions. Find out more about connected packaging in our full blog on the topic, here.

Benefits:

• Enhanced customer engagement through interactive content
• Transparency about sourcing, sustainability, and product safety
• Instant updates for compliance, reducing the need for physical label changes

These innovations help brands demonstrate their environmental responsibility while meeting evolving consumer expectations.

3. Supply Chain Traceability: Transparency at Every Step  

Traceability means knowing exactly where a product has been throughout its journey from manufacturer to consumer. While it has always been crucial for meeting regulatory requirements, it’s now equally important to consumers. Today’s shoppers increasingly value transparency, wanting to trace not only the origins of products and their ingredients but also the materials used in their packaging.

As regulations tighten and consumers demand more transparency, technologies like QR codes are essential so let's look at how they work and how they can support traceability.

What Are QR Codes and How Do They Work?

Quick Response (QR) codes are scannable barcodes that store information such as product details, tracking data, and compliance certifications. With a simple smartphone scan, consumers, retailers, and regulators can access this data instantly.
 

How QR Codes Improve Product Traceability:
 

• Businesses can update product information online without recalling products or reprinting labels, ensuring instant compliance.
• QR codes can store essential compliance data, simplifying audits and reducing the risk of regulatory fines.
• Avoiding label reprints reduces material waste, supporting sustainability goals.
   

Why Traceability Matters in Labeling and Artwork Production
 

• Enhanced visibility across the supply chain reduces operational risks and supports regulatory compliance.
• Transparency builds trust by offering clear information on sourcing, production, and environmental impact.
   

Stay Ahead of the Curve with Kallik  

Ready to future-proof your labeling and artwork process for 2025 and beyond? Our experts are here to help. Discover how Veraciti, our end-to-end cloud-based platform, can keep you compliant, efficient, and ahead of industry trends. Stay ahead. Stay compliant. Stay future-ready.

📞 Call Us: +44 (0) 1827 318100
📧 Email: enquiries@kallik.com

Download the product brochure 
 
Book a demo here 
 

As 2024 draws to a close, the Labeling and Artwork Management (LAM) industry finds itself at the forefront of innovation, driven by the need for efficiency, sustainability, and compliance. At the start of the year, we predicted key trends that would define the year ahead. Now, as we reflect, it’s clear these trends have become even more significant, particularly as businesses navigate updates to regulations like the new EU CLP FCC Broadband, HFSS, and Windsor Framework updates. 

These frameworks demand solutions that streamline global processes, enable mass changes quickly and easily, and ensure compliance without compromising accuracy. Here’s how 2024’s biggest trends have played out and why they matter.
 

Cloud-Based Systems: Essential for Compliance and Speed

The adoption of cloud-based platforms has continued to grow, driven by their ability to centralize data, enable global collaboration, and support instant updates. These systems have become indispensable in managing the rapid regulatory changes required by the EU CLP, HSFS, and Windsor Framework, empowering businesses to adapt efficiently. You can find more information on the benefits of cloud-based software in our recent blog, Cloud-Based vs On-Premise Labeling Software: Choosing the Right Solution for Your Organization.
 

AI and Automation: Transforming IFU Production

AI and automation have cemented their place in the labeling and artwork processes, particularly in the production of Instructions for Use (IFUs). As regulatory demands grow, especially in pharmaceuticals and medical devices, traditional methods of creating IFUs and Patient Information Leaflets (PILs) have proven insufficient.

Automated systems have revolutionized IFU production, enabling organizations to:

Streamline processes: Automating the creation of IFUs from a single source of truth reduces the risk of errors.
Break language barriers: Pre-approved translations ensure accuracy across multiple languages, eliminating reliance on less reliable tools.
Transition to electronic formats: eIFUs provide significant sustainability benefits, reducing waste and making updates faster and more efficient. For example, Veraciti has helped companies like Össur reduce the time required to generate EU MDR-compliant IFUs from hours to minutes, freeing up resources and enhancing compliance confidence. Learn more in our full case study with Össur, here.

To understand more about how the production of IFUs is changing, you can read our blog about transforming IFU management in the name of sustainability and better patient safety here.
 

Sustainability: A Core Focus

Sustainability continues to drive innovation. The shift to eIFUs aligns perfectly with eco-friendly goals by reducing paper waste and ensuring updated, accurate information is always accessible. This transformation not only minimizes environmental impact but also enhances user experience and operational efficiency.
 

Template Technology: A Game-Changer

Template-based systems have been crucial in maintaining consistency and compliance across vast product portfolios. Their ability to handle mass updates in response to regulatory changes has been a standout feature, particularly for businesses managing hundreds or thousands of IFUs.
 

A Year of Progress—and a Look Ahead

2024 has been a year of significant strides in digital transformation, however, the journey doesn’t end here. Next year promises to bring even more innovation. Stay tuned for our upcoming blog, where we’ll reveal our predictions for the biggest trends of 2025.

In the meantime, if you haven’t yet explored our Guide to Mastering Enterprise Labeling & Artwork in 2024, now is the perfect time. It delves into the transformative trends shaping the industry and offers actionable insights for staying ahead in an ever-evolving landscape. Download the guide here.

Get Ahead of the Curve
 

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

At Kallik, we believe that the success of our labeling and artwork management solutions is driven not just by cutting-edge technology but also by the incredible talent behind the scenes. Our Chief Delivery Officer, Beth Peckover, is a prime example of this, with nearly nine years of experience guiding organizations through transformative journeys with Kallik’s Veraciti. Her passion for seeing both our customers and team members thrive makes her an essential part of our leadership team.
 

A Unique Introduction to Labeling and Artwork

Beth’s entry into labeling and artwork management came about somewhat unexpectedly. While working as a business consultant for DXC Technology, she was introduced to Kallik. It was during this engagement that she had her "eyes opened to the labeling and artwork management world." As she recalls, “It's something that most people don’t tend to give much thought to, but once you start understanding how critical it is to each and every product-based organization, it’s a really fascinating space.” Beth was particularly inspired by Kallik’s founder, Neil, whose vision for how technology could revolutionize the labeling and artwork industry resonated with her. This inspiration led her to make the leap and join Kallik permanently—and as she says, she’s "never looked back since!"
 

The Reward of Customer Success

For Beth, the most rewarding aspect of her role is witnessing the tangible business outcomes that Kallik’s customers achieve through the use of Veraciti. "Implementing it correctly is crucial to ensuring our customers achieve their objectives. Our goal is to transform the way our customers manage artworks and labels," Beth emphasizes. Her pride in Kallik’s talented delivery and support teams is evident, “I’m also incredibly proud of the talented team we have at Kallik, in delivery and support but more broadly across the business, and I get enormous satisfaction in seeing them achieve great things every day.” It’s this customer-centric focus that makes Kallik’s approach to labeling and artwork management stand out in a crowded market.
 

Kallik’s Unique Approach to Labeling and Artwork
 

What sets Kallik apart from other players in the industry? According to Beth, it’s all in the way we think about labels. “When most people think of a label, they think about the finished label only,” she explains. “But we think about labels as being built up of individual elements—marketing text, claims, images, regulatory symbols and text, etc.” By focusing on deconstructing and controlling these elements, Kallik enables searchability, standardization, and reuse—ultimately leading to greater efficiency. Once these elements are in place, automation kicks in to build the finished label. “No one else thinks like us, and that's why our product Veraciti is so unique,” Beth summarizes.

Advice for Businesses Looking to Improve Their Processes

When asked for advice for businesses seeking to enhance their processes, Beth stresses the importance of seeing labeling and artwork management implementation as more than just a technical project. “Implementing a labeling and artwork management solution should be viewed as a strategic project driving major business transformation,” she advises. Beth believes that organizations must combine technical implementation with organizational change to fully realize the benefits. This often involves harmonizing business processes and ways of working across regions or business units—a task that requires the right people and strong executive sponsorship. “The most successful implementations of Veraciti I have seen have happened in organizations who take the change management aspect of these projects seriously and have the right level of executive sponsorship to help them embed the change,” Beth explains.

Balancing Work with Life

Beth’s commitment to excellence doesn’t stop at work—it’s a principle she carries into her personal life as well. Over the years, she has come to appreciate the value of work-life balance. “As I have got older, I have realized the importance of work-life balance, and that actually having this not only makes you more effective at work, but means you enjoy work more too and you’re more resilient to the challenges it may throw at you,” Beth explains. A self-professed morning person, Beth starts her day with a 6am gym session, which sets her up mentally for the day ahead. In the evenings, she enjoys unwinding with her husband on their daily walks.

But Beth’s talents don’t stop there—she’s also a keen cook, describing feeding people as her "love language." On weekends, she can often be found experimenting with new recipes or hosting friends and family. Her biggest culinary achievement? A three-tier wedding cake for a friend! And when Christmas rolls around, her frangipane mince pies are in high demand.

Words to Live By

Beth’s grandmother passed down a piece of advice that she continues to live by: “If a job is worth doing, it’s worth doing well.” Driven by a commitment to excellence, Beth says, “I am a bit of a perfectionist (unfortunately for my team and my husband!) but that's because I really give 100% to everything I do, and I expect the same from those that I work with.” It’s no surprise that one of Kallik’s core values, ‘pride,’ resonates with her deeply. “Ultimately, that’s what it’s all about—taking pride in what you do and doing it to the best of your ability,” she explains.

Beth Peckover’s journey from consultant to Chief Delivery Officer at Kallik highlights her dedication to driving customer success and fostering a culture of excellence. Her belief in the transformative power of technology, coupled with her passion for supporting her team, makes her an invaluable leader at Kallik. We’re proud to have Beth at the helm of our delivery operations, ensuring that our customers not only meet their labeling and artwork goals but exceed them.

Accurate and compliant labeling is a cornerstone of medical device manufacturing, yet it remains one of the most complex and challenging aspects of the industry. With the regulatory landscape continuously evolving, manufacturers must navigate a labyrinth of global requirements while ensuring workflows are efficient and error-free.  

This article will guide you through the foundational requirements in the US and EU, explore common challenges, and share best practices to help you streamline your labeling processes and maintain compliance.

What is Medical Device Labeling?  

Medical devices encompass a wide range of products designed to diagnose, treat, or prevent medical conditions. If you’re unsure whether your product qualifies as a medical device, the FDA’s classification tool can help clarify.  

But what exactly constitutes a "label"? According to the FDA's definition, it includes all written, printed, or graphic materials associated with a medical device. This extends to Instructions for Use (IFUs), packaging, and any accompanying materials.

Key Regulatory Requirements for Medical Device Labeling  

Both US and EU regulations share a commitment to ensuring safety, efficacy, and transparency. However, the nuances between these frameworks require manufacturers to tailor their processes accordingly.  

US FDA Requirements  

The FDA’s labeling requirements focus on providing clear, accurate, and comprehensive information about the device’s use, safety, and risks. Labels must include details like:  
- Device name and intended use
- Directions for use
- Warnings and precautions

You can find a complete overview on the FDA's device labeling page. For further insights into FDA requirements, explore our guide to 21 CFR Part 211.

EU MDR Requirements  

The EU MDR emphasizes multilingual compliance, CE marking, and detailed Instructions for Use (IFU). Essential label elements include:  
- CE marking  
- Unique Device Identifier (UDI)  
- Appropriate symbols and pictograms for clarity  

For detailed EU MDR labeling requirements, refer to the official documentation. Learn more about how our software supports EU MDR compliance on our dedicated page.  

Common Challenges in Medical Device Labeling  

Keeping Up with Regulatory Changes
Frequent regulatory updates can turn compliance into an ongoing challenge. Each change might require updates to tens of thousands of labels, creating a significant headache for suppliers. To stay ahead, it's crucial to have software in place that can quickly and easily manage these mass label updates—keeping you ready for whatever changes come next.

Managing Multilingual Labels
For global suppliers, ensuring labels are understood by consumers across different regions is critical. Multilingual compliance, especially under EU MDR, requires precise and culturally relevant translations—adding another layer of complexity to the labeling process.

Complex Approval Processes
The approval workflows for Class II and III devices can involve multiple stakeholders, often leading to long delays. That's why it's essential to use an intuitive, end-to-end platform that streamlines the approval process and keeps everything running smoothly and efficiently.

Discover how Kallik’s medical device labeling software helps mitigate these challenges. Having been built with compliance in mind, our end-to-end Veraciti™ software makes all of the above easier than ever.

Best Practices for Ensuring Labeling Compliance  

Automate and Centralize Processes  
End-to-end software solutions streamline label creation and updates by automating key tasks, reducing manual errors, and ensuring consistent regulatory compliance. Centralizing your labeling processes in one platform allows you to quickly implement changes across multiple regions, ensuring your labels are always up to date with the latest requirements and eliminating time-consuming manual revisions.

Implement Robust Version Control  
A solid version control system keeps track of all label iterations, ensuring only the most current version is in circulation. This reduces the risk of distributing outdated labels and simplifies audits, as you can quickly access historical versions and verify compliance. It also fosters collaboration by providing clear visibility into changes and approvals, keeping your labeling process secure and efficient.

Digital Proofing and Approval Workflows  
Automated proofing and approval workflows speed up the approval process by ensuring labels are reviewed and signed off quickly and accurately. With digital tools, you can spot errors early, streamline collaboration, and reduce delays, ensuring that labels meet regulatory and internal standards efficiently, without the bottlenecks typical of manual approval processes.

Learn more about how Veraciti's automated tools can help with your medical device labeling on our label management page.  

Leveraging Labeling Software for Compliance  

Kallik delivers speed to market, compliance and change management for complex product labeling and artwork portfolios that significantly challenge medical device organizations.  Whether driven by localized market requirements, merger and acquisition or the launch of a new product, our software can ensure that your organization completes artwork and labeling projects with unrivalled speed and compliance. 

With fully customizable role-based digital approval flows, label automation, advanced reporting, and full audit logs, you can ensure total regulatory confidence in your medical device product labeling and artwork. 

One example is our partnership with Ossur, where our solution enabled seamless global labeling compliance. By centralizing and standardizing IFU data, Össur gained complete visibility and streamlined the creation and approval of Instructions for Use (IFUs) across hundreds of products. This transformation reduced cycle times, cut translation costs, and ensured compliance while simplifying future regulatory updates. Veraciti’s automation and phrase reusability not only improved operational efficiency but also enhanced the customer experience by delivering clearer, standardized product information. Read the full case study here. 

Kallik has extensive experience partnering with medical device organizations and manufacturers. Our label and artwork management solution, Veraciti, is constantly evolving to meet the dynamic needs of the medical device industry. Contact us today at enquiries@kallik.com to discover how Kallik can streamline your labeling and artwork management process. Book a demo to see how Kallik can transform your labeling process.

Labeling is critical for industries ranging from retail to pharmaceuticals, and with ever-evolving regulations, label compliance has become more challenging than ever. Whether you're managing labeling processes on a small scale or distributing products globally, choosing the right labeling software can significantly impact efficiency, data security, speed to market, delivery of brand promise, and collaboration. In recent years, cloud-based labeling solutions have gained traction for their flexibility and scalability, yet some organizations still rely on traditional on-premise setups.

This blog will explore the differences between cloud-based and on-premise labeling software, highlighting the advantages of cloud-based solutions—especially for large-scale organizations. We’ll also dive into the unique benefits of cloud-based labeling, including improved collaboration, data security in the cloud, reduced labeling errors, and efficient label design.
 

Understanding Cloud-Based and On-Premise Labeling Software

Cloud-Based Labeling Software: This software is hosted on a cloud platform, enabling users to access it from anywhere with an internet connection. Cloud-based solutions allow for real-time collaboration, faster updates, and streamlined workflows—all without the need for additional hardware or extensive IT resources. Since updates are managed by the provider, IT teams spend less time installing software updates, and companies avoid the risk of becoming outdated or experiencing downtime for upgrades.

On-Premise Labeling Software: This software is installed on an organization’s local servers and typically requires dedicated hardware and IT management. While it offers control, on-premise software can limit collaboration and agility.

Cloud-Based vs. On-Premise Labeling Software: Pros and Cons

Here’s a breakdown of the pros and cons of both cloud-based and on-premise labeling software:

Why Cloud-Based Labeling is the Future

1. Enhanced Collaboration

For companies operating in multiple locations or dealing with remote teams, cloud-based labeling offers unparalleled collaboration. Teams can access and update labels in real-time, reducing miscommunications and ensuring consistent label compliance across all regions. By facilitating smooth, global collaboration, cloud-based solutions prevent costly labeling errors and ensure a faster time-to-market.

2. Improved Efficiency and Reduced Errors

Centralized data storage in the cloud allows for real-time updates to label designs, regulatory requirements, and product information. This reduces labeling errors that could arise from outdated information or isolated data silos. By streamlining these processes, cloud-based labeling minimizes errors and enhances the efficiency of label production workflows, ultimately leading to more consistent, accurate labeling.

3. Data Security in the Cloud

Security remains a top concern for organizations, especially when dealing with sensitive labeling data for industries like pharmaceuticals, electronics, and food. With advanced encryption, data redundancy, and multi-factor authentication (MFA), cloud-based labeling solutions offer robust data security protocols that surpass traditional on-premise setups. Cloud providers invest heavily in security measures, often providing levels of protection that smaller companies would struggle to maintain on their own. On top of this, cloud providers also often provide triple levels of backup to ensure no data can be lost.

4. Automatic Compliance Updates

In highly regulated industries, label compliance is critical, and even small errors can lead to costly fines or recalls. Cloud-based labeling software simplifies compliance by providing real-time updates to regulatory standards. Instead of manually updating each location or installation, cloud-based solutions ensure every user accesses the latest information, helping prevent errors and maintain label compliance.

Which Organizations Benefit Most from Cloud-Based Labeling?

While any organization can benefit from the enhanced features of cloud-based labeling, it is especially advantageous for:

- Global Enterprises: Companies operating in multiple regions benefit from real-time collaboration and regulatory compliance updates, which are crucial for label consistency across diverse markets.
- Highly Regulated Industries: Pharmaceutical, medical, food, and electronics industries require strict label compliance. Cloud-based solutions simplify adherence to these evolving regulations.
- Small to Mid-Sized Businesses (SMBs): For companies with limited IT resources, cloud-based labeling reduces operational costs by eliminating the need for server maintenance and on-site infrastructure.
- Companies with Remote or Hybrid Teams: As remote work becomes more common, cloud-based labeling allows team members to collaborate effectively from anywhere.
- Companies reliant on external suppliers like design agencies, third party manufacturers, printers, etc for whom SSO controlled access can be provided.

When On-Premise Labeling Software Might Be Suitable

While cloud-based solutions offer numerous advantages, on-premise labeling software may still be preferable for:

Organizations with Strict Data Sovereignty Requirements: Some industries, such as government or military, may require data to be stored on local servers to comply with legal regulations.
Industries with Highly Customized Labeling Needs: If a company has highly specialized labeling processes that require deep customizations, an on-premise solution may provide more flexibility.

Final Thoughts

Kallik’s VP of Europe Sales explains that cloud-based labeling software clearly stands out as the better solution for most organizations, particularly large-scale and/or global enterprises. With advantages in collaboration, efficiency, data security, and label compliance, cloud-based solutions streamline the labeling process, reduce errors and almost completely eliminate downtime, all while ensuring companies remain competitive in a rapidly changing market.

Investing in a cloud-based labeling platform enables your organization to move quickly, adapt to new regulations, and maintain a higher standard of labeling accuracy. As the digital landscape evolves, cloud-based labeling is not just a trend—it’s a strategic move toward future-proofing your business.

For more information on how we can support your merger and acquisition activities, speak to one of our labeling and artwork experts today at enquiries@kallik.com or call +44 (0) 1827 318100. For more information on what Veraciti can do for your business, download our free brochure here. 
 

As businesses look ahead to 2025, one of the most significant trends reshaping the labeling and artwork industry is the rise of electronic Instructions for Use (eIFUs). With increasing regulatory demands, technological advancements, and a growing emphasis on sustainability, eIFUs are fast becoming a key solution for companies aiming to streamline their processes, improve customer experience, and reduce their environmental impact.

What Are IFUs and eIFUs?

In the healthcare and medical device industries, Instruction for Use (IFU) documents play a critical role in ensuring the safe and effective use of products. Traditional IFUs are physical paper-based manuals or leaflets that accompany medical devices, providing essential information on their operation, maintenance, and safety precautions.

You might see one with a medical device like a glucose meter. The IFU would typically be a printed booklet or leaflet included in the packaging. It would provide essential information such as setup instructions, how to use the device properly, maintenance tips, troubleshooting guidance, and safety precautions. The IFU might also include diagrams or images to illustrate the steps clearly, ensuring users can effectively operate the device and understand its features.

However, with the rapid digitization of information, electronic Instructions for Use (eIFUs) are emerging as a modern alternative. eIFUs are digital versions of these instructional documents that can be accessed online or through electronic devices, offering advantages such as easier updates, reduced environmental impact, and enhanced accessibility for users worldwide.

An eIFU can take various forms, such as a downloadable PDF, an interactive web-based guide, or a mobile application which might be accessed by scanning a QR code on the product packaging or an NFC tag embedded in the product itself. These formats offer users easy access to comprehensive product information, ensuring they can efficiently utilize the product. For example, a medical device manufacturer might use an eIFU for a complex surgical instrument. Surgeons can access the eIFU via a secure app on their tablets, where they find step-by-step instructions, video demonstrations, and troubleshooting tips. This digital format allows healthcare professionals to familiarize themselves with the device before procedures, enhancing safety and efficacy in clinical settings.

How Do eIFUs Work?

eIFUs are designed to be easily accessible to end-users, whether they’re professionals in healthcare settings or general consumers. Here’s how they typically work:

Digital Hosting: Companies host eIFUs on secure, compliant platforms—often accessible via a simple website or through a mobile app.

Access Points: End-users can easily access the information by scanning a QR code, visiting a URL, or tapping an NFC-enabled device.

Version Control: Unlike printed documents that may become outdated, eIFUs can be updated in real-time, ensuring users always have the latest information without needing to reprint and redistribute materials.

Multilingual Options: eIFUs allow companies to provide multiple language options seamlessly, often reducing the complexity and cost associated with printing different versions for different markets.

The Benefits of eIFUs

The switch to eIFUs is not just about staying ahead of the technology curve—there are tangible benefits that can directly impact a company’s bottom line and sustainability initiatives.

Cost Efficiency: Printing, shipping, and storing physical IFUs are expensive processes. By going digital, businesses significantly reduce these costs, freeing up resources for other areas of development.

Enhanced User Experience: eIFUs offer a superior user experience, as they are always accessible and easy to navigate. With built-in search functions, users can quickly find the specific information they need, saving time and improving product usability.

Regulatory Compliance: Many industries, particularly healthcare, have stringent requirements for product labeling. eIFUs allow companies to ensure compliance with these regulations by providing real-time updates and version control, minimizing the risk of distributing outdated or non-compliant instructions.

Customization and Personalization: eIFUs can be tailored to individual users’ needs, offering additional information or guidance based on specific use cases. This level of customization is difficult to achieve with printed materials but is easily manageable in a digital format.

eIFUs: A Powerful Tool for Sustainability

Sustainability is no longer just a buzzword—it’s a core business priority. Companies across industries are striving to meet ambitious sustainability goals, and eIFUs are playing a key role in this effort.

Reduced Paper Waste: Traditional IFUs often run multiple pages and are included with every product, generating significant amounts of paper waste. Switching to digital formats cuts down on this waste, aligning with broader corporate sustainability goals.

Lower Carbon Footprint: By eliminating the need for printing and shipping physical documents, companies reduce their carbon emissions. The process of producing and distributing printed materials requires substantial energy and resources, from paper production to transportation.

Minimized Resource Use: eIFUs require fewer resources overall, from raw materials (like paper and ink) to the energy used in the printing process. This resource minimization is crucial as businesses aim to reduce their environmental impact and move toward more circular, sustainable practices.

Why eIFUs Will Dominate in 2025

As we move toward 2025, eIFUs are poised to become one of the biggest trends in labeling and artwork management. The combination of regulatory demand, technological ease, and a global shift toward sustainability means more companies will be adopting this digital-first approach to product labeling. The healthcare and pharmaceutical sectors are already leading the charge, but industries ranging from consumer electronics to cosmetics are quickly recognizing the advantages.

Moreover, the increasing adoption of cloud-based systems, AI, and automation in labeling and artwork management will make the creation, distribution, and management of eIFUs even more efficient. Solutions like Veraciti, with its AI-powered automation tools, are making it easier than ever to integrate eIFUs into existing systems, ensuring businesses can stay ahead of the curve while also meeting sustainability objectives.

Get Ahead of the Curve

eIFUs are not just a fleeting trend; they represent a fundamental shift in how businesses approach product labeling. With their cost-saving, user-friendly, and sustainable benefits, eIFUs are set to redefine the labeling and artwork landscape in 2025 and beyond. Companies that embrace this transition will not only be meeting regulatory requirements and enhancing customer experience—they’ll also be playing their part in building a more sustainable future.

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

With tomorrow being Halloween, it's the perfect time to talk about some real-life labeling and artwork "horror stories" that have left companies facing consumer nightmares and costly recalls. But don’t worry—there’s no need to scream in terror! We’ll also explore how you can avoid these frightful errors by implementing end-to-end, cloud-based, automated solutions to keep your processes smooth and compliant.

Here are five real-life cautionary tales of companies who fell victim to labeling errors—and how they could have been avoided with the right technology:

1. Pharmaceutical Dosage Disaster

In 2003, Pfizer faced a major issue with the hormone replacement therapy drug Prempro due to labeling problems that resulted in miscommunication about dosage and instructions. This labeling failure led to confusion among patients and healthcare providers, contributing to adverse health effects and subsequent legal actions. The incident eventually culminated in a large settlement, as Pfizer was accused of providing unclear or incorrect dosage details that heightened health risks for users, and the legal repercussions continued over the years as additional safety concerns related to the drug surfaced.

The legal battles Pfizer faced regarding Prempro included a larger settlement in 2011, amounting to over $330 million, when they resolved around 2,200 cases that alleged links between Prempro and increased risks of breast cancer. This case emphasized the serious consequences of inadequate labeling in the pharmaceutical industry, where even minor inaccuracies can lead to significant patient health risks and liability concerns for companies.

2. Leading Supermarket’s Allergen Labeling Fail

The 2015 Tesco allergen labeling incident involved a mislabeled batch of crisps that posed a serious risk to consumers with dairy allergies. A package of cheese and onion crisps was incorrectly labeled as salt and vinegar, omitting the presence of milk allergens. The oversight, part of Tesco's "Free From" range that caters to people with food allergies and dietary restrictions, exposed customers to potential allergic reactions, prompting the company to issue a recall and eventually resulting in a £300,000 fine from the Westminster Magistrates’ Court. The court emphasized the gravity of the incident, highlighting the responsibility of major retailers to ensure rigorous allergen labeling to protect consumers' health.

3. Cereal Manufacturer’s Peanut Residue Recall

In 2016, Kellogg’s recalled about 10,000 cases of its Keebler and Famous Amos cookies due to undeclared peanut residue. This oversight, traced to a flour supplier, posed serious risks to consumers with peanut allergies, who could suffer severe reactions from exposure. The affected products included several types of cookies, such as Keebler’s Animals Crackers and Famous Amos Double Chocolate Chip cookies. This widespread recall emphasized the importance of thorough allergen checks and clear labeling in the food industry. Although no illnesses were reported, the incident served as a strong reminder of the critical role accurate labeling plays in protecting consumer health​.

4. Frozen Meals Mislabeling

In 2017, Conagra Foods issued a significant recall on its Healthy Choice Power Bowls due to a dangerous labeling error. The meals, labeled as Korean-Style Beef, actually contained a chicken sausage and pepper product that included milk—an allergen not declared on the packaging. This posed a serious risk for those with dairy allergies, prompting the USDA to classify it as a Class I recall, indicating the potential for serious health consequences. Fortunately, no adverse reactions were reported before the recall went public​.

5. Packaging Pains at Leading Consumer Healthcare Manufacturer

In 2008, a leading consumer healthcare manufacturer recalled approximately 5 million bottles of its painkiller tablets. The recall was initiated after it was discovered that the labels failed to specify the presence of certain allergens, which could pose risks to individuals with allergies. The labeling error was significant enough to warrant a recall to prevent potential adverse health effects.

Labeling Nightmares Like These Can be a Thing of the Past with End-to-End Cloud-Based Solutions

Labeling mistakes like these happen when teams rely on disconnected, siloed processes or outdated manual checks. But it doesn’t have to be this way! AI and automation play a key role in preventing human error by flagging discrepancies and automatically checking regulatory compliance. Meanwhile, cloud-based platforms mean better collaboration—no more passing around versions via email and risking outdated or incorrect artwork slipping through the cracks. Ultimately though, it’s all about using an end-to-end solution, eliminating siloes and communication issues between stakeholders. By managing the entire process in one single solution, you are greatly reducing the risk of errors in your labeling and artwork, something which could not only save a lot of money, but also potentially save lives.

Key Benefits of End-to-End Cloud-Based Software:

AI-Backed Automation: Automated checks and regulatory compliance built into the process prevent costly human errors.

No Silos: A centralized platform allows all teams, from regulatory to marketing, to collaborate in real-time, ensuring the correct version of labels and artwork is used.

Version Control: Every update is tracked, and no outdated versions are used.

Real-Time Collaboration: Cloud-based systems allow teams across different locations and time zones to work together seamlessly.

Kallik’s Veraciti: Your Savior from Labeling Nightmares

At Kallik, our Veraciti platform does all this and more. Built specifically for labeling and artwork management, Veraciti ensures regulatory compliance, streamlines processes, and prevents costly errors. With AI-backed tools and end-to-end cloud-based workflows, Veraciti keeps your teams in sync, your artwork flawless, and your labels always accurate.

This Halloween, don’t let your labeling process turn into a horror story—equip your team with the tools they need to succeed. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

Navigating mergers and acquisitions can be an overwhelming process, especially for global organizations dealing with complex product portfolios. The stakes are high, with challenges ranging from integrating diverse labeling systems to ensuring regulatory compliance and managing intricate audit processes. Missteps in these areas can lead to costly delays and serious risks. However, with the right strategies and tools in place, these challenges can be transformed into opportunities for seamless integration and growth.

To help organizations navigate these complexities, we’re excited to introduce our new guide, "Navigating Labeling Challenges Through Mergers and Acquisitions." This comprehensive guide offers expert advice and practical tips to simplify the process, specifically tailored for large, global enterprises facing the daunting task of product integration.

Key Challenges in Mergers and Acquisitions

Mergers and acquisitions often reveal significant hurdles when it comes to labeling and artwork integration. These challenges are particularly pronounced in large organizations that may need to manage thousands of labels across various SKUs. Issues such as misaligned labeling systems, non-compliance with regulatory standards, and inefficient manual processes can derail timelines and inflate costs. Our ebook explores these common pitfalls and offers actionable strategies to overcome them, ensuring a smooth and successful integration process.

What You’ll Learn in the Guide

Our guide is divided into three parts:

1. Preparing for a Smooth Merger or Acquisition:
  - Harmonization: Align processes, cultures, and systems to create a unified operation.
  - Standardization: Implement uniform practices and technologies to streamline operations and reduce complexity.
  - Single Source of Truth: Establish a centralized, authoritative data repository to eliminate confusion and ensure data integrity.

2. Choosing the Right Labeling and Artwork Partner:
  - Centralized Management: Oversee the entire labeling process across global locations with real-time collaboration.
  - Automation and AI: Leverage automation and AI to increase accuracy, reduce manual effort, and accelerate time-to-market.
  - Cloud-Based Solutions: Ensure 24/7 support and scalability to accommodate growing product lines and evolving regulatory requirements.
  - Advanced Quality Control: Implement robust quality control and approval processes to minimize errors and ensure compliance.
  - Sustainability: Integrate eco-friendly processes to reduce waste and meet regulatory demands.

3. How Veraciti Can Revolutionize Your Integration Process:
  - Learn how Veraciti, with over 20 years of cloud-based expertise, is transforming the mergers and acquisitions landscape with cutting-edge features like Automated Artwork Generation (AAG), AI-driven migration tools, and 24/7 global support.

Why Download our Guide?

If you’re leading a merger or acquisition in a complex, global organization, this guide is a must-read. It’s packed with insights that will help you:

- Avoid Common Pitfalls: Learn from the challenges others have faced and avoid costly mistakes.
- Maximize Efficiency: Discover how to streamline processes and accelerate time-to-market.
- Ensure Compliance: Stay ahead of regulatory requirements with advanced quality control and centralized management.

Ready to Simplify Your Merger or Acquisition Process? Download the Guide Now 

For more information on how we can support your merger and acquisition activities, speak to one of our labeling and artwork experts today at enquiries@kallik.com or call +44 (0) 1827 318100.