Cardinal Health’s Journey to a More Connected Global Labeling Model

A label can seem like one of the smallest parts of a product launch until it becomes the thing slowing everything down and keeping you up at night. In regulated healthcare, labeling touches compliance, manufacturing, supply chain, quality, speed to market, and patient safety. For Cardinal Health, that reality helped drive a clear shift: labeling could no longer be treated as a local factory or warehouse process. It needed to become an enterprise asset.

Pete Jenny, Vice President of IT, Global Operations and Supply Chain at Cardinal Health, discussed this shift during Kallik’s publicly available webinar with MedTech Intelligence, which you can watch here. Reflecting on Cardinal Health’s labeling transformation, he explained: “We need to really start treating this as an enterprise asset rather than a warehouse or factory asset.”

Pharmaceutical environment


The Challenge


With operations spanning 30 plants and 50 distribution centers worldwide, Cardinal Health was managing labeling across a complex global footprint. The organization had six disparate labeling systems, many of which were outdated or no longer supported. As product portfolios expanded and regulatory demands increased, these disconnected systems created unnecessary friction.

Manual processes made label changes more time-consuming and limited standardization made it harder to maintain consistency across regions, sites, and product lines. Without a centralized repository, teams had less visibility into labeling assets, changes, and reuse opportunities.

Cardinal Health needed a scalable, enterprise-wide approach that could support global operations while making everyday labeling work faster, more controlled, and easier to manage.


The Kallik Solution


Cardinal Health partnered with Kallik to implement Veraciti™, Kallik’s cloud-based labeling and artwork management platform. The goal was to move away from fragmented local systems and toward a unified global platform that could centralize labeling assets, automate key processes, and support long-term transformation.

Kallik provided Cardinal Health with a centralized repository for labeling content and assets, helping teams access, manage, and move labels more easily across sites. Template automation helped reduce manual input and improve consistency, while the SaaS model offered the flexibility and scalability needed for a global enterprise environment.

The implementation also addressed one of the most challenging parts of labeling transformation: migration. Kallik worked with Cardinal Health to develop an automated approach for converting labels from one system to another, helping reduce migration effort and accelerate the move to a modern platform.

As Pete shared in the webinar: “Kallik really partnered with us and helped us come up with an automated way of converting the labels from one system to another.”

medical devices


The Results


By centralizing labeling and artwork management through Veraciti™, Cardinal Health has been able to create a more connected, consistent, and efficient labeling environment.

Pete described the impact clearly in the webinar: “We’ve been able to increase the amount of reuse that we have in labels. We have improved our overall timeframe to design and develop labels. But I think the biggest thing that we have is the access to the central repository of labels and that we can move labels from one plant to another plant kind of seamlessly.”

That ability to reuse and transfer labels across plants is especially valuable in a global operation. Instead of recreating work or managing updates in multiple disconnected systems, teams can work from a shared foundation. This supports faster label development, more consistent content, and greater control across the labeling lifecycle.

Kallik’s platform also helps Cardinal Health respond more efficiently to regulatory change. With centralized data, automated workflows, and improved visibility, updates can be managed with greater speed and confidence than was possible through legacy systems. Reducing manual input also helps minimize the risk of errors.


Business Benefits


Through working with Kallik, Cardinal Health has strengthened labeling and artwork management across several key areas: improved label reuse, faster design and development timelines, centralized access to labeling assets, greater consistency across regions and facilities, reduced reliance on outdated legacy systems, and improved visibility, traceability, and control.


A Partnership Approach


For Cardinal Health, the decision to work with Kallik was not only about platform functionality. It was also about finding a partner that could support a long-term transformation journey.

“Kallik really came at it from a partner standpoint and really has worked well with partnering with Cardinal,” Pete said in the webinar. “These journeys are over time and you really want an organization that will partner with you and adjust as things go forward. And then finally, the SaaS cloud nature of it is why we picked it.”

That partnership approach has helped Cardinal Health move toward a more standardized, automated, and scalable labeling model – one that treats labeling as a strategic enterprise capability, not just a local operational task.

Medical devices


Want to Know More?


Cardinal Health’s experience shows what is possible when labeling is managed as a connected enterprise process. For global health care and medical device organizations facing complex regulatory requirements, disconnected systems, and growing product portfolios, a centralized cloud-based platform can help improve control, reduce manual effort, and support faster, more confident change.

To learn how Kallik can help your organization modernize labeling and artwork management, speak to one of our experts today on +44(0) 1827 318100 or email enquiries@kallik.com. For further information on our leading, end-to-end, global label and artwork management software, read the brochure below or click here

Medical device in pharmaceutical environment

Streamlining Your Artwork Management Process

Artwork management is a crucial process in many industries. It involves organizing, approving, and distributing artwork files.

In pharmaceuticals, this process is vital due to strict regulations. Packaging and labeling must meet precise standards. An effective artwork management system can streamline these tasks. It provides a centralized platform for collaboration and reduces errors.

Key roles include project managers, graphic designers, and regulatory specialists. Each plays a part in ensuring compliance and efficiency. Understanding artwork management can lead to cost savings and improved time-to-market, so let's explore how to streamline this essential process.

What Is Artwork Management?

Artwork management involves the efficient handling of artwork files. It's essential for producing consistent and compliant packaging across various industries. This process includes organizing, reviewing, and approving artwork. It ensures that designs meet brand guidelines and regulatory standards.

Key components of artwork management include:

  • Creation of artwork files
  • Review and approval processes
  • Distribution of final artwork

An artwork management system streamlines these processes. It provides a centralized platform, improving collaboration and reducing errors. Such systems are particularly beneficial in the pharmaceutical industry. Here, strict regulations demand precise and accurate artwork management.

In summary, artwork management plays a critical role in ensuring quality and consistency. It impacts both brand perception and regulatory compliance.

Why Artwork Management Matters in Pharmaceuticals

Artwork management is crucial in the pharmaceutical industry. Strict regulations govern the packaging and labeling of products. These regulations require precision in presenting the necessary information.

Ensuring compliance and accuracy is vital. A single mistake can lead to significant consequences, including legal issues. Miscommunication or errors in artwork could result in costly recalls.

Key reasons artwork management is vital include:

  • Meeting regulatory standards
  • Ensuring clear and accurate labeling
  • Avoiding costly product recalls

The pharmaceutical sector benefits from efficient artwork management. It minimizes risk and supports compliance with evolving regulations.

pharmaceutical pill bottles

Key Roles in the Artwork Management Process

The artwork management process requires a collaborative effort. Several key roles are essential for success. Each role brings specific expertise and responsibilities.

Project managers oversee the entire process. They ensure timelines are met and resources are used efficiently. Their coordination is crucial for smooth workflow execution.

Graphic designers create and adapt artwork. They must translate branding and regulatory details into visually compliant designs. Accuracy and creativity are both vital in their work.

Regulatory affairs specialists play a critical role. They ensure all artwork complies with industry standards. Their insight helps navigate complex legal requirements.

Key roles in artwork management include:

  • Project Managers
  • Graphic Designers
  • Regulatory Affairs Specialists
  • Quality Assurance Teams

Quality assurance teams focus on error prevention. They review the artwork for compliance and accuracy. Their work mitigates risks and ensures product integrity.

The Artwork Lifecycle: Stages and Workflows

Artwork lifecycle management is a multi-stage process. Each stage requires specific actions and stakeholders. A clear understanding of these stages enhances efficiency.

The creation phase involves conceptualizing and designing the artwork. Graphic designers collaborate with branding teams here. Their goal is to ensure consistency and compliance from the start.

Next is the review stage. Stakeholders such as regulatory affairs specialists assess the artwork for adherence to standards. This phase includes feedback and revisions to perfect the design.

Once reviewed, the approval stage follows. This involves multiple sign-offs from different departments. The approval process is crucial to confirm all regulatory and brand requirements are met.

After approval, distribution occurs. The final artwork is shared with relevant stakeholders, and production begins. This step ensures that the approved designs are used in packaging or labeling.

Key stages in the artwork lifecycle include:

  • Creation
  • Review
  • Approval
  • Distribution

Proper workflow within these stages promotes streamlined processes. Each step builds on the last, ensuring the final product is flawless.

Common Challenges in Artwork Management

Artwork management presents several challenges. These obstacles can delay projects and increase errors. Understanding them is vital for finding solutions.

One key challenge is miscommunication among teams. Inadequate communication can lead to design errors and wasted resources. Misunderstandings can cause significant project setbacks.

Another common issue involves version control. With numerous revisions, managing the latest version becomes difficult. It often results in outdated designs being mistakenly used.

Regulatory compliance is also a critical hurdle. Industries like pharmaceuticals face strict guidelines. Ensuring compliance while maintaining quality is often complex.

Challenges often include:

  • Miscommunication
  • Version control issues
  • Regulatory compliance hurdles

Addressing these challenges requires proactive strategies. Enhanced collaboration and technology can mitigate these obstacles effectively.

pharmaceutical pills in packet

How Artwork Management Systems Streamline the Process

Artwork management systems offer a comprehensive solution. They centralize all artwork-related activities, creating a cohesive workflow. This reduces miscommunication and ensures all team members are on the same page.

These systems enhance collaboration through shared platforms. Teams access the same files, minimizing the confusion of outdated versions. This unified approach helps maintain the integrity of projects.

Automation plays a critical role in these systems. Many repetitive tasks like file uploads and approval requests are automated. This feature decreases manual errors and speeds up the process.

Key benefits include:

  • Centralized platforms
  • Improved collaboration
  • Automation of tasks

These systems can integrate with other enterprise tools. Such integration further improves efficiency and data management. Thus, implementing an artwork management system can be a game-changer.

Best Practices for Effective Artwork Lifecycle Management

Effective artwork lifecycle management requires structured approaches. Regular audits ensure high-quality and compliant artwork. Consider establishing clear protocols for each stage of the lifecycle.

Communication is vital. Foster open channels among teams to minimize errors. This practice enhances understanding and promotes a cohesive workflow.

Implementing regular training sessions keeps teams updated on new tools and processes. This effort boosts productivity and efficiency.

Key practices to adopt include:

  • Conduct regular audits
  • Encourage open communication
  • Provide ongoing training

Adhering to these practices can significantly enhance the management process. It ultimately leads to better outcomes and fewer errors.

The Future of Artwork Management: Trends and Technology

Artwork management is evolving rapidly with technology. AI and machine learning are optimizing workflows. They help automate tasks and identify issues.

Emerging trends focus on digital platforms and integration. These advancements enhance accuracy and efficiency. Staying ahead requires awareness of new developments.

Key trends include:

  • AI and machine learning integration
  • Enhanced digital platforms
  • Increased automation and efficiency

Embracing these trends ensures a competitive edge in artwork management. Adapting to technological changes is crucial for future success.

Conclusion: Building a Streamlined Artwork Management Process

Creating an efficient artwork management process requires careful planning. Implementing digital tools and clear workflows are essential steps. These efforts ensure accuracy and speed.

Regular training and collaboration further enhance effectiveness. Adapting to new technologies keeps teams ahead. A streamlined process saves time and reduces costs. Ultimately, it secures a competitive advantage in the market.

Want to Go Deeper into Global Labeling Readiness?

If you’re navigating increasing regulatory complexity, evolving global requirements, or growing pressure to scale faster without increasing risk, our latest research can help.

Download our free white paper, Kallik’s 2026 Global Labeling Readiness Report, to explore how global manufacturers are preparing for the future of product labeling, where common gaps still exist, and what leading organizations are doing differently.

So, how confident are you that your labeling processes are ready for what comes next? Speak to one of our labeling and artwork experts today to find out more. Fill in a form, email enquiries@kallik.com or check out our case studies to see real-world examples of how we’ve helped some of the biggest global manufacturers.

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Frequently Asked Questions About Artwork Management

What is artwork management in pharmaceuticals?

Artwork management in pharmaceuticals is the process of creating, reviewing, approving, and controlling packaging and labeling files for regulated products. It ensures all artwork is accurate, compliant, and aligned with both brand standards and health authority requirements.

Why is artwork management so important for pharmaceutical packaging?

Artwork management is critical because pharmaceutical packaging must meet strict regulatory rules. Even small errors in dosage instructions, ingredient lists, or safety warnings can lead to serious consequences, including product recalls or compliance violations.

What types of files are included in artwork management?

Artwork management typically covers all packaging and labeling assets, such as:

  • Cartons and box designs
  • Bottle and blister pack labels
  • Patient information leaflets
  • Multilingual packaging variations
  • Regulatory-approved templates

Managing these files correctly helps prevent outdated or incorrect versions from being used.

What is the difference between artwork management and document management?

Document management focuses on storing and organizing general business documents. Artwork management is more specialized and includes structured workflows for design review, version control, approvals, and regulatory compliance, especially for packaging materials.

Who is involved in the artwork management process?

Artwork management requires collaboration across multiple teams, including:

  • Project managers
  • Graphic designers
  • Regulatory affairs specialists
  • Quality assurance teams
  • Packaging and production teams

Each group plays a role in ensuring artwork is correct, compliant, and ready for production.

What are the biggest challenges in artwork lifecycle management?

Common challenges include:

  • Miscommunication between teams
  • Version control issues across revisions
  • Delays in approvals
  • Regulatory compliance complexity
  • Manual processes that increase the risk of error

An effective system helps reduce these risks.

How does an artwork management system improve efficiency?

An artwork management system streamlines the entire process by providing a centralized platform for file storage, automated approval workflows, and real-time collaboration. This reduces errors, speeds up approvals, and improves time-to-market.

How does artwork management help with regulatory compliance?

Artwork management supports compliance by ensuring only approved content is used, changes are tracked, and audit histories are available for inspections. This is especially important in industries like pharmaceuticals.

What is version control in artwork management?

Version control is the process of tracking every update made to an artwork file. It ensures teams are always working from the most current version and prevents outdated packaging designs from reaching production.

Can artwork management reduce the risk of product recalls?

Yes. Many pharmaceutical recalls are caused by labeling or packaging errors. A strong artwork management process reduces this risk by improving accuracy, enforcing approvals, and catching issues before printing or distribution.

What should companies look for in an artwork management solution?

Key features to prioritize include:

  • Centralized file management
  • Automated review and approval workflows
  • Regulatory compliance support
  • Role-based access controls
  • Integration with enterprise systems
  • Strong reporting and audit trails
How is technology shaping the future of artwork management?

New technologies such as AI, automation, and cloud-based collaboration are transforming artwork management. These tools help companies reduce manual work, detect errors earlier, and streamline complex approval processes.

What You Need to Know About ePI in Pharmaceutical Labeling

What You Need to Know About ePI in Pharmaceutical Labeling
Kallik Role 1
Content Manager
Blog Related to Industry Page

The pharmaceutical world is standing on the brink of a major transformation. The move toward electronic Product Information (ePI) is gathering pace, replacing static, printed inserts with digital, structured content that can be updated, accessed, and shared more easily.

When the Kallik team recently attended the Pharma Packaging & Labeling Innovation Forum in Berlin, it became clear that ePI has become one of the most discussed topics in the industry. For those of us working in labeling, artwork, and regulatory content, it’s not just another compliance change. It’s a complete rethinking of how medical information is created, controlled, and delivered.

What Does ePI Really Mean?

Electronic Product Information uses the same regulated content we already produce, such as the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and labeling details, but it is delivered in a digital and structured format.

Rather than distributing these materials as PDFs or Word files, ePI enables approved content to be published digitally through QR codes on packaging, online portals, or even directly integrated into healthcare IT systems. The European Medicines Agency (EMA) has already piloted ePI submissions to test how this approach can work in practice.

In essence, ePI doesn’t change what we say, but how we say it. It’s a smarter way of storing, managing, and sharing critical medicine information with patients and healthcare professionals.

Why ePI Is Gaining Momentum

Several forces are driving this shift. Regulators are keen to modernize the management of medical information, aiming to make it more accessible, responsive, and sustainable. With ePI, updates can go live almost immediately after approval, eliminating the delays associated with print runs or re-packaging.

For patients, ePI means easier access to accurate and up-to-date information. It can support larger fonts, multiple languages, or even audio for visually impaired users. For healthcare professionals, it ensures they always have access to the most current version of a product’s information.

The move to digital also supports environmental goals, cutting paper use and waste. Most importantly, ePI allows product information to connect with wider healthcare systems, creating a bridge between regulatory content and the digital health ecosystem.

How Does ePI Impact Labeling and Packaging?

The introduction of ePI will significantly reshape how labeling and packaging content is managed. Traditional labeling relies on static documents that are updated manually. ePI, however, uses structured and reusable content components, allowing for faster updates and greater consistency across regions and formats.

This new approach means that updates to product information must appear instantly and consistently across both printed and digital versions. Achieving that requires tighter integration between content management, artwork, and packaging systems, as well as robust version control and validation processes.

Packaging design will also evolve. Many products will soon include QR codes that link directly to the approved digital leaflet. Designers will need to consider placement, readability, and verification to ensure those links always direct users to the correct version.

During the transition, organizations will likely need to maintain both digital and paper versions, which adds complexity but also creates opportunities to streamline processes and improve overall content governance.

What Are the Main Challenges With ePI?

It’s clear there are many benefits to ePI, but it’s no secret that there are some concerns among professionals in the industry about the challenges ePI will bring. 

  1. Regulatory adoption is uneven across regions, and companies worry about inconsistent standards and timelines. Many organizations still rely on legacy document systems, making it difficult to convert years of labeling content into structured, digital formats.
  2. There are also concerns about validation and compliance. Digital systems must meet the same regulatory standards as printed labeling, including audit trails and data integrity.
  3. Accessibility remains another key issue, as not all patients have access to digital devices or reliable internet connections.

These are valid concerns, but it’s important to understand that these are not reasons to delay as the benefits significantly outweigh these challenges, which can be overcome with the right preparation and the right software. The transition to ePI will take time, but early adopters will have a significant advantage in building compliant, future-proof labeling systems.

What This Means for Kallik and Our Clients

At Kallik, we’ve always believed labeling is more than artwork creation. It’s about accuracy, compliance, and patient safety. ePI reinforces that view by placing data integrity and content control at the heart of labeling operations.

To prepare, pharmaceutical companies will need to adopt structured content management, ensuring that every label, leaflet, and artwork version originates from a single source of truth. They will also need to integrate digital validation processes to maintain accuracy across printed and electronic formats.

For Kallik and our clients, ePI presents an opportunity to move beyond traditional labeling workflows toward truly connected, data-driven systems. Our experience in automating labeling and artwork approval processes puts us in a strong position to guide companies through this evolution.

How to Start Preparing for ePI

Preparing for ePI begins with understanding where your product information lives and how it moves through your organization. From there, you can assess which systems and processes need to evolve to support structured content and digital publishing.

Running small-scale pilot projects is a practical way to explore ePI-linked packaging or QR code validation while identifying any gaps in workflow or technology. Training teams across regulatory, artwork, and packaging functions will also be vital to ensure everyone understands the implications of the shift.

The transition will not happen overnight, but the direction of travel is clear. Organizations that start now will be far better prepared for when ePI becomes the industry standard.

The Future of Labeling Is Digital

The move to electronic Product Information marks a defining moment for pharmaceutical labeling. It promises faster updates, more accessible information, and improved sustainability. It will also redefine how companies approach compliance and collaboration across departments.

Kallik is ready to support this transformation. Our technology, expertise, and deep understanding of regulated content make us a trusted partner for organizations looking to modernise their labeling operations and prepare for an ePI-enabled future.

Ready to begin your ePI journey?

Interested in learning how Kallik helps organizations achieve complete regulatory compliance with zero errors and total consistency? Contact us here or check out our case studies to see real-world examples of how we've helped some of the biggest global manufacturers.

Read our FREE digital transformation guide

We're Giving Away Five Amazon Vouchers for Answering our 2025/2026 Labeling Survey!

We’re currently running a short industry survey on labeling and artwork challenges for 2026, and we’d really appreciate your input! Your insights could help shape our upcoming 2026 industry report. If you can spare five minutes, take the survey and enter our draw for one of five $/£50 Amazon vouchers. 

Fill in the survey

What Are GS1 Standards And Why They’re Critical for Labeling

Today’s global and digital economy depends on clear product identification and easy information sharing. For regulated industries such as pharmaceuticals, medical devices, and cosmetics, this isn’t just about efficiency, but also patient safety, compliance, and trust. That’s where GS1 standards come in, so let's break down what they are, why they matter and how they affect labeling and artwork management.

Understanding GS1 Standards

GS1 is a global, not-for-profit organization that develops and maintains standards for business communication. Its most widely recognized standard is the barcode, but GS1 standards go far beyond that — they provide a universal language for identifying products, locations, assets, and logistics units throughout the supply chain.

Some of the most common GS1 identifiers include:

  • GTIN (Global Trade Item Number): Identifies individual products or SKUs.
  • GLN (Global Location Number): Identifies physical locations or legal entities (e.g., manufacturing plants, warehouses).
  • SSCC (Serial Shipping Container Code): Identifies logistics units like pallets or cases.
  • GS1 DataMatrix and QR Codes: Encode rich, structured data (such as expiry dates or batch numbers) in a compact format.

Together, these identifiers enable traceability, interoperability, and data accuracy across every participant in a global supply chain — from manufacturer to regulator to end user.

Why GS1 Standards Matter for Regulated Industries

In highly regulated sectors, the correct use of GS1 identifiers is a necessity for complete compliance and the safety of all involved. Here are some of the most important things to understand:

1. Ensuring Traceability and Patient Safety
Every product must be traceable from production to patient. GS1 standards underpin systems that track each unit’s journey, allowing for quick recalls, expiry management, and counterfeit prevention. For example, under the EU Falsified Medicines Directive (FMD) or the U.S. DSCSA (Drug Supply Chain Security Act), serialization using GS1 identifiers ensures that every package can be uniquely identified and verified.

2. Supporting Regulatory Requirements
Regulators across the world, including the FDA, EMA, and MHRA, endorse GS1 standards for labeling and serialization. Using GS1 data structures correctly is vital to meet UDI (Unique Device Identification) and pharmaceutical labeling mandates.

3. Driving Global Interoperability
Because GS1 standards are recognized globally, they simplify cross-border operations and ensure data consistency between trading partners, healthcare providers, and regulators. This is particularly important for multinational organizations operating under different regulatory regimes.

4. Reducing Risk Through Standardization
Using standardized identifiers minimizes the risk of labeling errors, which can have serious consequences — from product recalls to regulatory fines and, in worst cases, patient harm. GS1’s globally harmonized system ensures every product carries accurate, meaningful information.

The Role of Labeling and Artwork Management Software

Implementing GS1 standards demands robust systems and processes that manage product data, control artwork, and maintain compliance at every stage. This involves:

1. Data Integrity and Centralization
Modern labeling and artwork management platforms, such as Kallik’s, centralize master data and ensure that GS1 identifiers (like GTINs or GLNs) are accurate, validated, and consistently applied. This eliminates the risk of using outdated or incorrect codes during label design.

2. Automation and Rule-Based Compliance
Automation ensures that GS1 identifiers and barcode structures are applied correctly across thousands of SKUs. Rule-based workflows verify data at every stage, so compliance is baked into the process rather than checked after the fact.

3. Visibility and Auditability
Regulated industries must be able to demonstrate compliance during audits. A digital artwork and labeling system provides full version control, approval workflows, and audit trails, ensuring every label change can be tracked back to its source.

4. Adaptability to Change
As GS1 standards evolve (for example, the transition to 2D barcodes and GS1 Digital Link), flexible labeling systems allow organizations to adapt quickly without disrupting supply chains or re-engineering entire labeling templates.

The Bottom Line: Compliance Starts with Standards

GS1 standards are the foundation of trust and traceability in regulated industries. But compliance depends on the right tools to enforce them at scale. By integrating GS1 principles into labeling and artwork management software, organizations can ensure that every product label not only meets global regulatory requirements but also delivers on its ultimate purpose: protecting patients, consumers, and brands alike.

Interested in learning how Kallik helps organizations achieve complete regulatory compliance with zero errors and total consistency? Contact us here or check out our case studies to see real world examples of how we've helped some of the biggest global manufacturers.

Read our FREE digital transformation guide

We're Giving Away Five Amazon Vouchers for Answering our 2025/2026 Labeling Survey!

We’re currently running a short industry survey on labeling and artwork challenges for 2026, and we’d really appreciate your input! Your insights could help shape our upcoming 2026 industry report. If you can spare five minutes, take the survey and enter our draw for one of five $/£50 Amazon vouchers.

Fill in the survey

Trends Shaping the Future of Labeling: Key Insights from Recent Pharma and Med Device Events

Trends Shaping the Future of Labeling: Key Insights from Recent Pharma and Med Device Events
Kallik Role 1
Content Manager

At Kallik, we pride ourselves on staying close to the challenges, conversations, and innovations shaping the future of labeling and packaging. That means more than just keeping up with industry news, but being part of the dialogue.

In recent weeks, two of our team members represented Kallik at major industry events: Kallik’s Chief Delivery Officer, Beth Peckover, attended the 14th Pharma Packaging and Labeling Innovation Forum in Berlin, while Senior Vice President of Sales, Sharad Khusal, joined the virtual Q1 Productions 16th Semi-Annual Medical Device & Diagnostic Labeling Conference.

Both events offered a wealth of insight into where the pharmaceutical and medical device sectors are heading and what that means for labeling, artwork, and packaging operations. Below, we recap the major themes that emerged and look at how to stay one step ahead.

The Big Talking Point: ePI and the Digital Transformation of Labeling

One of the most prominent topics at the Berlin forum was electronic Product Information (ePI). As Beth shared, ePI was the subject of multiple discussions and presentations, and it’s clear why.

ePI represents the digital evolution of medical information, where product leaflets, patient information, and label content are made available electronically, typically via QR codes or online portals. The European Medicines Agency (EMA) is leading the way with pilot programs exploring how this digital approach can improve patient access, enable faster updates, and support more sustainable, paperless labeling.

While the concept may sound straightforward, the implications for labeling and artwork are significant. ePI requires content to be managed in structured, modular formats rather than as static documents. Every change, whether a dosage update or a new safety warning, needs to be reflected instantly across both printed and digital formats.

That demands a high level of content agility, data accuracy, and process integration. For artwork and labeling teams, this means rethinking how they manage product information: moving from manual updates to centralized, automated systems that ensure every label, leaflet, and QR code is perfectly in sync.

As the industry transitions toward digital-first product information, companies will need to strike a careful balance between compliance, accessibility, and user experience. At Kallik, we see this as a huge opportunity for organizations to modernize their labeling operations, reduce risk, and streamline updates, while ensuring the same quality and consistency across every channel.

Pharma Supply Chain Pressures and the Need for Agility

Another major theme Beth noted at the Berlin event was the growing challenge of supply chain disruption in the pharmaceutical industry. Shortages of key materials and ingredients are forcing companies to source from alternative suppliers at short notice.

That might sound like a procurement issue, but it has deep implications for packaging and labeling. When suppliers or components change, the product specifications often change too. This ultimately means labels and artwork must be adapted quickly to reflect new details, batch information, or manufacturing locations.

This is where agility in packaging and labeling becomes critical. Companies that rely on manual updates, spreadsheets, or disjointed approval processes risk significant delays, inconsistencies, and even compliance breaches.

The takeaway from the forum was clear: businesses need flexible, responsive labeling systems that can handle change efficiently. Whether that’s updating artwork across multiple SKUs or localizing information for different markets, agility must be built into the process and not bolted on as an afterthought.
Beth comments on this, “At Kallik, we’ve long emphasized the importance of flexibility. True agility in labeling comes from centralized data, automation, and digital collaboration, allowing changes to cascade instantly across all materials while maintaining full traceability and compliance.”

Medical Device Labeling: Integration, Security, and Global Flexibility

Meanwhile, over at the Q1 Productions event, Sharad found that the conversations around medical device labeling echoed similar themes of agility and digital maturity.

One key area of interest was interoperability: the ability for labeling content to integrate seamlessly with other systems. Delegates were particularly keen to understand how digital labeling solutions can support standardized data formats and integrations with enterprise systems such as PLM, ERP, and regulatory databases.

This reflects a growing recognition that labeling no longer operates in isolation. To achieve efficiency and compliance at scale, it must connect directly to the systems that feed it data to ensure a single, authoritative source of truth.

Sharad shares, “Following my presentation, I received questions about the types of label formats supported by modern labeling platforms, especially around flexibility and customization.” Many companies face the challenge of managing region-specific label variations to meet different country regulations and language requirements. This is why it’s crucial to use a platform that can handle this diversity while still maintaining consistency and control.

Another recurring topic was cybersecurity. As more labeling operations move to the cloud, delegates were rightly concerned about data protection, malicious attacks, and the safeguarding of intellectual property. The message from attendees was clear: labeling vendors must not only deliver flexibility and integration but also ensure that cloud-based environments meet the highest security standards.

A Clear Message: The Industry Wants Confidence and Control

Across both conferences, the common thread was unmistakable. Whether it’s ePI in pharma, supply chain agility, or digitized labeling in the medical device space, organizations are looking for confidence and control. They want systems that allow them to adapt quickly, maintain compliance, and collaborate securely without sacrificing quality or speed.

It’s encouraging to see the industry aligning around these priorities. As labeling becomes more interconnected with wider digital ecosystems, the focus is shifting from reactive problem-solving to proactive transformation. Businesses are looking not just to comply with regulations but to future-proof their labeling operations for the next wave of change.

How Veraciti™ Supports This Digital Labeling Future

These are exactly the challenges that Veraciti™, Kallik’s enterprise labeling and artwork management platform, was built to solve. Veraciti™ provides a single, centralized hub for managing labeling content across all markets, products, and packaging types.

It enables full traceability, ensuring every change is controlled, approved, and published accurately. With automated workflows, content reuse, and structured data management, Veraciti™ gives organizations the agility they need to respond to supply chain changes, regulatory updates, or global variations without introducing risk.

Its cloud-based architecture offers the highest levels of security and scalability, allowing global teams to collaborate in real time while protecting sensitive information. And as the industry moves toward digital standards such as ePI, Veraciti™ is ready and supporting structured content formats and integrations that will help companies transition confidently into the digital labeling era.

Looking Ahead

The conversations at both conferences reinforced what we already know: the pace of change in pharmaceutical and medical device labeling is accelerating. New regulations, digital standards, and supply chain challenges are rewriting the rules - but they’re also opening the door to smarter, more efficient ways of working. At Kallik, we’re proud to be ahead of the game with this, offering some of the world’s largest organizations the solution to all their labeling and artwork needs, all in one single, cloud-based platform.

If you’d like to learn more about how Veraciti™ can help your organization adapt to these industry shifts, get in touch with our team by calling +44 (0) 1827 318100 or emailing enquiries@kallik.com.

The Top 5 Labeling Challenges Pharma Companies Must Solve in 2025 — And How to Overcome Them

The Top 5 Labeling Challenges Pharma Companies Must Solve in 2025 — And How to Overcome Them
Kallik Role 1
Content Manager

In an industry as tightly regulated and globally interconnected as pharmaceuticals, labeling is far more than a back-office function; it’s a core business process. Done well, it enables speed to market, ensures compliance, and protects patients. Done poorly, it opens the door to costly recalls, regulatory fines, and reputational damage.

As we look to the second half of 2025, pharma businesses face a convergence of pressures: evolving global regulations, increasingly complex supply chains, rising demand for faster product launches, and the need for more agile digital systems. And at the center of all of these challenges? Labeling.

Here are the five critical labeling challenges pharma companies must address in 2025 and what a forward-thinking strategy looks like.

1. Disconnected Systems That Stifle Agility

Many pharma companies still manage labeling using fragmented systems: separate tools for artwork creation, review, translation, and approval, often spread across multiple global teams. This creates gaps in data flow, increases the risk of miscommunication, and makes traceability difficult.

IDC research highlights that interoperability and data integration remain critical to life sciences digital transformation, with organizations investing in unified platforms and control planes to reduce fragmentation.

The fix:
Integrated labeling platforms that connect directly with ERP, PLM, and regulatory systems allow labeling to evolve from a siloed process to a strategic asset. When data flows freely across functions, businesses gain speed, consistency, and control.

2. Regulatory Overload Is Reaching a Tipping Point

Compliance demands are only growing. From FDA and EMA expectations to country-specific serialization, language, and medical device regulations like EU MDR and the U.S. Drug Supply Chain Security Act (DSCSA), pharma businesses must now manage more requirements than ever, across more products and regions.

According to Deloitte, regulatory complexity has doubled in the past decade, and it continues to increase year over year.

The fix:
Digital labeling solutions that offer built-in version control, audit trails, and electronic approvals can dramatically reduce the risk of non-compliance. They also help ensure that any changes driven by regulation or internal updates are captured and deployed globally with confidence.

3. Manual Review Processes Create Bottlenecks

In many organizations, reviewing and approving label content is still a manual, time-intensive process involving emails, PDFs, and offline markups. This slows down product launches and creates room for human error.

McKinsey notes that regulatory work is often slowed by document-heavy, manual workflows, and that automation and AI can materially accelerate cycle times.

The fix:
Automated comparison tools, digital annotations, and workflow-driven approvals can cut label review times from hours to minutes, without compromising quality or compliance.

4. Global Complexity Adds Localization Pressure

Launching a product globally means managing dozens of local label variations — from language translations to regulatory disclaimers and packaging layouts. When done manually, this slows down launches and increases the risk of inconsistencies.

Research from IQVIA highlights that labeling and regulatory processes are often slowed by document-heavy, manual workflows, with inefficiencies compounding in organizations that lack standardized, automated review and approval processes.

The fix:
Modern labeling systems that support dynamic content management, built-in language libraries, and market-specific templates can accelerate localization, ensuring global consistency without sacrificing regional compliance.

5. Siloed Teams and Suppliers Limit Visibility and Control

Labeling often spans departments, from regulatory and marketing to external vendors and packaging suppliers. Without a unified system and clear role-based access, companies risk losing oversight and control over critical updates.

According to the FDA, over 50% of drug recalls in the last five years were related to labeling issues, many tied to coordination breakdowns during product or market changes.

The fix:
A centralized labeling environment with configurable access controls allows cross-functional teams and external partners to collaborate in real time, with clear audit trails, user accountability, and full visibility at every stage.

The Bottom Line

Labeling is no longer a static, back-office function. It’s a dynamic, strategic capability that touches every part of a pharmaceutical business, from regulatory affairs and supply chain to patient safety.

In 2025, the pharmaceutical companies that win will be those that treat labeling not as a necessary burden, but as a competitive advantage. By investing in integrated, digital-first solutions that solve these five challenges, organizations can achieve faster time to market, ensure global compliance, and minimize the risk of costly disruptions.

If you’re ready to explore what a future-ready labeling process could look like, book a demo with our team today and see how Veraciti™ can transform your labeling and artwork management. Alternatively, speak to one of our experts on +44 (0) 1827 318100 or enquiries@kallik.com. 

Why Now Is the Time to Upgrade Your Labeling and Artwork Management

Why Now Is the Time to Upgrade Your Labeling and Artwork Management
Kallik Role 1
Content Manager

The world of labeling and artwork management is undergoing a major transformation. What Gartner has coined as the “Upgrade Cycle” in their recent supply chain packaging report represents a critical moment for businesses, especially in highly regulated industries, to re-evaluate and modernize their labeling and artwork management systems. The driver? A perfect storm of increasing regulatory complexity, mounting business risk, and rapid advancements in cloud and AI technologies.

At Kallik, we believe this isn’t just an upgrade cycle. It’s a wake-up call. And Veraciti™, our cloud-based, AI-powered labeling and artwork management platform, is built precisely for this moment.

The Upgrade Cycle: What’s Driving It?

Gartner highlights several key forces behind this shift, and all of them point to the need for modern, integrated, and intelligent platforms.

Tightening Regulations & Compliance Risk

With the recent EU Packaging and Packaging Waste Regulation (PPWR) and revised Classification, Labelling, and Packaging (CLP) laws, its clear now more than ever that the global regulatory landscape is in constant flux, and as a result, manual and fragmented labeling processes leave companies dangerously exposed. As Gartner warns, “Mismanaged labeling and artwork processes can lead to costly recalls and regulatory fines.” It’s crucial to be prepared to make mass changes to your labels at any moment

The solution? Centralized control, versioning, and automated workflows that ensure that changes can be made quickly and easily while remaining compliant, accurate, and audit-ready across global markets.

Cloud, Artificial Intelligence & Machine Learning Are No Longer Optional

According to Gartner’s 2025 Top Trends Transforming Supply Chain Packaging Strategies, “By 2028, the label and artwork management market will be dominated by a small handful of vendors who have mastered cloud, machine learning and AI capabilities.”

By choosing a cloud-native platform that seamlessly integrates AI and machine learning, businesses can completely transform their process for the better. In the long run, businesses can expect to save hundreds of thousands to millions of dollars, as well as large reductions in production times.

Efficiency Is a Major Competitive Differentiator

Speed to market has never been more critical — and outdated systems are a bottleneck. Gartner emphasizes the business case for change: “Technologies and software suites in the labeling and artwork management market have rapidly advanced... enabling a robust ROI once fully implemented.”

By automating the creation, approval, and deployment of labels and artwork across product lines and geographies, businesses can slash time-to-market while reducing the risk of human error. That means faster launches, lower costs, and greater agility.

End-to-End Data Integrity & Traceability

Accurate, consistent labeling depends on more than just smart design tools — it demands integration with master data and product lifecycle systems. Veraciti™ connects the dots, ensuring traceability from source data through to final print, enhancing both compliance and quality control.

Why Choose Kallik And Why Now?

Gartner’s insights clearly show where the labeling and artwork management market is heading. Veraciti™ was built not just to keep up with trends, business targets and ever-changing regulations, but to lead. With one, single end-to-end platform, everything you need is in one place – all stored securely and reliably in the cloud, where it can be accessed from anywhere in the world. So that means, no need to manually install and update multiple pieces of software on your computer. We manage the updates on our end, using the extremely reliable AWS to prevent downtime and keep you working 24/7 no matter where you are in the world.

We specialize in serving complex, highly regulated sectors like pharmaceuticals, medical devices, chemicals, cosmetics, and manufacturing, where precision, traceability, and compliance are non-negotiable. With the power of automation and AI at your fingertips, Veraciti will significantly minimize manual input, not only making your labeling and artwork process more efficient, but also eliminating the risk of errors.

Veraciti™ is constantly evolving alongside the latest regulations, trends and technologies. Choosing Kallik today means staying ahead of what’s next, with a platform designed for long-term scalability and resilience.

The Bottom Line

The upgrade cycle is real, so don’t get left behind. Companies that hesitate to change risk falling behind, both in compliance and in competitiveness. As Gartner makes clear, the winners in labeling and artwork management will be those who act now and partner with vendors that have mastered the technologies shaping the future.

Your Partner for the Future

If you're ready to streamline your labeling processes, ensure global compliance, and future-proof your operations, let’s talk. Book a demo with our team today and see how Veraciti™ can transform your labeling and artwork management. Alternatively, speak to one of our experts on +44 (0) 1827 318100 or enquiries@kallik.com.

Pharmaceutical Labeling Requirements: Top Tips to Remain Compliant

Pharmaceutical Labeling Requirements: Top Tips to Remain Compliant
Author Name
Kallik Role 1
Content Manager

Pharmaceutical labeling requirements are critical for ensuring patient safety, meeting regulatory standards, and avoiding costly recalls. In this highly regulated industry, companies must adhere to stringent guidelines set by authorities like the FDA (Food and Drug Administration) and EMA (European Medicines Agency). Non-compliance can lead to hefty fines, damaged reputations, and severe consequences for public health.

This article offers practical tips to help pharmaceutical companies remain compliant with labeling requirements while showcasing how Kallik’s software simplifies compliance and streamlines workflows.

1. Understand the Key Regulatory Requirements

Navigating the complexities of pharmaceutical labeling begins with a deep understanding of the regulatory landscape. With each market presenting its own set of rules and expectations, ensuring compliance requires not only vigilance but also the right tools to stay ahead of ever-evolving requirements. By gaining clarity on the foundational guidelines, pharmaceutical companies can build a strong framework for labeling success.

Key Regulatory Bodies:

Let’s start with getting to know the key regulatory bodies for the pharmaceutical industry.

FDA Pharmaceutical Labeling Requirements: The FDA enforces strict labeling guidelines in the United States to ensure labels provide accurate and essential information for healthcare professionals and patients. Learn more about FDA Pharmaceutical Labeling Requirements.

EU Regulations: In the European Union, pharmaceutical labeling must comply with EMA guidelines, which emphasize multilingual content and design standards tailored to specific markets. Explore EMA’s product information requirements.

Kallik’s tailored solutions for the pharmaceutical sector can help you navigate these complex regulations, with expert help on hand to guide you to full compliance. Find out more about what we can do for pharmaceutical businesses here or read one of our case studies here.

Understanding the Key Elements of Pharmaceutical Labels

It’s also crucial to understand the key elements of pharmaceutical labels. These components are designed to convey critical information clearly and consistently, ensuring patient safety and regulatory compliance. Every pharmaceutical label must include specific details to meet the standards set by regulatory bodies.

Here are the critical components required for compliant pharmaceutical labels:

Required InformationPurpose
Product NameClearly identify the drug.
Drug Facts TableProvide a summary of key information.
Active IngredientsList the active pharmaceutical components.
Purpose and UseExplain the drug’s intended function.
WarningsHighlight safety risks and precautions.
DirectionsSpecify dosage and usage instructions.
Allergic ReactionsIndicate potential allergen risks.
Inactive IngredientsInclude non-active components for transparency.

2. Keep Track of Updates and Amendments

Pharmaceutical labeling requirements are frequently updated, creating challenges for companies managing extensive product portfolios across the globe. Staying informed is essential to ensure you have enough time to make the necessary changes and avoid compliance breaches and logistical headaches when updating labels.

How to Stay Updated:

You can find EU updates here.
You can find US updates here.

Kallik's software, Veraciti™, leverages AI and automation to help businesses stay compliant with ever-changing regulations by streamlining label and artwork updates. Key features like the ‘Where Used’ function, Automated Artwork Generation (AAG) feature, and Assisted Tool of Migration (AToM) AI technology, enable seamless bulk updates - allowing 10,000 product labels to be changed in 14 days rather than six months. These tools empower businesses to respond swiftly to regulatory changes, reducing update timelines from months to days and maintaining a competitive edge. Find out more about how our software can help here

3. Ensure Clarity and Accuracy in Label Content

Regulations mandate specific design requirements for pharmaceutical labels, such as font size, color contrast, and overall clarity. These standards ensure that critical information is easily understood by healthcare professionals and patients alike. It’s critical that the right information and symbols appear in the correct places in a way that’s easy to understand. Failure to do so can result in serious consequences, including costly product recalls, substantial fines, and reputational damage, as well as potential risks to patient safety if critical information is misinterpreted or overlooked.

Real-World Example:

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.

Top Tip: Ensure every label meets design specifications and undergoes thorough quality checks.

Click here to read more about the dangers and consequences of recalls and read our recent blog here to learn how Kallik’s cloud-based labeling and artwork management software ensures consistency and clarity across all product labels to reduce errors and maximize collaboration.

4. Implement Multilingual Labeling for Global Compliance

Pharmaceutical products are distributed across multiple regions, each with unique regulatory requirements. As such, meeting multilingual labeling requirements is essential to ensure compliance, patient safety, and accessibility. In regions like the EU, labels must accommodate several languages to cater to diverse populations, often requiring intricate coordination to ensure accuracy and consistency.

The Challenges of Multilingual Labeling in Pharmaceuticals

Multilingual labeling in the pharmaceutical industry is not just about translation—it’s about precision, compliance, and efficiency. Pharmaceutical companies must address the complexities of regulatory mandates while managing translations for active ingredient names, usage instructions, warnings, and more.

Traditionally, the process involved sending labels and artwork to various local offices or agencies for translation, which could be time-consuming, expensive, and error-prone. Each revision increased the risk of misalignment between the original and translated content, potentially leading to compliance issues, miscommunication, or even patient safety risks.

Additionally, pharmaceutical labeling often requires careful attention to technical and medical terminology, which must be translated accurately to avoid confusion or misinterpretation.

Key Benefits of Modern Software for Multilingual Labeling:

Thanks to advancements in intelligent, cloud-based labeling software, the challenges of multilingual pharmaceutical labeling are becoming easier to manage. Automation allows companies to create compliant, region-specific labels with greater speed and accuracy.

  • Pre-Approved Translation Libraries
  • Streamlined Workflow
  • Reduced Errors with Minimal Human Input and Faster Speed-to-Market
  • Version Control and Transparency
  • Improved Accessibility and Compliance

Top Tip: Automate multilingual labeling processes to reduce errors, improve efficiency, and meet global compliance standards.

With Kallik’s Veraciti™, pharmaceutical companies can eliminate the manual inefficiencies of traditional translation processes. Pre-approved translations for regulatory-compliant phrases, warnings, and instructions are stored in a centralized platform. This means companies can generate a localized label for any region in just a few clicks, saving time and reducing costs.

5. Utilize Digital Proofing and Version Control

Accurate version histories are vital in pharmaceutical labeling to ensure compliance with strict regulations and avoid serious consequences like product recalls or patient safety risks. Regulatory bodies require clear documentation of label changes to verify compliance, and any failure to maintain this can result in penalties, reputational damage, and operational delays. Managing multiple label updates across global markets, especially in different languages, increases the complexity and the risk of errors.

Without robust version control, you risk:

  • Compliance violations
  • Loss of trust
  • Operational inefficiency
  • Costly recalls

How to Maintain Accurate Version Histories

Using an end-to-end platform that integrates digital proofing and version control ensures pharmaceutical companies can manage the entire labeling process with precision. Here’s how:

  • Centralized cloud-based platform
  • Automated version control
  • Digital proofing tools
  • Global collaboration
  • Automated workflows and approvals

Top Tip: Implement robust version control systems to minimize the risk of outdated or incorrect labels being used.

Using an end-to-end, cloud-based platform like Kallik's Veraciti™ simplifies version control and ensures compliance. Kallik supports digital proofing and version control to ensure compliance at every stage of the labeling process. This approach minimizes errors, accelerates speed-to-market, and safeguards compliance in even the most complex labeling processes.

6. Leverage Software for Compliance and Efficiency

Automated labeling systems play a crucial role in streamlining compliance processes while minimizing the risk of human error. Pharmaceutical labeling involves managing complex regulations that vary across regions, requiring precise adherence to standards. Manual processes are prone to errors like missing mandatory details, inconsistent formatting, or outdated regulatory information, which can lead to costly fines, recalls, or compromised patient safety.

By integrating automated labeling software, companies can ensure labels remain compliant with the latest regulations. These systems can automatically update labeling requirements based on changes in regulatory guidelines, removing the need for manual monitoring. Automated workflows also eliminate redundancies, enabling faster approvals and reducing the time-to-market for pharmaceutical products. Moreover, advanced features like pre-approved templates and regulatory checklists ensure every label meets strict compliance standards consistently.

Top Tip: Use software that integrates with regulatory databases to automatically update labels in real time.

Case Study: Kallik brings helps Teleflex deploy an ambitious project for a Global Labeling System

Kallik supported Teleflex in eliminating the risk of errors and product recalls by helping the medical device company to establish a global system using Veraciti™. With multiple legacy systems across its global operations, Teleflex faced challenges in managing labeling consistency, compliance, and the risk of inaccuracies that could lead to recalls. By consolidating over a dozen outdated systems into a single, centralized solution, Kallik enabled Teleflex to standardize workflows, streamline asset management, and ensure 100% accuracy in its labeling operations. This transition significantly reduced compliance risks and operational complexities, while ensuring that labeling processes were consistent and reliable across all global facilities.

Brian Cannon, Senior Project Manager at Teleflex, commented on the implementation of Veraciti™: “As a major medical device provider operation worldwide, teams working across all of our sites and facilities will be involved with the labeling process at some point, meaning standardized control and processes were simply non-negotiable for future success.

“The implementation of Veraciti™ from Kallik has comfortably provided us with that central control and management identified as the keystone of our global labeling system.”

Don’t Delay, Make the Switch Today

In summary, adhering to pharmaceutical labeling requirements is a complex yet crucial task for ensuring patient safety and regulatory compliance. By understanding the key regulations, staying updated with amendments, ensuring clarity in label content, and implementing multilingual labeling, pharmaceutical companies can mitigate risks and enhance operational efficiency. Kallik’s Veraciti™ platform simplifies these challenges with its automated, AI-driven features, ensuring accuracy, compliance, and streamlined workflows. Whether you’re navigating complex regulations or managing a global labeling system, our solutions can help you stay ahead.

To learn more about how Kallik can help your organization achieve similar results get in touch with our experts today by calling +44 (0) 1827 318100 or emailing enquiries@kallik.com. Alternatively, click here to book a demo.

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Predicting the Biggest Labeling and Artwork Trends for 2025: eIFUs

Predicting the Biggest Labeling and Artwork Trends for 2025: eIFUs
Author Name
Kallik Role 1
Content Manager

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.

Labeling and Artwork Horror Stories and How to Avoid Them

Labeling and Artwork Horror Stories and How to Avoid Them
Author Name
Kallik Role 1
Content Manager
Blog Related to Industry Page

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.