If you work in medical device labeling, you already know that 2026 has brought significant regulatory changes. Between the FDA's Quality Management System Regulation (QMSR) and mandatory EUDAMED modules in the EU, the rules around labeling have shifted dramatically. Cloud labeling software helps you navigate these requirements by centralizing your assets, automating approvals, and maintaining the audit trails that regulators expect. Kallik Veraciti gives medical device manufacturers a single platform to manage labels and artwork across global markets.

This blog walks you through everything you need to know about enterprise labeling and artwork management software for medical devices. You'll learn what cloud labeling software does, how to evaluate your options, and how to implement workflows that keep you compliant while accelerating your time to market.

 

Key Takeaways: Cloud Labeling Software for Medical Devices in 2026
 

• Cloud labeling software centralizes your medical device labeling assets, giving you a single source of truth across all markets and products.
• 21 CFR Part 11 and EU Annex 11 compliance requires audit trails, electronic signatures, and validated systems that cloud platforms can deliver.
• Automated approval workflows reduce label cycle times by eliminating email chains and enabling role-based reviews with full traceability.
• Kallik’s software helps medical device manufacturers reduce label change cycles by up to 70% while ensuring EU MDR and FDA compliance.
• Choosing the right cloud labeling software requires evaluating integration capabilities, validation support, and regulatory feature sets carefully.
   

What is Cloud Labeling Software for Medical Devices

Cloud labeling software is a platform that lets you create, manage, approve, and distribute medical device labels through a web-based system. Rather than storing files on local servers or sharing artwork through email, you access everything through a secure online environment. This approach centralizes all your labeling assets, from symbols and regulated phrases, to translations and artwork files – all in one location. Your team members access the same current versions regardless of their physical location. Changes propagate instantly across your entire product portfolio.

How Cloud Labeling Differs from On-Premise Solutions

Traditional on-premise labeling systems require you to install software on your own servers. You manage the hardware, handle security updates, and coordinate access for remote team members.

Cloud platforms eliminate that infrastructure burden. Your vendor hosts the system, manages security, and handles uptime. You log in through a browser and get to work. For medical device companies with facilities across multiple continents, this means your team in Asia can approve the same label that your regulatory specialist in Europe just updated and without VPN complications or server synchronization delays.

Core Capabilities of Cloud Labeling Platforms

Modern cloud labeling software typically includes several key functions. Asset management lets you store and organize all your labeling components. Workflow automation routes labels through predefined approval paths. Version control tracks every change with timestamps and user attribution.

Integration capabilities connect your labeling platform to other enterprise systems like PLM, ERP, and QMS. Reporting tools let you pull audit data quickly when regulators come calling. These features combine to create an end-to-end system that handles your entire label lifecycle.

Why Medical Device Manufacturers Need Cloud Labeling Software in 2026

The regulatory environment for medical device labeling has grown more demanding over the past several years. Cloud labeling software addresses these challenges directly by building compliance features into your daily workflows.

FDA QMSR and 21 CFR Part 11 Requirements

The FDA's transition to the Quality Management System Regulation (QMSR) aligns 21 CFR Part 820 with ISO 13485:2016. For your labeling operations, this means tighter requirements around documentation, traceability, and validated processes.

21 CFR Part 11 specifically governs electronic records and electronic signatures. Your cloud labeling system must capture who made each change, when they made it, and why.

Electronic signatures require two distinct identification components, typically a user ID and password. The system must link signatures to specific records and maintain complete audit trails that regulators can review.

EU MDR and IVDR Labeling Obligations

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have introduced extensive new labeling requirements. Your labels must now include specific symbols from EN ISO 15223-1:2021, Unique Device Identifiers (UDI), and detailed manufacturer information.

MDR Annex I Chapter III Section 23.2 lists every element that must appear on your device labels. Cloud labeling software helps you manage this complexity by storing approved phrases, symbols, and translations centrally. When regulations change, you can update affected content once and push changes across all relevant labels.

Managing Global Labeling Complexity

Medical device companies selling internationally face labeling requirements that vary by market. Language translations, country-specific symbols, and regional regulatory statements all need tracking and management.

A cloud platform gives you visibility across your entire portfolio. You can quickly identify which labels need updates when a regulation changes or when you enter a new market. This centralized approach prevents the inconsistencies that lead to compliance gaps and potential recalls.

Essential Features to Look for in Cloud Labeling Software

When evaluating cloud labeling software for your medical device organization, certain features distinguish platforms built for regulated industries from generic design tools.

Audit Trails and Electronic Records Management

Your system must generate computer-generated, time-stamped audit trails for every action that creates, modifies, or deletes a record. These trails should capture the user who performed the action, exactly what changed, and the reason for the change.

The audit trail must be protected from alteration or deletion. During regulatory inspections, you'll need to export this data in human-readable formats quickly. Look for systems that let you filter audit data by date range, user, asset, or batch number.

Electronic Signature Capabilities

21 CFR Part 11 requires that electronic signatures include two distinct identification components. The signature must display the signer's printed name, the date and time, and the meaning of the signature (such as "reviewed," "approved," or "author").

Authority checks should verify that users have permission to perform the specific step they're signing for. The system should detect and flag any unauthorized changes after signing. These controls ensure that your electronic approvals carry the same legal weight as handwritten signatures.

Role-Based Access Controls

Not everyone on your team needs the same access to your labeling system. Role-based access control lets you assign permissions based on job responsibilities. A designer might be able to create and edit artwork, while a regulatory specialist can only approve or reject.

This segregation of duties prevents conflicts of interest and ensures that critical actions require appropriate authorization. Session timeouts and automatic account lockouts add additional security layers. Regular access reviews help you identify and remove excessive privileges before they become compliance issues.

Workflow Automation and Approval Routing

Automated workflows route labels through predefined approval sequences without manual coordination. When a designer finishes a label, the system automatically notifies the next reviewer. Deadlines and reminders keep projects moving forward.

Parallel reviews let multiple stakeholders review simultaneously rather than waiting in sequence. This capability can significantly reduce your label cycle times. Kallik's medical device labeling software includes configurable workflows that adapt to your organization's specific approval requirements.

Integration with Enterprise Systems

Your labeling platform should connect with other business systems where product data lives. API availability lets you pull device attributes from your PLM or ERP automatically, eliminating double-entry and reducing transcription errors.

Integration with quality management systems ensures that CAPA activities and label changes stay synchronized. Legacy system compatibility matters if you're migrating from an existing platform. Evaluate how easily you can import your current label library and historical data.

Understanding Medical Device Labeling Compliance Requirements

Compliance requirements for medical device labeling span multiple regulatory frameworks. Understanding these requirements helps you configure your cloud labeling system appropriately.

FDA UDI System Requirements

The FDA's Unique Device Identification system requires that every medical device distributed in the United States carry a UDI. This identifier has two parts: the Device Identifier (DI), which identifies the specific version or model, and the Production Identifier (PI), which includes lot number, serial number, expiration date, and manufacturing date.

Your labels must include machine-readable formats like barcodes – either GS1 or HIBC standards depending on your chosen issuing agency. The UDI must also appear in human-readable plain text. Class III devices and implants have the most stringent requirements, while Class I devices have more limited obligations.

EU UDI Requirements Under MDR and IVDR

The European Union has implemented its own UDI requirements under MDR Article 27. Devices must carry UDI carriers on labels, and manufacturers must submit UDI data to the EUDAMED database as applicable modules become operational.

IVDR introduces similar requirements for in vitro diagnostic devices. The phased implementation timeline means different device classes face different compliance deadlines. Your labeling system needs to track these requirements and alert you when deadlines approach.

ALCOA+ Principles for Data Integrity

Regulators expect your electronic records to meet ALCOA+ standards. Data must be Attributable (traceable to a specific user), Legible (readable and accessible), Contemporaneous (recorded at the time of the activity), Original (preserved as originally captured), and Accurate (complete and error-free).

The "plus" adds Complete, Consistent, Enduring, and Available. Your cloud labeling system should enforce these principles automatically through its design. Audit trails address attribution, version control maintains originals, and backup systems ensure enduring availability.

Step-by-Step Guide to Implementing Cloud Labeling Software

Moving to a cloud labeling platform requires careful planning. This step-by-step approach helps you manage the transition while maintaining compliance throughout.

Step 1: Assess Your Current Labeling Process

Start by documenting how your labeling process works today. Map out every step from initial design request through final production approval. Identify who touches each label, where bottlenecks occur, and how long each stage typically takes.

Catalog your existing labeling asset (symbols, phrases, templates, and artwork files). Note where these assets currently live and how different team members access them. This inventory becomes your migration checklist later.

Step 2: Define Your Requirements and Evaluation Criteria

Based on your current state assessment, define what your new system must accomplish. Distinguish between must-have features and nice-to-have capabilities. Consider your regulatory requirements, team size, number of products, and geographic distribution.

Create a vendor evaluation checklist that covers compliance features, integration capabilities, validation support, and user experience. Include questions about the vendor's experience with medical device customers and their regulatory expertise.

Step 3: Evaluate Vendors and Select Your Platform

Request demonstrations from vendors on your shortlist. Watch for how their systems handle specific scenarios you face – mass label changes, multi-language management, or complex approval routing.

Ask about validation documentation. Vendors serving regulated industries should offer accelerator packages including user requirements specifications, functional requirements specifications, and installation qualification scripts. These documents speed your validation but don't replace your responsibility to validate the system in your intended use.

Step 4: Plan Your Implementation Phases

Break your implementation into manageable phases. Many organizations start with a pilot involving a limited product line or geographic region. This approach lets you work out issues before full rollout.

Define clear success criteria for each phase. Establish who owns the project, what resources they need, and how you'll handle issues that arise. Build in time for training and documentation at each stage.

Step 5: Migrate Your Existing Label Library

Migrating your existing labels and assets takes careful attention. Verify that every symbol, phrase, and artwork file transfers correctly. Check that version histories and approval records remain intact.

Some platforms offer AI-driven digitization that can accelerate this process. These tools read existing labels and extract components into structured, searchable formats. The investment pays off through faster updates and better reuse of approved content.

Step 6: Configure Workflows and User Permissions

Set up your approval workflows to match your organization's needs. Define roles and assign appropriate permissions. Configure notification rules so team members know when actions require their attention.

Test your workflows thoroughly before going live. Create test labels and route them through your full approval process. Verify that audit trails capture everything correctly and that signatures appear where required.

Step 7: Train Your Team and Document Procedures

Effective training covers both system operation and regulatory requirements. Users need to understand why certain controls exist, not just how to click through them. Role-specific training ensures that designers, reviewers, and administrators each know their responsibilities.

Document your standard operating procedures for the new system. Include step-by-step instructions for common tasks and guidance for handling exceptions. Keep this documentation accessible and update it when processes change.

Step 8: Validate Your System

System validation demonstrates that your software operates as intended and meets regulatory requirements. Following vendor documentation helps but doesn't eliminate your validation obligations. You must validate the system in your specific intended use.

A risk-based approach focuses validation effort where it matters most—systems that impact product quality and patient safety. Document your validation activities thoroughly. Maintain evidence that tests passed and that any deviations were addressed appropriately.

Step 9: Go Live and Monitor Performance

Plan your cutover carefully. Some organizations run parallel processes temporarily, using both old and new systems until confidence builds. Others switch completely at a defined date.

Monitor key metrics after going live. Track label cycle times, error rates, and user adoption. Address issues quickly and adjust workflows based on real-world experience. Schedule regular reviews to identify improvement opportunities.

Best Practices for Medical Device Labeling Workflow Automation

Automating your labeling workflows delivers the biggest benefits when you design them thoughtfully. These practices help you maximize efficiency while maintaining compliance.

Design Workflows Around Your Actual Process

Map your approval workflows to how decisions actually happen in your organization. Forcing an artificial sequence creates frustration and workarounds. If your regulatory and quality reviewers typically work in parallel, configure parallel review steps.

Build in escalation paths for when someone is unavailable. Define backup approvers and timeout rules that prevent single individuals from becoming bottlenecks. Test these edge cases before they happen in production.

Use Templates and Component Libraries

Templates and reusable components dramatically accelerate label creation. Build approved symbol libraries, standard phrase collections, and pre-validated layout templates. When designers start from approved building blocks, they spend less time on repetitive work and make fewer errors.

Kallik Veraciti manages regulated content including text, symbols, translations, and claims centrally. This ensures consistency across your product portfolio and simplifies updates when regulations change.

Implement Automated Quality Checks

Configure your system to check for common issues automatically. Barcode validation ensures scannability before labels reach production. Spelling and grammar checks catch typos. Symbol placement rules verify that required elements appear where regulations specify.

These automated checks complement human review rather than replacing it. They catch obvious problems early so reviewers can focus on substantive evaluation rather than proofreading.

Track Metrics and Continuously Improve

Measure what matters: average cycle time, number of revision rounds, on-time completion rates, and error detection at each stage. These metrics reveal where your process works well and where improvements would have the most impact.

Schedule periodic process reviews with your labeling team. Ask what's working, what's frustrating, and what they wish the system could do. Small adjustments based on real user feedback add up to significant improvements over time.

How Kallik Veraciti Supports Medical Device Labeling Compliance

Kallik has spent over 20 years helping medical device manufacturers manage labeling and artwork processes. The Veraciti platform addresses the specific challenges that regulated industries face.

Single Source of Truth for All Labeling Assets

Veraciti centralizes your symbols, phrases, translations, and artwork in one cloud-based repository. Every team member works from the same current versions. When you update a symbol, that change flows through to every label using it.

The platform's "where used" functionality lets you quickly identify every label affected by a change. This visibility is critical when regulations change or safety information requires updates across your portfolio.

Automated Artwork Generation and Mass Change Management

Kallik's automated artwork generation tools create compliant labels from your approved content and templates. When you need to make changes across hundreds or thousands of labels, mass change capabilities let you apply updates uniformly rather than editing each file individually.

Medical device companies report reducing label change cycles by up to 70% after implementing Veraciti. This acceleration comes from eliminating the manual coordination that slows traditional processes.

Built-In Compliance for EU MDR, FDA, and Global Regulations

Veraciti includes features specifically designed for regulatory compliance. Full audit trails track every action. Role-based approval flows ensure proper authorization. Electronic signatures meet 21 CFR Part 11 requirements.

The platform supports EU MDR, IVDR, FDA UDI, FDA 21 CFR 820, 21 CFR Part 11, and EU GMP Annex 11 compliance. This regulatory coverage helps you manage requirements across multiple markets from a single system.

Cloud-Native Architecture on AWS

Veraciti runs entirely on Amazon Web Services with extensive security and compliance certifications. Cloud-native design means you get 24/7 availability, automatic backups, and access from anywhere your team works.

This infrastructure eliminates the IT burden of managing servers and security updates internally. Your team focuses on labeling work rather than system administration.

Common Challenges in Medical Device Labeling and How to Overcome Them

Even with strong systems, medical device labeling presents ongoing challenges. Understanding common issues helps you address them proactively.

Managing Multi-Language Labels

Products sold in multiple countries require translated labels. Managing dozens of language versions creates version control complexity and increases the risk that translations fall out of sync with source content.

Cloud labeling platforms address this by linking translated content to source phrases. When you update the source, the system flags all translations for review. Centralized translation management ensures consistency and simplifies the coordination with translation vendors.

Handling Regulatory Changes Across Multiple Markets

Regulations evolve constantly. New symbol requirements, updated safety statements, or changed UDI obligations can affect large portions of your label portfolio.

Effective platforms give you tools to assess regulatory impact quickly. You can identify affected labels, plan your update sequence, and track progress toward compliance deadlines. Automated alerts notify you when regulatory changes require attention.

Coordinating Approvals Across Teams and Time Zones

Global organizations often have approvers in different locations. Time zone differences can add days to approval cycles if you're waiting for sequential reviews.

Configure your workflows to enable parallel reviews where possible. Set clear expectations for review turnaround times. Use automated reminders to keep projects moving. These practices minimize delays without compromising review quality.

Integrating Acquisitions and New Product Lines

Medical device companies frequently grow through acquisitions. Each acquired company brings its own labeling systems, processes, and asset libraries. Integrating these into a unified platform takes planning and execution.

Cloud platforms simplify this integration because they don't require local infrastructure at each facility. You can onboard new sites quickly and migrate their assets into your centralized system. Standardized processes then ensure consistency across your expanded organization.

Future Trends in Medical Device Labeling Technology

Labeling technology continues to evolve. Understanding emerging trends helps you make decisions that position your organization well for the future.

AI and Machine Learning in Label Management

Artificial intelligence is beginning to change how organizations manage labels. AI-driven digitization can read existing labels and extract content into structured formats, accelerating migration from paper or file-based systems.

Machine learning algorithms can detect anomalies in label content, identify potential compliance issues, and suggest improvements based on patterns in your data. These capabilities augment human reviewers rather than replacing their judgment.

Electronic Instructions for Use (eIFU)

EU Implementing Regulation 2025/1234 expanded the scope of devices eligible for electronic Instructions for Use. For many professional-use devices, you can now deliver IFU content electronically rather than printing paper inserts.

This shift offers environmental benefits and cost savings while improving information currency. Your labeling system should support eIFU workflows including QR code generation, website hosting, and paper fallback procedures for devices that still require physical IFUs.

Enhanced Supply Chain Integration

Greater integration between labeling systems and supply chain partners continues to develop. Contract manufacturers, packaging suppliers, and logistics providers increasingly expect digital connections that eliminate manual handoffs.

API-based integrations let you share approved label files and production data securely with partners. This connectivity reduces lead times and ensures that your supply chain prints labels from controlled, current specifications.

In Conclusion: Choosing the Right Cloud Labeling Software for Your Medical Device Organization

The right cloud labeling software becomes a strategic asset for your medical device organization. It accelerates your time to market, reduces compliance risk, and gives your team tools that make their work easier rather than harder.

Focus your evaluation on the features that matter for regulated industries: audit trails, electronic signatures, role-based access, and validated workflows. Look for vendors with genuine experience in medical device labeling – the regulatory nuances matter.

Consider how the platform will grow with you. Your product portfolio will change, regulations will evolve, and your organization will expand into new markets. Choose a partner committed to adapting their platform alongside these changes.

Cloud labeling software represents an investment in operational excellence. When you centralize your labeling assets, automate your workflows, and build compliance into your daily processes, you create a foundation that supports your business objectives while protecting patient safety.
 

Frequently Asked Questions About Cloud Labeling Software for Medical Devices in 2026

The label on your product tells an important story that greatly influences buying decisions. However, it's rarely the whole story.

Behind every finished product is a chain of decisions, materials, suppliers, and processes that most companies struggle to see clearly themselves – let alone communicate to customers, regulators, or the next link in the supply chain. Therefore, digital product passports haven’t created a new problem, but they have highlighted one that's always existed. This is where the opportunity comes in.

What a digital product passport actually does

Let’s start with the basics: what is a digital product passport (DPP)? A digital product passport (DPP) is a structured digital record that travels with a product throughout its lifecycle, right from beginning to end. Accessed via a QR code, NFC tag, or similar data carrier, it stores verified information on where materials came from, how the product was made, its carbon footprint, how it can be repaired, and how it should be recycled.

Introduced under the EU's Ecodesign for Sustainable Products Regulation (ESPR), DPPs will become mandatory for certain product categories from 2027, starting with batteries, with phased expansion across electronics, textiles, construction materials, and more through to 2030. But the regulatory timeline is almost beside the point.

The real question DPPs are asking

Across regulated industries such as pharma, chemicals, consumer goods, and medical devices, product data is often fragmented across systems, held in spreadsheets, duplicated across markets, and manually managed at scale. The result is poor traceability, slow updates, and a constant risk of errors reaching the market.

Digital product passports ask companies to do something straightforward but demanding: know your product, end to end, and be able to prove it. That's a question that compliance teams, labeling managers, and supply chain leaders have been grappling with long before Brussels mandated an answer. DPPs now give that question a formal structure.

For businesses that have already invested in centralizing and controlling their product data, the DPP is validation. For those still managing product information in silos, it's the forcing function they probably needed.

Why DPPs are good for regulated industries

There's a tendency to view any new regulation as an additional cost layer. But DPPs are unusual in that the structured, accurate, centrally managed product data they require, is the same infrastructure that improves operations regardless of compliance obligations.

When a company can accurately track exactly which materials went into which products, across which markets, updated in real time, they're not just DPP-ready. They're better positioned to manage recalls, respond to supplier changes, support sustainability reporting, and handle the kind of rapid regulatory updates that have become a fact of life in global markets.

The circular economy goals embedded in ESPR reflect where consumer expectations, investor scrutiny, and procurement criteria are already heading. DPPs give businesses a credible, verifiable way to demonstrate that their products are what they say they are. That's not a compliance cost, but rather a market advantage.

The labeling connection most companies miss

There's one aspect of DPP readiness that often catches businesses off guard: the relationship between digital product data and physical labels. Regulatory markings, safety information, and required product details still need to appear on-pack. What a DPP does is create a parallel digital layer of product information, accessible via a data carrier that has to appear on the physical label itself.

That makes DPP compliance a major labeling challenge. QR codes and NFC tags need to be integrated into label design and print workflows. Product data needs to be accurate, current, and consistent between what's on the label and what's in the digital record. Any reformulation, supplier change, or market-specific regulatory requirement that requires information to be updated, now has to flow correctly through both.

For organizations managing hundreds or thousands of product labels across global markets, that coordination demands a structured, scalable approach to labeling and product data management from the outset.

Getting ahead of the curve

Businesses selling into the EU have a window right now to build DPP readiness properly The companies that do this well will have cleaner data, faster update cycles, and stronger traceability across their supply chains.

Ultimately, digital product passports ask a simple question: can you stand behind every claim your product makes? If you’re unsure where to start, Kallik can help. Speak to one of our labeling and artwork experts today by visiting the How Kallik Works page, getting in touch with our team at enquiries@kallik.com, or filling in a form here.

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Digital product passports are a serious hot topic in the packaging industry right now. Having attended the Packaging Innovations and Empack 2026 event at Birmingham’s NEC this week, it was clear that businesses are keen to understand how digital product passports are reshaping supply chains by improving transparency, traceability, and compliance. So in this week’s blog, we take a look at what digital product passports are, why the EU is pushing for them, and how they’ll affect packaging.

What Are Digital Product Passports?

Let’s start with the basics, what is a digital product passport? Digital product passports are structured digital records that capture data across a product’s entire lifecycle. This includes sourcing, manufacturing, distribution, environmental impact, and end-of-life instructions. 

So in simple terms, a digital product passport is like a digital birth certificate and diary for a product. It records where the product came from, what it’s made of, how it was manufactured, and what should happen to it at the end of its life. 

This information is all accessible through QR codes, NFC tags, or similar technologies, allowing regulators, supply chain partners, and consumers to view verified product information instantly. Not only is this a major time-saver, but can also provide major benefits when it comes to sustainability and traceability.

A digital product passport may include:

• Raw material origins
• Manufacturing and labor practices
• Carbon footprint data
• Compliance documentation
• Recycling and disposal guidance

The EU Push for Digital Product Passports

The European Union is leading adoption through its Green Deal and broader sustainability regulations. EU digital product passports are designed to increase product transparency, reduce environmental impact, and combat counterfeiting.

This regulatory momentum is influencing global markets. As more regions introduce similar requirements, companies that implement digital product passports early will be better prepared for evolving compliance standards.

For brands operating internationally, this shift makes digital product passports a strategic investment, not just a regulatory requirement. So if you’re wanting to stay competitive – which we assume you are – this is something you’re going to want to be on top of.

How Digital Product Passports Improve Packaging Transparency

Digital product passports transform packaging into a gateway to verified product data. By embedding scannable codes into packaging, brands connect physical products to dynamic digital records. Consumers can instantly access information about origin, materials, sustainability metrics, and recycling instructions.

This creates:

• Greater visibility across the supply chain
• Real-time product data updates
• Clearer recycling and disposal guidance
• Stronger brand transparency

Here at Kallik, we’ve always shouted about packaging being the key to success, but with digital product passports, more than ever, your product labels become a communication tool that builds trust and reinforces accountability that define your brand and determine its success.

Strengthening Supply Chain Compliance

Compliance is one of the strongest drivers behind digital product passports.

With centralized lifecycle data, companies can more easily:

• Meet environmental and regulatory standards
• Verify supplier practices
• Track products across global markets
• Manage recalls efficiently

Improved traceability also reduces product counterfeiting risks. By linking each product to verified digital records, brands protect their reputation and ensure authenticity. For supply chain teams, digital product passports improve visibility and reduce operational blind spots. For consumers, they provide confidence in product claims.

Enabling End-to-End Product Traceability

Digital product passports support true end-to-end traceability, from source to shelf. By tracking materials, components, and finished goods in real time, companies gain deeper insight into product performance and environmental impact. This improves lifecycle management and supports responsible sourcing decisions.

Enhanced traceability also simplifies audits and regulatory reporting, helping organizations respond quickly to disruptions or compliance checks.

Implementation Considerations

Adopting digital product passports requires careful planning. Businesses must integrate data systems, align supply chain partners, and ensure secure data management across every stage of the product lifecycle.

Success depends on building scalable digital infrastructure, fostering collaboration across the supply chain, and maintaining strong data governance and cybersecurity standards. While implementation requires investment, early adoption positions companies for long-term regulatory readiness, greater operational efficiency, and stronger resilience in an increasingly transparent market.

Supporting Smart Packaging and the Circular Economy

Digital product passports are a foundation for smart packaging and circular economy strategies.

They provide the data needed to:

• Improve material tracking
• Encourage recycling and reuse
• Reduce environmental impact
• Deliver transparent sustainability reporting

As regulatory pressure increases and consumer expectations grow, digital product passports will become standard practice across industries.

Why Digital Product Passports Matter Now

Digital product passports are no longer a future concept, they're here and they're changing the game for better. By enhancing packaging transparency, improving traceability, and strengthening supply chain compliance, they help businesses meet regulatory demands while building consumer trust. Organizations that act now will be better positioned for a more transparent and sustainability-driven market. But digital product passports are only as effective as the systems supporting them.

To meet evolving EU requirements and global compliance standards, businesses need accurate, connected product data that can be updated quickly and deployed at scale. If your current label and artwork management system cannot support rapid, controlled changes across markets and SKUs, it may be limiting your ability to respond to regulatory pressure.

Now is the time to strengthen your foundation

Solutions like Veraciti™ help organizations centralize product data, streamline artwork and labeling updates, and maintain compliance with confidence. By connecting product information with packaging execution, you can move faster, reduce risk, and deliver the transparency today’s market demands. Take a look at our partnership with Kenvue as an example of how we help businesses significantly increase speed-to-market without compromising on accuracy or quality. 

Why not speak to one of our labeling and artwork experts 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.

Frequently Asked Questions About Digital Product Passports

Struggling with labeling complexity in pharma?

You’re not alone. Pharmaceutical and life sciences companies face mounting pressure to meet global regulatory demands, maintain 100% labeling accuracy, and accelerate product launches — all while managing siloed systems and complex stakeholder workflows. Errors aren’t just costly — they’re dangerous. This white paper explores the real risks, challenges, and hidden inefficiencies that stem from outdated Labeling and Artwork Management (LAM) practices.

Discover how Kallik Veraciti transforms labeling for regulated industries

Purpose-built for pharma and medical device manufacturers, Veraciti is a cloud-native platform that centralizes label content, automates artwork generation, and ensures compliance with standards like FDA 21 CFR Part 11 and EU MDR. This paper shows how Kallik’s content-first, AI-enabled approach reduces errors, improves speed-to-market, and offers a true competitive advantage — with a side-by-side comparison against other major LAM solutions. 

View the white paper

Medical device manufacturers are required to provide clear, accurate, and up-to-date instructions for use (IFUs) to ensure patient safety and regulatory compliance. Traditionally these instructions have been provided in printed format, but as digital solutions become more practical and widely accepted, many manufacturers are transitioning to electronic instructions for use (eIFUs).

Adopting eIFUs can improve accessibility, reduce costs and is better for sustainability. However, it also introduces new compliance challenges and considerations. This guide explores eIFU regulations, benefits, challenges, and best practices for implementation, as well as how software can help manufacturers manage compliance efficiently.

What is an eIFU?

An electronic instruction for use (eIFU) is a digital version of the traditional printed IFU. Instead of being included in product packaging, eIFUs are made available through a secure website, QR code, or other digital formats.

The transition to eIFUs is being driven by regulatory updates, advancements in technology, and industry-wide efforts to reduce costs and environmental impact. Electronic IFUs enable real-time updates, ensuring that healthcare professionals, and consumers, always have access to the most accurate and up-to-date instructions.

Why transition to eIFU? 

While traditional paper IFUs have long been the standard, and are still required for some devices, advancements in technology and evolving regulatory changes have made digital alternatives more practical, sustainable and beneficial.

For manufacturers, healthcare professionals, and regulatory bodies alike, eIFUs offer several key advantages: 

“With so much change afoot in the industry, from regulations and policies, it’s no surprise that more and more medical device manufacturers are moving towards digital labeling and packaging. Traditional IFUs no longer meet the requirements, nor the increasing demand the industry continues to see.

With the right technology at their fingertips, eIFUs now take just minutes to update. Key information, across multiple products and markets, can be at the fingertips of medical professionals and, crucially, consumers, in an instant.

Critical to the future of the industry, the introduction of eIFUs will help to improve efficiencies, reduce error rate, remove additional burden from already time-pressed healthcare professionals and drive sustainable practices, all while ensuring the safety of patients. EIFUs are a welcome solution to the fast-paced medical device industry.” - Stuart Powell, Chief Product Officer at Kallik

What regulations apply to eIFU?

Medical device manufacturers looking to implement electronic instructions for use (eIFUs) must comply with strict regulatory requirements to ensure accessibility, accuracy, and patient safety. 

EU Regulations: MDR & Implementing Regulation 2021/2226

The European Union has established Regulation (EU) 2021/2226, which defines the conditions under which medical devices may provide eIFUs instead of printed documentation. This regulation applies to specific categories of devices, particularly those intended for professional use.

Key Requirements for eIFUs in the EU:

• eIFUs must be made available via a secure, compliant website that is regularly updated.
• The manufacturer must conduct a risk assessment to ensure that providing an eIFU instead of a printed IFU does not pose safety concerns.
• Printed IFUs must still be available upon request, and users must be informed of how to obtain them.
• The eIFU must be accessible in all official EU languages required for the device’s intended market.
• The eIFU must be designed to remain accessible for the expected lifetime of the device, even if the device is discontinued.
• Adequate cybersecurity measures must be in place to prevent unauthorized modifications to the eIFU content.

U.S. Regulations: FDA Guidance on eIFUs

In the United States, the FDA has comparatively less specific guidance on the use of electronic IFUs. However, they do permit eIFUs for certain prescription medical devices used in professional healthcare settings. This is outlined in Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)) which states:

“Required labeling for prescription devices intended for use in health care facilities may be made available solely by electronic means provided that the labeling complies with all applicable requirements of law and, that the manufacturer affords health care facilities the opportunity to request the labeling in paper form, and after such request, promptly provides the health care facility the requested information without additional cost.”

Key FDA eIFU compliance considerations:

• The eIFU must be accessible at the point of use and must not compromise device safety.
• The manufacturer must provide clear instructions on how users can access the eIFU.
• A printed version must be available upon request.
• The eIFU must be hosted securely to prevent tampering.
• Updates to the eIFU must be tracked and documented, ensuring that healthcare professionals always access the latest version.
• While the FDA has not yet mandated universal eIFU adoption, manufacturers considering digital IFUs should ensure they meet both FDA labeling regulations and Good Manufacturing Practices (GMPs).

How labeling management software can help

Managing electronic instructions for use (eIFUs) in compliance with regulatory requirements can be complex, especially for medical device manufacturers operating in multiple markets. Strict version control, multilingual requirements, real-time updates, and cybersecurity concerns make manual processes inefficient and prone to errors.

Labeling management software provides a structured, automated approach to eIFU compliance, streamlining workflows and reducing regulatory risks.

Kallik's end-to-end labeling and artwork management software helps medical device manufacturers to overcome challenges related to eIFU:

Automating compliance with regulatory standards:

• Comprehensive approval processes are required before publishing updates.
• Maintain audit-ready documentation for regulatory inspections.

Version control and change management:

• Automated version tracking, preventing outdated instructions from being accessed.
• Full audit trails, documenting changes, approvals, and user access.
• Role-based access control, ensuring only authorized users can edit or approve eIFU updates.

Centralized multilingual management:

• Ensure all language versions are consistent and compliant with local regulations.
• Updates can be efficiently applied across multiple languages without duplicating efforts.
• Translations can then be approved for accuracy, reducing the risk of misinterpretation.

Reducing manual work and human errors:

• Easily search for and replace specific symbols with automated ‘Where Used’ function
• Automate approval workflows, reducing delays in publishing updated IFUs.

Want to see how Kallik’s innovative software can benefit your labeling and artwork management process with the power of automation and AI? Get in touch by emailing enquiries@kallik.com or calling +44 (0) 1827 318100, or alternatively, book your one-to-one demo here. 

Last week, the team at Kallik had the privilege of attending the Gartner Supply Chain Symposium/XPO, the event of the year for supply chain professionals. The event was a fantastic opportunity to discuss the latest trends and hot topics while also exploring the most pressing issues in the industry. 

Supply Chain Hot Topics 

Across keynotes and sessions, a few clear themes stood out. In marketing, AI was the hot topic. It’s no longer just about using ChatGPT to write social posts. AI is already playing a major role in improving customer experiences and helping teams get more from their campaigns. But while the tech is advancing fast, there’s still a big need to understand the human side. Gartner pointed out how consumers are responding to AI in marketing and how CMOs need to balance the needs of real people with increasingly independent “non-human” audiences too.

On the supply chain side, resilience and agility remain front and center. Growth is still a key goal, and many companies are looking to expand into new markets using smart tech to help them get there. But there’s a challenge: talent. Finding the right digital skills is proving to be a real roadblock to full digital transformation. Add to that Gen Z’s demand for fast, seamless digital experiences, and it’s clear that supply chains need to keep evolving.
When it comes to technology, the spotlight was on connectivity and intelligence. Concepts like the “Augmented Connected Workforce,” “Polyfunctional Robots,” and “Agentic AI” point toward a future where smart, connected systems help teams work more efficiently and seamlessly. But Gartner also stressed that the right approach is key, as without a clear strategy, even the best tech can fall flat.

So What Does This Mean for Labeling and Artwork?

Just as AI is revolutionizing marketing and supply chains, it is poised to transform how we manage labeling and artwork. And as a vital part of the supply chain, it’s crucial that your labeling and artwork process is in the best possible shape. Imagine AI-powered tools that can predict potential compliance issues, automate the generation of variations based on regional regulations, and even assist in the creation of accessible and consumer-friendly label designs. The "Agentic AI" concept could translate to intelligent systems that proactively manage the artwork lifecycle, flagging potential bottlenecks and ensuring timely approvals.

The focus on data and analytics for improved performance, seen across marketing and supply chain discussions, is directly applicable to labeling. Robust artwork management platforms that provide comprehensive audit trails, version control, and real-time insights into the labeling process are becoming essential for ensuring compliance and building supply chain transparency. This aligns with the need for greater visibility to navigate market uncertainty. 

Meeting the Demands of the Digital Native: Gen Z's preference for seamless digital experiences and self-service extends to product information. Clear, accurate, and readily accessible labeling information, often delivered digitally, will be crucial for engaging this demographic. Artwork management systems need to facilitate the creation and distribution of digital label content across various touchpoints.

The Need for Digital Dexterity in Labeling Teams: The talent challenges identified by Gartner in the broader supply chain landscape are also relevant to labeling and artwork management. As the industry embraces more sophisticated digital tools and AI-powered solutions, professionals in this space will need to develop new skills and embrace a culture of continuous learning.

Discussing AI with Kenvue’s Director of Digital Acceleration

It was against this backdrop of evolving technologies and shifting priorities that Kallik, in partnership with Kenvue, hosted our session: "Driving Supply Chain Results via AI Artwork Management and Labeling: The Kenvue Story." 

Gurdip Singh, CEO of Kallik, set the stage by highlighting the often-underestimated complexity of labeling, stating, "I came and joined the industry, and I was shocked to hear how many manual processes operate, how many mistakes are made. And it's something that I think is really critical for leaders like yourselves to fully embrace in terms of how much value can really be derived from that." 

Joe Konopka, Director of Digital Acceleration at Kenvue, then shared a real-world example of how the leading consumer health company is leveraging best-in-class tools and artificial intelligence to transform its artwork management and labeling processes. The session saw Konopka highlight how Kenvue transformed its labeling and artwork process from a fragmented, manual, and error-prone system into a streamlined, end-to-end digital ecosystem. Facing challenges during their split from Johnson & Johnson, they created a bold vision focused not just on replacing systems, but on accelerating innovation, improving compliance, and reducing rework through digitization. 

And the results speak for themselves. In one case, they were able to make packaging changes 95% faster — just by reusing existing content: "Now, it’s as simple as copy-paste." More than just speed, the transformation helped change mindsets. Konopka explained, "And so we started to ask, 'well, what if it wasn't that way?' 'Could you make more changes?' 'Could we be more dynamic?' 'Could we be more agile?'"

By building a structured content library and integrating AI to automate data handling—from ingredient updates to Amazon listings—they enabled content reuse, quicker label changes, and improved consistency across markets. Crucially, they emphasized change management, taking a phased approach that won internal buy-in and shifted organizational mindsets toward data quality and digital-first thinking.

Singh concluded the session by urging attendees to reconsider their perception of labeling, stating, "My last message to everyone here is, do think about labeling very differently to it just being a back-end process that underpins the business. It's an absolutely invaluable asset to accelerate your business."

You can watch the full session here to find out more about Kenvue’s digital transformation and its benefits.

Want to Know More?

Overall, the Gartner Supply Chain Symposium/XPO was a great opportunity to have meaningful discussions with some of the world’s leading supply chain professionals. For those of us in labeling and artwork management, it’s clear that AI, smarter data use, changing consumer expectations, and the growing demand for digital skills aren’t just buzzwords—they’re real drivers of change. 

Here at Kallik, our experts are here to help businesses stay ahead of the curve, building labeling and artwork processes that are agile, compliant, and future-ready. Our session with Kenvue was a great example of what’s possible when the right technology meets a bold vision. Want to see how we can help you stay ahead of the change? Get in touch with us today by emailing enquiries@kallik.com or calling +44 (0) 1827 318100. Alternatively, click here to book a demo and see what our software can do for your business.

It’s no secret that the importance of supply chain traceability and transparency is increasing constantly, so much so that it’s becoming a business imperative for staying competitive. From ensuring compliance to managing recalls, companies need end-to-end visibility over every component of their operations. Yet, one area often overlooked is the artwork approval process.

Labeling errors or untraceable changes to packaging artwork can have serious consequences—misidentification of products, compliance breaches, and costly delays, not to mention the reputational damage and risk to lives. That's why more companies are recognizing that traceability starts with approval workflows.

At Kallik, we understand the importance of traceability and the need to close the visibility gap in labeling and artwork management, which is why we’re here to change the game!

Why Artwork Approvals Matter for Supply Chain Traceability

Before a product reaches the shelves, its label passes through multiple departments, each with their own requirements. Without a centralized system, these workflows become fragmented, undocumented, and difficult to trace. This creates blind spots that compromise supply chain integrity.

But you can eliminate this risk by bringing every step of the artwork approval process into a single, configurable workflow, ensuring full visibility and accountability across all stakeholders.

The Importance of a Label Audit Trail

Our partners at TEKLYNX emphasize the significance of maintaining a detailed label audit trail. In their blog post, they state: "A label audit trail is a reliable, consistent way of documenting changes made to label designs. Maintaining an accurate label audit trail reduces the risk of labeling errors and helps pinpoint the cause if they happen."

They further highlight that labeling mistakes are no small issue, noting that at least 40% of recalls published by the United States Food and Drug Administration (FDA) are due to labeling errors.

By implementing a cloud-based, end-to-end solution, you can ensure that every change is documented, every approval is tracked, and every label is accurate—thereby enhancing traceability and reducing the risk of costly errors.

How to Achieve End-to-End Visibility

Kallik’s end-to-end, cloud-based software, Veraciti, was designed with highly regulated industries in mind. Veraciti gives you complete control over the artwork approval process, with configurable workflows that reflect your internal structure—whether that’s a simple sign-off or a multi-stage route through marketing, legal, and regulatory. You can assign specific approvers at each step, and the system logs every action for full traceability. What’s key, is that it’s your choice! It can be completely adapted to meet the needs of your business.

Artwork can be reviewed directly in-platform, with tools for commenting, annotating, and highlighting specific layers or colours. These updates appear live, so multiple reviewers can collaborate simultaneously. All feedback is captured in an audit trail that’s locked down for integrity—while you can remove your own comments (with a required reason), other users' input is protected and cannot be altered, ensuring nothing slips through or is lost.

Built-in inspection tools highlight any changes between versions side by side, making it easy to review updates. And with the option of ‘pixel to pixel’ to compare visual assets at the pixel level, ideal for spotting graphical changes, or ‘text to text’ for detecting any variation in written content, its easier than ever to keep reviews error-free.

In addition, users must provide reasons for any rejections or changes, creating a clear record of decisions. You can also link order numbers to labels to ensure the right content is used for each product run.

Once approved, artwork is stored in the Asset Manager and made available for print at selected factories. Start dates can be scheduled, and outdated versions are automatically archived to avoid production errors.

Finally, Veraciti’s reporting dashboard gives you oversight across your entire process—showing approval times, identifying bottlenecks, and tracking project statuses to help you continuously improve.

No More Guesswork—Just Proof

By embedding traceability into the artwork approval process, Veraciti ensures that the right version of the right label gets to the right product, every time. Whether you're managing complex regulatory artwork for pharmaceuticals or multi-language packaging in consumer goods, Veraciti gives you the control and transparency needed for today's supply chains.

Want to see how Veraciti can make your labeling and approvals traceable from start to finish? You can read our free guide, A Supply Chain Director’s Guide to Labeling in 2025, for expert advice on how to future-proof supply chains with digital labeling and automation for end-to-end traceability. Alternatively, click here to book a demo or speak to one of our friendly experts by emailing enquiries@kallik.com or calling +44 (0) 1827 318100.

Even a small change to a labeling symbol can ripple across global operations, causing serious delays and risking costly recalls. With the newly announced shift from “EC REP” to “EU REP” as outlined in the latest amendment to ISO 15223-1, it’s important to get started on implementing mass changes as soon as possible to maintain compliance and prevent reputational damage. So, what does this latest regulation update mean for your business, and how can you stay ahead?

What’s Changing with ISO 15223-1?

The ISO 15223-1:2021+Amd 1:2024 standard introduces a key update: the traditional "EC REP" symbol used to indicate an authorised representative in the European Community is being phased out in favour of a more regionally adaptable “XX-REP” format.

For manufacturers selling into Europe, this means adopting the “EU REP” symbol to represent their European Union Authorised Representative. Other variations like “CH REP” (Switzerland) and “UK REP” (United Kingdom) are also emerging in local jurisdictions.

This change reflects today’s political borders and helps create a more adaptable approach to labeling in different regions as well as eliminating any confusion with the symbols. You can read more about the update here.

Why It Matters

While this may seem like a minor design tweak, the impact is significant—especially for manufacturers operating across the world. With every single use of the “EC REP” symbol needing to be identified, replaced and re-approved, companies often turn to expensive third parties to make these changes. With proper end-to-end labeling and artwork management software that can automate these changes, the process can be quick, simple and smooth, all while keeping costs down.

Beth Peckover, Chief Delivery Officer at Kallik explains: “While comprehensive labeling software may seem like a significant upfront investment, the ability to instantly implement thousands of updates in response to evolving regulations can save businesses enormous time, cost, and compliance risk in the long run. Regulations are constantly changing–and fast–meaning automation isn’t just a nice-to-have, it’s essential for staying competitive and audit-ready.”

How Kallik Can Help

At Kallik, we help medical device and pharmaceutical companies stay ahead of regulatory changes with powerful automation. With Veraciti™, you can update 10,000 labels in just 14 days—compared to six months using traditional methods—thanks to our smart, automated approach.

Our ‘Where Used’ function instantly identifies where a specific symbol or warning appears across all artworks and labels, enabling fast, accurate updates. Veraciti also flags layout issues, handles size variations across product ranges, and ensures changes don’t compromise compliance.

By replacing manual processes with cloud-based automation, customers have seen up to a 70% reduction in artwork costs. Tools like Automated Artwork Generation and Cascade maintain brand consistency and allow seamless integration with design tools like Adobe InDesign. Veraciti even automates approval workflows, cutting delays and accelerating time to market.

Future-Proofing Your Labeling Strategy

The update to ISO 15223-1 isn’t an isolated change—it’s part of a broader trend toward greater localization and increasing regulatory divergence across global markets. The emergence of country-specific reps and corresponding symbols (EU REP, UK REP, CH REP, NZ REP) only adds to the complexity.

This makes it more important than ever to modernize your labeling systems. Manual processes and fragmented artwork files simply won’t scale in a world where regulatory updates can happen any time, anywhere. With Kallik, your business is ready not just for today’s changes, but for whatever comes next.

Ready to Simplify Your Labeling Compliance

Whether you're preparing to update your EU REP symbol or facing broader challenges with global labeling requirements, Kallik can help. Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

Counterfeiting, product recalls, and supply chain disruptions are on the rise, meaning regulatory compliance is a non-negotiable for pharmaceutical companies. At the heart of that compliance sits one critical component: labeling. And when it comes to regulations like the U.S. Drug Supply Chain Security Act (DSCSA), the quality and accuracy of your labeling and artwork management processes could mean the difference between smooth operations and costly non-compliance.

What Is the DSCSA?

The Drug Supply Chain Security Act (DSCSA) is a U.S. federal law introduced in 2013 that aims to protect consumers from counterfeit, contaminated, or otherwise unsafe drugs. Its ultimate goal? To create an electronic, interoperable system that can trace prescription drugs throughout the entire supply chain.

Here’s what DSCSA requires in a nutshell:

• Every package and case of prescription drugs must carry a unique identifier
• Companies must be able to track and trace every unit across the supply chain at the unit-level
• Businesses need to verify the product’s legitimacy before it’s sold or returned
• Information about products must be shared digitally between supply chain partners

This regulation affects every player in the pharma supply chain—manufacturers, repackagers, distributors, and dispensers. And while much of the attention has focused on serialization and data exchange, one essential component is often overlooked: the role of labeling and artwork management in achieving DSCSA compliance.

Why Labeling Matters Under DSCSA

A label isn’t just a regulatory box to tick, it’s the vehicle for the serialized data that DSCSA requires and a critical touchpoint for verifying authenticity and ensuring supply chain continuity.

If your labels are:

• Inconsistent across products or facilities
• Incorrect due to manual entry
• Not linked to an audit trail
• Unable to adapt quickly to new regulations

…then you’re putting your business at serious risk.

What’s more, if you're still managing labeling processes manually or across disconnected systems, the chances of non-compliance skyrocket. Errors in serialization, mislabeling, or delays in label changes can lead to serious consequences, from major delays in getting products to market to recalls and fines, and not to mention the serious risk to consumers.

Why 2025 Is the Turning Point

With the DSCSA enforcement deadline now in full effect, 2025 is the year organizations will either succeed or stumble depending on their labeling and artwork process. And that’s not just about DSCSA. It’s about the future of supply chain compliance. The growing complexity of global regulations, such as the EU MDR, UKCA marking, and ESG reporting, means pharma companies must adopt a future-proof labeling strategy. Relying on manual methods or fragmented platforms simply doesn't cut it anymore.

The Solution: Digitization

Digitizing your labeling and artwork management process is a game-changer for compliance. A centralized, cloud-based platform like Kallik’s Veraciti™ empowers organizations to create and manage labeling and artwork with complete consistency and accuracy across the globe. By replacing manual processes with AI and automation tools, businesses can significantly reduce the risk of errors while increasing efficiency and, therefore, speed-to-market. Plus, every action and change is tracked in a full audit trail, giving companies the traceability they need to meet strict pharmaceutical regulations with confidence. With Veraciti, labeling is no longer a stressful, monotonous task, but a powerful tool for driving transparency, accountability, and operational efficiency across the entire supply chain.

Understanding the Future of Supply Chains: Download the New Guide

If your organization is struggling with compliance, our experts are ready to help. Our new guide, “A Supply Chain Director’s Guide to Labeling in 2025,” explores how to future-proof your supply chain with AI, automation, blockchain, and other technologies that go far beyond DSCSA.

Download the guide today to learn how you can:

• Eliminate compliance risks with smarter labeling
• Improve traceability across multi-region supply chains
• Reduce costs, errors, and time-to-market

Don’t let outdated labeling processes hold you back from DSCSA compliance. The future of pharmaceutical supply chains depends on transparency, accuracy, and agility, and it all starts with your labels. Want to know more about digitizing your labeling process? Speak to one of our experts on +44 (0) 1827 318100, email enquiries@kallik.com or click here to book a demo.

In our Meet the Expert series, we shine a light on the people behind the technology – the experts driving innovation, transformation, and customer success at Kallik. This week, we sat down with Sharad Khusal, our Senior Vice President Sales – Americas, to talk about what drew him to the labeling and artwork industry, what trends he sees on the horizon, and what inspires him both inside and outside of work.

Sharad’s Introduction to Labeling and Artwork Management

In my previous role as the head of the Global Life Sciences business at DXC Technology, I had the opportunity to work closely with a range of partners and explore their solutions. That’s when I was introduced to Kallik. Their approach to labeling and artwork management really stood out, especially in how they were digitally transforming a space that hadn’t seen much innovation at the time.

What impressed me even more than the technology was the leadership team. Their collaborative mindset and commitment to solving truly complex challenges in the pharma and medical device industries resonated with me. So, when Kallik approached me about joining their team to support growth in the Americas, it felt like a natural next step. I was excited to be part of a company with such a forward-thinking vision and potential to make a real impact.

I’ve been involved in the labeling and artwork industry for over a decade, particularly in the context of life sciences. Throughout my career, I’ve built expertise in regulatory compliance, document control, submission management, and broader supply chain support – all within highly regulated environments like pharma and medical devices.

These experiences have helped me understand what businesses in this space truly need – whether it’s navigating compliance, accelerating speed-to-market, or creating more scalable and efficient processes. I bring that insight to the table to help customers overcome roadblocks and future-proof their operations.

The Challenges and Rewards of the Job

The job definitely isn’t without its challenges. A few years ago, I was managing a key account for a global pharmaceutical distributor in the U.S. We were gearing up for a major executive presentation, but the project was off-track and missing key milestones. I was brought in to assess and turn it around.

I quickly realized that the core issue wasn’t technical; it was down to collaboration and communication issues. As a result, I stepped in to take over the role, reset team expectations, and re-establish a collaborative environment.

We realigned on goals, clarified roles, and rebuilt trust, not just within the team, but with the client too. By focusing on open communication and unity, we delivered the final presentation on time. That experience reinforced for me how vital leadership and collaboration are in driving outcomes.

Despite the challenges that arise sometimes, it’s an extremely rewarding role thanks to the relationships. For me, I enjoy building strong, trust-based relationships with our customers. Throughout my career, I’ve always been in customer-facing roles, and I’m driven by helping clients solve real challenges, making their day-to-day work easier, more efficient, and more successful.

The most satisfying moments are when clients reach out to me for guidance on matters beyond the immediate scope of my role. That level of trust, when they see me not just as a vendor but as a strategic advisor, means I’ve earned a place as a true partner in their success. That’s what I strive for every day.

Staying Ahead of Industry Trends

The pace of change in our industry is only accelerating, especially across regulated sectors. Some of the major trends I see include:

Regulatory complexity: Global regulations like FDA, EMA, MDR, and UDI are evolving fast, and businesses need agile, audit-ready processes to keep up.

• Digital transformation & automation: Companies are moving away from manual processes and embracing cloud-based, AI-driven platforms to boost efficiency and reduce risk.
• Sustainability: ESG goals are pushing for eco-friendly labeling practices, like waste reduction and digital traceability.
• Globalization: Businesses need scalable solutions that work consistently across regions and can adapt quickly to supply chain shifts.
• On-demand, personalized labeling: Advances in digital printing are making real-time, market-specific labeling essential.

At Kallik, we’re staying ahead of these shifts by investing in cloud-native technology, AI, and automation. Our platform helps customers stay compliant, streamline operations, and reduce waste – all while scaling globally and adapting to what’s next.

What Sets Kallik Apart

Labeling is often overlooked, simply considered a downstream task–something to handle at the end of the product journey. But here at Kallik, we know that couldn’t be further from the truth! At Kallik, we know labeling is a critical control point that affects compliance, time-to-market, and even patient safety. At Kallik, we help organizations turn labeling from an operational risk into a strategic advantage.

In my view, what really sets Kallik apart is our ability to offer a true end-to-end solution that covers the entire labeling and artwork process in one unified platform, eliminating the need for multiple tools or applications. We also lead the way in composability, providing a level of modular, flexible configuration that even Gartner has recognized. Our AI-powered onboarding tool accelerates migration significantly, while our Where Used functionality enables customers to make bulk changes at scale, quickly and consistently. And as a cloud-native platform from day one, we bring over 20 years of cloud expertise—something most competitors are only just beginning to build.

What advice would you give to businesses looking to improve their labeling and artwork processes?

My biggest piece of advice is to look beyond isolated features. You need to think holistically: what will truly improve efficiency, scalability, and compliance over the long term? I’d also suggest choosing a vendor with proven cloud experience, strong security credentials, and an integrated platform that unites collaboration, content management, and compliance in one place. A piecemeal approach just won’t cut it in today’s regulated markets. That’s why I believe Kallik is the best choice, as we don’t just help global businesses fix their labeling challenges, but also evolve their processes for the future.

Sharad Outside of Kallik

Outside of work, I enjoy listening to music, watching films, and taking long walks in the park – all great ways to reflect and reset. I also love spending time with my son, especially when we go go-kart racing or play pool together. It’s a fun way to stay active and connected.

One thing that might surprise people is that I used to be a goalkeeper on my high school soccer team – and I still enjoy playing and watching soccer today.

What Inspires Sharad?

Some things that have always stuck with me are from my father and teachers: “Never give up” and “Keep on striving.” Simple, but powerful. Another one I live by is the idea of “living a rich life now and a richer life in the future.” It’s about embracing growth and resilience and always aiming higher, both personally and professionally.

If I could have dinner with any celebrities, they’d be Mahatma Gandhi and Nelson Mandela. Their stories of resilience, patience, and nonviolent leadership are incredibly powerful. They didn’t just lead; they lived their values, even when the stakes were immense. During one of the most demanding periods of my life – working full time, travelling constantly, and pursuing an MBA – I found strength in their journeys. Their commitment to positive change continues to inspire me every day.

Speak to Sharad About Your Label and Artwork Process

Looking to improve your labeling and artwork management process? Why not chat to Sharad? Contact our experts by clicking here, emailing enquiries@kallik.com, or calling +44 (0) 1827 318100.