In labeling and artwork management, every stage of the process demands attention to detail, from initial design to final compliance checks. However, despite the focus often placed on the design, approval, and regulatory phases, the printing stage—the final hurdle—often remains fraught with challenges. Errors and inefficiencies during printing can derail an otherwise flawless process, leading to delays, reprints, and in some cases, costly product recalls.

What many companies fail to recognize is that these printing challenges are not inevitable. They are often the result of fragmented, outdated workflows. By streamlining the entire process with an end-to-end solution, organizations can eliminate these pain points and ensure the smooth transition from digital design to physical print.

Common Printing Problems

Here are some of the most common problems when it comes to setbacks and obstacles in the printing process.

Inconsistent File Formats

One of the most common issues arises when artwork files are sent to print in formats that aren't compatible with the printer's systems. Variations in file types and resolutions can lead to misprints, wasted resources, or the need for costly manual adjustments at the last minute. These problems arise from fragmented systems that do not standardize formats across the process.

Last-Minute Changes

Regulatory updates or internal decision-making often require last-minute changes to the label, and when these updates come too late in the process, they force rushed print jobs. This increases the risk of errors, such as incorrect product information, which can lead to non-compliance or even product recalls.

Manual Approvals and Proofs

Many organizations still rely on manual processes for approving artwork proofs before printing. This manual method is time-consuming and prone to human error, especially when multiple stakeholders are involved, or when approvals are needed across different departments or external partners. Miscommunication or overlooked details during these reviews can result in faulty prints that go unnoticed until it’s too late.

Data Misalignment and Compliance Issues

Inaccurate or outdated data in the artwork itself, such as incorrect barcodes, product codes, or legal information, can result in non-compliant labeling. If these discrepancies aren’t caught before printing, they can lead to costly recalls, customer dissatisfaction, and even regulatory penalties.

Communication Gaps Between Teams

A lack of coordination between the artwork management team and the printing department can lead to major miscommunication. Whether it's missing critical information about color specifications or misunderstanding deadlines, poor communication often causes avoidable errors that complicate the printing process.

Why End-to-End Software is the Solution

These challenges arise because many companies rely on siloed tools and manual processes that disconnect different parts of the labeling and artwork journey. By using disjointed systems, businesses increase the likelihood of mistakes that only manifest during the final print stage. However, by adopting an end-to-end solution that connects every stage of the process—design, approvals, data management, compliance, and printing—organizations can ensure that these pain points are eliminated.

A Cloud-Based, End-to-End Solution Provides:

A Single Source of Truth: Everyone involved, from the artwork team to external suppliers, works from the same system, ensuring that any updates are automatically reflected across all stages of the process. This ensures consistency and reduces the chance of last-minute surprises.

Streamlined Approvals: Automating the approval process means fewer manual errors and delays. An end-to-end solution ensures that all stakeholders can review and approve artwork in a timely and coordinated manner, preventing hold-ups at the printing stage.

Better Communication: With a connected, cloud-based system, there are no communication silos, no matter where you are in the world. Design teams and print departments have access to the same data, reducing the likelihood of miscommunication and making it easier to resolve any issues that arise before the printing process begins.

Fewer Last-Minute Changes: Because all relevant departments and external stakeholders are involved earlier in the process through automated workflows, changes can be made well in advance of the printing deadline. This reduces the need for rushed, high-risk print jobs.

Kallik’s Veraciti: A Fully Cloud-Based End-to-End Solution

Kallik’s Veraciti is an end-to-end labeling and artwork management solution that covers the entire process, from design to print, eliminating the pain points often encountered in the final stage. What sets Veraciti apart is its innovative and flexible approval workflows, a feature designed to adapt to the needs of each project.

Veraciti is unique in its ability to allow users to configure their approval workflows, selecting the most efficient approach for the task at hand. Whether you need to send approvals to every stakeholder simultaneously to allow parallel reviews or prefer a more sequential approach, Veraciti gives you the flexibility to choose. With the ability to group individuals or departments together, you can easily tailor the workflow to suit your organization’s unique needs.

Even more impressive is Veraciti’s capability to include both internal and external stakeholders in the approval process. This means you can collaborate seamlessly with partners, suppliers, or regulatory bodies outside your organization without the usual delays associated with external approvals.

By streamlining this part of the process, Veraciti ensures that when it’s time to print, you’re working from a finalized, approved, and compliant version of your label. No last-minute surprises, no unnecessary delays.

Want to Know More?

To see how Kallik’s Veraciti can revolutionize your labeling and artwork management, particularly the often-problematic printing stage, click here to book a demo today. Discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

When it comes to labeling and artwork management, understanding key terms is crucial for streamlining workflows, ensuring regulatory compliance, and optimizing product packaging. Below is a comprehensive glossary of essential jargon and technological terms to help you navigate this complex industry.

What is a DAM (Digital Asset Management) system?

A DAM system is a software solution designed to store, organize, and manage digital assets such as images, videos, and documents. In labeling and packaging, DAM systems help streamline content management and ensure version control, reducing errors in artwork management.

What is version control?

An essential feature in label design and packaging workflows that tracks changes made to digital assets over time. Version control ensures the correct and most updated design is used for label printing and production.

What is 2D barcode labeling and what are the benefits of 2D barcodes?

2D barcode labeling, including QR codes (Quick Response codes), adds a new dimension to product packaging by storing more data than traditional barcodes. QR codes can link to digital content, such as product manuals or sustainability initiatives. Using QR codes helps reduce the need for excess packaging material, aligning with eco-friendly labels while offering consumers easy access to additional product information.

What is the difference between labeling design software and artwork management software?

Label design software focuses on creating and customizing product labels, offering features like pre-built label templates, design elements, and support for printing barcodes. Artwork management software, on the other hand, manages the entire lifecycle of product artwork, from design to approval, version control, and ensuring compliance with standards like FDA or ISO 13485 (International Organization for Standardization).

Some providers offer a combination of both label design and artwork management software in one end-to-end tool. This integrated approach allows teams to handle everything—from label creation to artwork approvals—under one platform, making it an ideal choice for businesses seeking streamlined management and consistency across their packaging projects.

Why is the FDA important?

The Food and Drug Administration sets important guidelines and standards that are crucial for labeling, manufacturing, and packaging in industries like food, cosmetics, and pharmaceuticals. It is critical that products adhere to 21 CFR Part 11 and 21 CFR Part 211 for labeling accuracy and data integrity.

What is 21 CFR Part 11 and Part 211?

21 CFR Part 11 is a regulation by the FDA that sets criteria for electronic records and signatures to ensure their integrity, authenticity, and security in pharmaceutical and biotechnology industries. 21 CFR Part 211 outlines the current Good Manufacturing Practice (cGMP) requirements for finished pharmaceuticals, focusing on quality assurance, documentation, and production processes to ensure safety and efficacy.

What is the GHS standard for labeling?

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is a worldwide standard for labeling hazardous materials. GHS labeling ensures that chemicals are classified and labeled consistently to protect consumer safety.

What does ‘content creation’ mean in labeling and artwork management?

The process of generating and designing digital content, including label designs, artwork, and marketing assets, that align with a brand's vision. For packaging, content creation involves crafting product labels, ensuring they meet FDA compliance or GHS labeling standards.

What is meant by content collation?

Content collation is the gathering of various digital assets and information, such as product descriptions, regulatory information, and design elements, into a unified format. In packaging project management, content collation is critical to ensuring that all necessary label details are included before factory printing.

What are label templates and what are the benefits of using label templates?

Predefined designs that can be used to create consistent and accurate labels. A label template can simplify the label creation process, ensuring that all regulatory details, such as FDA labeling requirements, are met.

What is translation management?

Managing the translation of label content to ensure consistency across multiple regions. This is crucial for companies that operate globally, as they need to comply with local regulations, such as EU MDR or IVDR.

What is meant by factory printing?

The process of printing labels and packaging materials at scale in a factory setting. Factory printing must ensure that label designs are correctly applied and meet compliance standards like OSHA (Occupational Safety and Health Administration) for workplace safety or GMP (Good Manufacturing Practice) for pharmaceuticals.

What is Natasha’s Law?

Natasha's Law, effective from October 2021 in the UK, requires all food businesses to provide full ingredient lists with clear allergen labeling on pre-packaged foods made on-site for direct sale. Named after Natasha Ednan-Laperouse, who died from an allergic reaction, the law aims to protect consumers with allergies by ensuring transparency and safety.

What is meant by GXP Compliance?

A general term for regulatory guidelines that apply to manufacturing, laboratory, and clinical practices. GXP compliance encompasses standards like GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice), which are essential for product labeling.

What is the difference between FileDrop and batch printing?

Filing via Filedrop involves printing labels individually by uploading files one at a time, ideal for small, ad-hoc jobs. Batch printing, on the other hand, automates the process by printing multiple labels in one go, based on predefined templates or data sets, making it more efficient for large-scale, repetitive labeling tasks in artwork management.

What is an IFU (Information For Use) leaflet and how is it different to an eIFU?

An IFU (Instructions for Use) leaflet is a physical document provided with medical devices, detailing instructions, safety information, and usage guidelines. An eIFU (electronic Instructions for Use) is the digital version, accessible online or via digital devices. The eIFU offers easier updates, environmental benefits, and convenient access, but may require digital literacy and device availability.

Why Understanding These Terms Is Important

For companies involved in labeling, artwork management, and packaging, understanding these terms is essential for:

Regulatory Compliance: Many industries, such as pharmaceuticals and food, must adhere to strict regulations like FDA labeling requirements, CPSC, or ISO 13485.
Streamlined Operations: Terms like content management and artwork management software reflect the need for digital tools to manage the complex lifecycle of packaging and labeling projects.

Efficient Workflows: Using the right labeling software, label templates, and DAM systems can significantly reduce production times and improve label accuracy.
By mastering these key terms, your team will be well-equipped to navigate the ever-evolving landscape of labeling and packaging artwork management, helping you stay ahead of compliance standards and operational efficiency.

Understanding the terminology surrounding labeling and artwork management is critical for optimizing workflows and ensuring compliance. Whether it’s using a label maker software or managing packaging project management, these key terms are vital to efficient and accurate product labeling. Stay informed to boost both your operational effectiveness and regulatory compliance!

Want to know more about Kallik’s end-to-end labeling and artwork software, Veraciti?

Ready to leave behind disjointed, email and spreadsheet-driven labeling and artwork management? With Kallik’s end-to-end software, designed with compliance and consistency at the heart, you can streamline operations and ensure global regulatory alignment effortlessly. As the only solution utilizing AI to simplify the migration process, switching to our software is seamless. Join the future of labeling with Kallik and transform your approach today. Get in touch to see what we can do for you at enquiries@kallik.com, call +44 (0) 1827 318100 or book a demo here.
 

Regulatory compliance is much more than just a legal box to tick—it’s a critical responsibility that can protect lives. One heartbreaking example of the devastating consequences of overlooking compliance is the tragic story behind Natasha's Law. This legislation, named after Natasha Ednan-Laperouse, was passed following her untimely death due to an allergic reaction to a food product that lacked clear allergen labeling. Natasha’s Law, which requires food businesses to provide full ingredient lists and allergen labeling on pre-packaged foods, serves as a reminder of the importance of regulatory measures designed to safeguard public health.

As Natasha’s story shows, lapses in compliance can have tragic consequences. Regulations are not merely bureaucratic hurdles but necessary safeguards that protect consumers and patients from harm. In healthcare, pharmaceuticals, food and beverage, and countless other sectors, adhering to regulatory standards can be the difference between life and death. It ensures that companies meet the safety and transparency standards that consumers trust. Moreover, as industries grow and change, these regulations evolve, demanding constant vigilance from businesses to remain compliant.

Yet, maintaining compliance is a significant challenge for many companies. Regulatory standards can be complex, and with frequent updates and new laws coming into effect, keeping up with these changes requires robust processes. Without the right tools, staying ahead can feel overwhelming, especially when a single labeling error, oversight in product data, or failure to meet compliance standards can result in recalls, fines, or worse—risk to human life.

This is where innovative, future-proof compliance solutions play a crucial role. When it comes to the labeling and artwork process, choosing the right management software really can be a lifesaver. It’s important to look for software that is designed with regulatory and brand compliance at its core to ensure the safety of consumers and patients. It’s also key to choose a software that allows for quick and easy mass changes to be made across up to tens of thousands of labels and artworks when a new regulation is introduced or an existing regulation is changed.
 

Introducing Veraciti
 

One key differentiator of Veraciti is its ability to implement mass changes to labels and product information in as little as 14 weeks. Compared to the 6 months that many other platforms take, Veraciti’s streamlined and scalable tools drastically cut down the time required to respond to regulatory changes. This speed not only ensures businesses remain compliant but also saves significant time and resources. As regulations continue to evolve, having a system in place that can adapt quickly is critical to future-proofing your business and staying ahead of competitors.

Investing in Veraciti isn’t just about meeting today’s compliance demands—it’s about positioning your business to respond seamlessly to future changes, avoiding costly disruptions or penalties. Veraciti’s advanced technology, designed with compliance at its heart, ensures that your brand remains both compliant and trusted by consumers. In a world where regulations are ever-changing, choosing a solution that keeps you compliant in the long term is an investment that pays for itself time and time again.

Want to know more?
 

Kallik's Veraciti is your partner in compliance—whether for today’s needs or tomorrow’s regulatory landscape. Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

When it comes to labeling and artwork management, many businesses find themselves stuck with legacy systems that are slow, outdated, or inefficient. Yet, the idea of switching to a new software platform is often met with resistance. Why? Because the prospect of transitioning from one system to another feels like a daunting task. At Kallik, we understand these challenges, and that’s exactly why we’ve developed AToM—our revolutionary AI-powered software that dramatically simplifies this process.

In this blog, we’ll explore the main challenges of switching labeling and artwork software, and more importantly, how AToM helps overcome them with ease, making Kallik the industry leader in this space.
 

The Common Challenges in Transitioning Software
 

Switching from one software platform to another is never an easy decision. Businesses are often concerned about a range of potential obstacles:

1. Time-Consuming Data Migration
One of the biggest challenges companies face is migrating their existing data, such as label templates, artwork files, and regulatory information, from their current system to a new one. This is often seen as a lengthy, manual process that could lead to extended downtime.

2. Disruption to Business Operations
Transitioning software can disrupt day-to-day business processes. Employees who are comfortable with their current tools may find it difficult to adapt to new software. This disruption can result in a loss of productivity.

3. Complex Integrations with Other Systems
Many labeling and artwork management systems don’t exist in isolation—they are integrated with other systems like ERP (Enterprise Resource Planning) or PLM (Product Lifecycle Management). Migrating to a new system often requires complex integration work that could delay the transition.

4. Training and Onboarding
Training staff on a new system can be time-consuming and costly. Many businesses fear the learning curve that comes with switching to unfamiliar software, and they often worry that their teams will struggle to adopt new workflows.

5. Cost of Hiring Third-Party Experts
To overcome these challenges, companies frequently turn to third-party consultants or IT specialists to manage the transition. However, this can be an expensive option, both in terms of time and money.

Enter AToM: The Solution to Hassle-Free Software Transitions
 

At Kallik, we’ve developed AToM (Assisted Technology of Migration) —the first AI-driven labeling and artwork software designed specifically to tackle these challenges. AToM leverages cutting-edge AI technology to streamline the entire process of switching from legacy systems to our platform, without the common hassles.

Here’s how AToM makes a difference:
 

1. Automated Data Migration
One of AToM’s standout features is its ability to automatically migrate data from your existing software. Using advanced AI algorithms, AToM can analyze, categorize, and transfer your data in minutes or hours, not the weeks or months that traditional migration methods require. This means less downtime and a smoother transition for your business.

2. Minimal Disruption to Operations
AToM is designed to integrate seamlessly into your existing workflows. With a user-friendly interface and automated processes, the need for extensive retraining is drastically reduced. Employees can get up to speed quickly, and the disruption to your business operations is minimized.

3. Quick and Easy Integration with Existing Systems
Unlike other platforms that require complex, custom integrations, AToM offers pre-built connectors that allow for rapid integration with your existing systems, such as ERP or PLM platforms. This ensures a smooth, end-to-end process without additional development time.

4. Instant Onboarding & Training Support
AToM’s intuitive design and built-in AI assistance drastically reduce the learning curve. Our platform provides real-time, guided assistance to users, making it easy for teams to get started right away. This not only accelerates the onboarding process but also boosts employee confidence in using the new system.

5. Eliminate the Need for Third-Party Consultants
Because AToM automates so much of the manual work involved in switching platforms, there’s no need to hire costly third-party consultants or IT specialists. Our software does the heavy lifting, saving you significant time and money.

Why AToM Puts Kallik Ahead of the Competition
 

While other providers may offer solutions that involve lengthy transition periods and high costs, Kallik’s AToM is a game-changer. We’re the first in the industry to provide a platform that uses AI technology to simplify, streamline, and accelerate the entire transition process. Where our competitors take weeks or even months, AToM completes the job in just hours—making it clear that we are far ahead in offering a truly effortless solution.

Make the Switch with Confidence
 

If you’ve been hesitating to switch from your current labeling and artwork software due to the perceived hassles, it’s time to reconsider. AToM’s AI technology eliminates the pain points associated with data migration, system integration, and employee onboarding, allowing you to make the transition quickly and efficiently. With Kallik, the future of labeling and artwork management is here, and it’s faster and easier than ever before.

Don’t let outdated software hold you back. Make the switch with AToM and experience the benefits of cutting-edge AI technology that’s designed to make your life easier. Ready to make the switch? Contact Kallik today to learn more about AToM and how we can help streamline your labeling and artwork processes!
 

When it comes to managing complex labeling and artwork processes in industries like pharmaceuticals, cosmetics, and food & beverage, Kallik’s software, Veraciti™, stands out as a leader. However, customers and prospects often have many questions about the labeling and artwork process in this digital revolution and some of the terms we use. Below, we’ve compiled answers to some of the most common inquiries we receive.

Question: What is Asset Management?

Answer: Asset Management refers to the systematic handling of digital assets such as images, logos, and other artwork elements. Veraciti™ provides a centralized repository where these assets are stored, organized, and easily accessible, ensuring that the latest and most accurate versions are used across all projects. This minimizes errors and ensures consistency in branding and labeling.

Question: What role does Content Management play in the labeling process?

Answer: Content Management is crucial for maintaining the integrity of information across all labels and packaging. Veraciti™ allows users to create, edit, and manage content in a controlled environment. This ensures that all text, legal information, and branding elements are up-to-date and consistent across all products and regions.

Question: Can Kallik's software handle Digital Asset Management (DAM)?

Answer: Yes, Veraciti™ includes robust Digital Asset Management (DAM) capabilities. It provides a secure and organized way to store, retrieve, and manage digital assets such as images, graphics, and templates. This is critical for ensuring that only approved assets are used in final artwork and labeling, maintaining brand consistency and compliance.

Question: How does Translation Management work in your software?

Answer: Translation Management in Veraciti™ ensures that all text elements in your labels and artwork are accurately translated and localized for different markets. Veraciti™ does things very differently to our competitors by managing individual phrases and version controlling them and sending them for approval. This means that when a user is creating a label or artwork, they can quickly and simply select an additional country or region and let Veraciti™ automatically use the pre-approved phrases, translated into the language they need. This not only streamlines the process but also reduces the workload, enhancing product accessibility as well as cutting costs and providing faster speed-to-market.

Question: How does Factory Printing work in your software?

Answer: Factory printing needs to be carefully managed. It is the final stage of a very complex, tightly controlled process. Manual processes tend to be harder to control and track, which increases the chances of errors at the final hurdle. However, a global labeling solution like Veraciti™ enables full control and management of all labeling content in one centralized platform. This provides all stakeholders with full end-to-end visibility of the entire labeling process, from conception to print. Any discrepancies at any point in the process can subsequently surface much earlier, further reducing time-to-market and the risk of stock issues.

Question: What is Content Collation, and why is it important?

Answer: Content Collation refers to the process of gathering all necessary content—such as text, images, and regulatory information—for a specific label or artwork. Veraciti™ automates this process, ensuring that all required elements are collected and correctly placed in the artwork, reducing the risk of omissions or errors.

Question: How does your software manage Asset Approval?

Answer: Asset Approval in Veraciti™ is a streamlined process that allows stakeholders to review and approve assets at various stages of the artwork lifecycle. The software facilitates collaboration and ensures that only approved assets move forward, reducing the risk of non-compliance and errors in the final product.

Question: What are the benefits of Version Control in labeling and artwork management?

Answer: Version Control is essential for tracking changes and maintaining a history of all artwork and labeling revisions. Kallik’s software automatically manages versions, ensuring that the latest approved versions are used in production and that a complete audit trail is available for compliance purposes.

Question: Can Kallik's software integrate with other systems?

Answer: Absolutely. Veraciti™ is designed to integrate seamlessly with other enterprise systems, including ERP, PLM, CRM platforms and SAP. This integration ensures that all relevant data flows smoothly between systems, enhancing efficiency and reducing the risk of errors.

Question: What is the difference between Packaging Project Management and Labeling Project Management?

Answer: While both involve managing the lifecycle of packaging and labeling projects, Packaging Project Management focuses on the broader scope of the packaging process, including design, material selection, and production. Labeling Project Management, on the other hand, specifically deals with the creation, approval, and application of labels on products. Kallik’s software provides tools to manage both aspects efficiently.

Question: How does Packaging and Labeling Digitization Automation work?

Answer: Packaging and Labeling Digitization Automation involves using technology to automate the design, approval, and printing of labels and packaging. Veraciti™ uses automation and AI-powered technology to automate repetitive tasks, reduce manual errors, and speed up the entire process, from design to production.

Question: What does Prepress Ready Artwork mean?

Answer: Pre Press Ready Artwork refers to artwork that has been fully approved and is ready for printing. Veraciti™ ensures that all artwork is pre-checked for compliance, accuracy, and quality before it is sent to print, reducing the risk of costly errors.

Question: What is an 'end-to-end solution' in labeling and artwork management, and what are the benefits?

Answer: An 'end-to-end solution' in labeling and artwork management refers to a comprehensive system that covers every stage of the process—from initial content creation and asset management to final approvals and printing. This type of solution integrates all necessary tools and workflows into one cohesive platform, allowing for seamless coordination and automation across the entire lifecycle of a label or artwork.

Question: Does Kallik’s system integrate with Adobe InDesign?

Answer: Yes, Veraciti™ integrates with Adobe InDesign to automate the creation and updating of artwork files. This integration allows for quicker edits, consistent formatting, and the ability to handle large volumes of artwork with ease.

Question: What makes Kallik’s software stand out in terms of Packaging Design Automation?

Answer: Veraciti™ is the only software on the market using AI technology and we are constantly looking at new ways to innovate and offer our customers the best possible service. With a number of highly intuitive automation features and unique tools and functions, you are fully equipped for the future with Veraciti™, making it a great long-term investment for your organization.

Question: What are the advantages of using AI-powered packaging artwork tools?

Answer: Artificial intelligence is transforming the labeling, artwork, and packaging industries by automating tasks that were once time-consuming and prone to error. What used to be tedious, manual work—often resulting in costly mistakes—can now be handled with precision and speed, dramatically reducing time-to-market.

At Kallik, we're at the forefront of this revolution with our innovative AToM (Assisted Tool of Migration) technology. As the first solution of its kind, AToM automates the migration of digital labeling and artwork assets while ensuring accuracy, compliance, and operational efficiency. The results speak for themselves: we've seen time-to-market accelerate by an impressive 70%!

Question: Is Kallik's software cloud-based, and what are the benefits?

Answer: Yes, Veraciti™ is fully cloud-based, unlike many other solutions, and hosted on Amazon Web Services (AWS), which brings a host of additional benefits. AWS provides a highly secure, reliable, and globally scalable infrastructure, ensuring that our software is always available when you need it. With AWS, downtime is minimized to near-zero, meaning your operations can run smoothly without interruption. The cloud-based nature of our software also means that users can access it from anywhere, collaborate in real-time, and benefit from automatic updates and backups, all while enjoying the robust security measures AWS is known for. This setup ensures that your labeling and artwork management processes are not only efficient but also resilient and secure.

Want to know more?

By addressing these common questions, we hope to clarify how Kallik’s labeling and artwork management software can meet your needs. Whether you're looking to improve efficiency, ensure compliance, or streamline your packaging process, our solutions are designed to support your goals.

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.
 

In an effort to promote transparency and consumer empowerment, the Federal Communications Commission (FCC) has introduced new broadband labeling regulations. These rules, effective in 2024, require internet service providers (ISPs) to display comprehensive and easy-to-understand labels at the point of sale, similar to nutrition labels on food products. This initiative aims to provide consumers with clear information on broadband services, allowing them to make informed decisions and compare different offerings more effectively.

Summary of the Regulations

The new FCC regulations mandate that ISPs include detailed information on broadband labels, covering aspects such as:

- Pricing: Base monthly costs, fees, and introductory rates.
- Speeds: Typical upload and download speeds.
- Data Allowances: Information on data caps and any overage charges.
- Service Terms: Changes in service terms after introductory periods.
- Network Management: Links to information about network management practices and privacy policies.

These labels must be prominently displayed both online and in physical stores. The regulations apply to both wired and wireless broadband services. Large ISPs (with over 100,000 customers) were required to comply by April 10, 2024, while smaller ISPs have until October 10, 2024. Additionally, from October 2024, the labels must be machine-readable to facilitate data aggregation by third parties, potentially aiding in the development of comparison tools for consumers.

Implications for Manufacturers

These regulations have significant implications for manufacturers involved in label printing, packaging artwork, and label design. The requirements necessitate updates to product labeling, ensuring compliance with the new standards. Manufacturers must integrate these changes into their label templates, artwork designs, and packaging labels, ensuring all information is accurate and accessible.

Compliance Plan

Plan of Action for Manufacturers:

1. Assess Current Labels: Review existing labels and identify changes needed to meet FCC requirements.
2. Update Label Templates: Modify label templates to include all necessary information as per the new regulations.
3. Implement Changes: Use advanced label management systems and artwork management software to implement the required changes.
4. Test for Compliance: Ensure that the updated labels comply with FCC standards and are machine-readable.
5. Deploy and Monitor: Roll out the new labels across all points of sale and continuously monitor for compliance and accuracy.

How Kallik Can Help

Kallik’s Veraciti software offers a robust solution for manufacturers needing to comply with these new regulations. Veraciti can make changes to 10,000 labels in as little as 14 days, a process that typically takes six months with other software. This efficiency is achieved through our innovative automation tools and AI-backed technology, making us the only labeling and artwork software provider to offer such advanced capabilities.

Benefits of Using Kallik’s Veraciti:

- Automated Updates: Quickly update and print labels to meet regulatory requirements.
- AI-Backed Efficiency: Leverage AI to streamline label design and approval processes.
- Comprehensive Management: Manage all aspects of artwork design, label creation, and packaging artwork with our integrated label management software.
- Sustainable Labels: Support for eco-friendly labels and sustainable labeling practices.
- Real-Time Compliance: Ensure real-time compliance with ongoing regulatory changes using our advanced label manager and artwork management software.

By choosing Kallik, manufacturers can not only achieve compliance swiftly but also enhance their overall labeling processes, ensuring accuracy, efficiency, and sustainability. Our software for making labels and artwork approval software are designed to simplify complex labeling requirements, making us the go-to solution for all your labeling needs.

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.

Traceability is more than just a buzzword in the medical device industry—it's a vital component of regulatory compliance, operational efficiency, and ultimately, patient safety. At Kallik, we understand the critical role that robust traceability plays in ensuring patient safety, meeting regulatory requirements, and enhancing supply chain transparency. This blog explores the importance of traceability, the role of emerging technologies in enhancing it, and how advanced solutions like Kallik’s Veraciti™ are setting new standards in the industry.

The Crucial Role of Traceability in Medical Devices

Traceability in the medical device sector involves tracking every stage of a product's lifecycle—from development and manufacturing to distribution and usage. This meticulous tracking ensures that each device can be accurately identified and traced back through its supply chain, which is essential for several reasons:

Patient Safety: Traceability helps in promptly identifying and recalling faulty devices, thereby protecting patients from potential harm.

Regulatory Compliance: Regulatory bodies, such as the FDA in the U.S. and the European Medicines Agency (EMA) in Europe, require stringent traceability standards to ensure that all medical devices meet safety and efficacy requirements.

Supply Chain Efficiency: Effective traceability can streamline the supply chain, reducing errors and improving coordination among stakeholders.

The European Union’s Unique Device Identifier (UDI) system, mandated in 2020 for medical devices and 2022 for in vitro diagnostic devices, highlights the growing importance of traceability. Despite delays in the implementation of the EUDAMED database, the push towards comprehensive traceability remains strong, underscoring its significance in the industry.

The Role of Digitalization in Enhancing Traceability
 

Digitalization is transforming traceability in the medical device industry by breaking down traditional silos and creating a more integrated, transparent supply chain. By digitalizing various stages of the supply chain, manufacturers can achieve significant improvements in efficiency and visibility.

Cultivating Consistency

Life sciences supply chains are highly complex, involving multiple tiers of suppliers and wholesalers. Digitalization helps cultivate consistency across these complex networks. A key element in supply chain optimization is having a single source of content that is consistent throughout the ecosystem. This "single source of truth" can be a statement, symbol, image, or a combination, approved as the definitive version. With digitalization, this master source can be seamlessly integrated into every stage, from product development to customer fulfillment, ensuring everyone is using the latest, accurate content.

Ensuring Interoperability

For global traceability, digitalization ensures that labeling content meets local regulatory requirements and broader regional mandates. This includes accommodating local safety statements, symbols, and translations. A centralized digital system can trace all labels back to the original master source, maintaining integrity and clarity for local readers. This global interoperability is crucial for end-to-end traceability, giving organizations complete visibility of label content across all markets.

Addressing Organizational Challenges

Implementing a harmonized system for positive identification of medical devices is more of an organizational challenge than a technical one. Digitalization can overcome these challenges by establishing clear data governance and ownership. It ensures that the right stakeholders are responsible for decisions about changes and updates to labeling, critical for meeting local market requirements and maintaining compliance.

Enhancing Decision-Making and Collaboration

Digitalization also improves decision-making and collaboration within the supply chain. By integrating systems and data, stakeholders can operate more seamlessly and collaboratively. Regulatory, marketing, and manufacturing teams, as well as third-party partners, can access the same system overseeing the master content, allowing for efficient updates, modifications, and reviews. This enhanced collaboration ensures that everyone is working with the most up-to-date and accurate information.

Strengthening Supply Chain Infrastructure

Visibility across the supply chain is essential for effective traceability. Digitalization ensures that an authoritative master copy of the content for each label is easily identifiable and accessible throughout the process. This prevents the use of outdated symbols or statements and ensures compliance with traceability requirements. It provides real-time visibility of the most recently approved content and details of who approved it and when.

Overcoming Digitalization Challenges

Transitioning to a digitalized labeling management system can be challenging, especially when existing content is in non-editable formats like PDFs, printed documents, or emails. However, digitalization involves making content available at an atomic level, breaking it down into specific elements such as phrases, statements, or symbols. These elements can then be reconstructed and reused to create accurate new labeling, ensuring consistency and compliance.

How Veraciti™ Sets New Standards in Traceability

While many companies are leveraging emerging technologies to improve traceability, Veraciti™ stands out for its comprehensive and innovative approach. Veraciti™ offers a unique set of features that differentiate it from competitors, providing the best possible traceability solutions for the medical device industry.

1. Centralized Content Management

Veraciti’s centralized content management system ensures that all labeling and packaging content is consistent and up-to-date across the entire supply chain. This centralization eliminates silos, ensuring that every stakeholder has access to the latest, approved content, thereby reducing errors and improving compliance.

2. Global Interoperability

Veraciti™ is designed to meet local regulatory requirements while maintaining global interoperability. The platform supports multiple languages and regional mandates, ensuring that labeling content is accurate and compliant worldwide. This global approach ensures that every device can be traced back to a single source of truth, providing complete visibility and traceability.

3. Enhanced Collaboration

Veraciti™ facilitates seamless collaboration among all stakeholders, including regulatory, marketing, and manufacturing teams. By providing a single platform for managing content, Veraciti ensures that all parties can update, review, and approve content efficiently. This collaborative approach extends to third-party partners, ensuring an integrated and transparent supply chain.

4. Real-Time Visibility

Veraciti™ offers real-time visibility into the supply chain, ensuring that all activities are transparent and traceable. This visibility is crucial for maintaining compliance and quickly responding to potential issues. By providing detailed insights into the entire supply chain, Veraciti™ helps companies maintain high standards of traceability.

5. Future-Proof Solutions

Veraciti™ is designed with the future in mind, supporting the ongoing digital transformation of the medical device industry. The platform’s robust architecture and advanced features ensure that it can adapt to evolving regulatory requirements and technological advancements, providing a future-proof solution for traceability.
 

Leading the Way For Maximum Traceability

In an industry where traceability is paramount, digitalization is reshaping how companies track and manage their products. By breaking down silos and creating a more integrated supply chain, digitalization enhances consistency, interoperability, and collaboration. 

Veraciti™ is leading the way in the industry by leveraging these advancements to offer a comprehensive, future-proof solution that sets new standards in the medical device industry. By focusing on centralized content management, global interoperability, enhanced collaboration, and real-time visibility, Veraciti™ ensures that companies can achieve the highest levels of traceability and regulatory compliance.

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.

With regulations changing and tightening constantly and consumer demands shifting with a heightened focus on sustainability, it's no wonder that artificial intelligence (AI) and automation are taking the labeling and artwork world by storm. 

The digital transformation in labeling and artwork management is well underway and throughout 2024 so far we've seen a huge focus on innovation in AI and automation. Let's look at the benefits of AI and automation in artwork and labeling software and the risks of being left behind if organizations fail to digitize their processes.
 

The AI Revolution in Labeling and Artwork Management

Artificial Intelligence (AI) is no longer a futuristic concept; it’s a reality that is transforming the way businesses manage their labeling and artwork processes. AI’s capabilities in data analysis, predictive maintenance, and process optimization are proving to be game-changers.

How AI is Affecting the Industry:

Data Accuracy and Consistency:
AI algorithms can analyze vast amounts of data with unprecedented accuracy. This ensures that labels and artwork are consistent across all products and regions, reducing the risk of errors and non-compliance.

Predictive Analytics:
AI-powered predictive analytics can forecast market trends and regulatory changes, enabling companies to stay ahead of the curve. This foresight helps in proactive label and artwork management, ensuring timely updates and compliance.

Personalization:
AI allows for the creation of highly personalized labels and artwork tailored to specific consumer segments. This targeted approach can enhance customer engagement and brand loyalty.

The Automation Advantage

Automation is another key trend that is streamlining the labeling and artwork management process. By automating repetitive and time-consuming tasks, companies can achieve greater efficiency and accuracy.

How Automation is Affecting the Industry:

Workflow Optimization:
Automation tools streamline the workflow from design to approval, reducing the time required to bring new products to market. Automated processes eliminate bottlenecks and ensure smooth transitions between stages.

Cost Efficiency:
By reducing manual labor and minimizing errors, automation significantly cuts operational costs. Companies can reallocate resources to more strategic tasks, driving innovation and growth.

Regulatory Compliance:
Automated systems can be programmed to adhere to the latest regulatory standards, ensuring that all labels and artwork comply with industry regulations. This reduces the risk of costly compliance issues and product recalls.

The Risks of Not Adopting AI and Automation

The risks of not keeping up with AI and automation are substantial and could see your business left behind very quickly. During Kallik’s recent webinar, held in partnership with the Regulatory Affairs Professionals Society (RAPS), Gartner's John Blake discussed the importance of composability brought about by this digital transformation, likening it to the evolution of the compact disc. “I would have to go find the music I want to put on a CD, I’d have to find a blank CD and I’d have to find a CD burner. I’d then have to mail a physical copy out too. So quite honestly, that would probably take about two weeks to do. But with the introduction of streaming services, which is also digital music, it's composable. I could give you the name of a song or an artist, I wouldn't even have to spell it correctly, and you could find it and be listening to it in seconds,” John highlights the power of digitalization.

He went on to summarize, “We need to think about this in our business processes. We need to think about how we manage and utilize technology to really improve our processes around artwork and labeling. And certainly, that has benefits in the regulatory space.” The benefits in terms of regulatory compliance and efficiency are profound and should not be overlooked. Companies that fail to embrace these technologies may face:

Increased Errors and Non-Compliance:
Without AI and automation, manual processes are prone to errors, leading to non-compliance with regulatory standards. This can result in significant financial penalties and damage to brand reputation.

Higher Operational Costs:
Manual labeling and artwork management are labor-intensive and costly. Companies that do not automate these processes will find it challenging to remain competitive in terms of pricing and efficiency.

Slower Time-to-Market:
In a fast-paced market, speed is crucial. Companies relying on outdated manual processes will struggle to keep up with competitors who have streamlined their operations with AI and automation.
 

Why Choose Kallik:
 

Compliance Assurance:
Our AI-driven solutions ensure that your labels and artwork are always compliant with the latest regulatory standards, minimizing risk and ensuring peace of mind.

Cost and Time Efficiency:
By automating workflows and utilizing AI, we help our clients achieve significant cost savings and faster time-to-market, providing a competitive edge in a crowded market. Speak to one of our experts about our AToM (Assisted Technology of Migration) technology, developed in partnership with Aston University and driven by AI to significantly streamline and simplify the migration process.

Expert Support:
Our team of experts is dedicated to helping you navigate the complexities of labeling and artwork management. We offer personalized support to ensure you get the most out of our innovative solutions.

Want to know more?

The labeling and artwork management industry is undergoing a transformative shift, driven by AI and automation. Companies that embrace these technologies stand to gain significant advantages in terms of compliance, cost efficiency, and speed. At Kallik, we are proud to lead the way in this technological revolution, providing our clients with the tools they need to stay ahead of the competition. Don’t risk falling behind—partner with Kallik and embrace the future of labeling and artwork management today. 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.

When it comes to pharmaceuticals and medical devices, regulatory compliance stands as a cornerstone of patient safety and well-being. Yet, ensuring compliance with evolving standards and regulations poses significant challenges for organizations worldwide. Traditional methods of producing Instructions For Use (IFUs) and Patient Information Leaflets (PILs) have often proven inadequate in meeting these demands.

These documents serve as crucial sources of information for patients, providing guidance on the proper use of medical devices and medications. Inaccuracies or errors in these leaflets can have severe consequences. When it comes to pharmaceutical and medical device labeling, the risks can even be life-threatening.

Therefore, ensuring the accuracy and compliance of patient information and instructions for use leaflets is essential for safeguarding patient health and maintaining regulatory adherence. However, with the introduction of automation in the labeling and artwork industry, a new era of efficiency, compliance, and accuracy has arrived in IFU production.

Addressing Regulatory Gaps

As Bob Tilling, our label and artwork expert, highlights, regulatory compliance is crucial. Mid-sized device manufacturers often have to manage between 100 and 1,000 IFUs. Updating these documents to comply with the new EU Medical Device Regulation (EU MDR), which is significantly longer and more detailed than the previous directive, is a massive task.

Non-compliance with EU MDR labeling requirements not only puts patients at risk but also exposes organizations to legal repercussions and reputational damage. Traditional systems, including Product Lifecycle Management (PLM) systems, often fall short in controlling layout and content. Veraciti emerges as a beacon of hope, offering a comprehensive solution that not only manages content but also controls layout, ensuring compliance with regulatory standards.

Streamlining Processes, Eliminating Errors

The traditional approach to IFU production involves input from several stakeholders across the globe, consuming time and increasing the risk of errors. Veraciti revolutionizes this process by automating the generation of leaflets from a pre-approved single source of truth with automatic translations available, eliminating the need for manual intervention when creating and updating the leaflets.

Breaking Language Barriers, Ensuring Consistency

For IFU leaflets, it's crucial that the information can be correctly understood by patients and healthcare professionals worldwide. Veraciti enables organizations to swiftly generate IFUs in multiple languages within seconds. Unlike competitors who rely on less accurate methods like Google Translate, Veraciti offers pre-approved translations derived from a single source of truth, ensuring consistency and accuracy across all IFUs. This capability is a game-changer, empowering non-native speakers to access vital medical information with ease and confidence, ultimately contributing to improved healthcare outcomes globally.

Making the Move to eIFUs (Electronic IFU)

The transition from traditional paper-based IFUs to electronic formats marks a significant leap forward in efficiency and accessibility. Electronic IFU leaflets offer streamlined access, enhanced user experience, the ability to deliver multilingual content seamlessly, and significant sustainability benefits. With electronic IFUs, the process of updating information is far less time-consuming and involves less waste.

As Peter Muller explains in Med-Tech Intelligence, "Paper-based IFUs/PILs are printed in bulk, leading to waste when product/manufacturing information or safety advice needs to be updated. There may also be a level of risk to patients if they are accessing information that has been superseded."

Veraciti empowers organizations to generate IFUs in electronic formats, including XML files, ensuring compliance with regulatory standards while enhancing accessibility and integration. This capability enables organizations to navigate regulatory complexities with ease while delivering an unparalleled user experience.

Case Studies: Empowering Össur and Cardinal Health

Our collaboration with Össur, a leading provider of Class II medical devices, exemplifies the transformative impact of automation in IFU production. Össur faced numerous challenges, including disparate legacy systems, delays in product launches, and limited control over IFU assets. With Veraciti, Össur consolidated IFU phrases into a centralized system, enhanced visibility, and streamlined the approval process, ensuring compliance with regulatory requirements.

Similarly, our partnership with Cardinal Health, a global leader in healthcare services, highlights the critical importance of accuracy and compliance in IFU production. By streamlining the compliance process and eliminating errors, we have helped Cardinal Health navigate the complexities of regulatory standards, particularly in the context of MDR compliance.

Safeguarding Lives, Ensuring Compliance

By adopting our approach, the creation of multiple language EU MDR compliant 30-page IFUs has been reduced from 3-5 hours to just 30-40 minutes, with the time taken to generate individual labels reducing from 1 hour to around 10 minutes. For Class III devices alone, this efficiency has recovered 5 person-years of lost time.

In conclusion, automation in IFU production is a game-changer for compliance, accuracy, and efficiency. By leveraging the power of technology, organizations can streamline processes, eliminate errors, and ensure compliance with regulatory standards. Our partnerships with Össur and Cardinal Health underscore our commitment to empowering organizations with complete regulatory confidence.

For more information on the latest EU MDR and the issues with IFUs, read our blog: "EU MDR Labeling Compliance - Are We There Yet?" Looking for more advice? Speak to one of our experts by emailing enquiries@kallik.com.
 

With digital labeling and artwork management taking the world by storm, the concept of connected packaging is reshaping how consumers create products and how industries manage and deliver their goods. But what exactly is connected packaging, and how is it making such a positive impact?

So What is Connected Packaging?

Connected packaging refers to the integration of digital technology into product packaging, allowing consumers to interact with the packaging using their smartphones or other devices. Technologies like QR codes and NFC (Near Field Communication) tags enable this interaction, providing access to a wealth of information and services with a simple tap or scan.

Which Industries Are Benefiting the Most?

While connected packaging is making waves across various sectors, some industries are experiencing particularly transformative benefits:

- Pharmaceuticals and Medical Devices: Ensuring medication authenticity and offering dosage instructions.
- Fashion and Retail: Enhancing shopping experiences with virtual try-ons and style tips.
- Consumer Electronics: Offering installation guides and troubleshooting support.
- Food and Beverage: Providing detailed nutritional information and freshness tracking.

The days of cramming information onto your packaging are over!

By scanning a QR code or tapping an NFC tag, consumers can instantly access detailed product descriptions in any language they need, meaning there are no longer language barriers when it comes to marketing products and no need to modify labels and artwork for each country. Whether it’s a medical device needing instructions for use or a food or beverage item needing an ingredients list, a QR code can provide five or fifty language variations without affecting the label or artwork. Not to mention the opportunities for traceability so that consumers can understand where their products have come from and how they were made - vital in this day and age with people valuing transparency more than ever.

This brings us on to the topic of sustainability and understanding where and how packaging was made and what materials were used. Sustainability and environmental consciousness are increasingly important to consumers and manufacturers alike. Connected packaging is playing a vital role in promoting proper recycling practices by providing consumers with detailed, easy-to-access information. Here’s how connected packaging is making a difference:

Clear Recycling Instructions:

Material Identification: Connected packaging can help consumers identify the different materials used in the product and its packaging. For example, a product might have components made of plastic, glass, or metal, each requiring different recycling methods.

Step-by-Step Guides: Scanning a QR code or tapping an NFC tag can lead to step-by-step guides on how to recycle each component. This might include instructions on how to separate parts, clean them if necessary, and where to dispose of them.

Localized Recycling Information:

Custom Recycling Guidelines: Different regions have different recycling rules and facilities. Connected packaging can provide localized recycling information based on the consumer's location, ensuring that the instructions are relevant and accurate.

Recycling Centers and Drop-off Points: Consumers can be directed to nearby recycling centers or drop-off points, making it easier for them to recycle correctly.

Educational Content:

Environmental Impact Education: Brands can use connected packaging to educate consumers about the environmental impact of recycling and the benefits of proper disposal. This can include data on how much energy is saved by recycling, how recycling reduces landfill waste, and how it conserves natural resources.

Interactive Content: Interactive elements such as videos, animations, or quizzes can make learning about recycling more engaging and memorable for consumers.

Encouraging Responsible Disposal:

Incentives and Rewards: Some brands use connected packaging to offer incentives for recycling, such as discounts on future purchases, loyalty points, or donations to environmental causes. By rewarding responsible behavior, brands can motivate consumers to recycle more consistently.

Social Sharing: Consumers can be encouraged to share their recycling efforts on social media, using hashtags or participating in brand-led campaigns. This not only promotes recycling but also builds a community of environmentally conscious consumers.

Tracking and Reporting:

Recycling Data Collection: Brands can collect data on how often consumers access recycling information and how they engage with it. This data can help companies understand the effectiveness of their recycling initiatives and make improvements.

Transparency Reports: By providing transparency reports through connected packaging, brands can show consumers the real impact of their recycling efforts, such as the amount of material recycled or the reduction in carbon footprint.

Example Scenario

A consumer buys a bottle of water with a QR code on the label. By scanning the code with their smartphone, they access detailed instructions on how to recycle the bottle. The instructions include steps to rinse the bottle, remove the cap, and place the bottle and cap in different recycling bins.

The consumer is directed to a nearby recycling center and given the option to join a rewards program that offers discounts for every bottle recycled. The brand provides educational content on the importance of recycling plastic and how it helps reduce environmental pollution. The consumer can track their recycling efforts and see the positive impact they are making through the brand's transparency report.

Get Ahead of the Connected Packaging Revolution

The connected packaging revolution is transforming industries by making product information more accessible, improving supply chain transparency, and promoting sustainable practices. By integrating digital technology into packaging, brands can create richer, more engaging experiences for consumers while addressing critical issues like authenticity, transparency, and environmental impact. As this technology continues to evolve, we can expect even more innovative applications that will further enhance the way we interact with products and brands.

Kallik’s cloud-based, end-to-end innovative labeling and artwork platform, Veraciti™, is well equipped to help customers implement connected packaging, ensuring seamless integration of digital technologies and enhancing overall brand engagement and compliance. Our software can be used to generate and print QR codes with ease, enabling organizations to get ahead and take advantage of the connected packaging revolution.

Want to Know More?

Why not speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business to transform its product packaging process with the very best labeling and artwork management? Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.