The Future of Traceability in Medical Devices: Innovations and Emerging Technologies

The Future of Traceability in Medical Devices: Innovations and Emerging Technologies
Author Name
Kallik Role 1
Content Manager

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.

 

AI and Automation: Lead Labeling and Artwork Software Trends for 2024 So Far

AI and Automation: Lead Labeling and Artwork Software Trends for 2024 So Far
Author Name
Kallik Role 1
Content Manager

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.

 

Transforming IFU Production for Sustainability and Patient Safety with Kallik's Veraciti

Transforming IFU Production for Sustainability and Patient Safety with Kallik's Veraciti
Author Name
Kallik Role 1
Content Manager

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.
 

What is Connected Packaging and How is it Transforming Packaging Sustainability for the Better?

What is Connected Packaging and How is it Transforming Packaging Sustainability for the Better?
Author Name
Kallik Role 1
Content Manager

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.

 

Preventing Product Recalls and Saving Lives with Veraciti™

Preventing Product Recalls and Saving Lives with Veraciti™
Author Name
Kallik Role 1
Content Manager

Product recalls can be a nightmare for any company, and unfortunately, they’re more common than you might think with labeling errors a major cause for recalls. According to Packaging Digest, packaged product recalls increased by 63% in 2022.

In the pharmaceutical sector, according to Schlafender Hase, common labeling errors include incorrect dosage information, missing critical warnings, and incorrect storage instructions. For instance, mistakes such as "1-2 times a day" being printed as "12 times a day" or critical dosage information missing can lead to Class 1 recalls, where there is an immediate risk of death or serious injury.

Additionally, labeling issues often arise from manual proofreading errors and the complexities involved in updating labels to meet changing regulatory requirements across different regions. Errors in packaging content are among the most frequent culprits of recalls and where there is human input, human error is always to be expected.

Without a clear process for managing packaging content and the power of automation, companies put themselves and their consumers at significant business and personal risk. This is an area where paying attention to every detail is crucial in order to keep consumers safe.

Are you confident that your packaging management process can prevent recalls and keep your products safe for consumption? Let's explore how digital solutions can streamline your packaging content management process, safeguarding your brand, products, and most importantly, your consumers.


How Digital, Cloud-Based Labeling and Artwork Software Can Prevent Product Recalls


Content encompasses every element on a label or package containing a consumer product. Content management involves creating, modifying, organizing, and delivering this information. For packaged products, this includes everything from ingredient lists and nutritional information to packaging design and labeling. Content must be created and approved swiftly and accurately, often involving multiple stakeholders, making the management process complex.


To prevent recalls effectively, a solution should address the following key areas:


1. Centralized Information Repository: A centralized platform ensures that all packaging content is stored in one location, reducing the risk of errors and making it easier to track changes and updates. This central repository should support version control and audit trails to maintain a clear history of all content modifications.

2. Automation: Automation is crucial for reducing manual errors and speeding up the content management process. Automated workflows can handle repetitive tasks such as generating artwork, applying changes, and searching for content.

3. Error-Free Collaboration: Effective label and artwork management requires seamless collaboration among various stakeholders, including marketing, legal, regulatory, and design teams. However, when many teams are involved in editing and re-working content, it can be easy for errors to arise. Look for software that prevents these errors by flagging up mistakes.

4. Regulatory Compliance: Keeping up with regulatory requirements, such as the EU MDR, new Windsor Framework regulations, or the latest EU CLP updates, is vital to prevent recalls. A good digital solution should have tools and functions that make it quick and easy to automatically update content to meet the latest regulations despite tight deadlines.

5. Comprehensive Reporting, Version Control Management, and Approval Processes: Insightful reporting and effective approval processes help to monitor the performance of your process and ensure that the correct labels are printed every time. Look for software that provides detailed reports, version control management, and highly reliable approval processes.

6. User-Friendly Interface: A user-friendly interface ensures that all team members can use the software effectively without extensive training. The interface should be intuitive, with clear navigation and easy access to all essential features.

7. Scalability: As your business grows, your content management needs will evolve. Choose a solution that can scale with your business, accommodating an increasing volume of content and more complex regulatory requirements.


Choose Veraciti™ to ensure your labels and artwork are right first time, every time


At Kallik, we understand the critical importance of product safety and recall prevention. Imagine being able to create, review, and approve content for labels and artwork with complete confidence that you are 100% compliant. With our advanced digital solution, Veraciti™, you can make this a reality, just as Integra LifeSciences did. Since implementation more than five years ago, Integra reports it has not had a single issue with compliance. “We are delighted with our 100% success rate that Kallik helps us to deliver,” Senior Marketing Operations Manager, David Dreibelbis, enthuses.

Veraciti has also enabled Teleflex to completely mitigate product recalls thanks to the centralized cloud-based system. End-users benefit from standardized labeling processes and powerful features such as a dedicated asset search engine, enhanced phrase and translation management and end-to-end approval and audit trails.


What to expect from Veraciti™


Innovative, automated tools and functions such as the ‘Where Used’ function, the Rules Engine and Automated Artwork Generation (AAG).

Industry leading artificial intelligence (AI) driven technology such as Veraciti’s Assisted Technology of Migration (AToM).

As a truly end-to-end platform, Veraciti™ minimizes the need for input from multiple teams and external companies, ensuring a more seamless, efficient and error-free process. This also provides detailed audit trails at every step, enhancing transparency and accountability throughout the entire workflow.


How Veraciti™ Helps Prevent Recalls and Saves Lives


By investing in Veraciti™, you not only protect your brand and products but also safeguard the lives of your consumers. Accurate and consistent packaging content ensures that consumers receive the correct information, preventing potentially life-threatening mistakes. In doing so, Veraciti™ plays a crucial role in saving lives every day.

Don’t let a recall damage your brand’s reputation and endanger the lives of your consumers. Get in touch with us today to learn more about how Veraciti™ can help prevent product recalls and contribute to saving lives.


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.
 

Navigating Mergers with Ease: Bringing 100 New Products On Board with Ease

Navigating Mergers with Ease: Bringing 100 New Products On Board with Ease
Author Name
Kallik Role 1
Content Manager

When it comes to mergers and acquisitions, enterprise organizations face a myriad of challenges when integrating new products into their portfolios. From streamlining product integration to ensuring regulatory compliance and managing complex audit processes, the task can seem daunting. However, with the right tools and strategies in place, organizations can navigate mergers with ease, ensuring a seamless transition and unlocking new opportunities for growth. Enter Veraciti, a trusted partner in label management solutions, dedicated to simplifying the complexities of mergers and acquisitions for enterprise organizations. That’s where our end-to-end enterprise labeling and artwork software, Veraciti, can help.


Streamlining Product Integration:


One of the biggest challenges in mergers and acquisitions is integrating new products into existing portfolios seamlessly. Veraciti offers a comprehensive suite of tools and features designed to streamline this process. From automated artwork generation to centralized label management, Veraciti enables organizations to bring 100 new products on board with ease, minimizing disruptions and maximizing efficiency.


Rapid Name Changes:


Veraciti makes it quick and easy to change company names, brand names and company ownership of brands,thanks to our Automated Artwork Generation (AAG) tool and label templates. Gone are the days of hiring a team to spend months manually changing labels and artwork if your company undergoes a re-brand or merger, instead you can execute name changes in as little as 10 seconds with Veraciti. AAG ensures accuracy by maintaining one single, company and/or brand name, approved address and logo, automatically updating hundreds of labels in minutes.


Streamlined Logo Management:


Veraciti simplifies logo management by vectorizing logos, regardless of their size variations. With only one copy of each asset, resizing logos becomes effortless without compromising quality. This centralized approach also makes logo management easier and more efficient.


Automated Inspection:


Veraciti significantly reduces the need for manual inspection by utilizing automation to increase accuracy. Unlike other platforms where each label must be opened individually for inspection, Veraciti allows for sample checks, saving time and resources while maintaining precision.

With Veraciti, companies can navigate all of the usual complexities that come with mergers and acquisitions with ease, ensuring swift and accurate updates across all products and labels.


Ensuring Regulatory Compliance:


With regulatory requirements becoming increasingly stringent, ensuring compliance across a diverse range of products is paramount. Veraciti's robust compliance management capabilities help organizations navigate regulatory complexities with confidence. By providing real-time insights into labeling requirements and facilitating bulk changes seamlessly, Veraciti ensures that organizations remain compliant with industry standards throughout the merger process.


Scalability Made Easy:


One of the key benefits of partnering with Veraciti is scalability. As organizations undergo mergers and acquisitions, the need for scalable solutions becomes more pronounced. Veraciti's cloud-based deployment ensures that organizations can scale their label management capabilities effortlessly, accommodating new products and expanding operations with ease.


Case Study: Aspen's Success Story:


A 20-year-old major surgical device manufacturer comprised of 18 acquisitions, recently turned to Veraciti to standardize label printing across all factories. During Veraciti's implementation, Aspen brought on two more companies, seamlessly integrating them into the original project with no time overrun. Thanks to Veraciti's cloud deployment, the enterprise was able to add new companies with ease, demonstrating the scalability and efficiency of Veraciti's solutions.

So there you have it - navigating mergers and acquisitions doesn't have to be a daunting task. With Veraciti's comprehensive suite of label management solutions, organizations can streamline product integration, ensure regulatory compliance, manage audit and approval processes, and scale their operations with ease. By partnering with Veraciti, enterprise organizations can navigate mergers with confidence, unlocking new opportunities for growth and success.

Want to know more about how Kallik can help you? Download our free guide on labeling and artwork trends in 2024 to get started on transforming your cosmetic labeling and artwork management. Speak to one of our labeling and artwork experts for more information by emailing enquiries@kallik.com, calling +44 1827 318100 or filling in the form here.

 

The Need for Speed in 2024: Update 10,000 Product Labels in 14 Days

The Need for Speed in 2024: Update 10,000 Product Labels in 14 Days
Author Name
Kallik Role 1
Content Manager

In today's fast-paced business landscape, the ability to adapt and evolve is not just a competitive advantage; it's a necessity. With consumer preferences shifting, regulatory requirements evolving, and market dynamics changing rapidly, organizations must be agile in responding to these challenges. Nowhere is this need for speed more evident than in the realm of label management, where updating thousands of product labels swiftly can make all the difference between staying ahead or falling behind.


Everyone’s favorite hot topic: Artificial intelligence


The traditional approach to label management, with its manual processes and cumbersome workflows, is no longer sufficient in meeting the demands of the modern business environment. Thankfully, the emergence of AI and automation has ushered in a new era of efficiency and productivity. Veraciti, a leading provider of label management solutions, has been at the forefront of this transformation, featuring automation and investing in AI to aid and streamline label and artwork management processes.

Kallik’s Assisted Tool of Migration (AToM), the first of its kind in the labeling and artwork industry, leverages the power of AI to streamline the entire label and data migration process, from a variety of content sources, reducing manual effort and potential for errors. It works by extracting content labels or artworks in any format and generating intelligent templates with regulatory and brand logic included as standard. Further to this, AToM is also incredibly intelligent when it comes to identifying aspects of your content that may lead to errors and issues further down the line.


Let’s talk automation: Automated Artwork Generation


Another of Veraciti's flagship offerings is its Automated Artwork Generation (AAG) function. AAG dynamically assembles the chosen pre-approved content. By using intelligent pre-approved templates to automatically generate the artwork or label, the need for human input is removed, reducing the risk of errors as well as rapidly decreasing project completion times. Labels or artworks are created within seconds rather than days or weeks. This revolutionary technology not only accelerates the label design process but also ensures consistency and accuracy across all product labels - which is a huge improvement compared to traditional methods.


Speed without compromising on compliance with the ‘Where Used’ function


But speed alone is not enough; organizations must also ensure compliance and consistency in their label management processes. The ‘Where Used’ function is a key feature in helping to maintain compliance while also increasing speed-to-market. It has the ability to identify specific components and recognize every artwork or label where they have been used previously. With ever-changing regulations, this makes the process of making bulk changes to icons, images and phrases seamless, both facilitating and accelerating the process of achieving regulatory compliance. Whether it's updating warnings to meet FDA labeling requirements or incorporating new branding elements, the 'Where Used' function ensures that every change is implemented efficiently and accurately.


Change 10,000 product labels in just 14 days rather than six months


In a world where every second counts, efficiency is paramount. One Kallik customer using Veraciti updated 10,000 product labels in 14 days gain a significant competitive advantage, allowing them to respond swiftly to market demands and stay ahead of the curve. With Veraciti's AI-powered solutions and innovative features like AAG and 'Where Used,' organizations can unlock new levels of efficiency and productivity, enabling them to thrive in today's fast-paced business environment.

Want to know more about how Kallik can help you? Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even 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.

 

How Brexit is Still Affecting Product Packaging

How Brexit is Still Affecting Product Packaging
Author Name
Kallik Role 1
Content Manager

As Brexit unfolded, the packaging and labelling industry experienced a seismic shift in regulations. Manufacturers and distributors scrambled to adapt to new requirements governing product packaging, labelling, and artwork. In this blog, we explore the ways Brexit has impacted the industry so far and look at how businesses are still adapting today. We also look at how you can prepare your business for future regulation changes to ensure you’re staying compliant and ahead of the curve.


Brexit's Impact on Packaging and labelling:


Brexit brought about significant changes in regulations governing product packaging and labelling in the UK. With the UK's departure from the EU, businesses faced a slew of challenges and uncertainty, including navigating customs checks, tariffs, and country-of-origin labelling requirements.

Even now, there is uncertainty surrounding the UKCA and the latest Windsor Framework Regulations which will see the introduction of a ‘UK Only’ label for pharmaceuticals but not medical devices that contain pharmaceutical products like an inhaler. Moreover, the need to comply with UK-specific regulations alongside existing EU standards added complexity to an already intricate regulatory landscape.

Changes in Regulation: With the UK leaving the EU, there have been changes in regulations governing product packaging and labelling. UK-specific regulations now apply, and businesses must ensure compliance with both UK and EU regulations if they are trading in both markets.

Customs and Tariffs: Brexit has introduced customs checks and tariffs for goods moving between the UK and the EU. This has implications for product packaging as businesses may need to include additional information for customs purposes.

Country of Origin labelling: Products manufactured in the UK now require clear labelling to indicate their country of origin. This is important for both domestic and international trade, as it impacts tariffs and trade agreements.

Product Standards and Certification: UK businesses exporting to the EU must comply with EU product standards and certification requirements. This may necessitate changes to packaging and labelling to ensure that products meet EU regulations.

Changes in Import/Export Documentation: Brexit has introduced new documentation requirements for importing and exporting goods between the UK and the EU. This includes changes to paperwork such as customs declarations, which may need to be reflected on product packaging.

Health and Safety Regulations: The UK has the authority to set its own health and safety regulations post-Brexit. This may result in changes to labelling requirements to ensure compliance with UK-specific regulations.

Language Requirements: Products sold in the UK may no longer be required to have labelling in multiple languages as mandated by EU regulations. However, businesses exporting to the EU will still need to comply with EU language requirements.

Packaging Waste Regulations: The UK has its own packaging waste regulations separate from those of the EU. Businesses may need to adjust packaging designs to comply with UK-specific waste management regulations.

Product Marking: The UK has introduced a new UKCA (UK Conformity Assessed) marking to replace the CE marking for certain products sold in Great Britain. This change may require updates to product packaging and labelling to reflect the new marking.

Data Protection and Privacy: Changes in data protection laws post-Brexit may require adjustments to packaging and labelling to ensure compliance with UK data protection regulations, especially regarding the handling of personal data.

These changes are only some of the key areas where Brexit has impacted the labelling, and artwork of products sold and manufactured in the UK and there are still new regulations emerging even now in 2024. For example, the new Windsor Framework Regulations on the requirement to mark products as ‘UK Only’ will commence in January 2025. As a result, it is crucial for businesses operating in the UK market to stay informed about evolving regulations and to be prepared for further changes. If there is one thing that Brexit and its aftereffects has taught us, it’s to be prepared with a system that can handle mass changes with ease.


Adapting to Regulatory Changes with Veraciti™:


Now let’s talk about how to prepare your business for any future regulatory changes that may be on the horizon and could cost your organization a lot of time and money.

Bob Tilling, Kallik’s VP of Global Sales, explains how Veraciti™ can take the stress out of mass labelling and artwork changes. “Amidst the chaos, Veraciti™ has proven to be a reliable partner for businesses seeking to navigate the evolving regulatory environment post-Brexit. Leveraging its cutting-edge technology and expertise, Veraciti™ offers a comprehensive solution to ensure compliance and mitigate risks associated with regulatory changes.”

“Through features like 'Where Used' and Automated Artwork Generation, Veraciti™ empowers companies to make mass changes efficiently while ensuring compliance and accuracy. Additionally, Veraciti™'s label templates and Cascade feature significantly reduce errors and streamline the approval process, ultimately enhancing speed-to-market and reducing costs. With real-time updates, seamless integration supported by AI and 24/7 support from our experts on the Kallik Service Desk, you can navigate regulation changes with complete confidence thanks to Veraciti™.” Bob explains.

Brexit has undoubtedly reshaped the regulatory landscape for the packaging and labelling industry in the UK. However, with the right partner by their side, businesses can navigate these changes with confidence and ease. Veraciti™'s adaptable solutions empower businesses to stay compliant, meet deadlines, and thrive in a post-Brexit world.

Are you struggling to navigate the complexities of post-Brexit regulations? Download our FREE guide on navigating the new Windsor Framework regulations to stay ahead of the curve. Speak to one of our labelling 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.
 

Veraciti™ Sets New Quality Benchmarks at Integra LifeSciences

Surgical and medical instrument manufacturing leader Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons so they can concentrate on providing the best patient care. The New Jersey, US-based firm offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. Kallik’s Veraciti™ solution has embedded clarity and control into Integra’s artwork approval process — enabling the organization to streamline manufacturing operations, reducing time to market for new product launches.


Challenges


Like many other successful life sciences businesses, Integra LifeSciences was experiencing business growth pains that meant it had outgrown its legacy paper-based labeling and artwork based processes. As a result, it needed a completely new approach to cope with ever-increasing volumes of regulatory and product-driven changes.

“We wanted to implement a single organization-wide solution that would bring new levels of robustness into the artwork approval process,” notes the company’s Senior Marketing Operations Manager, David Dreibelbis.

“We had 20 different processes in place across the organization, making artwork and label management extremely challenging. We knew there was a knock-on effect on product launches, but with zero visibility, we couldn’t measure the impact, and so were unable to take corrective action.”


How Kallik helped


Integra’s brief was for a solution that would deliver greater transparency, enhanced compliance, plus deliver to internal stakeholders tools for improved oversight and governance, with an ultimate objective of being able to eliminate uncertainty and simplify all touchpoints in the lifecycle process. Operating a paper-based approval mechanism was also masking true process bottlenecks across Integra’s label and artwork management processes, while with an expanding product portfolio, and an ever-increasing volume of compliance requirements, Integra needed to achieve new levels of scale and consistency to meet its quality objectives.

Kallik’s Veraciti solution was able to meet all Integra’s requirements with its tailored artwork approval and asset approval lifecycle workflows. As Dreibelbis confirms, “Initially we were looking for an artwork approval tool with the capability of workflow management. We considered a number of established vendors, but Veraciti’s simple-to-use approval tools, plus the artwork creation functionality it offered, made it a clear choice for us.

“Veraciti’s artwork approval workflow satisfies all our compliance requirements,” he continues. “Because everything is in one place, retrieval of documents and artwork assets is a simple process for any stakeholder to access. This process now sets an unparalleled standard not seen before in our organization; the reports and audits available are first class.”

This was just the tip of the iceberg. Veraciti’s modular structure has made it both simple and effective to adopt additional functionality, such as Veraciti’s Automated Artwork Generator. Many manual repetitive tasks that previously consumed valuable resources have, as a direct result, been completely eradicated from internal Integra workflows.


Results


Since implementation more than 5 years ago, Integra reports it has not had a single issue with compliance. “We are delighted with our 100% success rate that Kallik helps us to deliver,” Dreibelbis enthuses.

Reduced time to market and increased productivity are two other significant outcomes, while as it’s now benefiting from fully task-driven, accountable processes, Integra’s throughput yield has improved significantly, yet without the need for any additional resources.

Veraciti has also been pivotal in simplifying transition of labeling content during periods of business acquisition. The flexibility to import and export data through multiple sources makes the solution agile enough to cope with meeting the individual requirements of multiple geographic regions whilst ensuring global levels of consistency.

For Dreibelbis, “Deploying the Kallik solution has been transformational for Integra, and has been a
great decision. What began with labeling has moved onto marketing materials and the launch of an online catalogue.

“Each of our commercial organizations has benefited hugely due to the simplicity of Kallik’s artwork approval workflow,” he goes on. “Real-time Business Intelligence (BI) reports give senior business stakeholders full visibility of product launches, while our QA team has peace of mind from being able to generate compliance reports at the touch of a button. We are now planning full roll-out of Veraciti across our entire organization.”


Additional Benefits:

  • 100% Compliance Reporting Success Rate Over a Period of 5 Years
  • Collapse of 20 individual siloed labeling & artwork processes down to one
Veraciti™ Sets New Quality Benchmarks at Integra LifeSciences

Factory Labeling Migration Following Business Acquisition

Headquartered in Ohio, this US based company is a leading provider of customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centres, clinical laboratories and physician offices worldwide, with approximately 50,000 employees in 46 countries.


Challenges


Risk of non-compliance

Faced with increasing complexity of regulations, markets and languages, plus a burgeoning volume of label changes and additions, the company recognized their existing in-house labeling solution could place them at risk of non-compliance. Governed by FDA regulations, errors anywhere in the labeling process could have resulted in labeling inconsistencies causing product recalls and punitive fines.

Lack of control

The provider also wanted to ensure they had accountability to each piece of content that appeared across labels, packaging and IFU’s - something their current solution was unable to provide.  Largely manual and disconnected labeling processes resulted in no one version of the truth, duplicated data, labeling inconsistencies and a complexity that could not scale to match the demands of the business. Much of their quality processes were paper based, limiting corporate level visibility and making it difficult to prove compliance.

Handling a major acquisition

With a new acquisition taking place around the same time, this acted as the catalyst for procuring a solution that would replace both their existing in-house system and de-risk the integration of the newly acquired business. Over 9,000 products needed to be re-labeled whilst manufacturing continued uninterrupted at the existing plant, before subsequently migrating the recently acquired company production lines to brand new facilities, all with zero downtime. This required re-branding and transitioning factory label printing to new facilities within extremely challenging timescales. Failure to achieve this would result in excessive financial penalties and potential non-compliance with FDA regulations. 


How Kallik helped


The medical device company chose Kallik’s Veraciti™ to replace both its existing factory print supplier and artwork management system with full integration to their ERP solution. Kallik’s Automated Artwork Generation (AAG) server along with its factory print capabilities were also selected as part of the solution, deployed as a SaaS and validated throughout its implementation.

Veraciti, with its support for 21 CFR Part 11 electronic signatures, would eliminate the use of paper-based quality processes. The option to make specific fields mandatory for certain individuals meant that the information was fully audited and could be passed through the business. Using Kallik’s ‘Project Brief’ to replace Excel and email based content collation would improve communication to artworkers, reduce effort for approval and manuscripts and enable the business to meet the following strategic goals:

• Drive cost out of the labeling process

• Reduce the time taken to review and approve artworks

• Provide flexibility and agility whilst creating a platform and process for future growth

• Enable comprehensive reporting against business KPI’s

• Eliminate the need to install on-site IT infrastructure

• Provide greater accountability, process transparency and robustness


Results


A solution was sought that would allow thousands of labels to be changed whilst production of products remained within the facility of the acquired business. They required transparency and control of the data to demonstrate that every piece of content of the new acquisition had been removed from the old labels within the timescales set to avoid penalty clauses. To do this, was necessary to first get control of the data by exporting all of labeling content from the existing internal IT systems into the Kallik solution.

The labels and IFUs of the acquired business were re-created with their new company branding and manufacturing address within the Kallik solution.  Once this was completed, the production and print facilities located in the existing site were connected to Veraciti™, removing any dependency on legacy IT and printing facilities. This gave transparency of label updates and print processes with full audit trails from day one.

This was a significant step in de-risking the integration process of the acquisition, granting the executive team complete transparency as well decoupling the labeling changes from the future physical move of the production lines to the new site. Kallik’s solution gave them the transparency and control they needed to make and report on label changes and provided a head start on the transition of the recent acquisition production facilities by initiating the change process within their manufacturing site.

Factory Labeling Migration Following Business Acquisition