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

Improving Össur’s IFU management and global business operations by overhauling legacy system

With over 50 years of experience in the non-invasive orthopaedics industry, Össur’s mission is to improve people’s mobility.

It is a global leader in non-invasive orthopaedics, developing and manufacturing innovative and life-changing solutions for the prosthetics and bracing & support market. Its operations span more than thirty countries worldwide across the Americas, Europe and Asia, employing over 4,000 staff to improve people’s mobility and quality of life.

Össur had already adopted the Kallik Veraciti™ label and artwork management solution as part of a change process project to drive value and decrease costs. However, new EU MDR regulations meant Veraciti soon became instrumental in the successful completion of MDR compliance across its operations.


Disparate data calls for consolidation into a centralized system


All Össur Class II medical devices require detailed Instructions For Use (IFUs). Due to the critical and often complex nature of these products, Össur’s IFUs contain large blocks of text with longer phrases than typical medical device labels. To add to the complexity, each of Össur’s existing IFUs had been developed by different employees at different times depending on the product release date, and stored in separate documents with a master spreadsheet of all phrases. This dated and manual process was sufficient to create individual IFUs one at a time, but to drive value and lower costs Össur needed to overhaul its legacy systems for more efficient processes.


Challenges
 

  • Disparate, non-standardized legacy systems
  • Delays to product launches
  • Limited control and management of IFU assets
  • Three key operational challenges stemmed from these legacy systems and processes: fragmented data management, a lack of consistency and delayed product launches.

 

1. Fragmented data management means no visibility
Because each IFU had a separate document for text and artwork, and each unique text asset required individual translation, processing and management, IFU data could only be processed piecemeal in a time-consuming and manual procedure. The resulting disparate IFU documents meant that Össur had very limited visibility across hundreds of global product lines.

2. Lack of consistency in terminology impacts tracking ability
This disparate system for storing IFU data and lack of visibility resulted in many similar products using completely different phrases in their IFUs, with different terminology for the same or similar processes. This not only made it difficult to track and manage product information, as well as translate and update IFUs, but potentially had a negative impact on user experience.

3. Product launch delays
IFUs are the last step in the design process for new products. The inconsistencies and lack of visibility across IFU data assets made IFU approval slow and manual, causing delays to the launch of new products, especially when translations were needed for international markets.

On top of these core operational challenges, pressure from new EU MDR requirements pushed Össur’s IFU management system of disparate documents and mismatched data to the limit. With hundreds of products affected by this regulatory change, thousands of long IFU documents needed updating in a limited amount of time. Össur did not have the visibility into the disparate data sets to fully determine the scale of this compliance task.


Replacing legacy systems with standardization


It is here that the Kallik label and artwork management solution, Veraciti, has helped transform Össur’s business operations. Implementation of Veraciti has allowed Össur to consolidate all IFU phrases into a single centralized system, providing enhanced visibility over all IFU assets. This enabled Össur to identify key phrases that could be reused in multiple product IFUs – even some of the more complex products had a higher rate of phrase reuse than expected. The reusability of key phrases has led to a standardization of IFUs and a streamlining of product information.

This level of control has also enabled Össur to identify the scale of the MDR compliance project and successfully manage the full IFU update process. The ability to pre-approve phrases before they are used ensures every IFU is correct and compliant the first time around, minimizing error and improving efficiency.


Solution
 

  • Veraciti™
  • Kallik implementation expertise and technical support
  • Smoother operations provide greater value to all stakeholders
     

Improved visibility and management of IFU phrase assets has significantly enhanced the IFU approval process. The standardization of IFUs through increased reuse of key phrases has reduced IFU cycle times, as IFUs can be designed and built quickly, addressing previous issues with delayed product launches. Increased reusability of phrases has also resulted in decreased costs for translation as less words need to be translated for different product lines.

Veraciti’s centralized database and automation capabilities allow for greater visibility into IFU assets. The increased standardization of IFUs has also made future regulatory compliance easier as Össur now has the powerful systems required to react swiftly and effectively to further regulatory change.

Össur customers also reap the benefits of this business transformation, as product standardization makes IFUs easier to understand and follow, enabling Össur’s customers to complete procedures correctly and efficiently.


Benefits

  • Single centralized solution for IFU phrase management
  • Simplified IT footprint for ease of management
  • Significantly reduced IFU cycle time and translation costs
  • Future advancements made possible with Veraciti
     

Today, Össur is in a strong position to expand Veraciti’s role within the business to label management and potentially along the rest of the value chain, to maintain consistent messaging and brand voice with a centralized data base accessible by all departments.

The advanced automation and cloud capabilities within Veraciti also make the possibility of digital IFUs and labels a reality. Within the platform Össur can create phrases and artwork that are easily integrated into a mobile format. By linking unique phrases with products for mobile use, Össur can provide new value with smart labels.

“For Kallik, software implementation is a partnership – we want to support our clients as much as we can throughout this process,” says Nick Harris, Head of Client Engagement at Kallik. “We are also learning from the experience of customers such as Össur and are always looking for ways to develop our software and continually add new value for our customers.”

Improving Össur’s IFU management and global business operations by overhauling legacy system

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

Teleflex is a multinational provider of specialist medical devices, with an established portfolio of products ranging from urology and cardiac care through to anaesthesia and respiratory care. The company’s sustained success has led to significant growth through acquisitions of other companies and brands in the medical device space, bringing new products and facilities under the Teleflex remit.

Seeking to streamline operations, centralise asset management and eliminate the risk of product recalls, the company has pursued a strategic, long-term project to establish a Global Labeling System, with the Kallik Veraciti™ labeling and artwork management solution at its heart.


Future-proofing operations on a global scale


Teleflex, a highly successful medical devices company headquartered in the U.S, has a significant global footprint both in terms of its physical locations and its targeted sales markets, with design and manufacturing facilities spread across the Americas, Europe and Asia.

Its strong performance in the global medical device market has been further boosted by a series of high-profile mergers and acquisitions. These acquisitions, such as the leading Arrow brand of vascular access products, add greatly to the operational complexity of the company’s already global highly regulated operations that must be handled by Teleflex management on a day-to-day basis.

High on the list of priorities is the labeling, artwork and associated assets that must be accurately tailored to every target market and language. The risk of introducing asset inconsistencies and siloed data within teams and Business Units scattered worldwide brings a low-lying threat of costly product recalls.

Acquisitions have also required the integration of existing standalone supply chains, IT systems and business processes into Teleflex. With a growing number of disparate legacy systems straddling multiple Business Units, the company needed to rationalise its deployments, phasing out outdated systems in favour of a single, centralised solution. This would ease the management burdens associated with multiple systems, reduce the risk of product recalls due to inconsistent or inaccurate labelling, and reduce any pressure and disruption caused by compliance demands in this highly regulated industry.

 

Consolidation is key


Faced with these challenges, Teleflex launched an ambitious project to establish a comprehensive, highly advanced Global Labeling System. This would seek to replace over a dozen outdated labeling systems in operation worldwide with a single, centralised solution to increase user control and transparency over routine label and asset work. The Global Labeling System would also need to be fully integrated with other upstream and downstream systems such as the Oracle Agile PLM suite and an existing ERP system from SAP.


Challenges
 

  • Disparate, non-standardized legacy systems spread across a global footprint
     
  • Risk of product recalls
     
  • Limited control and management of labeling operations

The long-term goals of the Global Labeling System project are aimed at introducing labeling consistency worldwide for every product range, by standardising workflows and businesses processes and providing employees involved in labelling with a core set of feature-rich tools and capabilities. This would in turn improve collaboration between sites and across geographies, reducing compliance risks and introducing sustained time and capacity savings.

As a cloud-based solution designed to establish centralised control over all labeling and artwork management within a company, Veraciti from Kallik represented a strong candidate to solve the pain-points experienced by Teleflex. The highly customisable nature of the solution, combined with extensive Kallik use cases in implementing Veraciti for global companies in highly regulated industries, led Teleflex to select Veraciti for the core of its new Global Labeling System.

Kallik technical experts and consultants have worked with the Teleflex team since 2015 to help make the Global Labeling System a reality, deploying Veraciti and onboarding specific production facilities and regions on a staggered basis to ensure minimal disruption to day-to-day business operations as legacy systems are phased out.


Solution
 

  • Veraciti™
     
  • Global Labeling System project
     
  • Kallik implementation expertise and technical support


A standardized approach to replacing legacy systems


Due to the significant scale and global nature of the Global Labeling System project, Kallik closely worked with the Teleflex team on a regular basis since project commencement in 2015, sharing best practice and methods developed throughout Kallik’s long-term history implementing Veraciti for global companies in the medical device sector.

"We have an excellent working relationship with Kallik, and their expertise in integrating Veraciti with third-party software and existing systems has been key to the continued success of the Global Labeling System," says Brian Cannon, Senior Project Manager at Teleflex. "Completion of the project will mark a major milestone for Teleflex in future-proofing our operations worldwide with standardised, feature-rich systems."


Benefits
 

  • Single centralized solution for labeling and artwork management
     
  • Simplified IT footprint for ease of management
     
  • Significantly reduced risk of non-compliance and product recalls


The Global Labeling System continues to be rolled out and advanced for Teleflex sites worldwide today, with a majority of the 20 global facilities completed and fully operational. The project has involved migration of tens of thousands of product assets to Veraciti as part of the phase-out process of legacy labeling systems and elimination of data siloes.


Greater labeling control to eliminate recall risk


Teleflex today benefits from advanced labeling and artwork management capabilities, all achieved because of the centralised cloud-based Veraciti 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. As a result, product recall issues have dropped to zero since implementation.

"Our work with Teleflex on supporting their vision for a Global Labeling System is another testament to the powerful interoperability and capabilities within our flagship Veraciti system,” says Dave Tarbuck, VP Global Customer Success at Kallik. "This project has looked beyond the goal of achieving a standardised labeling platform to deliver end-to-end benefits across the company, from factory print features through to effortless regulatory compliance.”

Teleflex Kallik Case Study

Kallik & Zebra Boost Efficiency in MedTech with IoT

Tamworth, UK, 17 February, 2015  – Global provider of labelling and artwork management solutions, Kallik, today announced a strategic technology partnership with Zebra Technologies Corporation (NASDAQ: ZBRA), a global leader in products and services that provide real-time visibility into organisations’ assets, people and transactions. The resulting solutions extend the reach and benefits of Kallik’s flagship Label and Artwork Management (LAM) system to the factory-floor printer. 

Are you ready for the new Windsor Framework Regulations? Our FREE guide to compliance

Are you ready for the new Windsor Framework Regulations? Our FREE guide to compliance
Author Name
Kallik Role 1
Content Manager

In the wake of Brexit, the regulations on medicinal products are undergoing significant changes. It is crucial for companies involved in the manufacturing and distribution of these products to the UK to keep well-informed in order to ensure compliance and avoid potentially expensive recalls and penalties.
 

Our labeling and artwork expert, Bob Tilling, VP of Global Sales here at Kallik, says, “When it comes to the pharmaceutical and medical device industries, compliance can be life or death for patients using the products. And with regulations changing constantly at the moment, it’s important to be using a labeling and artwork management system that’s futureproof and can easily make mass changes with minimal stress and hassle.”
 

The recent announcement of the new labeling and packaging requirements under the Windsor Framework Agreement means organizations will now have to make mass changes to their product packaging in order to stay compliant. To help you understand these regulations and their implications, we've compiled a comprehensive guide. Here's a brief overview of what to expect.

 

Download the guide

 

Part 1 - Understanding the New Windsor Framework Regulations, Who They’ll Affect, and What Steps to Take:


The Windsor Framework, born out of post-Brexit negotiations between the UK and EU, mandates labeling changes for goods intended for sale in Northern Ireland and Great Britain. Notably, from January 1, 2025, all UK medicinal products must bear a 'UK Only' label, impacting various stakeholders, including pharmaceutical companies and retailers. Failure to comply could lead to goods being halted at the border, causing significant delays and potential financial penalties.


Part 2 - How End-to-End Labeling and Artwork Management Software Can Help:


In the face of these regulatory changes, leveraging modern technology becomes imperative. Enter Veraciti™, an innovative software solution offered by Kallik, designed to streamline labeling and artwork management processes. 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.
 

Read Our Guide to Get Ahead Now


With the deadline for compliance looming, proactive action is essential. By understanding the Windsor Framework Regulations and leveraging tools like Veraciti™, companies can navigate these changes with confidence. Ensuring compliance not only mitigates risks but also safeguards consumer safety and maintains market competitiveness. Don't wait until it's too late. Take steps now to adapt and thrive in this evolving regulatory landscape.
 

Stay Informed, Stay Compliant, And Stay Ahead With Kallik


To delve deeper into these topics and explore how Veraciti™ can revolutionize your labeling and artwork processes, download our full guide for FREE today here. For further inquiries or assistance, contact us at enquiries@kallik.com or call +44 (0) 1827 318100.