On our twentieth birthday, we look back at the key milestones in Kallik’s history, a company always pushing the digital boundaries on its path from spin-off to recognition as a market leader in the Gartner Magic Quadrant

Since joining Kallik in 2019, I’ve had the privilege of leading an ambitious, forward-looking team that continues to innovate and advance the conversation on how digital solutions can reshape the way companies in highly regulated industries do business. Kallik today has a truly international customer base with over 3,500 users, all benefiting from unrivalled agility, transparency and process efficiency.

Amid all of the global disruption experienced over the past two years, Kallik has gone from strength to strength as a business, accelerating global implementations of our flagship Veraciti™ solution and pushing ahead with our transformative product development pathway that meets the compliance needs of industries in an increasingly regulated world. 

So where did it all begin? Our roots lie 20 years ago in digital asset management – a buzzword in the industry now but not when Kallik set out on its journey. We’ve come a long way since those pioneering days to firmly establish ourselves as a leading player in the global label and artwork management market.

Join us on our journey, values and key milestones to date:

Asset designers turned asset managers

Kallik was founded in 2001 by Neil Gleghorn, as a spin-off from an established digital origination company, The Box Room. Our target was to address the business challenge of cumbersome manual processes for building labels and artworks, with marketers, designers and product teams all involved as key stakeholders.

The team looked to develop a digital solution entirely in-house. The first iteration of Kallik’s artwork management software was designed to handle approval, workflow and asset management, based on pain-points and requirements laid out by a key international customer operating in regulated industries. 

The solution immediately showed business benefits, providing a significant reduction in the volume of manually handled assets, cutting cost and complexity while enhancing management capabilities for all stakeholders. 

Kallik soon became aware that a single centralised solution, further enhanced with digital capabilities, could fundamentally change the way businesses handle label and artwork management. 

Addressing a critical capability gap with pioneering technology

One of the biggest label and artwork management challenges experienced by companies is the level of disconnect between teams, data and operations. Packaging such as leaflets and cartons, for example, is often managed separately to labeling, which can create a disjointed review, version control and management process. Move to the end of the value chain, and the factory print process is even more disconnected and heavily reliant on manual operations.

Enter Kallik. 

Our Veraciti platform is unique. Within a single solution, Kallik can manage labels and packaging, extending all the way through to the factory print process. As the solution developed, we were committed to enhancing the capabilities of the original platform, to the point that now Kallik leads the way in leveraging automation and rules-based decision-making to cut manual processes and the risk of human errors being introduced. 

Our solution Veraciti has emerged as a field leading, tried-and-tested platform for ensuring compliance in highly regulated industries from chemicals through to cosmetics, satisfying industry legislation to safeguard reputations, consumer confidence and the bottom line.

A customer-focused ethos
 

The customer has always been key in our development. Our collaborative approach to implementation – working closely with customers throughout the process, from data discovery and migration through to system integration – is a key pillar of maintaining our high levels of customer satisfaction, routinely referenced by our customers in industry reviews.

In the highly sensitive and regulated markets we work in, this level of collaboration and partnership has been instrumental to our significant successes in for example the medical device market, helping global manufacturers beat tight deadlines to comply with landmark industry regulations such as EU MDR and IVDR.

Accelerating growth with ambitious investment partners
 

The acquisition by FPE Capital in 2019 has provided the power to further accelerate our growth trajectory. Working with FPE Capital has allowed the company to significantly scale up operations and solution development, recruit technical, customer service and leadership talent and expand rapidly into new geographies and industries.

This ambitious growth strategy and intensified focus on technology innovation and customer service has reaped early dividends, with the Kallik customer base growing 35% since acquisition and a significant double-digit growth in revenue, as businesses worldwide realise the benefits of digitising their operations.

Today, Kallik boasts a global engineering and service capability and experienced senior leadership team, driving the global expansion of the tried-and-tested Veraciti solution to new heights.

Ahead of the game with cloud – from a luxury to ‘must have’ foundation

Cloud has always been at the heart of our founder’s vision for Veraciti and Kallik services – providing ease of accessibility, high service availability and rigorous data security.

Kallik has been significantly ahead of the curve in delivering solutions via the cloud – originally offering a private cloud solution at a time when this was unheard of, before migrating to an established cloud host. 

Our cloud-based offerings have been further strengthened by our full migration to AWS in 2020, becoming the first solution provider in the market to do so. This AWS shift means we can today offer our entire global customer base the gold standard of secure, compliant and highly available cloud services.

Roadmap to the future – pushing the boundaries with AI and ML

Looking beyond cloud, Kallik has always led the charge for adopting disruptive and emerging technologies to transform label and artwork management operations. Veraciti was one of the first solutions in the market to provide a truly end-to-end solution, using automation to ease the burden of slow, repetitive manual processes that consumed disproportionate amounts of resources and capacity. 

Our roadmap for the future incorporates advanced technologies such as AI and Machine Learning, combined with an extension of our existing automation capabilities – adding further value to customer operations beyond the sustained cost savings, agility and compliance enjoyed today.

We have a firm development pathway to further establish Veraciti as a turnkey solution capable of supporting global businesses in industries spanning food & beverage, cosmetics, pharmaceuticals and beyond. 

What lies ahead?
 

With Gartner industry recognition for enterprise labeling, e-labeling and artwork management also landing in our twentieth birthday year, the future is bright for Kallik as we continue to help businesses reach digital maturity in label and artwork management. We’ve come a long way from our roots – but the best is still to come.

Want to learn more about how we’re helping leading companies transform and future-proof their global label and artwork management? Download our complimentary ‘Digital Maturity Curve’ white paper, or find out more about the capabilities of our flagship Veraciti solution.
 

Digital maturity is paramount in highly regulated industries, and we’re going to explain why

Of course, your first question might be: what is digital maturity? When we talk about digital maturity, we’re talking about how your business operates. So what does it mean for your business to be digitally mature? A digitally mature business is one which moves its operations from manual processes to digital, automated processes. We’re going to talk about it in the context of what we know best: the labeling and artwork management (LAM) process. After all, when it comes to LAM, digitization is crucial - particularly for medical device manufacturers.

Until recently, labeling had seldom been seen as its own discipline. However, with the recent implementation of EU MDR and upcoming IVDR deadlines, medical device organizations are now realizing that digitalization of the labeling process must occur in order to remain compliant. Manual processes have become too time consuming and prone to human error, and up to a third of medical device organizations have unfortunately learned the hard way that regulatory deadlines are simply no longer achievable using traditional methods. 

6 steps your business can take to become more digitally mature (and why you should take them)

Whatever the size of your business, becoming more digitally mature comes with countless benefits. We’ve broken down the process of digitizing your LAM to just 6 key steps:

1. Consolidate

Label data is often held in varying systems across the business, but it is crucial that data such as phrases, translations, and symbols are all easily accessible for seamless label transitions in the event of regulatory changes. Subsequently, each of these components need to be consolidated into one centralized, digital source of truth. Albeit time consuming, this is an essential step towards digital maturity - little technological deployment or integration can occur without it.

2. Structure

Once all of your label data has been consolidated, your business can switch to a centralized digital system with structured and controlled datasets. Having this ‘single source of truth’ allows for the scaling up of further features and integrations, boosting the efficiency of your business. Approval workflows can then be implemented for updates to datasets and traceability on a global scale can be considered to ensure the consistency of label content. This structured approach can also help to drive the reuse of label data.

3. Exploit

With all assets in a central repository, your business will then be able to exploit this data to achieve complete regulatory compliance. This is of critical importance in the medical device industry with the MDR and IVDR changes occurring over this decade. For multinational organizations, this can be duplicated on a global scale by pre-approving compliant assets to be reused in all geographical locations.

4. Automate

With this library of pre-approved assets, labels and artwork can then be automatically generated using the right software, cutting creation times from days or hours to mere seconds. This comes with vast cost reductions, as well as increased speed to market, often eliminating the requirement for third-party design agencies. Bottlenecks and the risk of human error are also eradicated as pre-approval ensures that automatically generated content is compliant.

5. Distribute

At this stage, all assets are now suitable for publication. Distribution of the final approved label or artwork must now be controlled effectively, with traceability of the entire process. From basic black and white shipping labels to a pre-press ready file being sent to a third-party printer, labels and artworks should be firmly linked with upstream creation and approval processes. 

6. Insight

This centralized solution and its associated capabilities lay the foundation for new high-level business insights, enabling medical device manufacturers to refine business processes. As a result, data can be analyzed and actioned, and you can improve the upstream process to optimize your ROI.

For further information on how to implement these 6 key steps, you can read our digital maturity white paper here.

So why is it essential?

The benefits speak for themselves, but it’s not just a choice, it’s a necessity. Centralizing all of your data provides a level of ease of access that can save months of company time. Label alterations as a result of changing regulations go from mass projects to relatively easy tasks the further you climb the digital maturity ladder. From this central hub of assets, labels and artworks can then be automated. Automation rapidly reduces time-to-market, with project completion time going from months or years to a matter of days. This is crucial following the era of COVID-19, where products need to be approved and available on the market as quickly as possible, without compromising on safety. In the medical device industry, regulatory compliance is therefore non-negotiable. The consequences of errors in labels or IFUs can include costly recalls and, on the more extreme end, endangerment of patient safety. It is vital for brand reputation that these risks are minimized. Pre-approval of assets ensures that compliance is seamlessly achieved. Traceability is also integral, which is far more easily achieved with the connected approach that digitizing your LAM provides. Finally, this process enables intelligent business insights to further optimize your business operations. Medical device manufacturers simply cannot afford to miss out on this.

Imagine a single, cloud-based LAM solution that can achieve all of these things. At Kallik, we don’t have to! Our software, Veraciti™ is an end-to-end solution that enables you to manage all of your label and artwork data from one central location. Here are just a few of our key features:

   -  Data migration services
   -  Centralized asset and phrase management for all label and artwork data
   -  Automated and semi-automated artwork generation
   -  Secure AWS cloud access 24/7
   -  Approval workflows and pre-approval of assets
   -  End-to-end auditing
   -  Comprehensive business intelligence and reporting

To find out more about how we can help your business with labeling and artwork management, contact us and we’d be more than happy to help. You can also visit our industry specific pages to find out how Kallik optimize the LAM process for each industry.
 

For medical device manufacturers, the compliance deadline is looming for the European Union's In Vitro Diagnostic Regulation (IVDR) for critical in vitro devices used to detect life-threatening diseases. It comes into force in May 2022 replacing the In Vitro Diagnostics Directive (IVDD), and is designed to enhance the safety, effectiveness and traceability of all in vitro devices currently sold or intended for sale in the EU market.

Over 80% of devices that previously did not require certification under IVDD will be covered by IVDR certification, so that means a lot more work for device manufacturers.

The new regulation is closely linked to the EU Medical Device Regulation (MDR), which is currently coming into force for multiple classes of medical devices. For those manufacturers that have already completed initial projects to comply with MDR by May 2021, it may be tempting to sit back and delay their IVDR efforts. But there have been significant lessons learned from MDR compliance attempts, not least the scale of these compliance tasks and the wide-ranging impact regulation has on end-to-end operations.

Setting a course for IVDR compliance 

Manufacturers that fail to ensure compliance with new regulations face losing revenue, market share, and even irreparably damaging brand reputation by exposing consumers to harm. Device manufacturers will need to start to plan now to deliver full compliance ahead of the IVDR deadline. This must span initial assessments to identify affected assets and project scale, processing label and artwork changes to satisfy new requirements and deploying fit-for-purpose technology to help automate compliance actions.

There are four critical focus areas where medical device manufacturers can take positive strides to ensure IVDR compliance:

1. Get to grips with the scale of the task as soon as possible

When working with medical manufacturers to reach MDR compliance, Kallik has often found that changes needed to span multiple sites, geographies and over 150,000 assets in some cases. It’s crucial that initial assessments capture the scale of the changes required, and that means being able to identify exactly how many devices and associated labels and artworks exist across global operations.

Complexities are introduced when data is housed in legacy systems, across disconnected regional offices and departments or scattered assets. Product translations and global supply chains can significantly add time and complexity onto a project. For example, amending individual phrase translations on each device in a product range for each of the EU’s 24 official languages threatens to add substantial time to compliance efforts.

Add in the possibility of further M&A activity bringing in new product lines and asset libraries and this issue is multiplied further.

2. Prioritize asset consolidation and standardization

Once all information siloes have been unearthed, before actioning label and artwork changes, manufacturers should look to consolidate all assets into a single, central source. Attempting to manage editing, review and approvals processes across multiple systems and departments is both highly inefficient and runs the risk of introducing costly version errors and further delays.

This is where businesses need to lean on an off-the-shelf label and artwork management solution that incorporates a single, centralized asset library to contain artwork, logos, phrases and other critical product data. Automated capabilities, such as those provided by the Kallik Veraciti™ label and artwork management (LAM) platform, aid with the extraction of content from data siloes and legacy systems, including supporting the subsequent standardisation and loading of data into a central cloud-based solution.

Consolidating all assets into an easily accessible ‘single source of truth’ significantly eases the monitoring, editing and management burdens when compared to attempting to do so across multiple systems and geographies. 

3. Get down to the detail with a helping hand from LAM technology

Once existing assets have been consolidated, manufacturers can begin to enact the changes that must be made to each label and artwork.

There are many factors to consider here, from label sizing and placement, to warning symbol positioning and Unique Device Identifier (UDI) inclusion – and these can be further complicated by country-by-country requirements. 

This is another situation where the consolidation of assets into a single LAM solution yields dividends. The Kallik Veraciti platform provides a powerful ‘Where Used’ feature that enables users to rapidly identify all labels affected by a minor design change and take action accordingly. Combining this capability with approved label templates within the LAM solution means users can effortlessly make changes to all labels in a product range – eliminating the need to manually identify and update each impacted asset.

4. Automation eliminates manual processes to ease the compliance workload 

As many businesses experienced during the initial MDR May 2021 compliance push, relying purely on ‘traditional’ methods and updating assets through manual work and processes has become increasingly unviable. These have been found to be typically slow, costly and risk introducing human error.

Deploying a cloud-based, centralized solution with a high degree of automation eliminates the uncertainty of manual processes. The result is an efficient operation, following best-practice procedures, providing a pre-defined outcome. 

Modern LAM solutions offer a greater amount of automation and more importantly, the potential for future efficiencies through for example AI integration. Such solutions harness rules-based automation to eliminate the need to manually search for, update and republish assets to ensure compliance, and deliver significant cost and capacity savings that scale over time.

Start automating now to steal a march on EU IVDR

With IVDR coming into force in May 2022, medical device manufacturers still have time on their side if they act now. Automation holds the key to ensuring they have the agility, adaptability and accuracy required to meet new regulations, and this comes by putting a dedicated label and artwork management platform in place to underpin their compliance efforts – now and into the future. 

Want to know more about how automated label and artwork management solutions can help your business comply with IVDR and future industry regulations? Download our latest white paper.

The UK has just over 8,000 ventilators, significantly fewer than the 30,000 the government estimates are needed to cope with the fallout from the peak of the Coronavirus epidemic. Clearly, the race is on for medical ventilator specialist manufacturers to ramp up production.

Manufacturers are being asked to close the gap, with firms like Dyson, Airbus, GKN, Rolls Royce, Megitt and others working on partnering with medical device manufacturers on new designs to meet the huge and unprecedented demand for the units.

But the danger is that these new entrants, very welcome as they are, may struggle with a key process: getting the product and package labeling elements correct and aligned with NHS needs.

And the inability to prove the required level of clinical evidence and correct labeling will ultimately prevent the new ventilators from getting to the NHS staff who need them in a timely manner, and time is of the essence.

What we can do as a supplier is to offer our expertise on this aspect. That’s because we have accumulated a great deal of experience in the medical device manufacturing space. We’ve helped our customers deal not just with national/international requirements, but the large amount of required text and graphics that must now be featured on individual labeling.

Based on our exposure to these issues, there are a number of practical measures you can take, in order to help you mount the quick and effective response to the current crisis required and get the new machines into the NHS in a timely, safe and acceptable manner. These are:

• Ensure that you are aware of the Government’s new regulatory exemptions as it relates to medical device manufacture during the current situation.The FDA has also updated their policy based on the current COVID-19 situation.
• Get up to date on which regulations you still need to comply with, namely EU Medical Device Regulation (MDR), US Unique Device Identification (UDI), and global product serialisation — but note that the former, which is formally due to take effect from 26 May 2020, may well be delayed, as the medical technology industry is lobbying for it to be postponed. This is a fast changing area, but we can help here, e.g. share current legislation information, best practice, and provide advice on how to navigate the rules with you if you’re not familiar with them
• Leave nothing to chance. To meet the tough deadlines and ensure nothing derails your manufacturing schedule, introduce a Corrective/Preventative Action process (CAPA) to quickly identify any potential non-conformity or issue to quickly respond to issues wherever and whenever they might occur to assure the problem can never be experienced again.

Kallik is working hard to ensure that all of our customers are able to continue to perform their essential labeling and artwork management processes during this uncertain time. If you are looking to take new ventilators or other medical devices to market faster during this time by automating your labeling lifecycle, Kallik can get you up in running in weeks, not months. Feel free to schedule a meeting with me HERE to find out more.

We are also proud to be a UK listed supplier, helping the public sector during the coronavirus COVID-19 outbreak. 

Stay safe and we will get through this together.