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? 

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100.

Where are we with MDR and what do you need to know to be compliant with IVDR?

Just over 4 months on from the implementation of the EU Medical Device Regulation (MDR), there are still manufacturers failing to meet requirements imposed by the new directive. According to a recent article published by The Regulatory Affairs Professionals Society, manufacturers are struggling with concepts of basic UDI-DI, under both MDR which has applied since the 26th of May 2021, and IVDR, which will come into effect by May 2022. It is agreed amongst MedTech organizations that MDR has become a major regulatory challenge, and Kallik has experienced those issues first-hand.

Don't fall at the first hurdle

Bob Tilling, VP Global Sales, who has worked closely with medical device companies in their MDR and now IVDR projects says that the first step towards meeting compliance - organizing the artwork - is possibly one of the biggest challenges. Finding and collating the artwork is the beginning of a long project, and the time it can take to pull these together is often underestimated. 

Our experience has shown that label content is normally dispersed and stored in different spaces, with some being at agencies or third party suppliers. After getting the content together, it is then necessary to change and update artwork, which, again, takes a lot more time than is generally expected. The delay in starting these projects, along with the belief of it being a straightforward task, is the first step towards missing regulatory deadlines.

What lessons can be learned from MDR and how can we apply them to IVDR?

Similarly to MDR, experts at MedTech Europe estimate that as few as 24% of IVD manufacturers will be compliant by the time the regulation is implemented, with 17% definitely failing to be certified on time. That leaves around 59% of manufacturers with undetermined futures, all depending on what they decide to do in the next few months. 

Kallik’s Bob Tilling believes that manufacturers must act now to be able to meet the IVDR deadline and avoid the current challenges organizations are facing with MDR, even 4 months on from its initial implementation. Our experience has demonstrated that with MDR, there was not a single company or project that was completed ahead of schedule, even with the 1 year extension due to COVID. Leaving the start of the process to as late as January or February 2022 will result in missing the deadline; the time that is needed to complete the project should not be underestimated. 

To meet the deadline, medical device companies will need to partner with a labeling and artwork management software company that not only offers technology able to resolve the challenges but also has extensive experience in working in the life sciences industry, particularly medical devices.

Want to know more?

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.

A recent survey of manufacturing leaders found up to 90% of manufacturers struggle with integration challenges, so when disruption happens, they are unable to cope quickly or effectively – causing a ripple effect right through the supply chain. As businesses of all sizes continue to ramp up their digital transformation efforts, end-to-end digital integration must be at the heart of these projects – and that, argues Arjun Khanna, Chief Technology & Innovation Officer at Kallik, means right down to the artwork and label processes that are essential to the smooth flow of the supply chain. He discusses the extensive operational challenges faced by businesses using disparate systems and siloed data, and how many of these issues can be overcome with careful integration of core solutions.

Avoid the disconnect

Siloed operations keep businesses vulnerable to disruption. Acquired a small competitor in a different region? New regulation enacted that requires changes to existing product labelling? Rolling out a new factory process at the very end of the value chain? Any of these could require a significant response to avoid major disruption. Disparate, disconnected systems leave businesses poorly placed to respond to deal with any disruption or shake-up in typical day-to-day operations.

Legacy systems – very little control, disparate data

Despite such threats to business continuity, many firms continue to operate a patchwork of core systems with either little to no integration with each other. They are often developed piecemeal with in-house fixes or manual workarounds. While this may help maintain the status quo of day-to-day operations, it is highly vulnerable to disruption and far from agile compared to more digitally mature competitors. 

Thankfully, the latest wave of digital transformation has placed an increased focus on cloud-based solutions and customisable implementations for core platforms such as ERP systems. However, other, more legacy systems or manual processes are equally critical to operational success – yet often neglected in the grand scheme of ‘digital transformation’ projects. This lack of integration is especially noticeable among businesses operating in highly-regulated industries such as pharma, medical devices or chemicals, despite these being prime candidates for short-notice impactful disruption.

Artwork, labelling and packaging must not be an integration ‘blind spot’

The disconnect is particularly noticeable in siloed product assets, such as labels, artwork and symbols. This essential part of the business process often is subject to minimal version control or global insight, and where integration with print requests and data flows from the ERP system, for example, are yet to be embraced on a significant scale. But these label and artwork management systems play an increasingly critical role in ensuring product consistency, consumer safety and regulatory compliance. As a result, having these operations and assets siloed is becoming non-negotiable. Integration with other platforms such as regulatory systems is a must.

The knock-on effects could be catastrophic

Take a label for a simple medical device intended for the EU market. This must pass through extensive review and approval processes to ensure medical, marketing and regulatory information – including various symbols and markings – are all present, correct and consistent. To be sold broadly throughout the EU, this device label would in theory need be translated into 24 different languages. This upstream process is therefore very delicate and susceptible to disruption or human error. If an incorrect version of a regulatory symbol is used, or some medical information is changed in one language then not updated across all other language versions, this could introduce a major error – potentially even threatening the health of the end-user and triggering a costly product recall.

If the systems involved in this workflow are not fully integrated into other critical businesses systems, processes and databases, the risk of recalls can rise significantly.

Find a complementary digital artwork and labelling system

Consolidation and integration is key when it comes to rationalising and standardising systems and processes as part of a company’s digital maturity project. That means finding proven, feature-rich solutions that can be deployed across all necessary department and locations worldwide, with full integration capability to ensure seamless operation with other core systems. Label and artwork management platforms are no exception. Indeed, these must be able to integrate with other critical software as standard – from Regulatory Information Management (RIM) systems, Enterprise Resource Planning (ERP) platforms and Product Lifecycle Management (PLM) solutions.

Integration in the cloud

Business leaders would also be well-advised to opt for a cloud-based solution that can be readily deployed and accessed in any location by any department, adding a new level of scalability. As businesses connect and integrate critical IT infrastructure, the benefits of truly unified operations and visibility become apparent.

For example, if a specific product asset or symbol must be replaced or updated at short notice, users can tap into the ‘Where Used’ functionality within a fully integrated management solution to identify every instance of the existing asset actively being used worldwide – and effortlessly make a bulk update in turn. No manual searching of data siloes, no piecemeal updates across multiple teams – this is all easily accessible and actionable in a ‘single source of truth’.

The benefits of end-to-end integration are all in one

This unlocks powerful end-to-end audit and version control capabilities – allowing any users with relevant permissions to make changes and flag comments in a clear, actionable format. By integrating a solution with further powerful features, such as automated artwork generation, businesses can significantly reduce the risk of human error in asset creation, updating and positioning. For artwork and label management solutions, a cloud-based end-to-end platform such as Veraciti™ from Kallik is an ideal candidate focus for any integration-minded business – providing a standard set of APIs out the box as a tried-and-tested ‘blueprint’ to follow during implementation. From a security perspective, shifting to a single artwork and label management platform also brings fresh benefits – with a single sign-on and corporate login enhancing system security, user management and data protection.

Keep pace with more agile, digitally-mature competitors

As the digital transformation race continues to heat up, now is an ideal time to take stock of your legacy IT stack and ensure software can either be heavily integrated or replace with a modern, fit-for-purpose alternative. Embracing this integration approach can help reduce artwork and labelling errors, ensure end-user safety and compliance in highly-regulated industries, and provide the agility needed for businesses to quickly go-to-market – whether in a new geography or with a new product. 

Want to know more?

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.

The Nordic region is a potentially lucrative area for medical device companies to expand into, with analyst research estimating Sweden alone to have a 2.7% market share of the €140bn European medical device market. But practical challenges, in particular operational obstacles on the regulatory side, have deterred many manufacturers from making the leap into this geography. Bob Tiling, VP Global Sales at Kallik, explains how effectively managing the simple device label could be key to overcoming the challenges of entering the Nordic market.

Expansion into one or even several Nordic countries may seem like a minor leap to today’s large, multinational medical device manufacturers – but business leaders with an eye on new market growth should beware the pitfalls. These range from special logistics labels on products for each healthcare association through to large-scale downstream compliance challenges. Dedicated label and artwork management software solutions have made significant strides in bringing advanced digital capabilities to bear on many of these challenges – and could yet again bring peace of mind to those exploring a push into the Nordic medical device market.

Here are my three major considerations that medical device manufacturers should focus on when weighing up expansion into the Nordics – and how technology can help solve them:

High risk, high reward? Weigh the costs vs. benefits to your business

At first glance, expansion into the Nordic market may seem like a case of ‘high effort, low reward’ for many medical device companies. The entire Nordic medical device market, for example, is smaller than the German market alone, and the Nordic market is far from the largest by value, given the relatively small populations of each nation within the region.

Yet medical device margins are significantly higher in the region when compared to most European nations and indeed to countries beyond. Nordic countries have a very high standard of living and per capita wealth is equally strong, with effective healthcare systems and high-quality products used in treatment. Healthcare spending is also typically very high as a percentage of GDP.

Expanding into or setting up in the Nordic market ultimately represents a calculated risk for many medical device companies – do they replicate compliance tasks and increase the volume of labels and assets managed internally to sell into this market, or do they cut their losses and focus on large, more lucrative targets such as Germany and the UK?

If manufacturers conduct suitable research and can identify a strong appetite or market niche in the Nordics to position proven, fully compliant medical device ranges, there is a potentially rewarding opportunity. The short-term risk, therefore, may be comfortably worth the long-term reward – but only if manufacturers have suitable systems in place to comfortably handle country-specific labelling and artwork requirements that can be customised to effectively handle national nuances.

National nuances mean labelling is a nightmare – a wake-up call for digital management

One of the main challenges facing medical device companies looking to ‘crack’ the Nordic market is the scale of it. Spanning Denmark, Norway and Sweden, Finland and Iceland, the market is fraught with differing product preferences, healthcare system priorities and customer expectations. Each national healthcare authority is also far smaller than other European counterparts such as the NHS, and each has differing back-end processes such as those covering general management, documentation and reimbursement. Beyond this, Nordic regulation and labelling requirements also closely follow the same path as the majority of Europe – following EU directives as a core regulatory framework. This today includes the recently introduced MDR and IVDR, and formerly MDD.

As a result, medical devices sold to and used in these Nordic countries require extra labels and markings on product packaging. Some manufacturers, still conscious of their often- disruptive compliance efforts to satisfy MDR and IVDR deadlines, have opted to avoid the market for fear of replicating similar compliance burdens several times over. Again, by looking to digital alternatives to the more ‘traditional’ legacy methods of manual spreadsheets and disparate systems, this is far easier to get to grips with on a single easily managed platform.

M&A ambitions just add to the problems with onboarding challenges

Can you buy your way in? Can medical device companies looking to expand in the Nordic market instead aim to achieve this relatively pain-free through merger or acquisition? The answer is not so simple.

Manufacturers that take over existing Nordic medical device companies could face a burden similar to the scale of MDR or IVDR compliance projects – something we at Kallik have seen pose a major challenge to day-to-day operations of medical device companies of all sizes.

Significant increases in the number of assets that must be amended for rebranding product lines, newly discovered siloes of information and a scattered workforce could all threaten to make a typical acquisition into an unexpected time- and resource-consuming challenge. Add the usual M&A challenges of translating assets into multiple languages for the region, and without the right digital backbone this quickly becomes a non-starter.

Focus on digital maturity now to avoid new market ‘growing pains’

It is clear that expanding existing medical device operations into the Nordic market is far easier said than done, with downstream compliance challenges, asset management and multiple languages all obstacles to be overcome. Embracing end-to-end label and artwork management within a single digital system offers a lifeline to medical device manufacturers. It helps ease the onboarding burden by allowing companies to establish pre-set templates and layouts suitable for products being sold into each Nordic country, and bulk update existing assets for acquired product lines.

Most problems stem simply from an enforced need to manually create, update and manage labels and other product assets – a lesson industry as a whole learned during the MDR and IVDR compliance rush.

Digital alternatives offer far more than a ‘luxury’ alternative to this – they are increasingly the norm for manufacturers to weather the storm of emerging regulations, customer expectations around product traceability, and other unexpected industry disruption. Those that can deploy and maintain a truly mature digital environment for label and artwork management will be laying the groundwork to flourish in potentially lucrative markets such as the Nordics.

Want to know more?

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.

Businesses and manufacturers in highly regulated markets - in particular pharmaceutical, food and beverage, cosmetics and consumer packaged goods (CPG) - have experienced huge change in recent years, most significantly in the technologies they use, the regulations they face, and the changing demands from their customers.

In 2023 these macro-level changes are going to have a serious impact on regulated industries – with technology-driven change exploiting the industrial metaverse right down to the packaging, labelling and artwork used when manufacturing each individual product.

1. The industrial metaverse will blur digital and physical like never before 

The global metaverse market is set to grow at an annual compound rate of 39.8% between 2022- 2030. As part of the wider metaverse umbrella, the industrial metaverse combines a mix of immersive technologies including physical-digital fusion and human augmentation to create digital representations of a physical environment. Early adopters are already seeing benefits in terms of streamlining logistics and processes, achieving tangible return on investment (ROI), and delivering high-quality products across multiple industrial applications.

Many companies are still trying to envision the future of the industrial metaverse, but its potential to transform design, manufacturing, and interactions across global ecosystems is gaining significant interest. We have already seen the introduction of digital twins during Industry 4.0, a virtual model designed to accurately represent a physical object. When supported by other innovative technologies such as artificial intelligence (AI), Internet of Things (IoT) and 3D rendering, the true powers of digital twins can be felt and the road to the full impact of the industrial metaverse becomes nearer.

In conjunction with digital twins, we can expect to see the use of 3D rendering rapidly increase in 2023. 3D rendering is the process of using a computer to generate a 2D image from a digital three- dimensional scene. At Kallik, 3D rendering for artwork and labelling has already been a core focus – it can help generate labels or artwork to put on the product and produce a 360-degree view of what it will look like on the product or even the shelf before it goes to market.

2. Get to grips with cybersecurity – put data at the heart of operations

Sophisticated hackers are increasingly finding ways through business security defences, so cybersecurity will become a clear focus in 2023. In the UK, nearly two-fifths of businesses experienced a cyberattack in the year leading up to July 2022. For the healthcare sector, cyberattacks have been a long standing issue – it received 20% of the UK’s cyberattacks in 2021. Its vast amount of personal data combined with a reliance on outdated, legacy technology has made the healthcare market a sought-after target and unfortunately, medical devices have become an easy entry point for attackers. Medical device manufacturers are on the front line and must integrate an effective cybersecurity plan throughout the entire product development lifecycle, from pre-market and post-market phases, to device disposal.

Prevention all comes down to data management – companies stand a much higher chance of warning off unwelcomed attackers by putting data at the core of operations. This applies right down to access control for critical recipes and formulas in the manufacturing supply chain – and that includes the label and artwork management (LAM) solution, where security is of upmost importance. LAM solutions are accessed by multiple parties across the manufacturing and distribution process, so product owners need to hold one single source of truth and be able to be sure there is no unwanted data sharing. They must ensure that not only users of the platform are only able to see information relevant to them, but also that out-of-date files are prohibited to reduce risk. Users must only be able to view and edit one version of a label that will need rigorous approvals thereafter. This will provide the necessary reassurance that a consistent audit trail has been followed and minimises the likelihood of data leakage, businesses can be confident that attackers are unable to edit or share data without access or permission.

3. The rise of “Eco-anxiety” – sustainable packaging remains at the front of consumer minds

Environmental, social and governance (ESG) may be no new phenomenon, but it is one that requires urgent action as pressure mounts daily from investors and an eco-conscious society. In 2023, this focus isn’t going to die down – organisations can even expect to lose their competitive edge or market share if ESG is not taken seriously. In a recent report by Kantar, 97% of consumers globally reported that they are prepared to take action and live a more sustainable life, with another 79% keen to purchase more sustainable products.

Most recently, microplastics have found themselves under the microscope – every minute, over seven kilos of microplastics from cosmetics and personal care products end up in the European environment. The cosmetics industry is at the forefront of this issue, as 87% of products from the ten bestselling cosmetics brands contain microplastics. The growing issue has sparked major interest – and consumers have called upon EU regulators to action new laws against the use of microplastics. If approved, the restrictions will have huge implications for manufacturers, not only to product composition but to a major uphaul of existing labels to reflect the ingredients change. Editing such a sheer number of labels will need an advanced and sophisticated LAM (Label & ArtworkManagement) solution to match – a LAM solution that can manage vast amounts of data, symbols, words, and phrases on a large scale.

Exacerbating these pressures is the real and unavoidable 2025 deadline for sustainable packaging. Although market challenges such as cost of living increases and supply chain shortages will wreak havoc for organisations, up to 70% of consumers are willing to pay more for products with sustainable packaging. It will require business leaders to rethink both operations and timeframes, including the use of sustainable materials, and how this will affect printing operations. Here, technology will once again prove its value, reducing long manufacturing development lifecycles and waste in the label and artwork management by easily allowing adaptability to fit new packaging sizes and types – LAM solutions such as Veraciti™, helps companies reduce labelling and artwork completion times by 50%. Indeed, Kallik has been assisting major consumer goods companies in2022 to migrate from plastic packaging to cardboard packaging. Key to this has been Kallik’s Veraciti™ LAM. This trend is expected to continue throughout 2023.

4. Become a data-centric business – growth and success on scale will follow

Finally, in 2023, more organisations will realise the true power of data when analysed and used at scale. Despite investment of trillions of dollars by U.S. companies into data analytics integration at scale, up to now only 8% of organisations are capturing real value. From a labelling and artwork management perspective, effectively harnessing data can unlock a whole host of opportunities and it can help prepare for changes in regulations, product updates, and react in the event of product recalls.

In the artwork and labelling space, being able to react to changing market conditions will be pivotal to stay compliant and operational – and companies must invest in a data heavy system, capable of examining, storing, and printing mass amounts of data, quickly. Take the postponed UKCA certification deadline. By end of year 2024, companies must have changed all labels to reflect the new UKCA marking to remain compliant. Or consider the move to sustainable packaging highlighted earlier, where companies will need to alter recycling symbols for each product based on the material type, regional recycling regulations, as well as the storage and recycling instructions for every region and every language – each of these will need an LAM solution to change speedily, safely and at scale.

Analysing data at scale and actioning cross-organizational change across thousands of product lines will be a long, arduous, and error-prone task with a manual or paper system. It is simply impossible now to adapt to change and to grow without the help technology.

With Veraciti™, companies can reduce artwork changes down to five minutes – a 55-minute saving per change compared to other solutions. The Veraciti™ database and rules engine function keeps products and predetermined phrases stored in 30-40 different languages, to allow users to quickly search and find the relevant data that can be used for artwork – saving time and risk of human error. While many large companies have been found to pass artwork and labelling tasks on to outbound agencies, Veraciti™ has proven savings of up to $3 million per year on third-party artwork agency fees for one large Kallik customer.

The proof is in the numbers – make sure you follow them in 2023

Despite previous years being filled with uncertainty, there is still much externally enforced change for manufacturers in highly regulated markets in 2023 – whether it be the rise of the industrial metaverse, preparing for upcoming regulations, tightening cybersecurity defences or an increased focused on ESG. This will give rise to an increased reliance on digital LAM solutions to ensure product packaging and labelling keeps pace with these developments.

For all manufacturers but in particular for those businesses in regulated industries, the label may be the last part of the production cycle, but it will be one of first parts to cause regulatory issues and even impact consumer safety.

Want to know more?

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.

Enhancing Compliance and Efficiency in Enterprise Labeling

Large enterprise companies face numerous challenges with their product labeling and artwork process. Compliance with regulations and getting products to market quickly can be a headache and requires a lot of manual effort. In addition, in regulated industries such as medical devices, pharma, and cosmetics, noncompliance with labeling regulations could mean severe consequences. In addressing these challenges, enterprise labeling software is often overlooked. Below, we’ll look at what enterprise labeling software is, its benefits to enterprise companies, and why you should consider it.

What is Enterprise Labeling Software?

Enterprise labeling software is a specialized technology solution designed to automate and centralize the labeling process within an organization. It enables businesses to create, manage, and automate labeling across many departments, locations, and languages. It contains features such as end-to-end approval trails, automated change management and a dedicated asset search engine. This software empowers labeling and compliance professionals to ensure regulatory compliance while boosting efficiency and decreasing time to market.

How Enterprise Labeling Software Increases Compliance

Meeting Regulatory Requirements: In regulated industries, compliance with labeling regulations is vital to ensure patient safety and product integrity. Enterprise labeling software provides a single platform to create and manage labels according to regulatory standards, such as FDA, EU MDR, and ISO. This software helps organizations stay updated with the latest regulatory changes and implement them seamlessly.

Traceability and Audit Trail: Enterprise labeling software offers advanced tracking capabilities, ensuring complete traceability throughout the labeling process. Compliance professionals can easily track label versions, changes, and approvals, with access to an audit trail in case of regulatory audits. This level of traceability enhances transparency and accountability, reducing the risk of non- compliance.

Automated Compliance Checks: Manual compliance checks are time-consuming and error-prone. Enterprise labeling software automates compliance checks across multiple artworks, verifying label content against regulatory requirements. It highlights any discrepancies or potential violations, allowing compliance professionals to rectify them before labels are printed or published. This automated validation saves time, minimizes errors, and mitigates compliance risks.

How Enterprise Labeling Software Boosts Efficiency

Centralized Label Management: Enterprise labeling software centralizes label design, data management, and printing across the organization. It eliminates the need for multiple software applications and manual data transfers, reducing errors and increasing efficiency. By maintaining a centralized store of label templates and product data, you can easily access and update information.

Streamlined Collaboration: With enterprise labeling software, different stakeholders involved in the labeling process can collaborate seamlessly. Compliance professionals, regulatory affairs teams, and marketing departments can work together in real-time. This reduces communication gaps and speeds up the label creation process. This collaborative approach ensures that labels comply with regulations while meeting branding and marketing requirements.

Agile Labeling Changes: In highly regulated industries, labeling updates and changes are inevitable. Enterprise labeling software enables organizations to respond quickly to regulatory updates or product changes. With efficient workflows and approval processes, compliance professionals can implement labeling changes rapidly, ensuring compliance without causing delays in product launches.

A proven enterprise solution

Enterprise labeling software is now a key tool for many large enterprise companies, particularly in regulated industries. Companies like Teleflex, a medical devices manufacturer have used it to great effect, stopping product recall issues. Teleflex benefits from advanced labeling and artwork management capabilities, all achieved because of the centralised cloud-based system from Kallik. End-users benefit from simplified processes and powerful features. These include a dedicated asset search engine, enhanced phrase and translation management, and end-to-end approval and audit trails.

"As a major medical device provider operating worldwide, teams working across all of our sites and facilities will be involved with the labeling process at some point, meaning standardised control and processes were simply non-negotiable for future success" - Brian Cannon, Senior Project Manager at Teleflex.

Another company benefiting from enterprise labeling software is Össur, a global leader in non-invasive orthopaedics. New EU MDR regulations meant their Kallik solution soon became instrumental in the successful completion of MDR compliance across its operations. With Kallik's software, Össur united 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 reuse of key phrases has led to standardization of IFUs and a streamlining of product information.

“The team at Kallik went above and beyond to support us during the implementation of their labeling software. This was the reason why the change process project was so successful despite challenges posed by MDR regulations.” - Sigurður Gísli Karlsson, Global Product Manager at Össur.

Time to embrace technology

Embracing this technology can result in improved efficiency, minimized risks, and enhanced brand reputation for enterprise companies operating in regulated industries. What's more, it can often be quicker and easier to implement than many other enterprise solutions. Kallik’s labeling management software allows you to create, edit, approve, and produce compliant and accurate labels and artworks in a flash. Make your work more efficient, reduce manual hours spent, and minimise product reworks. All at a time when safety, cost, and compliance are paramount.

Want to know more?

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.

Large enterprises often face significant challenges when it comes to updating product artworks. The process of manually creating and updating artwork for product labels can be time-consuming, error-prone, and resource-intensive. Add in multiple locations with many variants to edit, it becomes even slower and more prone to error. 

However, with the advent of artwork management, and now artwork automation tools, solutions are available to greatly improve this process. More and more enterprise companies, especially in regulated industries, are taking advantage of the significant improvements artwork automation can bring.

The Challenges of Updating Product Artworks

Large enterprises typically deal with a wide range of products and variations, each requiring unique artwork designs. Some of the key challenges faced by teams responsible for artwork include:

Time Constraints: Manually creating and updating product artworks is a time-consuming process. Dealing with a high volume of SKUs and multiple variants can be a complex process. Teams often struggle to meet tight deadlines, resulting in delays in product launches, delays in getting a product back out to market after a recall, and missed market opportunities.

Version Control: With multiple stakeholders involved in the artwork approval process, maintaining version control becomes complex and prone to errors. This can lead to confusion, rework, and errors in the final artworks. This can have severe consequences, especially in regulated industries where incorrect labeling cost lives, money, and reputation.

Compliance and Regulations: Different products may have specific labeling requirements based on industry regulations or locations. Ensuring compliance with these regulations manually can be a daunting task, increasing the risk of non-compliance and legal issues.

Basic artwork management is not enough

Artwork management solutions have been around for many years. These solutions can approve, store artwork in an asset manager, and manage version control. However, according to Gartner, these solutions are "only artwork management that governs artwork activities for the final product packaging”. 

Artwork automation, in contrast, can do a lot more than simply storing, tracking and approving artworks. A single, end-to-end enterprise labeling and artwork management (LAM) solution controls the entire labeling process. This enables automated artwork creation and modification in the same system. These tools can update artwork over thousands of variants and locations and generate new artwork ready for print. 

All this can be done in as little as 60 seconds, compared to the many weeks and months of revisions and reworks that are often commonplace.The savings from automating artwork creation and modification all in the same system that manages artwork storage and approval can be vast.

How automated artwork generation works

Automated artwork generation tools offer a powerful solution to the challenges and pains faced by teams responsible for artwork. Here's how they can transform the process:

Enhanced Efficiency: By using artwork automation, large enterprises can significantly reduce the time and effort required to create and update product labels. Automated tools can generate artwork templates, populate them with relevant information, and adapt designs for different product variations. This results in far faster iterations and a much quicker time-to-market.

Streamlined Collaboration: Automated artwork generation tools provide a centralized platform for collaboration and version control. Stakeholders can review and approve designs in real-time, reducing errors, rework, and delays. Seamless integration with project management systems and communication tools ensures efficient coordination among team members.

Compliance and Consistency: Automated artwork generation ensures compliance with industry regulations and labeling requirements. By integrating data from reliable sources, such as product databases or regulatory databases, these tools can dynamically generate accurate and up-to-date content, reducing the risk of non-compliance and legal issues.

Conclusion

Artwork automation is revolutionizing the way large enterprises create and update product labels. By automatically generating artworks in the artwork management system, new artworks can be created in seconds, instead of weeks. Adoption of this technology is increasing, especially in regulated industries.

Want to know more?

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.

In today's fast-paced world of artificial intelligence and automation, enterprises across industries are continually seeking innovative solutions to streamline their processes, save valuable time, and reduce costs. When it comes to labeling and artwork management (LAM), this is critical - that’s where cloud-based enterprise labeling and artwork software comes in.

However, we understand that there are misconceptions and concerns about the security and reliability of cloud technology when it comes to packaging artwork management software - especially in highly regulated industries. In this blog, Kallik’s LAM software expert, Bob Tilling, will address and debunk these misconceptions, shedding light on the advantages that cloud-based software brings to the table. We'll explore how it simplifies processes, enhances collaboration, and most importantly, ensures data security, ultimately making labeling and artwork management easier than ever.

Dispelling the Myths: Cloud Technology for Labeling and Artwork is Secure and Reliable

Before diving into the benefits, let's tackle the elephant in the room - security and reliability. It's not uncommon for businesses, especially large enterprises, to have doubts about moving their labeling and artwork management to the cloud. However, it's time to put those fears to rest.

Is Cloud-Based Software Secure?

Cloud-based art asset management solutions are as secure as, if not more secure than, traditional on-premises systems. Leading cloud software providers, like Kallik, invest heavily in state-of-the-art security measures to protect your data. These include encryption, multi-factor authentication, and regular security audits. When it comes to data security in the cloud, your data is, quite literally, in safe hands.

Is Cloud-Based Software Reliable?

Cloud software reliability is often questioned when we talk to prospective customers handling sensitive data and important digital assets - and rightly so! However, with redundancy built into the infrastructure (meaning your data is stored in multiple places instead of just one). This ensures that even in the rare event of a server failure, your operations continue seamlessly. Uptime guarantees are standard, so you can count on your labeling and artwork management processes running smoothly around the clock.

What are the Advantages of Cloud-Based Labeling and Artwork Management Software?

Now that we've set the record straight on security and reliability, let's instead explore the numerous advantages of using cloud-based software for labeling and artwork management. Enterprises managing extensive product ranges are often struggling to juggle different versions of label artwork and deal with a lot of back and forth over emails as artwork is edited and approved. Cloud-based LAM software solves all of these issues.

1. Simplifying Labeling and Artwork with Cloud Software From Start to Finish

Complexity can be the bane of large enterprises. With a vast array of products, variants, and markets to cater to, simplification becomes paramount. Cloud-based labeling and artwork management software streamlines and standardizes the labeling design and approval process. With seamless implementation, meaning there is nothing to be installed or maintained locally, it is quick and simple to get set up. The addition of label templates and simple artwork version control ensures consistency across all products, eliminates manual errors, and reduces time spent on tedious tasks. In turn, this leads to faster time-to-market, reduced costs, and enhanced overall efficiency.

2. Enhancing Collaboration with Cloud-Based Collaboration for Labels

Collaboration is key to success with label software, especially when dealing with large product ranges. Cloud-based solutions enable real-time artwork collaboration across geographically dispersed teams. Whether your team is located across different continents or simply in different corners of the office, everyone can access and work on labeling and artwork simultaneously making changes and approvals easier than ever. This boosts productivity and ensures that everyone is on the same page, no matter where they are.

3. Ensuring Data Security in Cloud Labeling and Artwork

Large enterprises are often under the scrutiny of regulatory bodies and subject to stringent compliance requirements. Cloud-based software, like Veraciti, takes data security and compliance seriously and makes it as simple as possible for customers to get it right the first time. Your data is stored in highly secure data centers with robust backup and disaster recovery plans in place. Compliance features are integrated into the software, making it easier than ever to meet regulatory requirements and pass audits with flying colors - ideal for organisations in highly regulated industries such as those looking for medical device labeling software.

4. Instant Updates Mean Your Software is Always up to Date 

Being cloud-based allows for the instant deployment of updates, patches, and enhancements worldwide with a single click. This eliminates the delays associated with on-premise solutions, where you rely on either the software provider or the customer to perform these tasks manually. With cloud technology, your solution is always up to date, ensuring your business remains compliant, efficient and competitive in today's fast-paced digital landscape.

See the Difference for Yourself with Kallik's Cloud-Based Labeling and Artwork Management Software

At Kallik, we understand the unique challenges that large enterprises face in labeling and artwork management. That's where we come in, our cutting-edge cloud-based software as a service, which has been helping some of the world’s biggest organisations to manage their labeling and artwork process for decades. Kallik's software has earned its reputation as an industry leader, being recognized by Gartner as a top label and artwork management software vendor. Engineered to simplify processes, enhance collaboration and ensure compliance, it is ideal for use in highly regulated industries, providing ultimate data security for enterprises managing extensive product ranges. Hosted on the leading cloud provider, AWS, our service comes with added peace of mind that you’re getting world-class service.

With Kallik, you can: 

• Streamline and standardize labeling and artwork processes, reducing errors and costs.
• Collaborate in real-time with teams across the globe, boosting efficiency.
• Rest easy knowing that your data is secure and compliant with industry regulations.
• Don’t just take our word for it, see what our customers have to say about Kallik in our case studies here.

Want to learn more? 

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.

In a recent webinar co-hosted by Kallik and Teklynx, industry professionals gained valuable insights into the evolving landscape of labeling and artwork content management for 2024. This event provided practical advice and innovative solutions, focusing on the "5 Top Tips for Effective Labeling and Artwork Content Management in 2024."

Missed out on the webinar? No problem. Find out all about it below and watch the full recording. Right from label design through to label printing, we can help every step of the way.

Tip 1: Content-Centric Approach for Labeling and Artwork Control

The webinar kicked off with a discussion on a content-centric approach to labeling. Imagine a world where labeling starts with content. It's not just a dream; it's a game-changer. This approach aims to create a central source of truth, reduce redundancy, maintain consistent templates, and identify errors before they become issues.

Tip 2: Harness the Power of Label Templates

Label templates, often underestimated, were emphasized for their ability to save time and money. Templates keep marketing teams happy, making it quicker and simpler than ever to ensure that packaging is consistent and artwork is on brand. Templates are also particularly useful in regulated industries where they simplify the process of incorporating essential information into labels. Whether it’s cosmetics packaging, chemical labels, medication labels, or food labels, you can significantly speed up your process with the ability to drag and drop the right assets into the right place with templates.

Tip 3: Simplifying Labeling Translations

The webinar then went on to address the challenges of label translation. Lost in translation? Not anymore! The days of Googling translations for your labels are over. There are two possible approaches you can take:

Approach One: Traditional Translation Process
 It's time-consuming and error-prone, resulting in variations and inconsistencies. We've got a better way…

Approach Two: Centralized Translation Management
It's like magic - translations stored in the cloud, linked to the master phrase, and accessible to all authorized parties. Master phrase linking allows non-native speakers to produce accurate localized labels without needing the language knowledge. So no more confusion, just clarity.

Tip 4: Embrace Global Labeling Solutions

The future of labeling management, as discussed, revolves around cloud-based SaaS solutions hosted on platforms like AWS and Azure. There are a long list of benefits, here are some of the favourites:

• Say goodbye to content approval delay headaches.
• Shared label templates for a consistent brand.
• Language variants managed with ease.
• External partners at your fingertips.
• It's Gartner recommended.

Tip 5: Automate Printing for Speed and Quality

Automation was recognized as a vital tool for simplifying the labeling process. It connects cloud data to local printers, enabling seamless data flow and efficient label printing. Automation eliminates manual tasks, IT complexities, and quality concerns.

Finally, we concluded the webinar by asking attendees which tip would be most beneficial to their business. Tip one, centralized control of content and artwork, proved most popular, closely followed by tip four, bridging the gap of cloud data to local printers. This suggests that businesses are focused on greater efficiency and consistency and the growing relevance of cloud-based solutions in modern business operations.

In summary, these five expert tips offer practical solutions for labeling and artwork content management, eliminating inconsistencies and inefficiencies. If you're looking to save time, resources, and alleviate the challenges in your labeling process, these insights provide a clear path forward. The future of labeling is here, and Kallik and Teklynx are at the forefront of these advancements.

Want to know more? Click here to watch the full webinar now.

Ready to Take Control?

Kallik's cloud-based labeling and artwork management solution is your ticket to labeling success. Want to know more? 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.

In today's fast-paced world, the demand for sustainable packaging and labeling has become an essential priority for businesses. As covered in Avery’s report, globally, labels and packaging legislation is more focused on sustainability than ever before.

As consumer awareness regarding environmental issues continues to rise, companies are finding themselves under increasing pressure to adopt eco-friendly practices. Traditional labeling and artwork management processes have long been a culprit of excessive waste and inefficiency.

This blog explores the environmental impact of traditional labeling, and how adopting online, cloud-based, automated software that uses label templates can transform your process. We'll also delve into a real-world example of food packaging labels to illustrate the sustainable journey from design to market. 

The Environmental Impact of Traditional Labeling

Traditional labeling and artwork processes often involve multiple manual steps, which contribute significantly to environmental concerns. From the design phase to the actual label printing, each step can result in waste and excess resource consumption. Let's break it down and explore how each stage affects the environment:

Design Phase: Traditional label and artwork design often relies on paper prototypes and multiple iterations, which results in excessive paper consumption, ink usage, and waste. Many iterations are necessary to perfect the label, leading to more environmental impact.

Label Printing: With a large proportion of labels in the UK still being printed on materials that are difficult to recycle - even materials that look like paper are often not - it’s more important than ever to reduce waste where possible. Conventional label printing usually involves large print runs, which can result in overproduction. Unused labels are discarded, leading to wastage of materials and energy. Additionally, printing errors are common, avoiding reprints and further environmental harm. This is where it’s crucial that labels are printed correctly the first time.

Distribution: Transporting printed labels to various locations can result in carbon emissions, thanks to the heavy logistical footprint of shipping and transportation. 

Embracing Sustainability with Cloud-Based platforms and Label Templates

With online, cloud-based, automated software that uses tools like label templates, there are a whole host of benefits that are music to the ears of environmentally conscious businesses:

Sustainable Labeling Templates: These platforms provide a range of customizable, pre-designed templates for sustainable labels. They help in reducing the need for excessive design iterations, resulting in less paper and ink waste. For our food packaging labels example, a nutrition label template that complies with FDA label requirements can be easily accessed and modified.

Reduced Errors and Waste: Labeling errors can be incredibly time consuming and costly as well as posing serious safety risks. For example, Trustwell recently reported that undeclared allergens made up the largest percentage of recalls overall, making up 47% of all recalls in 2022 and 63% of recalls in 2023, so far - something which can easily be solved with proper artwork management.

One of our biggest pharmaceutical customers typically dealt with around one error per month and since using Kallik’s solution they have experienced no errors at all. In the case of traditional labeling and artwork, mistakes can result in reprinting, wasted labels, and increased resource consumption. However, label templates and proofreading tools significantly minimize the risk of human errors in label design by having a pre-approved bank of assets that can be simply dropped into templates that meet all the relevant regulations for the product.

Efficient Printing: With cloud-based software, labels can be printed on-demand or in smaller, more precise quantities. This eliminates overproduction and minimizes discarded labels. The use of digital printing technology, which is often more eco-friendly, further reduces environmental impact.

Making it easy to switch packaging materials: Digital platforms are becoming instrumental in adapting to sustainable packaging goals. In addition to minimizing physical waste, with label templates, it is becoming quicker and easier than ever to adapt your packaging to be more sustainable. Customizable, pre-designed templates mean that the once colossal task of changing the size and design of thousands of labels to suit paper packaging rather than plastic can now be done with the click of a few buttons. 

A Sustainable Journey: Food Packaging Labels

Now, let's walk through the process of creating sustainable food packaging labels using online, futureproof, cloud-based software:

Design Phase: Start by selecting a nutrition label template that meets FDA label requirements. Customize it to your brand's specifications, ensuring it complies with sustainable labeling guidelines. Online software streamlines the design process, making it efficient and reducing paper and ink waste.

Collaboration and Approval: Cloud-based solutions enable team collaboration and instant feedback. Stakeholders can review the label design in real-time, reducing the need for multiple drafts and printed proofs. This step significantly minimizes waste and saves time.

On-Demand Printing: Once the label design is approved, you can print labels on-demand or in small batches, eliminating overproduction and reducing unnecessary waste. Digital printing technology is environmentally friendly and ensures high-quality, eco-conscious labels.

Distribution: With labels ready to go, you can efficiently distribute them to your products without the need for extensive logistics and long shipping routes, further reducing your carbon footprint. 

Take the Next Step Towards Sustainability with Kallik 

As businesses look for more sustainable options in labeling and packaging, it's evident that traditional processes fall short in environmental terms. Embracing online, cloud-based software, like Kallik's AWS hosted solution, recommended by Gartner, you can revolutionize the way you approach labeling and reduce your environmental impact.

By adopting sustainable label templates, reducing errors, and optimizing label printing, you can actively contribute to a greener future for your company. Want to know more? 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.