Emma Jarrett | kallik-new

Digital Labeling – A Business Rules Approach

Author Name

Kallik Role 1

Content Manager

Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) require labeling content to be published electronically in addition to print.

As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.

Transforming existing paper-based legacy artwork management systems and processes to a new digitally-driven environment are two concepts that can, in fact, work together to help highly regulated industries reduce the risk of non-compliance and costly product recalls.

Transforming your business with two concepts

Firstly, all parties or stakeholders, including regulatory, marketing and manufacturing must have access to the same system that masters the content – this means they must have access to the correct level of permissions in order to edit, modify and review the labelling content as needed.

Secondly, when much of the labelling content is held in a range of documents, emails, PDFs and printed documents, it can become difficult to construct, deconstruct and reuse labelling content.

These organizational challenges, therefore, need to be overcome, calling for the digitization of all labeling assets. Labeling and artwork processes have tended to be seen as more of a cost overhead rather than a core business activity. This can lead to systematic failures due to a lack of clear ownership, loosely defined decision-making processes and too much reliance on ‘tribal knowledge’.

In other cases, need to make repetitive ‘low-level’ decisions manually, where these could otherwise be easily automated can lead to fatigue and unnecessary errors. The end result can be costly product recalls potential fines and brand damage through non-compliance.

This is where the ‘business rules’ approach comes in – managing the decision-making process as a set of business rules allows for more responsive changes or additions to processes as this can be undertaken by business users as opposed to writing code. Whilst we could choose to implement a standalone business rules engine to automate many of the existing manual driven processes that often exist, we would still be left with the challenge of discovering and extracting the source content needed for each label variant.

The way we can overcome this is by digitalizing and versioning each of our labeling assets (logos, warning statements, images, etc.) and ensure that these are easily discoverable. We can then configure our business rules engine to find, and subsequently populate, each of the variable fields we may need on our labels depending on where the product is going to be sold and which local market legislation needs to be adhered to.

Seeing the opportunity in the EU MDR

Much of the medical device industry is quite rightly focused on understanding the impact of the legislative framework and being in a state of readiness to populate the EU equivalent of the GUDID, this being EUDAMED (European Database on Medical Devices) by May 2020. In addition, implementing the upcoming European Unique Device Identifier will require considerable investment and strategic planning for many organisations, so now is a good time to consider options for process re-engineering.

At Kallik, we see the EU MDR as an opportunity for organisations to review the effectiveness of their current labelling and artwork processes and how digitising supply chains can strengthen compliance and simplify evolution toward e-Labeling. Securely managing all product and prescribing-related information in a single version controlled environment enables unlimited composition, re-use and printing of any type of label anywhere. Furthermore, your labelling becomes ‘channel agnostic’, that is it can be delivered through multiple channels (web, mobile, social) as well as via the more traditional paper-based means of presentation.

Adopting labeling digitalization enables more robust regulatory submissions and ultimately increases the transparency of enterprise-wide review and approval processes. This can simplify the integration of extended supply chains and shorten time to market during periods of mergers and acquisitions.

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.

Document Versus Data: Why The Difference Matters

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

People often ask why we stress the difference between a document-oriented way of looking at managing your product and brand information and a ‘data’ one. It’s a great question, and can best be answered like this: you’re a manufacturer of a single product line. Let’s say you’ve had some success, and your product is sold in 10 countries. It gets a bit complicated now, but not unrealistically; let's say your product comes in three sizes or versions. Even at this level of simplicity, you have potentially 30 different labels (10 countries, three different iterations) to worry about and change.

Now, here’s the issue. In a document-centric world, where people are managing document files in the same computer system, that’s 30 separate items you are managing. Granted, 90%, maybe 99% of the content in all of those word documents is the same as in the other 29 Word documents, which means the same data is duplicated many times.

So what happens when you hand over those 30 documents?

Even if the documents are almost all identical, to an in-house graphics department or a third party to build artwork? First, artwork gets created at least two or three times. So, for each of the 30 artworks, I’ve now got 30 additional documents telling me what to change.

But here’s the thing, the problem on label number one is also wrong on all other 29 labels… so, I've got to change 30 Word documents and make the same change separately to each one. If they then get changed twice, or should I say ‘only’ twice, you’ve gone from having 30 documents to having 90 documents. And the reality is that when somebody reads a document that has been through three sets of changes, as they are only human, something they were happy with in the first version and passed, they now see in the third version and decide that it is wrong. They tell the designer to change it, they make the change, but the 29 labels are now out of sync.

This happens every day of the week. It even happened in your office today!

Remember, I’m only talking about one product here, but I have still ended up with 90 documents in circulation that can all potentially go out of sync. Add to that the files on the designer’s Macintoshes, and I’ve got another 90 Mac files on top of the 90 Word files in play. That’s what happens when you focus on documents.

We work with clients with thousands of products. That’s thousands of documents going wrong all over the place… thousands of files that need to be tracked down and updated separately with the vital textual change from the latest legal directive from the EU.

The problem with the way the Word, email or document-centric approach works is that you have to duplicate the data everywhere. This is simply unmanageable – and while it’s bad enough at one product, think 1,000 products or 2,000… Next time, we're going to present the other approach – the data one, which I think you will agree is a lot less confusing and difficult to manage and get right.

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Overcoming Aversion To Change When Adopting New Technologies

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

Processes and routines are two things that could be considered essential within the workplace. They are necessary tools to keep workflow going, businesses progressing, and employees focused on a day-to-day basis. But are they enabling change?

As important as it is to have recurring methods in place, the introduction of new systems and procedures can prove vital to the transformation towards a more productive working environment. Successful adoption often requires a change in organisational behaviour — some might even say culture.

Overcoming challenges

Technology has transformed medicine and has been instrumental in advances within patient safety. This can be seen in the design of single-use auto-disable syringes to electronic prescribing. Containing internal safety mechanisms, the ‘safety syringes’ ensure that after a single use, the syringe will not be able to be used a second time.

Patients and providers are embracing change, but what about the industry? Often, initial levels of adoption suggest a successful roll-out. Changes may happen in the short-term but aren’t always maintained. The more difficult part is migrating the entire organization across to new ways of working. Key people within the business will need to adapt and adopt the new approaches and lead the way in doing things differently. Some call these people ‘Change Agents’.

Breaking down barriers

Kallik recognises that technology on its own will not drive change. Change is more likely to be driven by new cultures and thinking. Increasing numbers of millennials entering industry will want to share and collaborate the same way they do at home.

Forbes suggest that millennials have been transforming the workplace for the last ten years and the trend is set to continue. Industry needs to actively encourage breaking down barriers between different departments and pushing collaborative critical thinking to support the new workforce. The pharmaceutical and medical device industries have continued to evolve over the last decade, but not fast enough.

Manufacturers in both industries have been presented with a fundamental challenge: adjust to a new business environment in an open, forward thinking way, to maintain an innovative edge or risk failure. By keeping the process simple and specific, working together as one team will see results improve, business confidence grow and solidify new approaches to problem solving in a cross-functional, constructive method. This method of working will look to see more people seeking to collaborate to discover better ways of working.

Coaching and shaping

Coaching and change management are crucial processes which can often be overlooked. Such a program brings greater ownership, leading to higher level of skills and knowledge delivering a productive long-term positive impact on the business.

Adopting the better work practices supported by new systems into an organization is crucial in seeing changes to the culture and working process of a business. Engaging individuals early on to help shape the solution will expose real value and encourage greater ownership. This will only help the workforce become more motivated and have a positive long-term impact on the business.

Organizations should seek an adaptable solution which help reduce time and streamline labelling and packaging artwork generation processes. Kallik looks to adopt ‘active prototyping’, which brings a solution to life very quickly so that users can see straight away what they’ll be getting and be able to shape the configuration of the solution to best fit their needs.

Embracing the future

Workplace culture plays a crucial role in changing the dynamic of any organization. An organization’s culture must develop and adapt to change what is considered the ‘modern’ working ways of a business. New ideas and technological advances are two key methods which will lead to culture change. These are fundamental in both the medical device and pharmaceutical industries, which will benefit greatly in the long-run from people and groups within an organization not afraid to make changes.

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How Automated Labeling Can Help Your Organization Meet Strategic Goals

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

Global medical device companies are increasingly looking at labelling from a strategic perspective. They have recognized that accurate labeling is critical for maintaining compliance, ensuring brand consistency and improving operational efficiency, with all three helping to support business growth.

To work as efficiently as possible, labeling needs to be integrated into an enterprise business process, as well as working efficiently with an existing solution. Below, we outline some of the best streamlined approaches organizations can implement for the long-term benefit of their business.

Adapt and adopt

Life sciences companies need to adopt processes and solutions that will enable them to respond rapidly to change and achieve actionable insights across the entire labeling life cycle. This will enhance collaboration with all relevant stakeholders and improve regulatory operations.

Adopting a strategic, enterprise-wide approach to labelling will see both huge benefits, and drive value to companies. By adopting a joined-up approach to managing labeling, text, artwork, packaging and promotional materials, medical device companies will be able to ensure country-specific legislation is obeyed and labelling changes can be made quickly and accurately.

There needs to be clear visibility between functions and regions, otherwise companies will struggle to achieve cost reductions and productivity that could otherwise have a positive impact on faster integration of newly acquired businesses. Improved management and visibility of labeling content also ensures better insight of compliance, which equates to greater alignment across artwork, packaging and promotional materials.

Managing deviations

Having a system that provides all stakeholders with visibility into any regulatory or market driven changes and deviations is of paramount importance to any organisation. Teams of people within an organisation are tasked daily with finding and updating phrases across all labeling documents. A solution which is capable of tracking deviations and having a traceable link back to a single master source of content both reduces the risk of uncontrolled artwork versions and simplifies updates within an organization.

Gaining efficiencies and realising cost benefits

Life science companies are obliged to prepare and submit a significant amount of labeling content before starting clinical trials. Multiple stakeholders across different departments and regions must coordinate to implement changes affecting numerous interrelated parts. This is highly resource intensive and a time challenge for companies. This means that medical device companies need to find ways to gain efficiencies with their processes early on in the product lifecycle.

But preparing artwork and labeling from structured content drives both quality and productivity, and allows all stakeholders to leverage standardized business assets, such as reusable imagery and phrases. Advances in technology and tools for labeling activities improves processes which involve the collation and storage of content. As a result, activities which typically take weeks to manage are completed within minutes.

Transparency and visibility

Ensuring transparency in labeling and preventing inaccurate or misleading content should always be a priority. If companies are to remain compliant and easily demonstrate proof of compliance, they must adopt a solution that easily integrates a number of controlled and managed data sources to transform content into compliant labeling components.

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5 Ways to Make Your Supply Chain More Efficient

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

Heavily regulated industries face ever-changing regulations and legislation. It is increasingly important therefore, to ensure your organization puts the necessary processes in place in order to remain compliant when it comes to labeling.

Improving the efficiency of labeling and artwork processes across your supply chain is one way to do this. Efficient labeling review and approval process across your supply chain reduces the time taken for products to get to market, allowing for time and money to be spent on other areas of the organization. Improved visibility and traceability will also ensure that you are able to remain agile, should changes in regulations occur. So, what steps can you take to ensure your supply chain is more efficient?

1. Consistency

Supply chains across Life Sciences tend to consist of many partners including contract manufacturing organizations (CMOs). They are also tremendously intricate, containing numerous layers of wholesalers and suppliers, dependent upon receiving accurate and timely labeling content. In the end-to-end process, compliant labeling is essential to smoothing the entire flow from product development right through to customer fulfilment. Labeling is entwined with numerous parts of the development and manufacturing processes, from the product itself, the packaging materials and the bulk transporter cases. Therefore, having one single source of content that is consistent across the entire supply chain reduces the risk of non-compliance and costly product recall.

2. Visibility

In a global marketplace, ensuring labeling interoperability is crucial. With local legislations requiring adherence and local translations of the original language, utilising a master file which contains the source content throughout the organization and the supply chain is essential, as it allows you to trace back any phrase, symbol or statement type to the original single source. Visibility is also the number one measure when looking to ensure compliance throughout the supply chain. When it comes to launching new products, or engaging new partners, many organisations tend to defer to the most recently used symbol or statement, which is not always the latest approved version. There must be visibility throughout the supply chain of the most recently approved content, who it was last approved by, and when it was approved. Ownership of each individual piece of content, whether regulatory, marketing, product development, etc. also needs to be captured and clearly defined.

3. Ensuring Connectivity

Connectivity between all stakeholders is a key element of decision-making in the supply chain. By being referred back to the same single piece of labelling content, all stakeholders in the organization will know that they are always using the most up to date, approved version. This will prevent inaccuracies later down the line and avoid time wastage and risk of non-compliance.

4. Reconstruction and Reusability

The majority of label content is held in documents that can’t be easily edited, modified or reviewed, such as PDFs, printed document and emails. Ensuring that this content is made available in a granular form, broken down to a specific phrase, statement or symbol will aid discovery and simplify the review and approval process. This will allow all stakeholders to discover the latest approved content with ease, rather than having to spend time searching for and extracting content from a range of uncontrolled sources.

5. Quickly Update and Repurpose Content

Storing labeling content as digital assets allows for a more integrated supply chain making labeling more transparent to all stakeholders involved in the process whether labeling is to be printed or published electronically (e-Labeling). This approach allows you to manage all of your labeling content from one single platform making it easier to share with multiple partners whilst maintaining consistency of content across all channels. This permits greater collaboration and sharing between all supply chain players and removes, reliance on either previously printed labels or local IT solutions as being the master source which can lead to introducing inaccuracies.

It is extremely efficient for all players to be able to quickly update and repurpose content for different types of print and packaging as well as electronic media and this is only possible where there is a single approved source made available to all parties Following these 5 strategies will enable your organization’s supply chain to be as efficient and transparent as possible when it comes to labelling. This will also help ensure your organization is able to quickly respond to changing legislation and in turn avoid the risk of potential fines, brand damage and disruption to product shipment.

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The Benefits of Applying Business Rules To Labeling In Highly Regulated Industries

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

Keeping up with changing regulations

Notwithstanding the upcoming implementation of the new EU MDR in May 2020, many organizations in the medical devices, pharmaceutical, chemicals and cosmetics industries are experiencing unprecedented demands from regulatory authorities and consumers alike.

Product labeling must be clearer, more informative and published electronically in addition to print. It must also satisfy local legislation and local market requirements tailoring of labeling content to meet these demands therefore is key, as is putting the necessary processes in place to make this efficient and accurate.

The problem most organizations have when implementing these processes however, is that they are often done so manually in a way which can hinder efficiency and accuracy. Procedures are often published in an array of formats and dispersed across multiple locations which can become out of date or uncontrolled quite quickly resulting in missing or inaccurate labeling. So, what’s the key to avoiding these roadblocks? It’s all about playing by the rules.

If we can automate many of the manual repetitive processes it’s likely that time savings and quality improvements will be one of the first outcomes we experience.

How can business rules help?

Think of it like a filling in an online application form – the presence of certain fields and whether these have been pre-populated or require you to input data will depend on how you have answered the previous questions. The rules engine will decide whether it needs to insert, delete or update facts in real-time, and prove you with wider benefits to your organisation including:

Ensuring your organisation is better positioned to keep up with the pace of change
Improving productivity and efficiency
Ensuring compliance with policy and regulation
Improving customer service
Opening new revenue opportunities

What other outcomes can applying business rules help achieve for your organisation?

Minimise the level of human intervention in completing complex tasks

Needing to make repetitive ‘low-level’ decisions manually, where these could otherwise be easily automated, can lead to unnecessary errors. The end result can be costly product recalls, potential fines and brand damage through non-compliance.

Ensure content alignment across all types of labelling

Where much of the labeling content is held in a range of documents, emails, PDFs and printed documents it can become difficult to construct, deconstruct and reuse labeling content. Transforming existing paper-based artwork management systems and processes to a new digitally-driven environment will help reduce the risk of non-compliance and costly product recalls.

Automate and simplify the capture and collation of labelling content needed to address specific product and market needs

Digitalizing and versioning each of your labelling assets (logos, warning statements, images, etc.) will ensure each of the variable fields you may need on your labels depending on where the product is going to be sold, and which local market legislation needs to be adhered to, can be auto-populated.

Tailor the system around your own business processes

Adopting a business rules approach to labeling and artwork means that your organization is able to tailor the system around your own business processes, rather than adapting your processes to meet the requirements of the system. It will also mean that by automating manual, repetitive tasks, you will be able to free up your resources, allowing you to attend to higher value activities.

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Key EU MDR Changes You Need To Know About

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

Understanding EU MDR

Europe’s medical device regulations are changing, bringing about some of the most substantial shifts to the ways in which manufacturers bring their devices into the EU market, and how compliance must be maintained throughout the product lifecycle. The regulations strive to increase the traceability and safety of medical devices in the EU market, expanding on requirements including product classification, own brand labelling, regulatory submission evidence, and post-market surveillance.

Although EU MDR came into place in May 2017, medical device organizations have until 2020 to transition completely. Despite this, there is still an overwhelming 78% of organizations who do not currently have sufficient understanding of the requirements. Failing to produce accurate, MDR-compliant labeling and patient information could cause delays in market entry or even product recall. It is imperative, therefore, that organizations begin reviewing their labelling ‘real estate’, documentation, and system processes to ensure compliance with new, more complex regulations. So, what are some of the key changes you need to be prepared for?

Device warnings and precautions

Previously, all written warnings and precautions relating to a device were detailed in the Information for Use (IFU), however, new regulations state that these must now be present on a label in text form. This will bring translation into the mix – requiring ‘clearly comprehensible’ labeling in the intended user or patient’s national language. In addition, this also brings about the issue of designing labels with adequate space for new information – especially with some languages requiring more than others.

EU UDI: tracking and tracing

As part of the MDR, a Basic UDI-DI is being introduced. This refers to the relationship between what is a family of products that may otherwise appear to be unique individual products e.g. if one product in a family has manufacturing defects and needs to be recalled, the Basic UDI-DI shows this relationship. The Basic UDI-DI itself doesn’t appear on the label, but an organisation must be able to identify and trace all other related products as a result of querying the UDI on the label via the EU UDI database (EUDAMED), in turn creating a more secure global supply chain.

This relationship is something that medical device manufacturers will need to capture and make available for on-demand searches by patients, providers, and notified bodies with the ask made much simpler by connecting previously disparate labelling processes.

How can you prepare?

See it as an opportunity - The challenge many organisations face is a lack of tools, systems, and processes to be able to dynamically identify and update product labelling in suitable timescales. All, of course, whilst retaining fluidity, compliance, and avoiding disruption of supply chains. Although challenging, the EU MDR should be seen as an opportunity for organisations to review the effectiveness of their current labelling and artwork processes, and how digitalising supply chains can strengthen compliance and simplify evolution toward e-Labelling.

Develop a clear strategy - Creating a clear strategy across your organisation for implementation will make the process of preparing your labelling infrastructure simpler. It is important to carry out an assessment of your current processes and documentation to determine which elements must be modified to meet the new regulations – these may include Quality, Regulatory, Operations, Supply Chain, Legal, and R&D. Engaging all teams will ensure a collaborative, more streamlined strategy and robust implementation is achieved.

Adapt your processes - Adopting a joined-up, cloud-based labelling and artwork management solution is a key way to ensure an organisation is prepared to manage the EU MDR’s regulation and compliance changes in a more efficient manner. A platform such as this allows all users to access labelling and artwork assets via a single, centralised system, giving them full line of sight across all data assets. In addition, this platform will allow for up-and-coming changes to be managed in a fast and efficient way, future-proofing an organisation’s labelling systems in all territories.

With May 2020 fast approaching, it is imperative you act now. Assess your labelling and artwork real estate and ensure you have the operational agility to prepare for change. The implications of the inability to market your medical device products in the EU can have huge ramifications on your organisation. The countdown has begun.

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EU MDR: An Opportunity For Medical Device Manufacturers

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

With the EU MDR looming, medical device organizations have an opportunity to improve organization-wide best practice, rather than seeing achieving compliance as a short-term business overhead. Enforced compliance such as this gives medical device organizations the chance to organize and cleanse their labeling data and in turn create downstream value now rather than later. Many organizations lack corporate oversight of their labeling estate and there are many reasons why this is the case.

The opportunity to put things right

Whilst there is no quick fix to the discovery, audit and update of labeling artworks dispersed across multiple sites, we see EU MDR as an opportunity to put things right. Implementing a cloud-based solution to ‘connect the disconnected’ is the approach we would recommend to take control of your labeling data now ahead of the next wave of regulatory changes. Failing to comply with EU MDR regulations can have huge consequences on your medical device organization, which may result in costly product recalls, and delays in the distribution of products in Europe.

Bob Tilling, Sales Director at Kallik says, “The most important thing to ensure compliance is to ensure you have a thorough understanding of the requirements. The biggest challenge is the scale of the task – you must investigate how many pieces of artwork you have to change and then create a plan to move through them. Once you’ve identified these, you need a project to make these changes, approve them, and pass them out to subject experts for verification that the changes are correct.”

Employing a joined-up, cloud-based labeling and artwork management solution therefore, can ensure you are using the changing regulations to your advantage. This approach has a number of benefits:

It connects historically disconnected people and processes: a cloud-based solution makes storing, versioning, and modifying existing label layouts to accommodate new symbology and statements required for EU MDR a much simpler task.

Increases traceability: each label is visible to all stakeholders and simplifies collaboration, change, and compliance.

Reduces the impact of future regulatory and organisational-driven labeling changes: each impacted label can now be quickly identified, updated and re-printed along with a complete audit trail of changes making it easy to demonstrate due diligence to regulatory bodies when requested.

Adopting a cloud-based approach better equips medical device organizations to respond quickly and efficiently to future changes in legislation, new market opportunities, and simply the daily labelling challenges in bringing new products to market.

“It’s all about connecting the disconnected. You’ll have master labeling and artwork assets in a variety of artwork management systems – all of which are disconnected. By having a joined-up, cloud-based artwork management system all of these things get joined up, from their very creation, to the changes required for MDR, right up to the label being attached to the product in the factory,” Bob explains.

At Kallik, we have responded to this challenge with our, cloud-based solution, Veraciti™. Once brought under control, Veraciti's ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button. The cloud-based nature of the solution means it is quick to adopt across the broader organisation and by manufacturing partners. This means that in times of uncertainty, revisions and updates can be made in confidence as and when is needed.

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Is Your Medical Device Organization On Track To Comply With EU MDR?

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

With May 2020 just over one year away, the clock is ticking on the need to ensure compliance with the EU Medical Device Regulation (EU MDR). The new regulations can be seen as not only a requirement, but a method of survival for medical device organizations, with key implications on product and package labeling.

What are some of the key EU MDR regulation changes?

The need to provide more clinical evidence to get products to market
A requirement for greater data transparency
Performance monitoring pre-and post-market
New risk classification system
Reduced time for reporting from 30 to 15 days

Bolster your compliance processes

Bob Tilling, Sales Director at Kallik advises that the most important thing to ensure compliance is having a thorough understanding of the requirements – “You then need to investigate the scale of the task, look at how many pieces of artwork you’ve got to change and then come up with a plan to move through them,” he explains. If you haven’t started preparing, it’s imperative that you begin to bolster your medical device organisation’s compliance processes, with requirements to even reclassify your products. The inability to prove the required level of clinical evidence and correct labeling will ultimately prevent your products from getting to, and remaining on the market, and failing to comply can result in losing your licence to trade in Europe.

Create downstream value

The EU MDR can in fact provide medical device organisations with the opportunity to improve organisation-wide best practice, rather than viewing achieving compliance as a short-term business overhead. Enforced compliance such as this provides the opportunity to organise and cleanse labeling data, and in turn create downstream value, now rather than later.

Addressing key challenges

The key barriers facing medical device organisations is a lack of transparency, a plethora of structured and unstructured data, and the absence of a single view of approved labelling content. These challenges prevent key team members from accessing version-controlled data, increasing response time, and limiting organisations’ ability to make informed decisions. As Kallik’s CCO David Bennett explains, “Without a 360 vision of your whole real estate of labeling, it’s impossible to tell when a regulatory change impacts and where it impacts.”

How you can prepare: become an evidence-led organization

Employing a single, joined-up, cloud-based labeling and artwork management solution will allow medical device organisations to store product information in a central data platform. This will allow for a quick and effective response to future changes in legislation, new market opportunities, and simplify the daily labelling challenges in bringing new products to market. Kallik’s Veraciti™ solution is a comprehensive, unified, cloud-based Labeling and Artwork Management solution which is infinitely scalable. Its ‘where-used’ capability makes it quick and easy to identify and update individual labelling assets and to produce time-stamped audit reports at the touch of a button.

Plan and prepare for the impact and uncertainty of the EU MDR with Kallik’s Veraciti™ solution. Get in touch with the team to find out how your organization can benefit here.

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How Automated Labeling & Artwork Can Handle the Regulation Tsunami

Author Name

Emma Jarrett

Kallik Role 1

Content Manager

We recently caught up with a prominent executive from the chemicals sector to find out what they think are the important trends in their industry in 2020 and beyond. What we found: a real need to simplify the complexity of labeling management in their global industry so that ever-intensifying regulatory demands don’t crunch too hard on market growth.

Trust, transparency and, above all, the safety of process/supply-chain intermediaries and consumers is of paramount importance to the global chemicals industry. At the same time, increasingly stringent regulations about product/substance-based declarations, hazard warnings, and use of mandatory safety statements and symbols is definitely taking its toll on the supplier end; there are now so many regulated elements that must be carried on product packaging and labeling that they’re potentially starting to impinge on the market’s ability to execute. A specific area of concern here is the complexity. As an industry, we have to deal not just with new international, regional or country-specific requirements but the sheer volume of required text and graphics that must now be featured on individual labeling.

To maintain market authorization in each market and to uphold brand standards and market confidence, manufacturers must have 100% control over the quality, consistency, accuracy and currency of everything that appears on their labels and the legibility/user-friendliness of that content. In 2021, chemical products will need to carry a unique formula identifier (UFI), a 16-character alphanumeric code required on the label of any products that contain a hazardous mixture, assigning almost batch-specific traceability to chemicals. This will constitute a further obligation on manufacturers and brand owners to manage on their labeling, whether their products are destined for consumers or industry.

Regaining Control

Such is the scale of the challenge that the industry has been dialoguing with regulators about alternative approaches to help ease the burden. These suggested help-mates range from the use of market-agnostic pictograms for safety advice to the option to move finer detail to product inserts or online rather than have to try to fit them on to the smallest spray-can, or tube of adhesive. In future, it is more than possible that apps and scan-able QR codes will make it easier to link physical and complementary digital labeling, reducing the need to attach so much information directly onto products.

But that’s in the future. For now, when changes to labeling are required, or if errors or omissions to printed content are identified, companies risk having to recall products or re-label many thousands of items while also setting up to dispose of all the labels and instructional materials already printed. As well as being very costly — potentially running into tens of thousands of dollars each time current labeling stock is rendered obsolete— this often runs counter to existing organizational commitments around sustainability and social responsibility.

Whether a manufacturer’s chemical products are consumer-facing or designed for industrial use, regaining control over spiraling complexity requires that labeling can be tracked and managed on a global, enterprise-wide scale, and assembled in a structured way that makes lighter work of change and variant management.

Centralizing Labeling Management Capability

To get there, streamlining requirements and boosting control must start with a clear line of sight across everything that is going out to the market, anywhere in the world. This means creating a single source of labeling truth of approved, current label components. If anything changes — to the brand, to the product or its ingredients, or to regulatory requirements — it can be managed in a controlled and robust way from a single, central vantage point.

One of the biggest benefits of imposing centralized structure and control like this: it creates certainty. Certainty that the right information is going out on every product, every time, in every market. In this way, the manufacturer is able to maintain safety, compliance and market confidence, plus reduce the risk of product recalls, fines for mislabeling, and the high cost of labeling reprinting and reissue.

A centralized labeling management capability can also stop teams starting from scratch when just a small aspect of a label, such as a logo or listed substance, needs to be amended or replaced, enabling a much more efficient change process. The ability to create standardized labeling templates and treat each labeling item as a composite of pre-approved text or artwork components, eliminates unnecessary process duplication, leaving skilled professionals free to focus more of their time on the elements that do need to change.

Sensitivity Parameters & Smart Tools

Enterprise labeling management can also help transform the processes involved, for instance in discovering label inter-dependencies if requirements or other conditions change, as all global label activity is mapped and tracked. The central platform can also be used as a reliable look-up for latest country-specific requirements and sensitivities, and to calculate quickly the ramifications of a single change request. Sensitivity parameters and smart rules can also be set to ensure that required logos and symbols are included, and that important information is displayed in legible fonts.

The verdict’s clear: through automation of your complex labeling activity, our sector’s regulatory burden can become controllable.

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