With operations spanning across different time zones and locations, global businesses require assistance that transcends geographical boundaries and operates around the clock. This is where cloud-based software really shines. With a remote 24/7 service desk that can instantly be accessed anywhere across the world at any time, keeping your business running like clockwork has never been easier thanks to the cloud.
 

Let's look at the pros of the globally accessible, around-the-clock support available through cloud software and how it can transform the way businesses operate.
 

Benefits of Using Cloud-Based Software service desk:

Standardized support: Cloud-based support systems ensure a standardized service by ensuring that all users worldwide are consistently operating on the same version of the system. This uniformity simplifies the support process, as there's only one common product and method of operation to address. With cloud software, updates are automatically applied to all users, eliminating the challenges of assisting customers on different versions. This standardization streamlines support efforts, making it easier to provide efficient assistance to users across the globe.

Resolving Critical Issues Off-Hours: Emergencies don't adhere to traditional office hours. Around-the-clock support ensures that businesses can address critical issues promptly, even during weekends or holidays, minimizing downtime and potential losses.

Supporting International Clients: With a global clientele, businesses need support services that align with their diverse operational hours. Accessible support enables seamless communication and assistance for clients worldwide, fostering strong relationships and trust. There’s no need for various service desk teams dotted around the world, with one harmonious team based in the same location offering support to clients thousands of miles away. No matter where you’re based or where your provider is based, you get the same fantastic service.

 

Veraciti's 24/7 Global Support:

At Kallik, we understand the importance of providing uninterrupted support to our clients. Our global service desk is available 24/7 through various channels, including phone, website, email, and live chat. We've streamlined the process of seeking assistance through an easy-to-navigate form, allowing you to convey the impact on your production, thereby prioritizing critical issues efficiently. Whether you're in London or Los Angeles, Sydney or Singapore, our dedicated professionals are available around the clock to assist you. With our global reach, you can access support whenever you need it, regardless of time zone differences.
 

Multiple Channels for Convenience

We understand that every customer has their preferred mode of communication. That's why we offer multiple channels to reach our service desk, including phone, website, email, and live chat. Whether you're on the go or in the office, getting in touch with us is effortless and convenient.
 

Streamlined Ticketing Process

Our streamlined ticketing process ensures that your issue is addressed promptly and efficiently. With an easy-to-navigate form, you can provide us with all the necessary details upfront, including the impact on your production. This helps us prioritize your ticket appropriately and expedite the resolution process.
 

Transparent Communication

Once you've created a ticket, our system ensures transparent communication and efficient resolution. You'll receive an email acknowledging the creation of the ticket along with a unique ticket number. With our easy-to-use Kallik Service Desk portal, you can track the progress of your ticket, ensuring visibility and accountability.
 

Proactive Engagement

Our service desk team doesn't wait for you to reach out—we're proactive in our approach to resolving issues. We'll provide regular updates via email, informing you of any actions taken on your ticket. If further information is required, we'll reach out promptly, ensuring a swift resolution to your issue.
 

Empowering Self-Service

Through the Kallik portal, you have the power to manage your support cases with ease. You can filter your cases, add comments, and track the status of your tickets—all from one centralized platform. Our goal is to empower you with the tools and resources you need to resolve issues independently whenever possible.
 

Worried About Not Having a Local Service Desk?

Some organizations may have concerns about receiving support from a team located remotely. However, our global service desk team is equipped with the expertise and tools necessary to provide exceptional assistance, regardless of geographical proximity. With prompt responses, personalized attention, and a commitment to customer satisfaction, our service desk team ensures that distance is never a barrier to quality service. 
 

The Stats Speak for Themselves:

In February 2024 alone, the Kallik Service Desk team achieved fantastic SLA (service level agreement) compliance rates. With 100% response and resolution rate for severity 1 incidents, closely followed by 100% for response and 95.65% for resolution for severity 2 incidents.. What’s more, the team’s average response time ranged from just 11.5 to 14 minutes depending on the severity of the incident. Internal quality checks on the team’s ticket management resulted in an average compliance score of 93%.

Despite serving Veraciti users scattered across the globe, he geographical distance between our Service Desk and our customers posed no issue, as our team efficiently resolved incidents and provided top-tier support with ease.
 

Benefits of 24/7 Support:

Having service desk that offers 24/7 support brings many benefits, including:

• Increased operational efficiency
• Minimized downtime and disruptions
• Enhanced customer satisfaction and loyalty
• Improved productivity and business continuity

In conclusion, choosing a cloud-based platform like Veraciti that offers 24/7 global service desk support means unparalleled accessibility, convenience, and efficiency. With multiple channels for communication, a streamlined ticketing process, transparent communication, proactive engagement, and empowering self-service options, we're committed to delivering exceptional support experiences to our customers worldwide. So, if you’re looking to move to a cloud-based platform but you’re worried about the level of support you might receive, rest assured that fantastic service is far easier to achieve with the cloud, no matter where you are in the world.

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.

As we celebrate International Women's Day (IWD), it’s a chance to reflect on the importance of representation, opportunity, and inclusion in the technology industry. Highlighting the contributions of women in tech not only recognizes their achievements but also inspires the next generation of female leaders.

Our CEO, Gurdip Singh, shares his thoughts on the significance of IWD and our commitment to empowering women in the industry: "IWD serves as a powerful platform for highlighting the contributions of women in tech and encouraging a new generation of female talent. At Kallik, we are proud to support and celebrate women in the workplace, and we are committed to creating a more inclusive and diverse environment for all. 

"We believe that diversity is not just a goal – it's a necessity for driving innovation and creating a better future for all."
 

The Importance of Diversity in Technology

The importance of diversity in the workplace cannot be overstated. The digital world is evolving every day and it’s essential that the teams building these technologies reflect the diverse perspectives of the global population.

Despite progress in recent years, women remain underrepresented across many areas of the technology sector. According to research from Women in Tech, women currently make up around 26% of the UK tech workforce and in engineering and technology roles specifically, women make up just 16.9% of the workforce.  

Across STEM professions more broadly, women now make up 27.6% of the UK workforce, representing over 1.4 million professionals, the highest level recorded to date, but progress continues to be gradual.
 

The Power of Representation 

Representation plays a key role in encouraging more women to consider careers in technology. Throughout history, women have made significant contributions to technological progress.

Ada Lovelace, widely recognized as the world’s first computer programmer, wrote the first algorithm designed for machine processing. Hedy Lamarr helped develop frequency-hopping technology that later influenced WiFi and Bluetooth systems. And the mathematicians featured in Hidden Figures played a vital role in NASA’s early space missions.

Highlighting these stories helps show that women have always been part of technological innovation and will continue to shape its future.

Technology Careers are More Diverse Than Many People Think

Encouraging more women to pursue careers in tech starts with awareness of the many different roles available within the industry.

You don’t always need to be technical to work in tech!

Beth Peckover, Chief Delivery Officer at Kallik, emphasizes the importance of recognizing the diverse range of roles available within the tech industry, both technical and non-technical. “I think one of the big issues is that young girls thinking about their future career don't see working in tech as something that appeals to them, and that only people who can code or know the ins and outs of computing can work in this space, which absolutely isn't the case,” Beth said.

Equally, Trupti Pradhan, VP Quality at Kallik, talks about the need to emphasise all careers available in the IT world: "I would advise all young women, to take a set back, rethink on where they want to be? Re-think about their current career growth, earnings, how competent they are and develop their skills in such a niche industry, there are tremendous options available just by doing some research and breaking the stereotypes. Seeking an early education about the different areas of the IT world, when they step in, would just make the future path easy and maintain balance in the education and work experience.  I truly believe we have an immense power, strength and decision making ability, just matter of using it at the right place and at the right time."

Technology organizations rely on professionals across project management, quality assurance, marketing, operations, and many other disciplines. Raising awareness of these career paths can help broaden perceptions of the industry.

Looking Ahead

Diversity is not just a buzzword. It is a key driver of innovation and progress. At Kallik, we are committed to supporting women in technology through inclusive policies, mentorship opportunities, and a culture that values diverse perspectives.

As we celebrate International Women’s Day, it’s an opportunity to recognize the progress made while continuing to work toward a future where everyone has the opportunity to succeed in the tech industry.

Advice for the Next Generation

Finally, we wanted to conclude this piece with some advice for young women who may be starting out in the tech industry, may be considering whether a job in tech is right for them, or may be feeling overwhelmed and wondering where to go with their career. 

Beth Peckover, Chief Delivery Officer: "For those that have decided to pursue a career in IT, this would be my advice: Apply for the job even if you don't tick all the boxes. Statistically, men apply for jobs where they meet only 60% of the qualifications, while women often hesitate unless they feel fully qualified. Instead of focusing solely on the qualifications you lack, highlight the skills, experiences, and strengths you do possess. Remember, employers often value potential and attitude just as much as they do specific experience.

“Scary is good. You need to push yourself out of your comfort zone in order to grow and develop, and if you feel you are just coasting in your current role, it's time to look for something new which will challenge you.

“Find your champion. I have been fortunate in my career to work with people who wanted to help me to progress and gave me advice and opportunities to do so. Work hard, be kind, help others to succeed and you'll find you get the same in return.”

Trupti Pradhan, VP Quality: "I would advise all young women, to take a set back, rethink on where they want to be? Re-think about their current career growth, earnings, how competent they are and develop their skills in such a niche industry, there are tremendous options available just by doing some research and breaking the stereotypes. Seeking an early education about the different areas of the IT world, when they step in, would just make the future path easy and maintain balance in the education and work experience. 

"I truly believe we have an immense power, strength and decision making ability, just matter of using it at the right place and at the right time."

As we celebrate International Women’s Day, it’s important to recognize both the achievements of women in technology and the opportunities ahead. By continuing to champion inclusion, mentorship, and opportunity, we can help inspire the next generation of women to shape the future of technology.

Medical device manufacturers can turn new product identifier requirements to their competitive advantage if they treat them as an excuse to make bigger changes to the way they manage label creation. Among the latest regulatory requirements vying for the attention of medical device manufacturers is the unique device identifier (UDI) – a universally accepted product identification standard. Included on product labels, it will make individual items much easier to trace as they move through the supply chain and out into the world. 

The FDA requires UDI compliance in the US by as soon as September 2014, with Europe to follow within the next 2-3 years, then China and the rest of the world. UDI is a positive step in improving patient safety. It will also help device manufacturers minimise risk and make any product recalls much easier to contain. But making the transition to UDI is a significant undertaking, so it is important that companies take a wider perspective - to help justify the investment required.

Why stop at UDI?
 

Addressing UDI traceability in isolation is a wasted opportunity. Companies that do this are failing to acknowledge other significant, related issues – issues which really they need to address with equal urgency. For most companies, simply adding UDI traceability codes when all of the underlying label management processes are a jumbled mass of complexity and inconsistency is to merely paper over the cracks. 

So rather than focusing solely on UDI requirements, think of this as a great time to sort out everything else too. That way, the wider benefits – and there will be many - will more than pay for any investment being made. All of the work Kallik has been doing with medical device producers not only takes care of UDI but,  by centralising and automating the way all forms of product packaging, labelling and customer documentation are created, approved, delivered and managed, we consistently deliver significant cost, time and risk reductions. 

For companies operating internationally, and those keen to take advantage of new growth opportunities in emerging markets, this efficient adaptability (which includes the ability to cater for individual country requirements, without additional labour), offers a huge advantage. It increases visibility, ensures labelling accuracy, and makes it much easier and faster to make changes to labelling output as requirements change.

Colossal savings at Coloplast
 

Among the forward-thinking manufacturers that have understood these broader benefits of a unified approach to label creation and management is Coloplast. The Danish company supplies specialist medical therapy products around the world, to hospitals, institutions, wholesalers and retailers. It has production facilities in Denmark, Hungary, France, China and the US, as well as international custom manufacturing facilities. Each year, it produces around 60,000 different labels. Until recently, Coloplast’s label production processes were highly manual, spanning a series of home-grown content management systems that were not interconnected. 

Now, however, it has migrated its labelling artwork assets to Kallik’s powerful end-to-end enterprise artwork management solution, Veraciti™. This is now up and running across several of Coloplast’s manufacturing facilities around the world. The system connects all of the different locations, and provides full, centralised control of approved legal and regulatory labelling information, while managing all localised and translated texts for individual markets. 

Says Jette Byg, Coloplast’s Head of Labeling & Packaging, “When we saw Kallik at an exhibition, it brought a completely different perspective to the way we could manage our content management activities. Previously, all of our labelling and packaging content had been stored as artwork files. Every change meant starting from scratch and could take months to implement, requiring approvals of local translations from 30-40 countries. Because changes happen all the time in our dynamic market, this meant we were never in compliance - we were always behind.” 

A year into its labelling transformation project, Coloplast has a head start with UDI, a position many of its competitors are likely to envy. Coloplast is also taking UDI compliance to the next level, by integrating its Kallik solution with its SAP back-office systems so that it can report on its UDI traceability performance.

Unified processes make UDI automatic in the US
 

Another major life sciences company, which prefers not to be named, is even further along in its labelling artwork management initiative. Based in the US, it is directly affected by the UDI deadline of September 24, 2014. The company is a world leader in medical devices and implants for use in orthopaedics, neurosurgery, spinal, reconstructive and general surgery. Recently, in one of its manufacturing sites, it needed to make no fewer than 10,000 changes to labelling artwork. 

Traditionally this process has involved 90 weeks’ work in repeat cycles of new artworks being developed, amended and eventually signed off. By investing in a centralised content management and integrated artwork generation and system from Kallik, the company has not only prepared effectively for UDI but, in the latest application involving 10,000 artworks, has reduced the effort from 90 weeks to just 10 days. This is resulting in cost savings that could run into millions. The company is also able to get its products to market much earlier, safe in the knowledge that all labeling is fully compliant with UDI and other regulatory changes (eg. involving safety symbols used on labels).

“Kallik allows us to manage all changes and approvals centrally, in a single location,” explains David, a marketing associate at the company. “Everyone works on the same, latest version of the content, rather than a series of emails that have been sent back and forth. In terms of compliance control, our use of Kallik AMS is about managing label content across the organisation - so that we can change a symbol very quickly as these are updated, and understand where patent numbers are located as these expire.”

 

German medical device manufacturer stays one step ahead of regulators
 

The world’s leading suppliers in casting, bandaging, wound care and compression stockings, is another manufacturer to have taken a centralised, automated approach to label artwork management, which has set it in good stead for UDI compliance. 

The German headquartered company has implemented Kallik’s Veraciti artwork automation solution to streamline the way it manages labeling for more than 14,000 different product lines, many of which have secondary and tertiary packaging. Previously, the content for individual packaging was treated as its own artwork job. 

“This involved the manual collation of input via phone calls and emails from global marketing, packaging development, product development, scientific & regulatory affairs, quality management and external sources,” explains its Head of Packaging Development. Typically, it would take up to 10 goes to get artwork content approved. 

The Kallik system saves artwork coordinators having to ‘reinvent the wheel’ each time they need to update content, or create new labelling from scratch. Routine amendments to packaging artwork can now be done without the need to involve an agency or design team. Cycle times are being reduced substantially too - from 1-2 weeks to prepare simple artwork, to 1-2 hours now.

Meanwhile compliance with all sorts of requirements, including UDI, is much easier to manage. “What stands out about the Kallik system is its completeness,” says the Head of Packaging Development. “Given the rate at which regulation can change, the level of control provided by Kallik is vital."

Change is the only constant
 

In September 2013, the industry had a further reminder of the frequency with which regulatory requirements can change - when the European Commission introduced new measures to restore patient confidence in the medical devices sector in the wake of the PIP breast implants scandal. Among the demands are clearer labelling (down to individual product level), and the EC has held up the UDI as an essential facilitator. In addition, manufacturers must have up-to-date procedures that describe all the processes that ensure regulatory compliance. So manufacturers must first get the internal controls right, and then be able to show the measures they have taken.

Getting the right help
 

With the first UDI deadline looming large, manufacturers can’t afford to bury their heads in the sand. Companies are likely to need a lot of help as they make the transition to new systems. Kallik provides a full toolkit as well as comprehensive migration support services, so can guide medical device manufacturers through the entire journey – both as they strive both to tick regulatory boxes, and as they attempt to achieve a good payback from their investment. As tempting as it might be to rush down the pure UDI route (if time has become an issue), this is a false economy. UDI is not the only new regulatory requirement on the agenda, and a point solution will only lead to a lot more duplication and work in the long run, without any real payback. Kallik’s approach to compliance involves working from a single approved set of master data which can be reused and repurposed with minimal effort but under strict central controls. It is only with this kind of transformation to internal processes that companies can hope to turn UDI and other regulatory requirements to their advantage.

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.

We’ve been having a discussion about compliance: why it matters and how you can see it as not just a necessity but as a ‘mother of invention,’ – a way to sharpen up your business processes, and as a ‘free’ benefit of putting all you need in place to be compliant. Here’s another benefit that not everyone considers: compliance as self-protection. Both of the big sectors we work in, cosmetics and medical devices, have seen large amounts of consolidation in the past few years.

You will find large cosmetics companies buying niche cosmetics companies and medical device companies doing the same. In fact, a lot of the medical device sector is made up of small businesses; over the years they get acquired into larger organisations’ portfolios. When a large organization acquires the smaller one, they are not just buying the business, e.g. the IP, the customers, the assets – they are also acquiring responsibility. They are now liable for that firm’s mistakes as much as its successes. From the time you buy a company, in other words, if one of its products is in non-compliance, even though you didn't create the original labelling or manufacture it – it is still now your responsibility because you own that business.

Are you ready to cope with that? We speak to customers who say they need to reduce the risk of non-compliance on a range of products that they have just taken responsibility for. You need to be thinking this way, too – and seeing beyond the immediate benefits of any M&A and taking the long-term view. What you need is a plan that will help you get control over that new acquisition – which you can only do if you fully understand the risks, so you can plan to reduce them, and make your acquired asset fully compliant. We are finding a lot of our customers use Kallik solutions to assist with merging the acquisition into their business much more rapidly than would have been otherwise possible.

So that’s just a few insights on compliance – why we have it and why it can help you. I hope you’ve found our discussion interesting and we’d love to know your own views. Do you agree, for example, that you really aren’t compliant until you-know-what hits the fan – or that 

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 this guest blog, a key Kallik partner at professional services firm Kalypso shares their perspective on the importance of integration in the modern enterprise.

Why does integration matter?
 

If you don’t do integration right, you are failing to truly maximise the investment you have made in enterprise software, in the sense of leaving too big a gap between two very important business functions. Let’s back up a little so I can show you the basis of my understanding a little better. 

Kalypso is an Ohio-based consulting firm focused on helping clients to improve productivity and boost innovation. To that end, we’ve found the Kallik system a highly useful tool in our armoury, especially in the packaged goods sector. 

This is because packaging integrity and brand identity are becoming more and more important in this market, for all sorts of reasons – compliance being very important, of course, but many of these companies’ leadership see the need for integration between all the elements in their systems. And a lot of the time, we encounter two sorts of enterprise IT systems in those customer environments: the central corporate platforms, the Oracles and the SAPs, the classic Enterprise Resource Planning (ERP) suites at one end of the scale and at the other, the PLM, the Product Lifecycle Management applications, which can sometimes be from the same suppliers. 

Generally speaking, the first set of systems is there to take care of the overall business – to process orders, handle the finance side, and so on. At the other end of that spectrum, we have the smaller PLM solutions, whose main job is to manage the integration of product design. This is a very typical snapshot of a lot of the consumer goods as well as regulated industries, I think you’ll agree.

Where does integration come in? It comes in when you want to marry the two sides up – when you want to connect the data that is in the ERP system with what you have in the PLM system so as to have a properly unified single source of truth for all your product information. It is probably worth saying at this point that the tool we use to help bridge the gap between the ERP and the PLM sides of the business - by working with our PLM assets on artwork and labelling content which is then integrated to ERP - is, the Kallik Veraciti™ Labeling and Artwork Platform, which we are happy to see is fully compatible with the leading products in both sectors.

A new systematic way of working
 

But there are challenges on the way to achieving that desired integration – a lot of them. We can start with the human one. A lot of teams outside the IT side of a business can often end up resisting what they feel are ‘monolithic’ attempts to unify all their data and workflows: you find quite typically that the IT department want everything in SAP, which can be difficult for some people in the business given the complexity of that very rich system. 

That’s sometimes compounded, in our experience, by the artwork side of the house not being too keen on being expected to work with PLM-style systems, either. Sometimes, you find the artwork team is just not really that convinced of the value of working in a systematised way, be that with ERP or PLM. The next level up in terms of integration challenges is the technical aspect of the integration (between ERP, PLM and artwork and labelling). 

To make that work, you have to be very sensitive to the architecture underpinning the proposed joined-up system you want to see emerge here. The key here is the old adage of KISS – it really does pay to Keep It Simple (Stupid). In the past, the technical elements of an integration project might be much more nuts and bolts, to do with making two non-standard or niche systems talk together. That’s less of an issue now, as so many organisations have standardised on SAPs and Oracles, for both ERP and PLM, as well as SQL RDBMS. So the main face of integration now is that overall architecture side, we are finding. Beyond human/cultural issues and possibly technical/compatibility hassles, what other challenges are there to effective integration around the packaging and labelling process? We find the final one to often be around business process integration. How does a business process around packaging, artwork and labelling management need to be adapted for seamless integration of data to take off?

The human factor (redux)
 

To some extent, this hearkens back to the people issue I mentioned, but at a level of greater complexity. There are often big changes here in the work styles and daily activities of team members that need to be carefully thought through and sensitively handled; get this stage wrong and your whole effort may end up going nowhere, frankly. Make sure you build in time for people to get used to new ways of working with artwork and labelling post the introduction of an integrated process via Kallik, is my advice. And we all may have to. 

In the past 20 years or so we here at Kalypso have seen more and more parts of our customers having to get to grips with integration, which is now touching more and more highly creative people who haven’t been asked to deal with this sort of technology before. We need to help them get used to this and get comfortable first if we want to get the main benefits of integration here: better throughput and efficiency. No pain, no (lots of) gain? It’s easy to lose sight of why we’d want to put in efforts around integration. 

The truth of the matter is that there is a huge value to be gained, despite these challenges. I always point to the Kalypso customer that implemented integration via Kallik and realised a 40% improvement in turnaround due to saved time and errors as the proof point as to why we want to do this. And if we can not just produce accurate artwork assets quicker but re-use those assets throughout the enterprise, then that’s also promoting efficiency as we are clearly not re-inventing any wheels any more.

My final comment, then, is that for any sort of company that has a lot of investment in packaging and labelling, that needs to get them right or done better, integration – for all the organisational, and, to a lesser extent these days, technical challenges it creates, it really does have to be the face of the future. I wish you good luck with all your integration efforts!

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.

Transparency and visibility – most would agree that both are essential for accurate insight of any enterprise-wide process. Labelling and artwork management is no different. More often than not, it’s the lack of tools and not the lack of intent that’s the problem. 

In our last blog, we spoke to you about the problems caused by poor oversight and the need to better manage the constant flow of changes coming from multiple sources. Addressing these issues is the key to better management of corporate labelling activities that by nature, are often complex and highly dispersed. 

Lack of accurate insight, process delays and re-works aren’t problems that labelling and artwork teams should learn to live with because with the right approach they can be fixed. Also, identifying the bottlenecks and taking corrective action to shorten the labelling cycle is not just a technology issue. It will require commitment and personal ownership. Some changes may feel uncomfortable, but this is better than allowing problems to fester, compromising best business practice.

The alternative to more rules and procedures
 

We’re probably all guilty of getting email attachments and forgetting to do our due diligence – reading the content, taking action, sharing with others and filing appropriately. When it comes to labelling and artwork, the issue is compounded by the sheer number of people and tasks engaged in the process. More rules and procedures are not the answer. 

What’s needed is to automatically capture all actions taken by contributors and reviewers as they complete each of their tasks. This enables the move from managing by perception to managing by facts. Also, if robust processes are in place and people realize they are being monitored – albeit in an ethical way – they are more likely to complete tasks on time. 

Being able to drill down and produce a report that shows who received a piece of text or image for approval and when, makes it’s easier to identify and fix issues that may be causing costly delays. Such a capability has value at a high level and in terms of detailed insight, giving you a 50,000 foot view of your overall labelling processes, spotting where the disconnects occur, and then being able to hone in on the precise problem and determine what the hold-up is, why and how best to move forward. Is it a process issue? Is it an individual problem? Or is the challenge departmental?

Having this level of insight makes it easier to fix the problem and fosters a culture of accountability. It’s no secret that every day spent waiting for documents to finalize labels or tackle labelling changes is a capital loss for a life sciences company. So companies can’t afford the hold-ups that occur because of poor process or lack of accountability.

What needs to happen to bring about better, more efficient processes?
 

The first thing you need to do is to store all labelling as structured content. For example, the phrase "not suitable for children under 12" constitutes an individual asset. If translated into a different language this would be classed as another asset, each being individually version controlled. In this way, all actions associated with any piece of content are captured, giving a comprehensive audit log of any changes. Every interaction is timestamped including when an artwork or asset transitioned from one person to another. Let’s go back to an issue we raised in the last blog: that changes represent between 75% and 90% of labelling activities. Now imagine you’ve approved and stored the phrase, “not suitable for children under 12” but that phrase now needs to change to “not suitable for children under 15”.

Clearly all impacted labels need to reflect the change – including localised translations. The problem is how do you know where that phrase appears, and how are you going find that information? Done manually this can take months and you’ll never be sure that all impacted labels have been updated. If everything is stored as a unique traceable asset, you can then find it immediately. Changes can be made simply and quickly. You will then be in a much better position to demonstrate compliance without the overhead of pulling together disparate pieces of evidence contained in documents, emails and attachments.

That’s the type of issue that typically keeps regulatory affairs executives up at night wondering, Questions such as: “Did I also change those labels for Argentina, was the translated phrase approved and how can I demonstrate this to the auditors?” They struggle constantly with unknowns and uncomfortable uncertainty. Accurate reporting of approval and review processes, encouraging accountability and being able to manage data as structured content will give regulatory affairs executives peace of mind and, perhaps, put a stop to those sleepless nights. 

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.

Last week’s UDIs and Traceability Conference in Brussels brought with it some excellent weather and it was a delight to experience this vibrant city in such fine conditions. However, it wasn’t just the weather that was topical. The publication of the European Medical Devices Regulation on 5th May 2017 and its impact on the industry has also been raising the temperature of the debate within some circles.

Let's recap the event

Before we get into that, we should first thank IQPC for assembling a highly relevant conference programme delivered by some of the leading industry experts in their field, including our own CEO, Neil Gleghorn. We were highly privileged to receive first hand insight from speakers spanning the regulatory, standards and device manufacturer communities including the FDA, GS1, GMDN, Teleflex, Abbott and bioMérieux to name but a few.

So what did we learn? Well, in a nutshell, it’s all about the data. The FDA for one acknowledged that not only does data have value, but structured data has increased value. It transpires that the biggest problem the FDA have experienced to date with submissions to the GUDID has been data accuracy. As UDI implementation in the US is moving closer to Class I devices an increasing number of healthcare providers are picking up inconsistencies between what’s printed on the package label and the content uploaded to the GUDID – clearly impacting compliance and traceability. Switching our focus to the European equivalent of the GUDID - The European Database for Medical Devices, (or Eudamed) we’re likely to see more of these challenges.

The newly introduced EU MDR
 

Firstly, the EU MDR directive introduces a new identifier not seen elsewhere: Basic UDI-DI. This is the primary identifier of a device model used for market surveillance and clinical investigations. The Basic UDI-DI needs to be assigned ahead of product registration and enable device traceability across all corporate functions, not just the supply chain. Secondly, we’re going to be seeing different drivers from different countries spanning data sets required for regulatory, traceability and commercial purposes. The UK NHS eProcurement Strategy, being one such example. Thirdly, all data for all classes of device must be submitted to Eudamed by May 26 2020. That’s a tough ask when the general industry consensus is a 3 to 5 year implementation timeframe.

So how does this impact device labelling? 

Despite the requirement for printing of UDIs on product and package labelling coming after the above date, we here at Kallik see little distinction between the two. Reflecting back on the FDA’s comment regarding the value of structured data it seems to make sense to apply this to attributes associated with labelling. Doing so vastly simplifies the capture, collation, approval and traceability of such content. Also, given that we’re currently waiting for clarity on the data elements required for Eudamed submission, getting started now with adopting a structured approach to managing labelling content will trigger the organisational culture changes needed to ensure readiness. In my next blog on this topic, I’ll look more at these issues and discuss how having a single source of truth for labelling content sits comfortably within an enterprise-wide data governance approach for achieving UDI compliance.

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 our last blog, we discussed the need for transparency and visibility throughout the labelling process. Reducing the risk of product recalls and non-compliance being the goal. Most would agree that given a clear mandate plus an appropriate level of investment, this can be achieved. Not always easy, but certainly possible. Introducing the required cultural and organisational changes can be a different subject altogether! 

But what if part of your labelling processes are outsourced either because you’d prefer not to have the overhead or, like much of the life sciences industry, your supply chain spans many CMOs (Contract Manufacturing Organisations)? Now let’s add some new legislation into the mix just for fun.

If you’re a pharma manufacturer, meeting the DSCSA (Drug Supply Chain Security Act) and FMD (Falsified Medicines Directive) requirements for product and package level serialisation is probably going to be at the forefront of your mind right now. If your business is med devices, then it’s likely to be maintaining integrity of UDIs throughout the supply chain and the task of getting your labelling content ‘fit for purpose’ ahead of upload to either the GUDID or EUDAMED (or possibly both) that will be grabbing mindshare. 

Current supply chain trends

Before we go any further, let’s look at current supply chain trends across the life sciences industry. According to a survey carried out by NICE Insight in 2016, 69% of pharma and biotech companies expected to increase their use of CMOs going forward – business drivers being to increase agility whilst reducing costs. Gaining rapid entry into emerging markets, portfolio transformation and new partnerships and alliances are contributing factors to this increasing trend. The flip side of this being the risk of non-compliance from introducing multiple potential points of failure.
 

Maintaining integrity and accuracy
 

So how do you maintain the integrity and accuracy of your labelling content when your global supply chain may include tens, if not hundreds of affiliates sitting between you and your end customer? How do you also validate that what your partners print on the label aligns with content submitted as part of the regulatory approvals process, including that which is required to satisfy local HA’s?

This is where the cloud comes in...
 

This is where adopting a cloud based labelling and artwork management solution helps to remove the barriers and disconnects that can often occur across highly fragmented supply chains. Implementation can be quick and easy and new partners can be onboarded with minimal integration effort. Suddenly, the headaches of trying to exchange and align both static and variable labelling content across 3rd party systems and processes is removed as everyone and everything is connected. Content is all held in one place – safely and securely. Every partner can be become a user of the solution and with appropriate permissions, users can review, edit or approve content. Better than this, corporate oversight becomes a given ensuring management by truth and not perception. So much for managing static content.

How about the challenge of ensuring alignment of serialisation and UDI content across highly distributed supply chains. How do you also ensure integrity of variable data at print run time with the inevitable disruptions caused by manufacturing downtime and labels that need to be re-printed for quality purposes? Well, here again having ‘variable’ (i.e. print run time) as well as ‘static’ content captured in one single place makes it easy to recover from such situations without risking duplication or inconsistencies. In our next blog, we’ll talk more about the specifics of capturing and managing variable run time data and how this might work in practice. 

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 our previous UDI blog, we talked about the dynamic nature of labelling and artwork content. We also suggested that there could be a difference between what is classed as ‘master data’ and what might be a single source of truth’. 

In this, our third and final blog reflecting back on the IPQC UDIs and Traceability conference in Brussels last month, we’ll be discussing how adopting best practice for managing labelling and artwork related content can bring early business value to UDI projects. Before we do that, let’s return to some of the discussion points from the event around data quality. We heard from the FDA that the biggest issue in the US is the quality of data submitted to the GUDID.

UDI is not simple 

Granted that out of the 65 data attributes uploaded to the GUDID for each product, only 12 or possibly 13 are related to labelling content, but inaccuracies in product nomenclature could at best lead to expensive product recalls and at worst, patient injury and huge fines. It was also said by one prominent speaker that UDI is a company-wide project. The point made here being that UDI is not something that can be successfully implemented by one department alone, it needs executive level sponsorship with cross-functional collaboration and clear ownership.

So accepting that UDI is not simple, let’s turn our attention back to data quality in the context of labelling. Data quality is characterised by levels of accuracy, completeness and consistency (or standardisation). Having the wrong name on the wrong product is not a data quality issue, but having a misspelt product name or one obfuscated by spurious characters is. So what can be done to minimise these risks and why the attention paid here to a subset of UDI attributes rather than the majority? Well, when we questioned the FDA at the conference as to whether any penalties had been so far levied on organisations submitting inaccurate and/or incomplete data to the GUDID, their response was a simple “no.”

They said they recognised the enormity of the task for some companies (particularly as we move through Class II to Class I devices) and are preferring to take a supportive rather than a vengeful approach. This would not be the same for inaccurately labelled products – this we can be sure of! It is understandable why the majority of the industry is focused on getting submission data right first as the EU MDR calls for all attributes relating to every class of product to be uploaded to Eudamed by 26 May 2020. But like the FDA, plus given the enormity of the task facing manufacturers selling into the EEA, it’s likely the EMA will go for a ‘soft’ rather than ‘hard’ enforcement. However, the problem the industry is trying to solve is not ‘just’ submitting the right data in the ‘right’ format to either the GUDID and/or Eudamed database, it’s much broader than this. It requires (as one speaker from the industry asserted) corporate level sponsorship, executive oversight and buy-in from all stakeholders. So back to labelling and artwork.

The opportunity in UDI
 

At Kallik, we see UDI as an opportunity to jump start implementation of best practice for UDI compliance. By first getting to grips with discovering, standardising and nominating stewardship of each of the attributes that constitute a product label, you’ve taken the first steps towards implementing a robust data governance framework. This will also provide ‘advance standing’ for broader UDI compliance. Everyone from regulatory through to supply chain has a role to play in labelling, so why not start here and use this as a pilot for rolling out the policies and procedures needed for the broader suite of attributes required for UDI?

The great thing about taking this approach is that it will demonstrate clear productivity gains for labelling and artwork processes and potentially de-risk your broader UDI project. None of the above requires you to rush out and invest in an IT solution may in the end turn out as not being fit for purpose. A better approach is to first look at where your priorities lie, understand who owns your data and what needs to be done to make it UDI ready. Focusing first on the subset of data required for labelling is likely to make this much more manageable. If you do decide to explore this as an approach, we here at Kallik would be delighted to support you throughout your journey.

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.

Every day it seems we see more and more articles published promoting the benefits of embracing digital transformation across healthcare supply chains. Few, if any however, seem to provide much insight on how to ‘digitally enable’ labeling and artwork processes to embrace this revolution.

What actually is a digital transformation in the healthcare industry?

Before looking at this specific challenge in more detail, let’s reflect on what a ‘digital transformation’ in healthcare means and who it impacts. Firstly, no one would dispute that we would want patients to be the greatest beneficiaries both at the diagnosis or treatment stage. After all, we are all likely to find ourselves at the receiving end of healthcare provision at some point in our lives.

Secondly, there are the healthcare providers. It’s possible that the traditional patient-doctor relationship will cease to exist as we each become better informed. We’re also likely to see an increasing level of diagnosis and treatment delivered electronically. Mobile and wireless applications are already transforming the role of healthcare provision in patient monitoring and treatment as reported by the Financial Times (2017).

Thirdly there are the manufacturers to consider. Both Pharmaceutical and Medical Device companies are experiencing disruption caused by the digital transformation in healthcare, both in areas of diagnosis and treatment. A recent study carried out by Roland Berger (2016) estimates the value of digital healthcare products and services to exceed USD200bn by 2020, growing 20% per year. In their article entitled ‘ Six ways digital is changing the pharma & healthcare industry’, Econsultancy (2017) suggests that consumers are becoming ever more motivated by finding the best treatment and the cheapest price.

Steps to digitally enable labeling and artwork processes

If we are each in agreement that we are in the midst of a digital healthcare journey, we need to ask ourselves what steps we’re taking to digitally enable our labeling and artwork processes. Without doing so, we risk jeopardising the agility of our healthcare supply chains and ultimately, patient outcomes. But it’s not just the digitization of supply chains that will be disrupted, if unable to quickly and accurately persist electronic product and prescribing information across multiple channels, healthcare providers and ultimately their patients are likely to look to more enabled suppliers for their medicines and devices.

This is one reason why here at Kallik we’ve always believed that the best way of managing labeling content is as a library of re-usable digital assets. 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.

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.