Last week’s UDIs and Traceability for Medical Devices conference in Amsterdam highlighted some of the key developments in UDI implementation and alignment across regulatory, supply chain and customer environments as we move one year closer to the EU MDR. We had the opportunity to hear from and engage with key speakers and delegates from some of the leading medical device companies, as well as our own CEO, Neil Gleghorn who delivered a very well received presentation on how embracing UDI can create a more connected digital labelling enterprise.

As UDI regulations begin to mature across the EU and US, countries including India, China and South Korea are beginning to adopt a similar strategy. From this, it is highly likely that there will need to be multiple iterations of labelling for the same products in order to meet these evolving requirements. Healthcare providers (including the NHS) will also be looking for specific labelling content to meet their individual procurement and supply chain requirements.

Dennis Black, Director of e-Business Solutions Group, BD provided some interesting insights around this. Dennis believes that regulators and providers should work towards a global, harmonised approach but recognises that this may not be entirely possible. The impact of not doing so is the cost and the risk of errors being introduced each time a market specific or provider specific requirement needs to be captured on the label. The ultimate risks being non-compliance with regulatory requirements with the result of losing valuable contracts with healthcare providers.

A recent study carried out by McKinsey & Co. demonstrates just what can be achieved by having better connected systems and processes. These include reduced time to market and inventory costs of between 20-50% and an increase of 45-55% in productivity. It must be advised that changes to labelling alone will not deliver these figures, but without addressing the challenges around disconnected labelling systems and processes, we predict it’s likely that these figures would diminish.

So, how does this impact medical device labelling? Organisations must be able to adapt quickly to labelling changes driven by the evolving maturity of UDI. This will ensure they don’t lose out to competitors that may have more dynamic systems in place. The FDA acknowledged that they are now sharpening their focus on data quality, and specifically, addressing the need for accurate labelling data uploads to their UDI database (GUDID). This is in the interest of ensuring that patients, having received an implantable, or who are using medical devices, receive accurate and transparent information relating to their use, manufacture and authenticity. This applies equally, whether reading from a printed label, manufacturer’s webpage or searching the GUDID.

A subject that was widely discussed at the conference was that of ‘Basic UDI-DI’. 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 all other related products as a result of querying the UDI on the label via the EU UDI database (EUDAMED). 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.

The challenge for many organisations is that they lack the 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.

This is where Kallik’s ‘where used’ function can really help. At the press of a button, it allows any authorised user to quickly locate one or more product families from one single identifier (i.e. the Basic UDI-DI).

Are you interested in finding out how Kallik can prepare your organisation for the upcoming EU MDR as well as simplify compliance with the Basic UDI-DI? Get in touch with our labelling and artwork management experts here and/or visit our resources page for more insights.


By Graham Francis, Channel Marketing Manager, Kallik Ltd.

In my last blog I talked about how organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require labelling 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. 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 organisational challenges therefore need to be overcome, calling for the digitisation of all labelling assets.

Labelling 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, needing 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 digitising and versioning each of our labelling 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.

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


Want to find out more? Join us at UDIs & Traceability for Medical Devices on 17th May at 11.40am. Kallik Founder and CEO, Neil Gleghorn, will be discussing why connected labelling systems and processes are essential prerequisites to minimising disruption and enabling greater productivity across extended supply chains, ensuring enhanced compliance with MDR. Book a meeting.

The Kallik team will also be on-hand to discuss how you can embrace digital technology to transform your labelling and artwork processes, achieve readiness for e-labelling and increase global supply chain collaboration. If you’d like to find out more, get in touch with the Kallik team.

Take a look at our recent White papers.

By Graham Francis, Channel Marketing Manager, Kallik Ltd.

As March approaches, there’s much that those working within heavily regulated industries need to be focusing on for the rest of the year to stay compliant, take cost out of supply chain operations and increase their speed to market.

At Kallik, we spend a lot of time researching how we can help our customers achieve these goals through making best use of emerging technologies. We’ve previously discussed ‘Connecting the Disconnected’, Industry 4.0, and Digital Transformation – what each of these approaches has in common is the underlying use of digital technology to make it easier to create, share, approve and print, labelling and artwork content. We’ve seen organisations previously hampered by document centric and paper based process released into the 21st century by adopting this approach, achieving impressive gains in productivity and quality to boot.

Whilst we’re delighted to have been part of this revolution, we believe there is a lot more to come. If we look across industries such as finance, banking, insurance and retail, we’ve seen an explosion in the services and products available, much of it driven by competition and consumer demand. This has resulted in a huge number of choices available underpinned by hugely complex business decisions and massive amounts of data – which some would call Big Data.

Many of these industries have responded to this opportunity by automating their manual, repetitive and time-consuming decisions by implementing business rules technologies and building rule sets that map to organisational processes. This approach delivers greater consistency, eliminates costly errors and vastly increases productivity. Now becoming mature, robust and well-proven as increasingly well understood throughout industry, we believe that business rules engines have a significant role to play in the labelling and artwork management arena. We believe this to be the ‘next big thing’ for labelling and artwork and have just published a brand new white paper to help share our vison – A Rules Based Approach to Labelling and Artwork Management.

Download your copy of the paper here.

If you’d like to learn more about how Kallik can help you innovate across your labelling supply chain, you can get in touch with the team here.

Firstly, Kallik would like to wish all of its customers a very happy and prosperous New Year and would like to thank you for your continued business and support.  We would also like to extend our greetings to our technology partners and those who are seeking to transform their labelling and artwork processes going forward but have yet to reach a decision on who to choose as their industry partner.

Looking ahead, 2018 is going to be an exciting and eventful year as we begin to see the effect of new legislation and regulation taking shape across several continents.  Further extension of the UDI Final Rule will see this impacting hundreds of thousands of devices not previously affected.  By the end of September this year, all packaging and labelling associated with Class I medical devices sold into the US must bear a UDI as the FDA moves closer towards completion of its UDI roll-out across the industry.

Continuing with the UDI theme, 2018 will see Europe moving closer to the date when the new Medical Device Regulations (MDR) will replace the existing Medical Device Directive (MDD).  This now being just over two years out.  With much of the impacted industry focusing on capturing and compiling the content required for submission to the EU equivalent of the GUDID (EUDAMED), the additional requirement for publishing all labelling content electronically (including eIFU’s and labelling content being published on manufacturer’s websites) has not been given the attention we believe it requires.  This is one area where you can expect to see new thought leadership from ourselves as we move further into the year.  Please feel free to visit our blog pages where we’ll be posting our first post on this topic later this month with subsequent articles and papers to follow.

Turning from Medical Device to Pharmaceuticals and serialisation, the previously announced delayed enforcement of the US Drug Supply Chain Security Act (DSCSA) by one year to November 2018 acknowledged that some pharmaceutical manufacturers along with their contract manufacturers were not in a state of readiness to comply.  It is less likely that the deadline will be extended further, so the pressure is increasing to ensure all impacted medicines will carry a product identifier on their labelling and packaging.  Focusing back on the EU, the deadline for complying with the Falsified Medicines Directive (FMD) is approaching fast with this currently set for February 2019.  Many of the challenges faced by European based manufacturers are expected to be similar to those encountered by their US counterparts, including the need for a unique serial number to be made present on all packaging and labelling.

As both the chemicals and cosmetics industries continue to seek further growth through gaining entry into new emerging markets, compliance with local labelling legislation is a must in order to prevent delays in satisfying import controls that could otherwise see stock being impounded for months.  Here again, clear corporate oversight with an ability to capture and tailor product labelling content to satisfy local markets is paramount.

So, what can you expect from Kallik this year?  Well, this year will see us further strengthen our enterprise-wide labelling solution for heavily regulated industries.  Some of these enhancements will make it easier for our customers to encapsulate all their labelling and artwork processes in one single solution across all types of print and packaging.  This will give greater visibility, control and corporate oversight both in-house and out across extended supply chains.  Other enhancements will simplify the roles of all those involved in capturing and collating content, further de-risking potential non-compliance whilst at the same time, increasing productivity.  We’re looking forward to sharing some of these enhancements with you very soon, so please check back with us here on a regular basis for further updates.

Finally, once again, all of us here would like to wish you all continued success both throughout 2018 and beyond and we look forward to continuing to develop both existing and new relationships across the industry.

The Kallik Team

By Graham Francis, Channel Marketing Manager, Kallik Ltd.

Last month’s Supply Chain Innovation Summit confirmed that there is a good deal of activity across the pharma industry right now to try to improve the efficiency of supply chain operations. Much of this is being driven by the need to improve levels of productivity and quality, but there are other drivers too; such as minimising inventory and responding to an increased demand for personalised medicines. Research into smart packaging being carried out by the Medicines Manufacturing Industry Partnership (MMIP) is also helping the industry develop its technology roadmap. You could say much of what was discussed was around ‘connecting the disconnected.’

In terms of quality, we heard from CMAC that first time manufacturing across the industry is generally very poor – typically 60,000 defects per million which equates to just over 3-sigma. The effect of this being an estimated 25% of manufacturing resource being engaged in quality activities, with much of the pharma industry using ‘batch’ as opposed to ‘continuous’ manufacturing methods. Whilst manufacturing in batch was probably the best approach for blockbuster drugs, it’s not seen as best fit for producing more niche, personalised medicines. CMAC’s research in this area suggests a shift towards continuous manufacturing could deliver an 86% reduction in working capital across the industry.

This shift from ‘make from stock’ to ‘make to order’ is something that the automotive industry has been embracing for longer than is often thought. In fact, Toyota introduced this methodology back in 1953 and it’s what we now often refer to as Industry 4.0. Back then, it was the post-war scarcity of resources that drove this approach. Whilst today’s drivers are different, the adoption of lean manufacturing processes across the industry is what enables personal choice without the need for billions of dollars of inventory.

Of course, manufacturing is just one element of the global supply chain. We also heard from a number of suppliers offering broader supply chain solutions that could help the industry meet EU GDP guidelines. These seek to address challenges around logistics, environmental and temperature monitoring as well as track and trace. One pharma company having put such systems and processes in place shared with us how this helped to identify and eliminate sources of temperature violations. This saving weeks of investigative and reporting effort in locating the source of the problem.

Moving on to look at some other strategies embraced across pharma, agrochemical and cosmetics industries, we heard how Leo Pharma, Novartis, Syngenta and COTY had introduced greater accountability across all forecasting activities. This resulted in reduced stock-outs, cut inventory and improve traceability. Despite operating across different markets, the drive towards having one single version of the truth, greater process transparency and increased levels of personal accountability were common themes that delivered results.

So, how does this align with our vision for ‘connecting the disconnected’ when it comes to labelling and artwork? Actually, many of the concepts discussed at the summit apply equally to labelling supply chains as they do product. In fact, a product doesn’t become a product until it carries a label. That’s one of the reasons why we believe enterprise-wide engagement is essential in getting label content right first time. Encouraging greater transparency, supporting personalisation through late stage printing while adopting cloud-based technologies to achieve higher levels of collaboration are also concepts we support. It’s great to see the industry embarking on new initiatives in these areas and it’s something we will continue to support and encourage across all regulated industries.

If you’d like to learn more about how Kallik can help you innovate across your labelling supply chain, please feel free to leave a reply below or get in contact with us here.

Simplifying your Labelling Supply Chain - Kallik

By Graham Francis, Channel Marketing Manager, Kallik Ltd.

In my previous blog discussing the relationship between Industry 4.0 and best practice labelling and artwork, I talked about the need to have all stakeholders fully empowered and connected at all times. In this blog, I’m going to look at some of the steps that can be taken to simplify your labelling supply chain, along with some of the operational and financial benefits that this can deliver.

Frequently, global organisations are hampered in their attempts to improve supply chain efficiency. Often, this is due to multiple, localised approaches that have evolved over time to solve individual country needs despite product commonality. Alternatively, it could be the result of M&A activity, with newly acquired operations continuing to run their own discrete systems and processes. In many cases it’s usually a combination of both.

Although not without risk and potentially being highly disruptive, moving to a more streamlined supply chain needs to be embraced if organisations are to remain competitive and reduce time to market. In their report earlier this year, the World Packaging Organisation emphasised the importance of accurate packaging and labelling and how this can contribute to overall supply chain performance. Furthermore, consolidation of multiple production facilities can only be achieved if the labelling integrity can be guaranteed at a local level. The question is, “How can I achieve this without disrupting existing supply chains?”

One way is to eliminate as much complexity at the local level as possible by transitioning from ‘tribal knowledge’ to formal processes. Rationalising stock down to a minimal quantity of graphically consistent labels is the first step. You then need to look for a solution with in-built flexibility to accommodate local language and branding variations that link back to master content managed centrally. This will drive down complexity across the print supply chain and reduce the amount of time spent unnecessarily managing duplicate content. Migrating to a new cloud-based platform that simplifies connectivity with local print resources also means that much of this consolidation can be achieved ‘off-line’, without risk of disruption to existing production processes. This also unlocks your supply chain, simplifies late stage printing and enables you to collaborate with multiple partners whilst improving labelling accuracy.

Where adopting this approach, we’ve also seen organisations being able to increase artwork production capacity without increasing numbers of staff. This being due to the vast reduction in the number of label layouts being managed. Having the ability to ensure exact placement of graphics also makes it possible to leverage greater return from investment in print plates through their re-use.

Consolidation of label creation around a global master file also simplifies change management. The almost constant stream of updates driven by country specific regulatory changes and differing language combinations that global organisations often experience can be managed as ‘business as usual’. This also makes it much easier to demonstrate compliance against approval processes, eliminating the need to trawl back through email and country specific documentation to find the necessary supporting evidence.

If you’d like to learn more about how Kallik can help you to simplify your supply chain, why not join us at the Supply Chain Innovation Summit in Barcelona later this month? Alternatively, please feel free to leave a reply below or get in contact with us here.

Industry 4.0: Digital Labelling for a Connected Enterprise

By Graham Francis, Channel Marketing Manager, Kallik

In my last blog, I talked about the relationship between digital transformation and digital labelling and the benefits this brings in terms of transparency, compliance and consistency. I’m now going to reflect on the relationship between Industry 4.0 and best practice labelling and artwork.

In preparing for presenting and exhibiting at the forthcoming Supply Chain Innovation Leaders Summit in Barcelona later this year, I’ve been undertaking some background reading into this initiative and I’ve been surprised by what I’ve learnt. Following early adoption by the automotive industry, in particular Toyota and Nissan, Industry 4.0 has been gaining much ground across other sectors including Chemical, Pharmaceutical and Medical Device manufacturers.

Working in the technology industry, X.0 initiatives seem to be commonplace and sometimes it’s not easy to separate hype from reality. All too often it seems there is a plethora of research, positioning and publishing undertaken by industry experts and suppliers alike, but a lack of conviction and clarity of delivered benefits often seems to weaken the investment case.

Industry 4.0 appears to be different. According to research carried out by PwC in 2016, there are some quite staggering figures being reported across a mix of industries. US$439bn p.a. in revenue gains and US$421bn p.a. savings point to strong returns on an annual investment of US$907bn across the industry. Of course, as pointed out by Deloitte in their article discussing the rise of the digital supply network (DSN), ‘Change is often hard, but the digitisation of information and the application of advanced technologies present the opportunity to drive business value throughout the supply chain.’ The move towards a more agile, connected community through embracing digital supply chain concepts is never going to be an easy transition, but the benefits are clear to see.

Despite all the challenges of migrating from a vertical to a horizontally integrated business, increased use of manufacturing and distribution partners spanning a global market means that industry has to change if it is to remain competitive. But it’s not just external partners that need better integration, each internal function right from R&D to customer fulfilment needs end to end transparency to support real-time collaboration and informed decision making. The only way to do this is to have all stakeholders fully connected and empowered at all times.

Here at Kallik, I’m happy to say that we are strongly aligned with Industry 4.0. We see labelling and artwork as an enterprise-wide process and one that is fully integrated across global supply chain operations. Early in our development as a company, we recognised that our customers needed to move from a document to data centric world that would make it easier to share content and collaborate on new initiatives. They also needed dismantle the traditional boundaries that existed between the various functions engaged in label design, approval and production and the easiest way to do this was to move to a cloud based deployment model to ensure everyone stayed connected. And if it’s not already obvious, what they’ve achieved by doing so is to have undertaken an important step in their journey towards full Industry 4.0 implementation.

If you’d like to hear more about our how we can help align your global supply chains with Industry 4.0 by embracing more agile labelling and artwork processes, why not join us at the Supply Chain Innovation Leader’s Summit in Barcelona later this year.

See also our latest news outlining our recent successes in this area: Kallik Leadership Team Delivers on Bold Growth Plans

 

By Graham Francis, Channel Marketing Manager, Kallik

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’ labelling and artwork processes to embrace this revolution.

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) suggest that consumers are becoming ever more motivated by finding the best treatment and the cheapest price.

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 labelling 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 digitisation 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 labelling 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.

If you’d like to hear more about our how we can help you accelerate digital transformation of your global supply chains through embracing more agile labelling and artwork processes, why not join us at the Supply Chain Innovation Leader’s Summit in Barcelona later this year.

We look forward to welcoming you there!

By Graham Francis, Channel Marketing Manager, Kallik

In this, my final blog in the series expanding on key points discussed in our recent labelling white paper, I’m going to look at how life can be made much easier for regulatory affairs by fixing some of the common issues that affect downstream compliance.

When Kallik first engages with new clients we often hear the same things being said; “length of time to complete the approval process, inability to prove labelling compliance, unable to keep track of changes, delays in reacting to legislation and achieving time to market.” These are just a few examples, but quite often the root causes for each are often poor communication, lack of accountability and/or process inefficiencies.

This is not to say that heavily regulated industries including pharma, medical device, chemicals and cosmetics are not actively trying to fix these issues, it’s just that the systems and processes they have in place are not optimised for their labelling and artwork processes. When we start asking how information is captured, shared, reviewed and approved, often we find that PDFs, Excel spreadsheets and email form the backbone of the process. Consequently, information goes missing, emails are misinterpreted and quality suffers. All potentially increasing the risk of labelling being non-compliant.

Often, the reason behind this is that companies are using the lowest common denominator for capturing and sharing content, meaning the tools are driving the process, rather than the process driving the tools. This is unsurprising as taken separately, each is reliable, robust and omnipresent. However, the use of siloed tools for capture and communication of content inevitably leads to multiple versions of the truth and a resultant lack of transparency.

At Kallik, we look at things differently. As our CEO, Neil Gleghorn often reminds us; “First you have to define what it is you want to do and only when this is agreed, do you implement and configure the required tools to make it happen.” Evidence of adopting this philosophy is clear when our customers start to talk about how much easier it is to demonstrate labelling compliance plus embrace new supply chain initiatives referred to by the likes of McKinsey & Company as Industry 4.0. after implementing our solution.

By adopting a single connected solution to digitize their labelling and artwork processes, organisations are immediately freed from previous constraints imposed by disconnected systems and processes. The boundaries enforced by legacy technologies are removed and all stakeholders have clear visibility of assigned tasks. In practical terms, this means that anyone inputting, changing,reviewing or approving content is always working from the latest version – even when working across global supply chains.

As every action throughout every step of the process is now captured, process inefficiencies and bottlenecks can be quickly spotted and addressed. Regulatory Affairs now have the corporate oversight that enables them to pin-point potential areas of non-compliance and to respond quickly to legislative changes. Supply Chain heads can drive greater efficiencies from CMO engagement and Marketing executives achieve faster ROI from mergers, acquisitions and re-branding.

For more best practice insight, please visit our solutions page and/or download our recent white paper ‘Connecting the Dots across the Labelling Lifecycle.’

By Graham Francis, Channel Marketing Manager, Kallik

In my previous blog, I discussed the challenge of ensuring labelling compliance across supply chain. In this blog, I’ll be discussing best practice for adding variable content to pre-printed labels at print run-time. The pharmaceutical industry refers to this as late-stage customisation.

It’s often the case that late stage customisation is disconnected from primary and secondary packaging. Most often, this occurs where stand-alone print solutions have been implemented at remote production facilities.

This fragmented approach introduces several complications into the late stage customisation process. Firstly; there is the risk of variable content being incorrectly positioned against the base label making it unreadable. Secondly; there’s often a large volume of base label templates that need to be managed. Thirdly, it can be very difficult for regulatory affairs to prove that print and packaging is of the latest approved version across all sites and regions, especially where multiple CMOs exist.

With serialisation coming into force across Europe and the US in the form of the DSCSA and the FMD, unclear or inaccurate labelling on product packaging could put many organisations at greater risk of non-compliance. This all puts much greater emphasis on the accuracy of late stage printed labels.

Even where organisations have chosen to implement new software systems to gain better visibility and control of the artwork creation and labelling processes, this often excludes the print production element from their solutions. As pointed out by Stephen McIndoe of Be4ward in his serialisation blog earlier this year, without the successful and timely implementation and integration of CMO serialisation capabilities, Pharma companies will no longer be able to supply product.

So what’s the answer? We believe the best approach is to manage all primary, secondary and late stage customisation (or factory) print content within one solution. Approved base labels along with variable run-time data are captured in a central repository. This makes it simple to generate a detailed audit trail of all changes and provides traceability down to each unique label. It also minimises the risk of content held in localised databases becoming out of alignment with approved statements. Perhaps best of all, it enables CMOs to continue to use their existing localised print solutions, reducing the cost of serialisation compliance.

As all labelling content is managed centrally, including manufacturing data generated by ERP it offers enhanced traceability. With all factory printers now operating in ‘closed loop’ mode any labels not printed due to printer error/failure are captured and reported. This helps to maintain integrity between serialisation data and the content on printed labels.

This all makes it easier for regulatory and labelling teams to trace and recall products down to individual unit level irrespective of where they were manufactured, labelled or distributed. This ability to search within a finer tolerance than say recalling a batch of broader products can greatly reduce the likelihood, cost and disruption of any potential product recalls. Overall, managing all labelling content and processes from a centralised solution ensures everyone gets connected and enhances corporate oversight.

For more best practice insight, please visit our solutions page and/or download our recent white paper ‘Connecting the Dots across the Labelling Lifecycle’.