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.

As leaders in highly regulated industries embrace Industry 4.0 and best practice labelling and artwork, they must recognize that all stakeholders need to be fully empowered and connected at all times. Here are some of the steps that can be taken to simplify your labeling supply chain, along with some of the operational and financial benefits that this can deliver.

Frequently, global organizations are hampered in their attempts to improve supply chain efficiency. Often, this is due to multiple, localized 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 organizations 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 labeling 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. Rationalizing 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 labeling accuracy.

Where adopting this approach, we’ve also seen organizations 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 organizations 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.

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.

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

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

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

Transforming your business with two concepts

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

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

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

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

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

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

Seeing the opportunity in the EU MDR

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

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

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

Want to know more? 

Whether you’re in the food and beverage, pharmaceutical, medical device, chemical, or even the cosmetic industry, our experts are ready to help you transform your labeling and artwork management with the help of our innovative software, leading the way in the labeling and artwork software space.

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

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

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

So what happens when you hand over those 30 documents?

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

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

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

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

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

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

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.

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

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

Overcoming challenges 

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

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

Breaking down barriers 

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

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

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

Coaching and shaping

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

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

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

Embracing the future 

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

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.

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

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

Adapt and adopt 

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

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

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

Managing deviations 

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

Gaining efficiencies and realising cost benefits 

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

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

Transparency and visibility 

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

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.

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

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

1. Consistency 

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

2. Visibility

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

3. Ensuring Connectivity

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

4. Reconstruction and Reusability

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

5. Quickly Update and Repurpose Content

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

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

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.

Keeping up with changing regulations 

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

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

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

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

How can business rules help? 

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

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

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

Minimise the level of human intervention in completing complex tasks

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

Ensure content alignment across all types of labelling

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

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

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

Tailor the system around your own business processes 

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

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.