The recent Regulatory Affairs Professionals Society (RAPS) webinar, featuring labeling and artwork experts John Blake, Senior Director Analyst at Gartner and Gurdip Singh, CEO of Kallik, discussed in depth the intricate world of labeling and artwork management and what process maturity looks like in 2024. With a focus on regulatory compliance, the webinar explored evolving industry trends, challenges faced by organizations, and transformative strategies for digital maturity.
 

John Blake, representing Gartner, a global technological research and consulting firm, began the discussion by underlining the pivotal role of labeling and artwork management in ensuring regulatory compliance. Providing a comprehensive overview of the evolving landscape, John emphasized the shift from traditional label and artwork management to the digital, online management of labeling and artwork and how this digitalization is seeing artwork and labeling merge as the two become more difficult to separate. 
 

The stages of maturity

The topic of maturity then came up as John went on to discuss the maturity levels within organizations, highlighting the common challenges faced in the early stages. Focusing on companies stuck in what is described as the second stage of maturity, John said: “I would say, regardless of industry, regardless of size of company, the vast majority of organizations and functions within those organizations are just at that stage of identifying that they have a problem. You know, delays, cost overruns, recalls, they’re at that firefighting stage.”
 

Then discussing the third stage of maturity, where organizations tend to introduce tools and technology but in a very siloed fashion, it then becomes about how to communicate and collaborate better across the organization. “We see the vast majority of companies in these earlier stages, regardless of industry or size of the company.”
 

Moving up the maturity stages

John goes on to look at the opportunities being missed within the label and artwork management process and how removing traditional processes can benefit businesses. “I think about what we have in our homes, our pictures are stored on the cloud, we have cameras in our doorbells, we are streaming music online. But then we go into work, back into our business operations and there are still a tremendous amount of manual processes, from spreadsheets to back and forth over emails and even printed copies for approvals. There’s a real opportunity in the label and artwork management space to bring those digital tools into those processes.”
 

The importance of composability

Introducing the concept of composability, John illustrated the importance of discoverable data and autonomy in updates. Using the analogy of music, he highlighted the power of composability in business processes. “I would have to go find the music I want to put on a CD, I’d have to find a blank CD and I’d have to find a CD burner. I’d then have to mail a physical copy out too. So quite honestly, that would probably take about two weeks to do. But with the introduction of streaming services, which is also digital music, it's composable. I could give you the name of a song or an artist, I wouldn't even have to spell it correctly, and you could find it and be listening to it in seconds.”
 

With the emergence of cloud-based, collaborative, automated systems that offer composability, the way that organizations manage their label and artwork processes is transforming. Eliminating mistakes, saving time and money and offering complete regulatory confidence, the future of label and artwork management is clearly in these digital solutions.
 

John summarized: “The legacy systems can just no longer keep up. It's costing organizations too much time, too many resources, and certainly the inability for systems to break down those silos, it’s just causing businesses too many problems.”
 

Gurdip Singh, Kallik’s CEO, then took over to offer his expertise on the benefits of cloud-based, digital platforms. Gurdip stressed the global significance of labeling, extending beyond physical labels to encompass critical information impacting billions of lives daily. 
 

How labels and artwork keep the world spinning

Recalling a recent conversation with a customer, Gurdip emphasized the importance of ensuring your label and artwork process is up to scratch. “He said to me that if all of the labeling companies around the world just decided to stop one at any point in time, it wouldn't be very long before the world came to a standstill. And I thought, actually, that's a really, really important point. Every product that is out there has labeling around it.
 

“It's not just about the physical label on the product itself, it's the information on that product. The information for you, the packaging that goes around it - if you didn't know how to use that product, let's say, in a medical situation, a clinician using a piece of apparatus without the right instructions, then it could cause serious harm.” Although there are significant time and cost savings to be made when properly utilizing digital platforms for the process, it could ultimately save lives by preventing dangerous mistakes and helping to ensure compliance.
 

Making mass changes accurate and compliant

Discussing the difficulties of making mass changes across tens of thousands of labels and artwork while maintaining that accuracy and compliance, Gurdip went on to reiterate that composability is the answer. “The enterprises that we work with can have around 80-90, 000 changes taking place. In fact, we had one global medical device company that alone had to make 90, 000 changes in one year just to be compliant with European Union medical device regulations. 
 

And just trying to find those in your ecosystem, let alone change them can be quite a daunting task. As a result, things become slow. You miss out on, you know, really getting value, your product out there, generating further income, generating further revenue and also getting products out there faster.” Gurdip then emphasized the need for proactive investments in labeling and artwork processes, shifting from reactive fixes to a holistic digital maturity approach.
 

Teleflex: A label and artwork success story

Reiterating the significance of the digital maturity model, Gurdip emphasized the shift beyond basic organization towards optimization, integration, and strategic significance in businesses. Recognizing some of the most common challenges, such as informed mindsets, reactive behavior, and the complexity of involving multiple stakeholders, Gurdip talked through a customer success story with a medical device provider, Teleflex. By using Kallik’s platform, Veraciti, Teleflex were able to completely eliminate mistakes, preventing product recalls thanks to the composability provided by a cloud-based, automated solution. This highlighted just how crucial composability is and how the digital transformation of the labeling and artwork process is enabling composability, ultimately providing organizations with complete accuracy, regulatory confidence and reducing the time-to-market.
 

Overall, the RAPS webinar brought together insights from Gartner and Kallik to offer a comprehensive perspective on the challenges and opportunities within the artwork management and labeling space. As organizations navigate the complexities of regulatory compliance, the key takeaways include the importance of composability, the digital transformation and the requirement for proactive investment in advanced solutions to drive efficiency and address regulatory challenges effectively.
 

Looking for advice on how to improve your label and artwork process? Get in touch with a Kallik expert today by emailing enquiries@kallik.com.