Keeping Regulatory Affairs happy with Compliant Labelling

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.’

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