How to Get a Good Night’s Sleep: Traceability, Accountability and Due Process in Labeling

Transparency and visibility — most would agree that both are essential for accurate insight of any enterprise-wide process.  Labeling and artwork management is no different.  Often it’s the lack of tools and not the lack of intent that’s the problem. In my last blog, I spoke 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 labeling activities that, by nature, are often complex and highly dispersed.

Lack of accurate insight, process delays and reworks aren’t problems that labeling 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 labeling 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. 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 labeling 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 labeling processes, spotting where the disconnects occur, and then being able to home in on the precise problem and determine what the holdup 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 labeling changes is a capital loss for a life sciences company. So companies can’t afford the holdups 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 labeling 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 classified 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 time-stamped, including when an artwork or asset transitioned from one person to another.

Let’s go back to an issue I raised in the last blog: that changes represent between 75 and 90 percent of labeling 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 affected labels need to reflect that change — including localized 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 affected labels have been updated. But, if everything is stored as a unique traceable asset, you can 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: “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.

Learn more about labeling by downloading the DXC Technology and Kallik white paper, “Connecting the Dots Across the Labeling Life Cycle.”


Graham Francis is Channel Marketing Manager at Kallik.

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