According to Jackie Leslie, BLUE’s Director of Business Development, one of the top three challenges life sciences companies are facing today is artwork versioning. Specifically:
- How do you track versions in a “constant change” environment?
- How do you ensure localized versions are kept in sync with the masters?
- How do you manage overlapping regulatory requirements?
- How do you manage versions within versions?
These are important questions to ask, because 43% of recalls are caused by incorrect labeling, and each product recall has the potential to cost an organization on average more than eight million dollars.
But why is it so complex?
First, consider this: one product does not equal one label. Those who are responsible for artwork know this, but sometimes it’s hard to explain how complicated this is. Take this example: a product comes in four sizes and each size is available in 10 markets with different language requirements in each. Suddenly you’re up to 40 labels, and if you have multiple manufacturing sites, this number goes up again. Add on the cartons, inserts, and other components, and the number keeps growing. And there can be no “rogue” labels. Despite language and size variations, each label still has to sync with the master label content map, which includes:
- Marketing content (i.e., brand name)
- Legal content (i.e., “Manufactured and Distributed by…”)
- Regulatory content (i.e., “Store at room temperature…”)
- Operations content (i.e., “50mg…”)
- Printing content (i.e., “Batch number…”)
Next, there are usually a significant number of people involved in the labeling process – from those who provide input, to those who approve content and design, to those who are responsible for the creation of the label. And as more stakeholders are involved in the label production process, it becomes more difficult to ensure everyone involved has visibility into labeling projects and the ability to easily provide input and approve labeling assets.
There is also a tremendous amount of information beyond what you see on the actual label that needs to be tracked. For example, some label content, such as safety information, may originate from a core data sheet. When a claim is made on the label: “Lasts for up to eight hours!” the label approver will need to reference some supporting documentation to substantiate the claim. In addition, there are dielines to track and printing information that needs to be available to the printer(s).
Finally, the most complex part of version control is managing multiple changes to the same piece of artwork. The reality is, your label production process from design to distribution rarely follows a linear path. The more common scenario is that at some point during the label production process, the number of label versions you manage changes because:
- Your company decides to launch the product in another market.
- A manufacturing site is changed or added.
- A regulatory change is required.
You now have changes on top of changes, and you need to make decisions about how to track all of these versions. When do you bundle changes together? When do you unbundle changes in order to meet your deadlines?
How to Make It Easier
To master these complexities and make artwork versioning control easier, Jackie recommends the following six steps:
- Establish a single source of truth.
- Link the content repository to the process.
- Ensure you have state-of-the-art search capabilities within the content repository and for work-in-progress.
- Implement technology with automated version compare functionality.
- Close the loop with automated updates to your content repository.
- Get granular: manage versions within versions by using a database for storage.
To learn more about these steps and how they can yield artwork management savings, download our new white paper: “Mastering the Complexities of Artwork Versioning Control.”