While production labelling controls often attract greater attention, errors in packaging artwork and Instructions For Use (IFU) design files can still prove problematic. However, there are now some smart technological solutions to ensure content controls extend to graphic design activities, as Simon Jones, vice president global products of PRISYM ID explains.
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Artwork creation is an increasingly important aspect of the production of inserts, leaflets and packaging files. For medical device manufacturers, producing error-free packaging artwork and IFUs is critical when launching multiple product variants in many markets.
Yet in many cases artwork creation remains prone to errors because design teams typically work outside of the established controls put in place for other aspects of production labelling. Adobe InDesign and Apple Macs are the predominant design tools, but they traditionally require designers to manually type text and content and save artwork files on their local computers before approval.
The approach is heavy on human processes – which itself carries risk – and it also limits the ability to ensure effective version control, approvals, and audit logging. The result is that artwork creation can sometimes be the weakest link when it comes to ensuring compliance, putting pressure on downstream review processes to identify and resolve errors.
Fortunately, there are some smart solutions. Drawing on feedback from users, PRISYM ID has recently developed tools that enable its label management features and controls to be extended to support packaging design teams. These unique features work on the principle that by greatly reducing the introduction of manual entry errors at the start of the process, subsequent review phases are much easier and faster as there are fewer errors to identify and rectify, thereby reducing risk and making the process more efficient.
Ensuring accurate inputs with a PRISYM 360 InDesign plug-in
The first of these is an Adobe InDesign compatible plug-in, which provides the graphic designer with access to approved content within PRISYM 360 in real-time. This content may comprise product names, dosage and expiration information, caution statements, translations, die lines, symbols and logos for example.
This content can be simply ‘drag & dropped’ onto the InDesign page, avoiding the need to manually type in content and therefore minimising the risk of mistakes. The use of variable placeholders means the InDesign files can be used as templates, so artwork can be revised or adapted by simply selecting different data records.
InDesign files and associated PDFs are saved directly to PRISYM 360, providing version and state control and ensuring file integrity and information ‘metadata’ is saved with the InDesign files and PDF files, enabling PRISYM 360 to report on the content components used within the artwork file.
Finally, opening these InDesign files will automatically retrieve the relevant data records, and enable them to be easily updated, if they have changed within PRISYM 360.
Managing changes with confidence
The use of approved content in the creation phase further drives labelling and artwork teams to use standardised versions of text, images, symbols, and phrases. Doing this means it is possible to enforce a single source of truth throughout the process. It also means that updates are easier to plan and manage, particularly through a second feature – the change impact tool within PRISYM 360.
This functionality reports on where a specific piece of content is used, even across multiple labels and artwork files, using the metadata stored with the file. After creating a new version of the content, this can be updated in the relevant artwork simply by opening the artwork file and selecting the latest approved data record – with no change to the layout required.
It is a process that takes minutes and removes risk. The resulting artwork files are stored in PRISYM 360, which means they are automatically version and state controlled, and recorded in the 21cfr part11-compliant audit log.
Conclusion
In short, packaging artwork creation and changes need not be a ‘special case’ that is reliant on painstaking and flawed human processes to ensure accuracy.
These new tools have been designed to integrate seamlessly with how design teams operate, providing a fast and efficient way of ensuring artwork is subject to the same robust controls as all other aspects of labelling content.
Together, they should give organisations added confidence, knowing that their artwork files are not secretly harbouring small errors that may result in recalls or patient safety issues down the line.
To find out more about these tools, and other key features of the PRISYM 360 platform, visit www.prisymID.com/prisym-360
