Compliance Gap: Why Labeling and Instructions for Use Documents Need to Be a Single Process

Fragment of the conveyor of sticking labeling machine. Abstract industrial background. | Image Credit: © Aleksandr Matveev - stock.adobe.com

While pharmaceutical and medical device manufacturers have successfully navigated the raft of labeling regulations that have come their way over the past 18 months, instructions for use (IFU) documents, both electronic and paper, seem to be a blind spot for some. So how can manufacturers clear the backlog of updates in IFUs in the most efficient and accurate way possible?

Labeling compliance is non-negotiable in the pharmaceutical and medical device industries, and it’s heartening to see just how quickly and successfully manufacturers have responded to changes in labeling regulations over the past 18 months.

Working closely with this highly regulated industry, we know that many have been modernizing labeling and artwork management for some time now. They are moving away from arduous and error-prone manual processes and instead embracing cloud technology that allows them to maintain data quality and automate time-consuming tasks.

Compliance is one of the biggest drivers, but at the forefront of manufacturers’ minds is the risk of harm to patients should medication labels contain errors or incomplete information. They’re also well aware how damaging a product recall is, both financially and reputationally.

The good thing about cloud-based software is that it provides a single version of the truth, throughout the entire artwork and labeling lifecycle. It means that any labeling updates—whether related to new legislation, a new formulation, or mislabeling—can be easily and accurately managed in-house, with a clear digital trail of activity.

Rather than relying on a myriad of different systems (e.g., enterprise resource planning, creative software, and spreadsheets), a cloud-based solution can control and coordinate everything, including critical market-facing information around materials, in one place. This functionality enables manufacturers to deftly respond to changes such as the labeling requirements for medicines, agreed to as part of the Windsor Framework; a post-Brexit agreement between the EU and the UK, which required goods entering Northern Ireland from Great Britain to provide the proper paperwork to demonstrate they comply with relevant EU laws.

Preparing for this one change alone, before it comes into force on Jan. 1, 2025, would be a huge drain on resources for United Kingdom companies reliant on manual processes if they are distributing tens of thousands of products in Northern Ireland. To put it into perspective, it could typically take 10 employees several weeks to change just 1000 product labels manually.

What about IFUs?

While it’s clearly good news that manufacturers are strengthening their labeling processes, some may still lag behind when it comes to other customer-facing information, such as IFU leaflets.

Because of how much information IFU leaflets contain—including details on active ingredients and possible side effects, as well as diagrams, barcodes, and certifications—updating them is an altogether more complex task.

For one thing, it requires input from far more stakeholders compared to labeling, particularly in global companies where IFU documents might be translated between 25 and 30 times. Where this is done manually, including outside of label management systems, you run the risk of error. It takes up a lot of time too, of course.

Then there is the design of the IFU itself to consider. Whereas labeling might be handled by the company’s production team as part of one seamless manufacturing process, IFUs usually fall to various regional design departments or they might be outsourced to creative agencies, depending on what’s needed.

Even simple design adjustments can throw out the layout, leave a barcode partially missing, or obscure critical wording, errors that would all trigger a recall if these products were released. This is where expert designers can help to ensure that documents are properly branded, easy-to-follow, and meet design guidelines.

Yet outsourcing design, even internally, can also cause a disconnect between teams and the systems they use. Miscommunication or missing information can result in designs falling short of what is required. Designers will also use creative software rather than specialist labeling and artwork management systems so, again, there’s the potential for key information to be missed when files are transferred.

Mistakes notwithstanding, outsourcing IFU updates to other departments or external agencies can still be time-consuming and expensive.

Compliant by design

Pharmaceutical manufacturers aren’t the only ones who may be held back by manual IFU updates; medical device companies have found themselves in a similar position. A large number of them didn’t update their IFU leaflets when the European Union Medical Device Regulation (EU MDR) came into force in 2021. Many have been left panicking as a result because of the scale of the problem. And while product lifecycle management (PLM) software can help with the content, it doesn’t ensure the layout will be correct.

One company that is bucking the trend is global medical device manufacturer Össur, which has been working in the non-invasive orthopedics industry for more than 50 years. Because Össur’s products are so complex, its IFUs contained large blocks of text with longer phrases than typical medical device labels. Over time, the company amassed a large bank of IFUs, developed by different employees at different times depending on the product release date, and stored in separate documents with a master spreadsheet of all phrases.

In addition to the time pressure this puts on teams, Össur was left with limited visibility across hundreds of global product lines due to the number of disparate IFU documents it had. At times, the IFUs for similar products contained different terminology, even if the processes were the same or similar. As a result, it was extremely difficult to track, manage, update, and translate IFUs, all of which could potentially undermine user experiences. Lack of visibility and manual processes also led to delays in product launches while IFUs were translated and approved in different markets.

Össur wasn’t alone in being tied to manual processes, but it was determined to overhaul its legacy systems. The company rolled out a new system that would remove the need for human input by generating pre-approved translations for IFUs. This system not only reduced errors, but also saved time and money by not having to pay for external agencies to handle these changes, nor spend long periods of time briefing them. Instead, the changes were handled by internal teams within a single shared workspace.

The company was able to design and approve in their native language, and with a couple of clicks, create multiple versions in different languages, each containing accurate and consistent instructions. This is a significant cost-saving when you consider that otherwise the company would have to pay for 25 (or more) translators or artworkers, or use an online translation service.

It’s also worth noting that some labeling management solutions also resort to using these online services, which aren’t nuanced enough for something as complex as pharmaceuticals or medical devices. To ensure accuracy and consistency, pre-approved translations, derived from a single source of truth, are beneficial to an end-to-end labeling and artwork management system.

Where next?

In the digital age, there is growing demand for electronic IFUs because they’re easy for patients and healthcare practitioners to use. They simply scan a QR code or type in a web address to open up electronic leaflets about their product. Using their computer’s IP address, they are able to access documents in the right language for the country they are in, rather than having to flick through 40 or so pages to find instructions in their language.

What’s particularly helpful is if the IFU can be downloaded as an XML file, as well as the most common PDF option. An XML version can be uploaded to a website straightaway, so the latest information is always available. One can even set up automatic updates so webmasters are notified when the electronic IFU is ready to be coded into the website, eliminating the need for an email.

IFUs are just one part of a manufacturer’s operations, yet streamlining and improving them can deliver benefits for both patients and the business. Taken together, this could reduce the time-to-market for life-saving and life-enhancing new treatments, drive down the cost of delivery, and ensure the highest standards of safety and compliance are maintained.

Dave Cash is chief product evangelist at Kallik.