Labels for medical devices go through approval processes, ensuring that all medical, marketing and regulatory information is accurate and consistent. Not only can this upstream workflow process take a long time, but having multiple stages of approval means that there are more opportunities for error and often those errors will lead to a recall. In fact, almost 15% of all drug recalls from January 2017 to September 2019 were due to issues with labelling.
A lot of factors can contribute to mistakes on labels. Human error is always a risk, and last minute edits or changes made by people accustomed to different region’s regulations or not working in their native language all increase the likelihood of things going wrong. Additionally, having multiple datasets for label information may mean that out-of-date data is used, so old logos or information that has already been corrected get printed.
When it comes to highly regulated industries, incorrect labelling can be far more disastrous than the expenditure associated with updating logos or branding. False information can lead to the misuse of medical devices or pharmaceuticals, which could be fatal for the end user, and not having connected systems will make it difficult to pinpoint where the error originated.
Veraciti, developed by Kallik, is a label management solution that ensures transparency and agile change requests. According to Rob Woodall, chief technical officer at Kallik: “We have multiple key integration points. We have connections with product life cycle (PLM) systems, where we enable project change requests to come in for the label and management process, and we have web services that facilitate that. Customers can generate change requests for labels, and trigger those in Veraciti.
“If you create a project change request, you can then create the correct labels, capture the data for the labels, and then get them approved to walk through all of our workflows and store them in a digital asset manager.”
Integrating web services is essential in this digital age, and processes that still rely on manual input are sure to fall behind. Veraciti allows changes to be tracked and acts as a single source for the most up to date, correct data, where customers can synchronise a dataset with phrase and asset libraries.
“Phrase integration enables regulatory datasets of phrases and images to be input into Veraciti, and then those phrases of regulatory data can be selected as part of the project change requests,” Woodall explains.
As well as label data that is printed to communicate information to the user (such as logos and instructions), Veraciti datasets can also include the label code, the number of labels that need to be printed, and barcodes, so that the system can automatically collate variable data and send it to operators to print. This whole process is audited for efficient tracking.
“If you look at recalls, labelling is the biggest source of errors,” Bob Tilling, VP of global sales at Kallik explains. “We get somebody to approve the content, the layout of a label, and the print quality. So why does it go wrong? If someone makes late changes, all those quality checks upstream fall down right at the last minute, because it’s an uncontrolled process at the end of an otherwise very controlled process. But integration with realtime data means that there’s no operator typing at print time, so last minute errors are eradicated.”
Kallik has helped companies globally to manage their labelling processes, and has seen countless examples of how small errors can create major problems that could have been prevented with Veraciti.
“A company manufacturing vapes recently needed to make a change because the tobacco regulation that affected their medical device changed last year, so they manually changed all their labels and products to be compliant,” Tilling explains.
“However, they forgot about the product batches in Germany, so they didn’t change the German ones. In January, the German government stopped them selling their products and they lost $1 million a month. They managed to fix it in May, totalling a loss of $5 million. With Veraciti, that could have all been avoided.
“Essentially, Veraciti allows businesses to make changes to their labels quickly, which means they can sell them faster. If it’s changing to go to a new market or launch a new product, we will have the artwork and the labels ready so they can start selling. We’re helping to give our customers a competitive advantage.”