Connected Systems in Label Management: How Integrated Software Saves Time, Money and Lives
Medical device labels 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 approval stages means there are more possibilities for error and often those errors will result in a callback. In fact, nearly 15% of all drug recalls from January 2017 to September 2019 were due to labeling issues.
There are many factors that can contribute to label errors. Human error is always a risk, and last-minute changes or modifications made by people who are accustomed to regulations in different regions or not working in their native language all increase the likelihood of things going wrong. Additionally, having multiple datasets for label information can mean that outdated data is being used, so that old logos or information that has already been corrected is printed.
When it comes to highly regulated industries, improper labeling can be far more disastrous than the expense 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 systems connected will make it difficult to identify the source of the error. .
Veraciti, developed by Kallik, is a label management solution that guarantees the transparency and agility of change requests. According to Rob Woodall, CTO at Kallik: “We have several key integration points. We have links to Product Lifecycle Systems (PLM), where we allow project change requests to enter for the labeling and management process, and we have web services that facilitate that. Customers can generate and trigger label change requests in Veraciti.
“If you create a project change request, you can then create the correct labels, capture the data for the labels, and then have it approved to go through all of our workflows and store it in a digital asset manager. ”
Web service integration is critical in the digital age, and processes that still rely on manual entry are sure to fall behind. Veraciti keeps track of changes and acts as a single source for the most recent correct data, where clients can sync a dataset with phrase and asset libraries.
“Sentence integration allows regulatory data sets of sentences and images to be entered into Veraciti, and then those regulatory data sentences can be selected as part of project change requests,” says Woodall.
In addition to label data printed to communicate information to the user (such as logos and instructions), Veraciti data sets can also include label code, number of labels to print, and codes. -bars, so that the system can automatically collect the variable data and send it to the operators for printing. This entire process is audited for effective monitoring.
“If you look at recalls, labeling is the number one source of errors,” says Bob Tilling, vice president of global sales at Kallik. “We have someone approve the content, the layout of a label and the print quality. So why is it going badly? If someone makes late changes, all of that upstream quality checks come in at the last minute, because it’s an uncontrolled process at the end of an otherwise very controlled process. But integration with real-time data means there’s no operator typing at print time, so last-minute mistakes are eliminated.
Kallik has helped companies around the world manage their labeling processes and has seen countless examples of how small mistakes can create major problems that could have been avoided with Veraciti.
“A company making vapes recently had to make a change because the tobacco regulations that affected their medical device changed last year, so they manually changed all of their labels and products to be compliant,” Tilling explains. .
“However, they forgot the product batches in Germany, so they didn’t change the German batches. In January, the German government stopped them from selling their products and they lost $ 1 million a month. They managed to fix it in May, totaling a loss of $ 5 million. With Veraciti, all of this could have been avoided.
“Essentially, Veraciti allows businesses to quickly change their labels, which means they can sell them faster. If that changes to go into a new market or launch a new product, we’ll have the artwork and labels ready so they can start selling. We help give our customers a competitive advantage.