UDI - quality assurance

How UDI compliance can be the key to digitally transforming quality assurance

Susan Gosnell Medical Devices

2020 is a year etched into the minds of many medical device manufacturers (MDMs). Not only does the United States Food and Drug Administration’s (FDA) UDI compliance date for Class I and non-classified devices fall in that year, it’s also the year the recently approved European medical device regulations (MDR) go into effect. These impending deadlines have MDMs taking a long, hard look at their labeling to make sure they can meet the various labeling requirements in the countries where they do business.

Within that long list of labeling requirements and regulations lies a unique opportunity for MDMs to transform their quality assurance processes. To outline this opportunity, we spoke with Ken Moir, VP of Marketing at NiceLabel, and Felix Klebe, Product Manager, Verification at Microscan to find out how MDMs can leverage UDI compliance to digitize quality assurance.

End-to-end quality assurance starts with label creation

Ken: “The whole thing starts with the way you create and design your labels. Digitizing label creation is about moving away from a legacy approach, like having IT hard-code label templates to match different printers or to have different languages. It means empowering business users to process label change requests by giving them an intuitive, familiar interface in which to design labels.

By creating intelligent label templates that can be customized by business users, MDMs can reduce the number of label templates they have to maintain and make it easier to create and update templates for new markets and to meet new regulations.

Once you’ve created the compliant labels, you have to store them. In an offline world, this was all about maintaining paper-based catalogs and manual approval process of label templates and offline records of printed labels. Digitizing this is about moving the entire label database online into a Document Management System (DMS). This provides a complete version and print history as well as electronic records and electronic signatures (ERES) for each label. All label changes are tracked and quality control personal can compare label versions to see what changes have been made before approving. The approval process is digitized and completely streamlined, and MDMs get instant documentation of who changed what and when.”

Ensuring accurate label information

The next step in the process is establishing the one source of truth.

Ken: “Now you’ve digitized your label design, you’ve digitized your label catalogs, you’ve digitized the quality assurance process. Then by integrating label printing with the MES, ERP or WMS systems, MDMs can ensure they have one version of truth, and they can instantly verify and change label information to meet new regulations as they go into effect.”

All of this ensures that the information that goes on to the label is accurate. Yet end-to-end quality assurance is also about ensuring the quality of the label once it’s printed as well.

Felix: “Here there are several approaches. Of course, you can use an off-line verifier to make sure that the label’s barcodes meets the data structure required by GS1. You can also do random sampling during label production, but you still don’t know whether something has happened along the way, like poor media quality or a change to a printer setting, that could result in a label being printed that doesn’t meet requirements. Testing 100% of labels in-line lets you design the template not just to look at the barcode but the entire label including text elements etc., to make sure it’s correct.”

In-line verification: the final step in end-to-end quality assurance

Felix: “With automated, in-line verification, you design an inspection template to look at the barcode and other information on the label and compare these to a ‘golden template’. This ensures that all the information on each label meets the minimum quality requirement. Because it’s built right into the printer, there’s no misalignment risk or field engineering needed. With in-line verification you can look at multiple barcodes simultaneously without compromising print speed. If there is an error, you can prevent the run from continuing and address it immediately.”

Digital transformation addresses the hidden costs of labeling

Taking these steps ensures that the information on each label is accurate, that the label design and information meet the applicable regulations and that the barcodes printed are verified and compliant. Yet, the benefits of transforming quality assurance in this manner go far beyond UDI and MDR compliance.

Ken: “We usually tell people that the costs of legacy labeling are greater than they think. Just think about how digitizing the entire quality assurance process really reduces what we call indirect costs, the costs of ensuring quality labels. First off, you avoid errors that can come from manual processes. But you also save time and resources that were spent doing manual checks and inspections.”

The key to business process improvement

Felix: “And then by digitizing the quality assurance process, you make it more transparent, so you can identify areas for business and process improvement. For example, MDMs get a better view of their printing efficiency. They can see the error rates on different printers and identify individual printers that aren’t performing well. By gathering analytics around different types of labels, they can identify which aspects of a label design are proving problematic in terms of compliance or quality. They can avoid label designs that are not easy to print successfully. They can also determine how much information can be put on a label while maintaining print quality, especially in a multi-language situation. As the density, or the amount of information they have to display on a label, increases, this information can help them to see the limits of how much they can put on a label while still getting adequate print quality.”

Ken: “So by digitally transforming quality assurance, MDMs are able to make more informed decisions because they have a better understanding of what’s happening at every phase of their label production and printing process. More informed decision making and optimized processes lead to a more agile business that is in a better position to compete in the challenging marketplace that is medical device manufacturing.”

Ken and Felix recently participated in a webinar, where they also spoke about how medical device manufacturers could use European MDR compliance as an opportunity to digitally transform their quality assurance processes. You can read more about what digital transformation means for labeling here. You can read more about barcode verification here.

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