Medical device firm wins with barcode labeling software

CFR enterprise barcode labeling software helps QTS reduce risk, increase efficiency, and become compliant with UDI and FDA 21 CFR Part 11 regulations.

From small medical device assembly projects to complete medical device outsourcing, Minneapolis-based Quality Tech Services (QTS) provides medical device packaging, assembly, kitting, and other services. Its facility includes ISO Class 7 cleanrooms, an engineering lab, inspection suite, and warehousing area.

As the company’s business grew, however, it needed to improve its workflow process and reduce risks. To accomplish that, QTS turned to TEKLYNX Intl., a global developer of barcode labeling software.

By integrating TEKLYNX CENTRAL CFR with its Enterprise Resource Planning (ERP) system, QTS significantly reduced the likelihood of labeling errors by completely eliminating manual data entry and reducing the need for barcode scanning. The TEKLYNX barcode label management system also increased efficiency by 40%, speeding time-to-market and improving compliance with Unique Device Identification (UDI) and FDA 21 CFR Part 11 regulations.

“The TEKLYNX CENTRAL CFR solution ultimately enables us to serve our customers better and more efficiently,” says Todd Engelken, Value Stream Engineering Manager at QTS. “We have a very high level of confidence regarding our compliance with UDI standards. I can absolutely say we made the right choice with TEKLYNX.”

TEKLYNX’ focus on developing industry-focused barcode label software products that are designed to support compliance regulations and specific standards has transformed labeling processes for healthcare industry manufacturers. Its tiered barcode label software product offering allows organizations to easily grow with TEKLYNX.

As QTS’ production requirements diversified and became more complex, the QTS team found itself managing more than 900 active label templates. As its product lines expanded, QTS leveraged TEKLYNX’ label converter functionality to quickly and easily transition its labels from LABEL MATRIX, TEKLYNX’ basic label design application, to TEKLYNX CENTRAL CFR, which offers more advanced features and ERP integration. The TEKLYNX label conversion tool saved the QTS team more than 400 hours in production time.

“Thanks to significant business growth, QTS required the more advanced capabilities of TEKLYNX CENTRAL CFR. Various features, including a browser-based interface and complete ERP integration, allowed QTS to streamline their label printing processes,” says Nick Recht, Enterprise Product Manager at TEKLYNX.

To read more about QTS’ experiences with TEKLYNX CENTRAL CFR, download the full case study here.

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