Quality Tech Services Achieves UDI Compliance with Enterprise Labeling Software
08 June 2015
TEKLYNX CENTRAL CFR helps medical device packaging provider QTS reduce risk and increase efficiency in their labeling processes
MILWAUKEE, WI (June 8, 2015) − TEKLYNX International, the world’s leading developer of barcode labeling software solutions, recently implemented an industry-leading enterprise labeling application for Quality Tech Services (QTS) that has driven workflow improvements and risk reduction for the medical device packaging and outsourcing solutions provider.
By integrating TEKLYNX CENTRAL CFR with its Enterprise Resource Planning (ERP) system, QTS has 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 solution has 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,” said 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 solutions that are designed to support compliance regulations and specific standards has transformed labeling processes for manufacturers across the healthcare industry. 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 over 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 over 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,” said Nick Recht, Enterprise Product Manager at TEKLYNX. “Our solution offers full regulatory compliance capabilities that help organziations like QTS efficiently create UDI-compliant barcodes and adhere to 21 CFR Part 11 criteria for electronic signatures.”
To read more about QTS’ experiences with TEKLYNX CENTRAL CFR, download the full case study at http://www.teklynx.com/en/products/enterprise-label-management-solutions/teklynx-central-cfr/qts/
Visit TEKLYNX at the Annual UDI Conference at the Hilton in Baltimore, Maryland on June 24th & 25th, 2015. TEKLYNX will be at booth numbers 2 & 3 for the premier event dedicated to guidance, training, and solutions for those impacted by the UDI regulation.
About TEKLYNX International
TEKLYNX International is the world’s leading developer of barcode labeling software solutions. More than 620,000 companies in 120 countries rely on TEKLYNX integrated software solutions for supply chain automation, regulation compliance, warehouse management, shipping and receiving, inventory control, and asset management. TEKLYNX is a Microsoft Gold Certified Partner, Oracle Gold Partner, has internal GS1 Certified Barcode Professionals and invests to develop SAP Certified solutions. TEKLYNX barcode labeling software is CFR Part 11 compliant, and is capable of printing GS1 and HIBC required to generate the AIDC technology labels for UDI compliance, as well as GHS compliance, with support for thermal and thermal transfer printers. TEKLYNX is headquartered in France with operations in the United States, Europe, Japan, China, and Singapore. For more information on how TEKLYNX can help organizations in the medical device and healthcare industry, visit http://www.teklynx.com.