Packaging: Manufacturer achieves compliance, efficiency

Quality Tech Services (QTS), a provider of medical device packaging and outsourcing solutions, was growing and recognized its manual data entry processes could result in labeling errors. It also faced a deadline for compliance with the with the FDA’s unique device identification (UDI) rules. After integrating bar code label management software, the company has reported workflow improvements, risk reduction and compliance ahead of the deadline.

As production requirements diversified and became more complex, the QTS team found themselves managing more than 900 active label templates. As its product lines expanded, the company leveraged a label converter functionality to transition labels from a basic label design application to a full-featured solution integrated with the company’s enterprise resource planning (ERP) system. The label conversion tool saved the QTS team more than 400 hours in production time.

By integrating the solution with its ERP, QTS has significantly reduced the likelihood of labeling errors by completely eliminating manual data entry and reducing the need for bar code scanning. The industry-specific software includes a browser-based interface, speeds time-to-market and improves compliance with both UDI and FDA 21 CFR Part 11 regulations for electronic signatures.

“The 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.”
Engelken estimates the solution has already increased efficiency by 40%.

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