Case Study: Aspen Medical Products improves labeling accuracy and compliance with TEKLYNX CENTRAL CFR

TEKLYNX CENTRAL CFR Improves Labeling Accuracy, Reduces Label Approval Time & Simplifies Labeling Compliance for Aspen Medical Products

Aspen Medical Products, a medical device manufacturer of spinal orthotics, needed to replace a manual, error-prone labeling process that relied on lots of data entry and had to support a growing global user base. The company also needed its labeling to integrate with its IQMS ERP system and meet medical device compliance requirements, including FDA 21 CFR Part 11. TEKLYNX provided TEKLYNX CENTRAL CFR to address these labeling and compliance challenges.

TEKLYNX implemented TEKLYNX CENTRAL CFR as a centralized, browser-based label management system that integrated with Aspen Medical Products’ ERP and automated critical label data such as country of origin. The result was improved labeling accuracy, faster label approvals, and stronger regulatory compliance. Aspen Medical Products reported that corrective actions tied to labeling errors dropped from about three per week five years ago to none in the past year, while global contractors could access and print the latest approved labels directly from the system.

Aspen Medical Products

Israel Lopez

Planning Manager