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

Aspen Medical Products cuts corrective labeling actions from 3 a week to 0 with TEKLYNX

Aspen Medical Products, a medical device manufacturer, faced challenges with its manual labeling process, which was prone to errors and struggled to meet global compliance standards like FDA 21 CFR Part 11. They partnered with vendor TEKLYNX to implement their TEKLYNX CENTRAL CFR enterprise label management solution to gain control, improve accuracy, and integrate labeling with their ERP system.

The solution from TEKLYNX automated data entry, centralized label management, and provided tools for regulatory compliance. The results for Aspen Medical Products were significant: they eliminated weekly corrective actions for labeling errors, reduced label approval time from weeks to nothing for global contractors, and gained the ability to seamlessly manage labels across their international operations.

Aspen Medical Products