Enterprise Labeling Helps Orthotics Maker Brace for Future

Aspen Medical Products implements a labeling system that eliminates manual entry and meets global regulatory compliance issues.

Aspen Medical Products designs, develops and markets upper and lower spinal orthotics in the healthcare industry, with its breakthrough spinal bracing designs improving patient recovery and outcomes—not just in the U.S., but around the world.

As the Irvine, CA looks ahead to future, it continuously evaluates processes and systems to ensure it can support expected growth as efficiently as possible. The company’s labeling system, however, represented one area falling short of meeting both current and future business needs.

“We had a lot of manual entry in our labeling process,” explains Aspen Medical Products Planning Manager Israel Lopez. “We were looking to implement a standalone labeling system that would eliminate manual entry and integrate with our existing IQMS ERP system.”

Aspen Medical Products sought a system that could better manage labels, not just design and print them. This was particularly important as much of its recent growth was coming from expanded distribution in international markets.

“We needed a labeling system that could handle language translation demands,” notes Lopez. The company also wanted to improve its ability to meet the vast and ever-changing medical device compliance standards, such as the FDA’s standard 21 CFR Part 11, which requires approvals via electronic signature.

Enter enterprise label management

In an effort to meet its labeling goals, Aspen Medical Products contacted supply chain automation specialist VantageID to discuss its options. In turn, VantageID partnered with Aspen Medical Product’s existing barcode software provider TEKLYNX to determine that its TEKLYNX CENTRAL CFR enterprise label management (ELM) software would position Aspen Medical Products to address its current labeling issues while meeting the following additional business needs:

• Provide support for a global, multi-user labeling environment, where 40+ different employees in locations including the U.S., China, Europe and Mexico needed to access and print desired labels.

• Serve a leanly staffed label design environment where four employees are responsible for managing labels of more than 350 different products.

• Integrate with the company’s ERP system now and into future: Aspen Medical Products wanted to implement a standalone labeling system that could not only integrate with its existing ERP, but also with a new ERP system in the future.

• Ensure that its labeling environment was equipped to manage compliance with medical device manufacturer labeling regulations such as those required by the FDA’s standard 21 CFR Part 11.

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