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

“Enterprise label management was hands-down the best option for Aspen Medical Products,” says TEKLYNX Channel Partner Manager Casey Sciano. “As the company continues to expand distribution internationally and face complicated regulatory compliance standards, TEKLYNX CENTRAL CFR can streamline labeling globally, simplify compliance and provide the bandwidth for future growth.”

TEKLYNX partnered closely with Aspen Medical Products throughout the implementation process to ensure all existing label templates were transitioned from its existing labeling system, TEKLYNX LABEL MATRIX, to TEKLYNX CENTRAL CFR. In addition to transitioning label templates, Aspen Medical Products relied on technical support from TEKLYNX to automate its critical “country-of-origin” designation on product labels.

Benefits of new ELM system

With its former labeling system, Aspen Medical Products relied on manual lookups and operator entry to designate the country of origin on each product label. This process was time-consuming and error-prone. With the new ELM system, Aspen developed coding, formulas and database integrations to automate country of origin on labels based on lot numbers. This new system eliminated the room for human error on a critical labeling component.

In addition to increased label automation, upgrading to TEKLYNX CENTRAL CFR meant Aspen Medical Products’ labeling system would now be integrated with its ERP system. Doing so would allow team members globally to print labels from a browser-based printing interface, a benefit that would better position Aspen Medical Products to support international growth.

“We wanted to provide global users the ability to print from a central source using standard templates housed and centrally controlled from our company’s document control department,” says Lopez. “This would give us the ability to control revisions and push changes to templates seamlessly without disruptions to global users.”

Aspen Medical Products was intent on transitioning its labeling environment from “design and print” to “label management.” Says Lopez, “With our former labeling process, we had a lot of production stoppages. Our IT labeling infrastructure simply wasn’t able to cooperate with our ERP system.”

Aspen Medical Products now has a centralized labeling process that manages labeling from start to finish. A noticeable labeling improvement resulting from the implementation is increased labeling accuracy.

With its former labeling process, the company’s production operators relied on manual entry, leaving room for labeling errors in cases where operators selected the wrong lot or item number. The company’s goal was to eliminate manual input and replace as many labeling data entry tasks as possible with barcode scanning.

“Five years ago, we averaged three corrective actions a week due to labeling errors,” notes Lopez. “Now that our operators simply have to scan barcodes, I haven’t seen a corrective labeling action all year.”

In addition to improved labeling accuracy, the company’s implementation of TEKLYNX CENTRAL CFR eliminated weeks from its label approval process when dealing with global contractors. “In the past, when our contractors in China would make a label, we would send out label copy and ask them to generate a label using their own system and send it back to us,” explains Lopez. “This back and forth label creation and approval process could take weeks.”

Aspen Medical Products can centrally control labels and make changes without disruption to print users globally, eliminating weeks from its label approval. “Our contractors simply log in to our TEKLYNX labeling system, access and print the latest version of the label without the need for back and forth approvals,” says Lopez.

Further labeling environment enhancements include the following:

• Improved ability to support its growing, global multi-user labeling environment

• Access to True Internet Printing allows users to print labels from anywhere in the world

• Ability to print labels from up to 1,000 printers provides the necessary bandwidth to support future growth

• Improved ability to comply with medical device manufacturer labeling regulations

• Aspen Medical Products now has access to a label approval module that allows for electronic approval while providing the required security and traceability in accordance with FDA 21 CFR Part 11

• Added ability to create complex, UDI-compliant barcodes, such as HIBC or GS1 Databar, to meet FDA compliance and healthcare industry standards

• The regulatory compliance software ensures that electronic signatures are linked to relevant electronic records by requiring User ID and password sign-in to perform all functions

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