Seeking a cure

Several years back, Irving, Calif.-based Aspen Medical Products, a maker of upper and lower spinal orthotics, faced a labeling challenge. The company had expanded its distribution in international markets and was anticipating further growth overseas. But it was clear that it would need to re-evaluate some aspects of its operations to ensure they could support that growth.

One of those was its product labeling process. Aspen's existing procedure was heavily reliant on manual data entry, which was both slow and prone to error. The company needed something faster and more automated—basically, a system that could better manage labels, not just design and print them.

As for what it wanted in a new system, Aspen Medical had a number of items on its list. For instance, it wanted a standalone system that would integrate with its existing enterprise resource planning (ERP) software. It also wanted a solution that could improve its ability to meet the vast and ever-changing medical device manufacturer labeling regulations. And it was looking for something that could scale up as the company grew.

For help selecting the right system, Aspen turned to supply chain automation specialist VantageID. VantageID, in turn, teamed up with Aspen's existing labeling-system provider, Teklynx International, to find the right enterprise label management solution.

The solution the partners eventually chose is Teklynx Central CFR, a browser-based integrated label management system that combines label design, printing, and tracking capabilities into a single regulatory solution. As far as Aspen's requirements were concerned, the product checked all the boxes: It could be integrated with Aspen's ERP as well as any ERP system the company might transition to in the future. It's specifically designed to meet regulatory standards, such as the Food and Drug Administration's (FDA) standard 21 CFR Part 11. And perhaps most importantly of all, the system replaced the time-consuming manual label data entry process with bar-code scanning.

GOING GLOBAL

During the implementation process, Teklynx worked closely with Aspen to transition the medical device company's label templates from its old Teklynx Label Matrix system to the new Central CFR software. It also provided technical support where needed. For example, the Teklynx integration team developed coding, formulas, and database integrations that automated the "country of origin" designation on product labels. With its former labeling system, Aspen had to rely on manual lookups and operator entry to designate the country of origin on each product label, a time-consuming and error-prone process. The new system automatically designates the country of origin based on lot number, eliminating the risk of human error on this critical labeling component.

Today, with the Teklynx Central CFR system in place, labels are made using standard templates that are centrally housed and managed by Aspen's document-control department. Aspen team members anywhere in the world can print them from a browser-based printing interface.

Among other advantages, the new system shaved weeks off Aspen Medical's 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 then send it back to us," said Israel Lopez, planning manager for Aspen Medical Products, in a case study published on Teklynx's website. "This back-and-forth label-creation and -approval process could take weeks."

In addition to the time savings, the new system has brought about a noticeable improvement in labeling accuracy, according to Aspen Medical executives. Under the former process, it was all too easy for production operators to select the wrong lot or item number. Replacing manual entry with bar-code scanning has eliminated that risk. "Five years ago, we averaged?three corrective actions a week due to labeling errors," Lopez noted in the case study. "Now that our operators simply have to scan bar codes, I haven't seen a corrective labeling action all year."

GOOD PROGNOSIS

As a result of the implementation, Aspen now enjoys a centralized label system that seamlessly manages labels globally. The automated process has improved labeling accuracy, while the regulatory compliance software has enhanced its ability to comply with labeling regulations.

To top it all off, Aspen is now prepared for future growth. "As the company continues to expand distribution internationally and to face complicated regulatory compliance standards, Teklynx Central CFR can streamline labeling globally, simplify compliance, and provide the bandwidth for future growth," said Casey Sciano, Teklynx's channel partner manager, in the case study.