Aspen Medical Products is a spinal orthotics manufacturer that provides spinal bracing designs to improve patient recovery and outcomes. Although the company has grown each year, the majority of its recent growth has come from international markets, a factor that led the company to take a closer look at its labeling processes and systems.
To date, the medical device manufacturer had relied on manual entry throughout its labeling process, but the company was looking to implement a labeling system that could better manage labels, not just design and print them. This was particularly important as the company sought to handle labeling language translation demands, along with its need to comply with vast and ever-changing medical device compliance standards such as the FDA’s standard 21 CFR Part 11, which requires approvals via electronic signature.
The company implemented an enterprise-level barcode software solution that could integrate with its existing ERP system. This allowed it to centrally control labels while giving employees and authorized contractors around the world the ability to access and print required labels using a browser-based printing interface.
The barcode software implementation eliminated weeks from the company’s label approval process with global contractors. In the past, the company’s contractors in China would make a label, Aspen Medical would send out a copy, ask the contractor to generate a label using their own system and then send it back to the company. This back and forth label creation and approval process could take weeks.
Aspen Medical wanted to provide global users the ability to print from a central source using standard templates housed and centrally controlled from its document control department. Using its newly implemented enterprise-level barcode software solution, the company can centrally control labels and make changes without disruption to global print users. Its contractors simply log in to their labeling system, access and print the latest version of the label without the need for back and forth approvals.
The platform’s label design software also helped the company to comply with increasingly complex medical device manufacturing regulations, and provided 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.
The software also ensures that electronic signatures are linked to relevant electronic records by requiring User ID and password sign-in to perform all functions. The label design module provides the ability to create complex, UDI-compliant barcodes, such as HIBC or GS1 Databar, to meet other FDA compliance and healthcare industry standards.
The barcode software implementation also improved labeling accuracy. With its former labeling system, Aspen Medical Products had to rely on manual lookups and operator entry to designate “country of origin” on each product label. This process was time consuming and error prone. With its newly implemented enterprise-level barcode software solution, formulas and database integrations automate “country of origin” on labels based on lot numbers. This new system eliminates the room for human error on a very critical labeling component.
Yet another 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, the company averaged three corrective actions a week due to labeling errors. Now that its operators simply have to scan barcodes, the company has not seen a corrective labeling action all year.
With its newly implemented enterprise-level barcode labeling solution, Aspen Medical Products is equipped to meet its current labeling challenges and is prepared for growth because the software is designed to scale-up as the company grows. This positions the company to label better and expand rapidly into new markets so they can impact more patients in need.