SUPPORTING NEW SYSTEMS AND 3RD PARTY LABELING WITH SEAMLESS INTEGRATION
COMPANY OVERVIEW
A multinational medical device company producing surgical devices for more than 100 years. Their surgical technology and solutions have revolutionized surgery with minimally invasive procedures. For more than 15 years Pragmatyxs has been a trusted advisor and has continued to provide full range support of their labeling solutions.
THE CHALLENGE
- Ensuring the company’s labeling solution integrated seamlessly with a new ERP (SAP) and Quality system.
- Maintaining design and content control while extending print functionality to a 3rd party contract manufacturer. They needed to accomplish this while adhering to all Medical Device Regulations (MDR) and complying with the FDA’s Unique Device Identifier (UDI) regulations for labeling.
PRAGMATYXS’ SOLUTION
An efficient, reliable, and scalable solution was designed and implemented to make critical production order information such as lot numbers, product descriptions, manufacture, and expiration dates available for label printing. This solution ensured data efficiently and accurately flowed between ERP, Quality, and Labeling systems. While the manufacturing would be managed by a 3rd party, the product owner needed to maintain control of the product label data and design. In the new system, label printing is initiated through the system remotely by the 3rd party manufacturer to their local printers. The labeling system is an off-the-shelf solution combined with Pragmatyxs’ tailored extensions, which are fully supported by a “Pragmatyxs Critical Care plan”. By splitting data and design control from print execution, Pragmatyxs was able to assist the customer in delivering an efficient and high-performing solution while ensuring compliance with all quality and regulatory requirements.
The labeling system is an off-the-shelf solution combined with Pragmatyxs’ tailored extensions, which are fully supported by a “Pragmatyxs Critical Care plan”.
THE RESULTS
Strong system integration and stringent labeling controls were non-negotiables for our customer. The medical device industry continues to face recalls that are time-consuming and costly. Mislabeling is a primary driver. This project provided the company with the ability to:
- Ensure accurate and consistent product labels
- Adhere to strict labeling compliance regulations
- Quickly react to labeling changes, decreasing cost, time to market, and avoiding recalls due to labeling defects
- Ability to remotely print new product label revisions on-demand immediately after change
- Expertise to support 3rd party manufacturing within the current infrastructure, data, and designs