A global medical equipment manufacturer Datex-Ohmeda needed an FDA-compliant data management system that would shorten the time to market and knit together its international engineering teams. To meet those goals, the company connected its engineering and manufacturing in Europe and U.S. with MatrixOne's eMatrix PLM system. Datex-Ohmeda eventually turned to IntegWare Inc., Ft. Collins, Colo., (integware.com) to set up PLM in the U.S.
But there was more to it than just bringing in the PLM system. For instance, it had to accommodate FDA regulations 21 CFR-820 and 21CFR-11, which govern electronic records and signatures. In addition, each site has significantly different processes and data. “If a part designed in Helsinki is to be manufactured in Colorado, every employee must have access to the same designs,” says Mary Lauristen, engineering services manager at the Datex-Ohmeda's Louisville, Colorado division. “This is now easier than it once was.”
Another problem turned out to be the number of signatures required at each site. For example, a rule at the Wisconsin facility called for many cross-functional departmental signatures based on the data and change being made. In Helsinki, however, signing responsibility rested on the team that “owned” the product.
“PLM has led to a global, team-oriented approach to design and manufacturing. IntegWare's medical focus and expertise with FDA requirements, along with eMatrix's UI software, were key to providing FDA-compliant processes and tools,” says Lauristen.
The system now gives controlled access to over 300 types of product data that were once scattered across different locations. Datex-Ohmeda says combining engineering data and processes with resource planning improves quality and time to market by eliminating manual inputs.