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Endologix, Innovative Medical Device Firm, Chooses MasterControl Software
SALT LAKE CITY – Oct. 2, 2006 – MasterControl Inc. today announced that Endologix Inc., a developer and manufacturer of minimally invasive treatments for vascular diseases, has chosen the MasterControl™ software solution to optimize its quality management system and boost its FDA compliance efforts.
Endologix, based in Irvine, Calif., is focusing on the development and marketing of its patented technology for the treatment of abdominal aortic aneurysm (AAA), a disease that affects about 1.7 million people in the United States . The company's Powerlink® System for AAA, approved by the FDA in 2004, is an innovative, one-piece endoluminal stent graft used in treating AAA. Among Powerlink's significant advantages over stent graft alternatives is its unibody-bifurcated design, which eliminates the possibility of limb detachment and provides quick and simple delivery through a single cut down.
The company looked at 10 software solutions before choosing MasterControl. ?Functionality and price were big considerations for us. But more importantly, MasterControl's responsiveness led us to believe that even after the sale is completed, we would continue to receive the support we needed,? said Wolenchuk.
Endologix is in the process of implementing the MasterControl quality suite, consisting of MasterControl Documents™, MasterControl Forms™, and MasterControl Training™.
Under 21 CFR Part 11, FDA-regulated companies that choose to maintain electronic records to meet predicate rules are required to validate their electronic record-keeping systems. MasterControl will be helping Endologix with its validation project by providing IQ and OQ protocols and a Validation Toolkit, which includes SOPs, templates, and risk assessment forms.
"With MasterControl, we expect to streamline our quality processes, enhance efficiency, and maintain our regulatory compliance," said Wolenchuk.