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K2M, Leading Orthopedic Medical Device Company, Goes Live with MasterControl™ Quality Management Suite
SALT LAKE CITY April 3, 2006 MasterControl Inc. today announced that K2M, a medical device company specializing in innovative spine and orthopedic technology, has gone live with MasterControl™ quality management suite as part of its FDA compliance efforts.
With more than 50 issued and pending U.S. or international patents, K2M is a rapidly expanding new player in the spine and orthopedic medical device market. Its products include the Denali? Spinal System, which offers a variety of hooks, screws, and other implants and instruments for correcting complex spinal pathologies.
K2M, based in Leesburg, Va., went live with the Web-based MasterControl quality management suite on Dec. 20, 2005. The system manages 4,000 documents. K2M users include the engineering, quality, production, marketing, sales, and customer service departments. ?MasterControl is very user-friendly. It's easy to navigate and it has a great search engine,? said Ed Crown, K2M's quality systems and regulatory affairs manager.
K2M previously managed its thousands of documents using a manual system. The company evaluated 12 software packages and providers before choosing MasterControl.
Functionality and price were among the factors that gave MasterControl the competitive edge, said Crown. But K2M was also looking specifically for a software solution that would be able to control files with multiple documents and attachments. ?MasterControl was the only software that was able to tackle this challenge,? said Crown, citing the InfoCard, the MasterControl tool that provides basic information for every record and tracks all changes made to the record. K2M can attach related documents (such as a PDF, DRW, and ASM) in every InfoCard, giving the company increased control over these documents, which would otherwise be filed separately.
Even prior to K2M's choice of MasterControl, Crown and several colleagues were familiar with the software's robust features, having used the MasterControl client/server system in their previous jobs. ?We liked it back then, but we're blown away by the Web-based version,? he added.
Using a 100 percent Web-based platform, the MasterControl quality management suite gives access to authorized users (employees, vendors, customers) from virtually anywhere. It seamlessly integrates the different quality processes critical to compliance, such as document control, CAPA, change control, training, audit, and customer complaints, for a holistic and more effective quality management.
K2M expects MasterControl to facilitate FDA compliance, promote enterprise-wide efficiency, and reduce overall compliance costs. The company is covered by stringent FDA regulations such as 21 CFR Part 820 (Quality System Regulation for medical device manufacturers) and 21 CFR Part 11 (the rule pertaining to electronic records and signatures).
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