Mentor Corporation Begins Implementation of TrackWise as its Enterprise Quality Management System
Holmdel, NJ - February 1, 2007 – Sparta Systems, Inc., (Sparta), the maker of TrackWise®, and the market leader in enterprise quality and compliance process management software, today announced that Mentor Corporation (Mentor), a leading supplier of medical products for the global aesthetic market, has recently begun implementation of TrackWise as its enterprise tool for complaint management and related corrective and preventive actions (CAPA).
TrackWise is a 21 CFR Part 11 compliant, web-based tracking software tool used by medical device and other companies to electronically manage, track, and trending quality and regulatory issues and action items across the enterprise. TrackWise offers web-based, centralized process management that enforces workflow, improves productivity and ensures compliance.
Mentor conducted a thorough evaluation process prior to selecting TrackWise. The company cited vendor experience, flexibility, overall functionality, and ease of use as key decision factors. A company representative stated that "Sparta Systems clearly demonstrated its broad experience in providing quality management tracking solutions for the medical device industry."
Mentor is deploying TrackWise using a phased approach, initially implementing the system to manage customer complaint handling and medical device reporting (MDR). MDR is the regulated method for manufacturers to report medical device adverse events to the Food and Drug Administration (FDA). Mentor also will be implementing TrackWise for Corrective Action and Preventive Action (CAPA) tracking and Supplier Quality Management functions in subsequent phases.
"As a single, integrated system, TrackWise provides Mentor greater visibility of quality trends, improved accuracy, and greater efficiency to drive continuous improvement," stated Ran J. Flam, President and CEO of Sparta Systems, Inc. "The ability to manage all of our quality management processes also reduces implementation time and on-going maintenance costs."
"It is well known that that FDA is requiring all companies to implement better systems surrounding complaints and medical device reporting. Further, the expectation is that companies integrate these systems into the larger overall quality management system to ensure a closed-loop process. Mentor is taking a proactive approach by implementing a best-in-class system, which was built around this philosophy," stated Bryan Koslow VP, Sales, Sparta Systems.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve personal well-being. More information about Mentor Corporation can be found at www.mentorcorp.com.
About Sparta Systems
Sparta Systems, Inc. is the industry leader for global quality and compliance management systems. Its TrackWise product is a web-based software application used by quality, manufacturing, and regulatory affairs professionals to manage quality and compliance issues across the enterprise. The company has more than 12 years of experience and an extensive customer base in the life sciences and other highly regulated industries. Sparta Systems offers its customers a complete solution for global quality management needs, including the onsite support required throughout the project lifecycle. More information about Sparta Systems and TrackWise® can be found at www.sparta-systems.com.
Media Contact: Jon RabinowitzDirector of Marketing
Sparta Systems, Inc.
Phone: (732) 203-0400 x121
Email: jon.rabinowitz@sparta-systems.com
Sparta Systems Inc. and the Sparta Systems, Inc. logo, TrackWise and the TrackWise logo are trademarks or registered trademarks of Sparta Systems, Inc.
All other company and product names are used for identification purposes only and may be trademarks of their respective owners. Sparta Systems, Inc. cannot guarantee completion of any of the aforementioned products or product features, and no reliance should be placed on their availability. Sparta Systems does not undertake an obligation to update the forward-looking information contained herein.
