Press Releases

  • Plus Orthopedics AG Selects TrackWise software as its Enterprise Quality and Compliance Management System

    Centralized Solution, Flexibility, Integration and Reputation Lead to Selection

    Holmdel, NJ - May 2, 2007 – Sparta Systems, Inc., (Sparta) the maker of TrackWise® and the market leader in enterprise quality and compliance management software, today announced that Plus Orthopedics AG, a leading global provider in the joint replacement industry, has selected TrackWise as its enterprise tool for managing deviations, internal and external audits, customer complaints, and corrective and preventive actions (CAPA).

    Medical device manufacturers are required by the Food and Drug Administrators (FDA), as well as European and other international regulators, to maintain effective systems for managing quality issues, corrective actions and documents. Recognizing it would soon outgrow its current tracking systems, which consisted of spreadsheets and isolated databases, Plus Orthopedics made a proactive decision to implement an enterprise quality management software tool that would support the organization's current and future compliance needs.

    TrackWise, a 21 CFR Part 11 compliant web-based tracking software tool, will allow Plus Orthopedics AG to ensure compliance, increase efficiency, and reduce risk by harmonizing quality management processes throughout the company. The system will enable the company to electronically record all quality issues and action items in a single, integrated system. TrackWise's built-in workflow tools, integrated reporting and trending, and automated escalation features will help Plus Orthopedics AG to eliminate errors and reduces operational costs.

    "With Sparta Systems we found a competent and reputable partner to support us in our constant improvement process," stated Daniel Kuehler, Quality Assurance Manager at Plus Orthopedics AG. "With TrackWise we will achieve higher quality, reliability, traceability, and faster processes for detecting, addressing, and mitigating our quality related issues. TrackWise supports Plus Orthopedics in achieving its commitment to be a first class orthopedic medical device manufacturer."

    Plus Orthopedics AG company cited that TrackWise's flexibility, automated workflow engine, patented business rules engine, and standard interfaces to other systems, such as its Enterprise Resource Planning (ERP) system, were the key reasons leading to its selection of the system. "From all the different candidates and their demonstrations, TrackWise received the highest ratings from our selection team," stated Daniel.

    "Medical device manufacturers have embraced TrackWise as their enterprise solution to solve many of the pressing challenges that the industry is facing," stated Sahaf Flam, Managing Director at Sparta Systems, Europe, Ltd. "Companies are finding they not only improve compliance and reduce risk, but also achieve substantial cost savings and high return on investment."

    About Plus Orthopedics AG 

    Plus Orthopedics AG was founded in 1991 as Plus Endoprothetik AG, and its development has soared ever since. The holding company (Plus Orthopedics Holding AG) now has a network of subsidiaries, marketing organizations and production facilities around the globe. The Swiss firm Plus Orthopedics AG is part of the Plus Orthopedics Holding AG with subsidiaries and a production facility in Aarau. Of the almost 800 employees of Plus Orthopedics Holding, approximately 300 work in Switzerland. For more information on Plus Orthopedics AG please contact info@plusorthopedics.com.


    About Sparta Systems

    Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Our solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment. Sparta is privately owned and headquartered in Hamilton N.J, with offices across Europe and Asia. We support close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences, consumer products, discrete manufacturing and more, rely on Sparta.

 
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