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News

Sparta's TrackWise software offers audit support for Plus Orthopedics

Sparta Systems : 07 May, 2007  (New Product)
Plus Orthopedics has chosen Sparta Systems' TrackWise to be its enterprise tool for internal and external audits, managing deviations, 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.

Recognising 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 to ensure compliance, increase efficiency, and reduce risk by harmonising 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 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.

'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 orthopaedic medical device manufacturer'.

Plus Orthopedics 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, .

'Companies are finding they not only improve compliance and reduce risk, but also achieve substantial cost savings and high return on investment'.
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