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What was the most significant headline in the medical device manufacturing industry in 2008 and what is likely to make a huge impact in 2009? Medical Design Technology, December 2008
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This year witnessed a revitalized awareness in the importance of quality management at global biopharmaceutical organizations. Organizations took stock of potential risk factors of insufficient quality initiatives across all departments and, consequently, enterprise-wide quality management has become a top priority for both companies and their stakeholders. BioPharm International, December 1, 2008
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Software is available to help with nearly every possible packaging project. It would be impossible to cover every software offering in one feature, but this article will highlight a few of the latest solutions. Read More... Pharmaceutical & Medical Packaging News, December 1, 2008
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The complex manufacturing processes organizations have are designed to control the working environment to ensure quality production, high productivity yield, safety, compliance, and overall efficiency. Yet, companies need to examine their global safety tracking and reporting systems frequently and make sure they are meeting current organization needs and regulatory requirements. Controlled Environments Magazine, November 2008
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Thought leaders, including Sparta Systems’ VP Research & Development, comment on how companies can continue to innovate with technology solutions despite intense regulatory scrutiny. Medical Design Technology, September 2008
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The time for implementing eMDR has arrived, and technologies available today are enabling medtech executives to plan for the regulatory future. This article explores what you need know about electronic medical device reporting and how to prepare for the pending FDA mandate. MX Magazine, July/August 2008
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This article, written by Sparta Systems’ subject matter expert, explores the challenges and impediments with establishing a culture of quality. Read more to find out what are the 10 Recommended Steps to Create a Culture of Quality. Quality Digest - August 2008
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Change control in life-sciences organizations is a critical business issue in terms of risk, safety, and performance. This article examines common shortcomings in change control when implementing non-enterprise solutions and the functionality derived from enterprise-level change control. PharmTech.com - July 9, 2008
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Sparta Systems, Inc. has announced general availability of the latest version of its TrackWise quality management software solution, featuring new enterprise-class reporting capabilities. The new features and functionality in TrackWise provide for additional efficiency and effectiveness in the management of reporting for all quality and regulatory compliance efforts across globally distributed operations. PharmaManufacturing.com - July 2, 2008
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Six Sigma projects, when managed centrally and with an enterprise process management software application, yield organizations tremendous value in a number of areas. At the top of this list are a few primary categories where this value lies. These include customer satisfaction, increased productivity and reduced costs. bpm.com - June 2008
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Of the systems available to effectively deal with contamination emergencies, CAPA management has been proven time and again as the most efficient system for preventing future occurrences with minimal drain on the time and resources that companies generally view as impediments to profitability. Clean Rooms, - May, 2008
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Sparta Systems, a vendor of enterprise quality and compliance management software, now offers its list of the top supplier-related challenges facing the manufacturing industry at the 2008. The list, compiled from conversations with Sparta Systems customers in the manufacturing, life sciences, and food & beverage industries, outlines the most significant challenges facing organizations for gauging, prioritizing, and mitigating supplier quality issues across the global organization. Manufacturing Business Technology, - May 8, 2008
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A round table discussion involving Sparta Systems, SAP, Oracle and others who discussed the software landscape for the pharmaceutical industry. The experts talk about the successes and challenges of software for enterprise and risk management, regulatory compliance, and incidence tracking. Pharmaceutical Technology, November, 2007
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Cangene gets wise to workflow optimization
Jeffrey Hartry, director of quality systems and information, explains why Winnipeg-based biotech company Cangene selected TrackWise to manage its workplace and enterprise process changes. IT Business, May 22, 2007
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Streamlining Software is on the right track
Sparta Systems and customer ImClone discuss TrackWise as the solution of choice for replacing paper-based processes and automating worfklow. The Record, April 17, 2007
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All Business Organizations Will Benefit
Sparta Systems talks with NGP Magazine about the benefits of implementing TrackWise for quality and regulatory compliance management, and reasons why the EMEA chose TrackWise as its quality system. NGP Pharma, February, 2007
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TrackWise keeps tabs on Polish pharma quality management
Spotlight on Polish pharmaceutical manufacturer Polpharma's implementation of TrackWise as its quality management and compliance system. in-Pharma Technologist.com, November 2006
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Highlights software products created to build accuracy, efficiency, speed, and cost savings into many areas of the packaging industry. Pharmaceutical & Medical Packaging News, May 2006
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Spotlight on how clinical and commercial drug manufacturer Human Genome Sciences, Inc. utilizes TrackWise to integrate and manage more than 23 cGxP quality tracking areas. Quality Digest, December 2006
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Configurable off-the-shelf software (COTS) reduces high costs attributed to customized systems. September / October 2006
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While corrective and preventive actions (CAPAs) are handled differently at many pharmaceutical manufacturers, experts agree that the best practices for handling complaints and investigations revolve around certain core activities, a basic process and, more often than not, some enabling technology. Pharmaceutical Manufacturing, July/August 2006
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A practical examination of how an integrated electronic quality management system drives efficiency by relating all quality and compliance-related events. Medical Design, May 2006
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Achieving Enterprise Quality and Compliance means Utilizing a Centralized Software Platform Pharmaceutical Formulation & Quality, 2006 Food Quality, 2006 Contamination Control, 2006
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Using a Centralized Software Solution to Manage all Quality Management Needs Next Generation Pharmaceutical, 2005
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Evolving Trends in Quality Data Management in HACCP Food Quality, Feb / March 2005
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A practical and realistic approach to achieving cGMP standards BioProcess International, 2003
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