Sparta Systems. Proven Enterprise Quality Management Solutions

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1 Sparta Systems Proven Enterprise Quality Management Solutions

2 Sparta Systems global enterprise quality management solutions (EQMS) enable high-value organizations to safely and efficiently deliver products and services to market. Our TrackWise enterprise quality management software, a trusted standard across a wide range of industries, is used to reduce risk, improve safety and help ensure operational excellence across the global enterprise. For nearly 20 years Sparta Systems has been providing companies with a complete technology platform that manages quality-related risk across their enterprise and their critical supplier networks. TRUST SAFETY EFFICIENCY Using TrackWise, organizations have complete transparency and accountability for the critical processes that govern the creation, compliance, manufacturing and delivery of products and services to market. We protect our clients customers lives and world, shareholder value and reputations by providing a solution that safeguards their critical processes. By identifying and preventing mistakes before they happen, TrackWise streamlines processes throughout the product life cycle, reducing waste, reducing costs and providing the insights and opportunity to create new revenue.

3 Reduced risk. Improved safety. Efficient compliance. Complete Technology Solutions for Enterprise Quality Management Today s manufacturers are facing a multitude of escalating challenges: mounting regulatory oversight, increased public scrutiny, lengthening supply chains, growing business process complexity and increased pressures on the bottom line. Sparta Systems proven software solution helps organizations across a variety of industries manage complicated business processes throughout the product lifecycle from supply chain management manufacturing to customer service while mitigating risk, controlling costs and gaining greater efficiency. In a highly complex and challenging business environment, the task of managing quality, compliance and regulatory issues can be daunting. Sparta Systems products provide powerful visibility and traceability across the broad range of a company s quality and regulatory management activities. Our software enables corporations to identify, define, manage, track and report on critical business processes such as deviations, audits, change control, complaint tracking and supply chain management. Our team of quality and business process experts is completely committed to your success. We will collaborate with you to address all aspects of system implementation and maintenance, including business requirements analysis, configuration, prototyping, testing, validation, training, go-live and ongoing support. And as your needs change, we will be there with you to ensure that your system continues to deliver exceptional value over time. That s one of the many reasons why companies stick with TrackWise over the years, extending it to support many different processes long after their initial investment has been amortized. One Solution for All of Your Company s Quality, Compliance & Regulatory Needs The company s flagship product is TrackWise enterprise quality management software - used by quality, manufacturing and regulatory affairs professionals to manage quality control and compliance issues across the enterprise. It is the only enterprise quality management solution that can be conveniently and flexibly scaled to your company s unique business needs and processes, whether you re part of a small- or medium-size company or a multibillion-dollar enterprise. Using TrackWise, organizations can achieve peace of mind in ensuring they have the process management controls to proactively protect their company brand while also being prepared to handle possible issues as they arise. TrackWise has been designed with flexibility in mind. Our software uses a centralized database structure that can hold any number of record types, giving you the ability to manage and track just about any business process. TrackWise integrates with leading ERP solutions and legacy systems easily and efficiently, minimizing the need for investment in additional resources. Sparta Systems offers solutions that minimize risk and provide ROI for customers with an enterprise system flexible enough to manage any business critical process and scalable enough to support thousands of users around the globe.

4 A Heritage of Quality Founded in 1994, Sparta Systems has an extensive track record of helping companies both large and small manage their quality, compliance and regulatory needs. With hundreds of thousands of satisfied TrackWise users, our unrivaled expertise can help you get the most from your investment in an enterprise quality management solution. Maximize Control, Minimize Risk, Improve Quality Improved accountability, control and transparency Consistency across business units and sites Centralized reporting and trending Greater visibility into operational and compliance risks Faster resolution and closure of quality issues Faster time to market Operational excellence Brand and reputation protection Minimized exposure to regulatory penalties TrackWise provides our organization with a compliant and effective tool to interrelate our quality systems. The ability to quickly configure workflows and reports to meet new requirements has drastically increased our agility as a competitive, quality-driven biopharmaceutical organization. Human Genome Sciences The EMA evaluated more than 25 vendors before selecting TrackWise as its quality management and tracking system. Ease of configuration and the ability to integrate with existing software were key factors in our decision. European Medicines Agency Improving the Cost of Poor Quality Cost of Poor Quality Continuous Improvement Operational Efficiency Risk Mitigation

5 Sparta Systems by Industry Pharmaceutical & Biotechnology Sparta Systems is the leading provider of enterprise quality management solutions to global organizations in the pharmaceutical and biotechnology sectors. Providing centralized and consolidated tracking, workflow management and regulatory reporting for all critical business processes that affect global pharmaceutical and biotechnology manufacturing operations, TrackWise software is used by 30 of the top 30 pharmaceutical and biotechnology companies. Medical Device Sparta Systems helps medical device manufacturers mitigate risks while reducing costs associated with the production, sales and service of medical devices and diagnostic products. TrackWise enables medical device companies to manage strategic partnerships across the value chain with a closed-loop quality system, consistent with industry best practices. Leading device manufacturers worldwide rely on TrackWise software to manage, track and report on incidents, to help ensure compliance with regulatory requirements, to manage the supply chain and to reduce cycle time and decrease time to market. Contract Research Organizations Contract research organizations (CROs) conduct simultaneous trials in multiple countries under the supervision of varied regulatory governances, and a growing number are turning to TrackWise by Sparta Systems for assistance with quality assurance and compliance. Increasingly stringent regulatory requirements, good clinical practice (GCP) and good laboratory practice (GLP) standards have heightened the need for a sound approach to quality, regulatory and compliance management. TrackWise delivers an end to end solution to track and manage all quality events and processes from pre-clinical, clinical and postmarket activities. Consumer Products Increased public and media scrutiny alongside a rapidly growing diverse supply chain has created a greater demand for operational excellence and risk mitigation with consumer product manufacturers. Food and beverage (F&B), consumer packaged goods (CPG) and tobacco manufacturers all face similar issues with managing compliance, quality, low operating margins, traceability, risk, changing demand, and supply-chain visibility. While they seek new and better ways to improve time to market, these companies must have effective systems and controls in place to guarantee product safety and quality. Electronics Manufacturing Sparta Systems solutions enable companies to effectively administer quality management processes to ensure the highest quality standards across the enterprise and with suppliers. The software helps companies avoid costly recalls which can damage brand reputation by providing centralized and consolidated tracking, workflow management and reporting for all critical business processes significantly increasing operational efficiencies. TrackWise s comprehensive platform helps support a quality-driven business culture for all relevant processes, including FRACAS, customer complaints management, audit management and supplier quality management which are integrated seamlessly with existing enterprise pillar applications. Other Industries TrackWise helps streamline processes and improve operational efficiencies, supporting quality and compliance activities across a wide range of industries, including oil and gas, energy, utilities, blood services and more. Companies are seeking greater visibility into and control over their business processes, moving from labor-intensive manual processes to systems that are more scalable and transparent. From procurement and processing to fielding and remediating customer complaints, TrackWise can help companies conduct their business operations more efficiently and effectively.

6 Total Commitment to Your Success Sparta Systems is more than a software vendor. We are enterprise quality management experts. And we will partner with you to implement a robust, scalable, and effective quality and compliance management system that will meet all the current needs of your business and grow with you as your business needs evolve. Sparta Systems professional services organization is committed to delivering the highest level of customer service and support throughout your entire engagement with us. During the implementation, expansion or upgrade process, we offer best practices and expert guidance that will save your company valuable time, reduce project costs and result in a superior outcome. We can implement both highly tailored solutions and out-of-the-box systems scaled to meet the needs and the budget constraints of any organization. As we move through the steps of the process, we facilitate decision-making, guide your project team and call attention to potential pitfalls so you can avoid costly mistakes. Ultimately, we streamline the implementation, expansion or upgrade process to make sure your project is delivered on schedule, within budget and according to specifications. We continue our support through an extensive training and education program that empowers your installation team members and support personnel. The TrackWise Education Program is comprised of multiple courses, delivering world-class training and knowledge of the TrackWise suite of applications, enabling attendees to maximize your company s return on investment. It was apparent from our research in the quality management solution market that TrackWise was the most widely accepted and successfully used solution by the regulated industries. Hitachi Engineering, Sparta Systems Partner TrackWise gives us the control to structure and configure quality processes in prioritized, enforceable ways to drive focus toward the most important issues. Bristol-Myers Squibb

7 Companies are waking up not just at an operations level but in the boardroom to the fact that quality can either really cripple your brand or enhance it, and are looking actively to design it into the enterprise as a core competence. Simon F. Jacobson, Research Director, Gartner, Inc.,

8 Trust. Safety. Efficiency Sparta Systems has been delivering powerful enterprise quality management solutions to high-value organizations for nearly two decades. Our track record of product excellence, superior customer service and continued innovation has led to enduring partnerships with some of the world s most respected brands. TrackWise by Sparta Systems empowers these organizations to improve quality and productivity, reduce costs, and identify operational and compliance risks by managing the full product lifecycle, both within their own organizations and throughout their entire supply chains. Whatever your operational needs may be, Sparta Systems can help. Contact us today. Sparta Systems global quality management solutions enable high-value organizations to safely and efficiently deliver products and services to market. Its TrackWise Enterprise Quality Management Software, a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing and consumer products markets. Global Headquarters 2000 Waterview Drive Hamilton, NJ (888) (609) European Offices Berlin London Tel Aviv Vienna Asia Pacific Offices Hong Kong

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