Tag: Sparta Systems

Holmdel, NJ Mar 16, 2011 – Sparta Systems, Inc., the maker of TrackWise® and the market leader in enterprise quality and compliance management solutions, today announced that TrackWise Connection 2011, its European and North American user events, will take place from May 23-26, 2011, in Berlin, Germany, and Nov. 7-10, 2011, in Carlsbad, California. The conferences will bring together users of Sparta Systems’ market-leading TrackWise enterprise quality management software (EQMS) from around the globe to share best practices, network with peers and learn the latest tips for ensuring quality and compliance with TrackWise software.
For organizations in regulated industries, the need to manage product quality and maintain compliance with regulatory authorities remains a critical, ever-present necessity no matter where they are located. Best-in-class companies of all sizes have implemented Sparta Systems’ TrackWise EQMS system to harmonize a broad range of quality processes – including change control, audit management, investigations, deviations, Corrective and Preventive Actions (CAPA) and many others – while also ensuring that the data related to these events is efficiently and centrally managed for reporting to regulatory bodies. The 2011 TrackWise Connection European and North American user events will allow TrackWise software users at these companies to hear from Sparta Systems employees, industry experts and like-minded peers about the latest features, functionality and strategies that will help them better leverage their EQMS implementations.
When and where:
TrackWise Connection 2011: Fourth Annual European User Conference
May 23-26, 2011
The Westin Grand
Friedrichstrasse 158-164 – 10117 Berlin
TrackWise Connection 2011: Ninth Annual North American User Conference
Nov. 6-10, 2011
The Park Hyatt Aviara
7100 Aviara Resort Dr.
Carlsbad, CA 92011

Holmdel, NJ Feb 25, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will present at the 2nd Annual Innovations in Medical Devices conference in a session titled “Regulatory Reporting for Medical Device Companies” on Friday, Feb. 25, 2011, from 11:15 a.m.-12:15 p.m. The event, taking place in Berlin, Germany, will present attendees with proven strategies for implementing an electronic reporting platform.
As global regulations for the reporting of adverse events and incidents in medical device manufacturing become increasingly stringent, more organizations have recognized the benefits of transitioning to electronic systems to track and manage the necessary data for reporting of these incidents. While transitioning to an electronic system for device reporting provides numerous benefits, such as increased efficiencies and improved accuracy of reports, the process can appear to be a daunting and complex challenge for companies seeking to make the switch. This panel discussion will offer attendees best practices for selecting and implementing an electronic medical device reporting solution. The panel, made up of esteemed industry experts, will share experiences and advice for deploying such a solution and gives attendees a roadmap for implementing their own electronic reporting system.
WHO: Moderator:
Joe Goodman, Manager, Solutions Consulting, Sparta Systems
Participants:
Matthias Buerger, Vice President, Quality Assurance and Regulatory Affairs, EMEA, Zimmer
Ursula Morjaria, Director, Clinical Affairs, GE Healthcare
WHEN: Friday, Feb. 25, 2011, 11:15 a.m.-12:15 p.m.
“Regulatory Reporting for Medical Device Companies”
WHERE: Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany

Holmdel, NJ Feb 16, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it entered into a partnership with Synertec Asia, a multi-disciplined consulting practice providing specialist engineering and compliance services primarily to life sciences customers in Southeast Asia. Synertec Asia will provide Sparta Systems with an established, regional presence for the rapidly growing life sciences markets in Southeast Asia from offices in Singapore and Malaysia.
As a select Channel Partner in the Asia-Pacific (APAC) region, Synertec will provide full support of all TrackWise applications, benefiting existing TrackWise users with greater access to technical support from locally based experts. Life Sciences organizations looking to establish new or upgrade existing quality management systems will benefit from the ease of communication, implementation and ongoing support from a reputable, local agent.
“Our partnership with Sparta Systems further demonstrates Synertec’s long-term commitment to meeting the needs of our customers by establishing local technical expertise for deployment and support of TrackWise products,” said Nick Kotlarski, General Manager, Synertec Asia. “We are excited about the opportunity to provide Sparta Systems’ leading global quality management platform to better assure safe products from our regional manufacturers.”
“As the life sciences sector has matured in Southeast Asia, Sparta Systems has sought ways to bring greater value to its customers and greater TrackWise product availability to prospects,” said Critz Chan, Managing Director, Sparta Systems Asia. “Synertec has provided specialist life science engineering support for more than 15 years and is a recognized leader in best-in-class information management systems and key value-added services. Partnering with Synertec will help extend the power of TrackWise software throughout Southeast Asia and beyond.”
About Synertec
Synertec Asia Pte Ltd is a specialist consultancy practice focused on Southeast Asia with offices in Singapore and Kuala Lumpur. Along with Synertec in Australia, the company operates extensively within the Life Sciences sector, providing a range of engineering, validation and GMP-compliance services to companies engaged in the manufacture of therapeutic products and medical devices. Synertec was incorporated in 1996 and currently employs over 90 professionals in Singapore, Malaysia and Australia. Read more about Synertec Asia on the corporate website www.synertecasia.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 14 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.spartasystems.com.

Holmdel, NJ Jan 26, 2011 – On Jan. 4, 2011, President Obama signed into law one of the most comprehensive changes to U.S. food safety since the Food, Drug and Cosmetic Act of 1938. The Food Safety Modernization Act gives the Food and Drug Administration (FDA) and related government agencies the authority to develop and enforce more stringent standards and more severe penalties for food manufacturers not in compliance with new regulations.
Across the industry, organizations can expect the upcoming changes to food safety standards to result in more frequent on-site audits and more rigorous testing requirements for food manufacturers; expanded authority for the FDA to initiate product recalls; additional records required in safety data collection; and stronger industry-wide safety standards.
Sparta Systems’ team of quality experts advises food manufacturers to proactively evaluate their quality and compliance processes in preparation for upcoming changes. The following are best practices for ensuring the safety of products delivered to consumers and for responding to quality incidents in a timely fashion:
• Monitor critical processes, identify gaps and improve regulatory compliance with audit management. While regulatory compliance questions are being raised in light of recent food safety headlines, manufacturers should always implement proactive measures to collect data resulting from supply quality incidents, take the necessary steps to investigate these incidents and report all critical data to regulators.
• Safeguard supply quality with enterprise-wide supplier quality management tools. As food manufacturers source ingredients from more suppliers and locations around the globe, manufacturers need to identify and manage risks across the supply chain to protect both company stakeholders and, more importantly, consumers.
• Manage, track and report on nonconformances, investigations, complaints and other processes in food manufacturing operations. Food and beverage manufacturers need a holistic and centralized system in place to quickly respond to supply quality issues and limit the impact of incidents that can lead to a brand-damaging recall.
Overall, the impending changes introduced by the Food Safety Modernization Act necessitate more effective quality processes in food manufacturers’ operations. The most successful businesses will critically examine the advanced technologies available in the marketplace that can help food manufacturers go above and beyond today’s governmental guidelines and prepare for tomorrow’s regulatory changes.
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 14 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.spartasystems.com.

Holmdel, NJ Jan 25, 2011 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that it will present at the Institute of Validation Technology’s (IVT) upcoming 9th Annual Change Control Conference in a session titled, “Implementing an Enterprise-Level Change Control Solution – A Complex Process,” on Tuesday, Jan. 25, 2011, from 10:45 a.m.-12:15 p.m. Sparta will also present at IVT’s co-located Quality Risk Management Conference in a session titled “Integrating a Risk Management System with a Quality Management Solution,” on Thursday, Jan. 27, 2011, from 1:30 p.m.-3:00 p.m.
The current economic environment has forced companies to streamline their quality operations and more effectively harmonize processes across the global organization. Additionally, regulatory pressures stemming from high-profile product safety incidents have made it imperative for organizations to bolster their investments in technology as a way of minimizing risk and ensuring quality in the supply chain. As the global leader in quality management software solutions, Sparta Systems will offer attendees to these sessions proven strategies for leveraging technology to standardize change across the organization and integrating quality management and risk management solutions for a complete, enterprise-wide approach to these mission-critical functions.
WHO: Tim Mohn, Industry Principal for Sparta Systems and former Manager, Worldwide Quality Systems for Johnson & Johnson Ortho-Clinical Diagnostics
WHEN: “Implementing an Enterprise-Level Change Control Solution – A Complex Process” Tuesday, Jan. 25, 2011, 10:45 a.m.-12:15 p.m.
“Integrating a Risk Management System with a Quality Management Solution”
Thursday, Jan. 27, 2011, 1:30 p.m.-3:00 p.m.
WHERE: Sir Francis Drake Hotel
450 Powell Street
San Francisco, CA 94102

Holmdel, NJ Dec 16, 2010 – Sparta Systems, Inc., the maker of TrackWise quality management software and the market leader in enterprise quality and compliance management solutions, today announced that Coloplast, the leading global supplier of intimate healthcare products, has selected Sparta’s TrackWise Enterprise Quality Management Software (EQMS) to replace its customer complaint handling system.
Coloplast’s decision to phase out its existing Lotus Notes-based system was made following an extensive review of the needs of the business by a joint team from Coloplast and Sparta Systems. Additionally, Coloplast conducted an extensive review of the complaint handling products and solutions being used by leading medical equipment manufactures and life sciences companies, determining that the TrackWise solution possessed the industry-wide reputation for ease-of-use, configurability and ability to integrate with existing applications that would meet and exceed Coloplast’s demanding requirements.
“TrackWise software appears to be very straightforward to use,” said Per Larsen, IT project manager at Coloplast.” There should be a minimal learning curve for our complaints management teams and, therefore, we expect the resulting increase in efficiency to be immediate. The software platform is also extremely flexible and will integrate easily into our existing network and applications set-up.”
Coloplast will transfer its existing complaint management process to the TrackWise platform. Once fully deployed, almost 300 of the company’s customer care consultants will rely on the TrackWise solution for the logging and resolution of user complaints. The second stage will be to move validation documentation management and all controlled workflows into the TrackWise EQMS.
“At Coloplast we have a strong track record within quality and complaint handling, but we want to be even better,” said Larsen. “Efficient complaint management is a must-have. If a manufacturer is not able to show the handling of complaints properly it could lose its license to operate. The management, handling and rectification of a complaint is the first port of call for an auditor.”
Moving forward, Coloplast plans to migrate all of its quality management processes into the TrackWise platform, linking the company’s 30-office network to a centralized quality management software platform. Once completed, it is expected that TrackWise software will be used to monitor the quality management of all processes along the supply chain, from supplier contracts through to change management.
“Every department within Coloplast is audited at least once a year by an external party, more so if there is a quality complaint made,” said Yaniv Vardi, managing director, Sparta Systems Europe. “This is a major administrative task and one that leaves no margin for error. TrackWise software makes the compilation of the customer complaint reports simple, ensuring that all the required data is logged and reported when the auditors come calling.”
For more information, visit www.spartasystems.com.
About Coloplast
Coloplast develops products and services that make life easier for people with very personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this intimate healthcare. Our business includes ostomy care, urology and continence care and wound and skin care. We operate globally and employ more than 7,000 people.
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 14 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.spartasystems.com.

Holmdel, NJ Dec 1, 2010 – Sparta Systems, Inc., the maker of TrackWise® quality management software and the market leader in enterprise quality and compliance management solutions, today announced that Jason Reynolds, a 20-year software and life science industry veteran, has been named vice president of North American sales. In this role, Reynolds will oversee all of Sparta Systems’ sales activities across the region, helping global organizations leverage the company’s market-leading TrackWise enterprise quality management solution (EQMS) to improve their quality and compliance initiatives.
Prior to joining Sparta, Reynolds served as vice president of North American sales at Phase Forward, a provider of integrated data management solutions for clinical trials and drug safety, where he successfully contributed to the company’s growth and completion of its initial public offering in 2004. Before this, he served in multiple sales positions at Interneuron Pharmaceuticals and G.D. Searle & Company, where he continually exceeded company sales goals. He received a bachelor’s degree from Fairfield University.
“Jason possesses exactly the right combination of sales and industry expertise to guide our North American sales efforts,” said James E. McGowan, CEO, Sparta Systems. “His unique experience in both the life sciences and software industries will prove to be invaluable as we extend Sparta’s leadership in providing unparalleled quality and compliance management solutions to organizations in highly regulated industries. “
“I’m excited to join a company that has an impressive history of delivering innovative, market-leading solutions,” said Reynolds. “Sparta Systems is well positioned to address the growing quality and compliance needs that organizations in highly regulated industries face, and I look forward to working with the team to continue the company’s strong momentum.”

Holmdel, NJ Sep 29, 2010 – Sparta Systems, Inc., the maker of TrackWise quality management software and the market leader in enterprise quality and compliance management solutions, today announced that Qualitest Pharmaceuticals, a top-six provider of high-quality generic pharmaceuticals, has selected TrackWise® software to streamline multiple quality and compliance processes.
As the manufacturer of more than 600 high-quality generic pharmaceutical products, Qualitest’s mission includes operating current Good Manufacturing Practices/Quality at and above industry best practices. Qualitest management faced the challenge of maintaining its stringent quality requirements while enhancing efficiency to support business growth, and reducing the costs associated with its existing, resource-intensive processes. The company identified a need for a software solution that would automate these processes, lower costs and bolster efficiencies across the enterprise.
“The generics market is extremely competitive,” said Marvin Samson, Chairman and CEO at Qualitest. “Like many companies, we were adding headcount to address the increasing workload. The EQMS project was one of several initiatives in place aimed at lowering costs, preserving margins and maintaining our competitive advantage.”
After a thorough evaluation of multiple quality management solutions, Qualitest chose a phased implementation of TrackWise software for its ability to deliver a flexible, low-risk solution to manage a wide range of quality processes, and its scalability to meet the company’s future growth. Qualitest will first deploy Sparta’s quality management software to address customer complaints, investigations, deviations, corrective and preventive actions (CAPAs) and change control, and then will implement TrackWise software as a complete document management solution for the entire organization’s document repository and for training management.
“We chose TrackWise software not only because its technology offers the best possible solution for meeting our quality and compliance needs, but also because of Sparta’s reputation as a strategic partner for its customers,” said Goff Baker, Vice President of Quality at Qualitest. “Sparta’s experts demonstrated that they understood the intricacies of our business and could provide a solution to meet the complex challenges we face. The Sparta team helped us build a business case by assessing potential cost avoidances using industry benchmarks. We anticipate the efficiency improvements and cost avoidance measures resulting from our TrackWise implementation to exceed millions of dollars over a 5-year period.”
“Generic pharmaceutical manufacturers operating in today’s marketplace require technology solutions that not only address their quality and compliance requirements, but also add efficiency to their operation,” said Mike Jovanis, Vice President of Product Management for Sparta Systems. “Qualitest proactively identified an opportunity to automate critical processes that will result in tangible business gains. We look forward to a long and mutually beneficial partnership with the company in the years to come.”
Click here to read more about the extensive benefits of TrackWise enterprise quality management software for global pharmaceutical manufacturers.
About Qualitest
Founded in 1983, Qualitest has dedicated itself to being a preferred provider of high-quality, affordable generic pharmaceuticals. In addition to corporate headquarters and distribution facilities in Huntsville, Alabama, Qualitest operates multiple manufacturing facilities in Huntsville, Alabama and Charlotte, North Carolina providing a portfolio exceeding 600 products that is supported by a workforce of 1,200 dedicated employees. Qualitest is ranked in the top 6 for generic manufacturers in the U.S. As of November 2007, funds advised by Apax Partners Worldwide LLP, a leading global private equity firm, acquired Qualitest Pharmaceuticals.
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 14 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.spartasystems.com.

Holmdel, NJ Aug 11, 2010 – Sparta Systems, Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, today announced the general availability of TrackWise SelectStart, a packaged solution designed for small- and medium-sized businesses (SMBs) seeking to rapidly deploy a quality management system. With TrackWise SelectStart software, growing life science organizations now possess a complete solution for efficiently and effectively managing complex quality and compliance processes.
In a climate of stringent regulatory requirements and increasingly constrained budgets, SMBs in the life sciences industry must meet quality and compliance demands with limited resources. TrackWise SelectStart offers a total solution for quality systems workflows based on industry best practices, a comprehensive validation package including full performance qualification, and a documented, industry-tested deployment plan to allow for a rapid, cost-effective implementation.
Using SelectStart, companies can deploy any number of the following processes in either a phased approach or as a holistic quality management system:
• Deviation handling
• Complaint management
• Internal and external audit management
• Fully integrated CAPA with effectiveness analysis
• Change management
• Document management
• Employee training and qualification
Furthermore, SMBs can achieve the following benefits from automating and managing their quality processes with SelectStart’s out-of-the-box solution:
• Meet stringent compliance mandates through a closed-loop automated system
• Reduce analysis and definition cycles through out-of-the-box deployment approach requirements
• Minimize validation costs and timelines through configuration with vendor-provided validation documentation that can be either adopted as-is or executed at the client’s site
• Leverage a broad range of industry best practices from trending and summary reports, allowing for proactive monitoring
SelectStart provides the scalability to meet enterprise growth, with the ability to add and expand processes and give companies the flexibility to evolve as their organizational quality requirements become more complex and demanding.
“Emerging SMBs face the same regulatory compliance challenges as large companies – but without the same financial resources or staff,” said Mike Jovanis, vice president, product management, Sparta Systems. “TrackWise SelectStart addresses the needs of these SMBs by giving them an easily deployable and total solution to support a culture of quality, backed by enterprise level services, support and product teams.”

Holmdel, NJ Jun 9, 2010 – Sparta Systems., Inc., the maker of TrackWise® software and the market leader in enterprise quality and compliance management solutions, today announced the general availability of Version 8 of its TrackWise enterprise quality management solution (EQMS). Already featuring the highest level of configurability of any EQMS, TrackWise 8 provides new capabilities that will enable the rapid, parallel deployment of business processes in enterprise environments as well as increase usability for the infrequent user.
Highly regulated companies are under increased pressure to accomplish more with less, while maintaining control of their processes and products. Sparta Systems’ TrackWise EQMS now offers customers an accelerated deployment capability, enabling multiple groups to simultaneously configure and deploy processes with minimal impact on one another. The added flexibility in TrackWise software will also allow companies to perform a wide variety of maintenance activities independent of new project development. This furthers companies’ ability to continue to adapt existing processes to meet changing business requirements and regulations while independently continuing the rapid build-out of new business processes.
As quality systems have become broadly proliferated enterprise systems, the number of infrequent users of these applications has gradually increased over time. This makes a clear and concise user experience even more important so the broad user base can perform their job functions efficiently and effectively. With that need in mind, TrackWise software now includes a revised form layout with new workflow visualization functionality that graphically displays where users are in the workflow, how they got there, and what they can do next.
“At Sparta Systems, we are constantly investing our resources in making TrackWise software the most complete EQMS solution available; for both new and existing customers,” said Mike Jovanis, vice president, product management, Sparta Systems. “The new enterprise-class capabilities in TrackWise 8 take an already-powerful migration platform and add a greater level of agility and concurrency to system expansion and maintenance, while our workflow visualization is aimed towards helping infrequent users work in a self-guided fashion. We will continue to partner with our customers to identify and develop new functionality and usability enhancements aligned with the needs of businesses.”