Menarini Group chooses Enterprise Quality Management Solution to manage quality and maintain regulatory compliance
HOLMDEL, N.J., - Sparta Systems, Inc., the maker of TrackWise(R) software and the market leader in enterprise quality and compliance management, today announced that Menarini Group, the world's leading Italian pharmaceutical group, has selected its TrackWise Enterprise Quality Management System (EQMS) to simplify quality processes throughout distributed manufacturing sites. The company will leverage TrackWise software to help achieve the harmonization of quality assurance (QA) processes and availability of critical information for organization-wide regulatory compliance.
The development and production of all pharmaceuticals requires companies to implement meticulous procedures for documentation and auditing to ensure compliance with global regulatory authorities. Often these procedures are in the form of error-prone, paper-based models, making it difficult for companies to reconcile and monitor pharmaceutical quality across more complex global supply chains. As a result, streamlining processes and reducing the cost of compliance while maintaining the highest quality standards is a top priority.
Menarini sought to replace a time-consuming, paper-based and spreadsheet model to track and manage all corporate quality assurance processes. The company selected Sparta Systems' TrackWise software to manage a multitude of QA processes, including deviations, change control, complaint handling and audits. By deploying TrackWise software, the company can harmonize quality procedures between sites, reducing the time spent validating efforts and providing greater insight across the company's global pharmaceutical manufacturing efforts.
"The implementation of TrackWise in up to 14 different plants of the Menarini Group has already resulted in higher workflow efficiency, greater quality event safety and, more strategically, a harmonization between companies throughout our organization," said Dr. Sauro Resti, corporate quality director, Menarini Group. "The system's full configurability allows us to implement in several countries simultaneously without revalidating our efforts -- ultimately, reducing the cost of our quality management and compliance efforts across the supply chain."
"In today's complex manufacturing environment, leading pharmaceutical companies like Menarini require a comprehensive view of processes across all locations to improve quality and identify trends and operational risks," said Yaniv Vardi, managing director, Sparta Systems Europe. "As the industry standard for managing quality and compliance at life sciences companies across the globe, TrackWise has helped hundreds of organizations realize the benefits of more effective quality management, resulting in greatly improved operational efficiency and significantly reduced costs."
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