Sparta Systems Announces Availability of TrackWise Digital Winter Release with IIoT Connectivity to the Shop Floor to Enable Proactive Quality December 16, 2020 The latest release includes digital innovations that enable proactive quality through IIoT manufacturing operations integration and connected risk and supplier quality management HAMILTON, NJ – DECEMBER 16, 2020 – Sparta Systems, provider of industry-leading Quality Management System (QMS) platforms TrackWise® and TrackWise Digital®, announces the availability of its TrackWise Digital Winter ‘21 Release with QualityWise.ai’s new IIoT enabled capabilities to connect operational and quality data, expanded supplier quality management and integrated risk management capabilities to drive proactive quality management. Sparta expands TrackWise Digital’s QualityWise.ai℠ capabilities to include IIoT enabled quality management in addition to its existing AI/ML capabilities to augment human decision making. QualityWise.ai connects TrackWise Digital to the shop floor through a partnership with Quartic.ai to detect anomalies in manufacturing operations, create and triage quality events to address potential issues in near real time. This reduces the cost of poor quality by preventing the distribution of products that may have resulted in a recall or patient harm. The IIoT enabled capabilities also include a contextualized product disposition workflow to review and approve batches for market release. TrackWise Digital customers can achieve faster time to market by reducing the time required to review batches while maintaining the same quality standards. “Sparta is on a mission to make proactive quality a reality for our customers,” says Dana Jones, Sparta Systems CEO. “We are at a point in history where for the first time product quality can be measured and analyzed in real time during manufacturing operations, where design researchers can connect with production and post-market risk data to make better design decisions, and where a distributed supplier network can collaborate in the same QMS.” With the IIoT connections to QMS, Sparta is bringing forward capabilities to proactively identify and manage risks during the manufacturing process. The Winter ’21 Release also includes new capabilities to address the growing use of risk management in the life sciences industry. To support this trend, TrackWise Digital’s integrated Quality and Risk Management module allows organizations to manage risks of medical products across the life sciences in accordance with ICH Q9 and ISO 14971:2019. New features include multiple risk analysis tools and heatmaps to visualize overall residual risk for better management of product quality risk. An increased reliance on external suppliers and contract manufacturers creates added supply chain complexity and risks that require closer collaboration with quality teams. TrackWise Digital’s Supplier Quality Management module introduces a new Supplier Portal to externalize quality management to the vast ecosystem of third-party collaborators and suppliers to efficiently onboard and manage distributed supply chain quality. These new capabilities help digitize interactions driving greater insights and improved quality beyond the four walls of the organization. The TrackWise Digital Winter ’21 Release and IIoT connectivity available in QualityWise.ai delivers the advanced digital capabilities required for life sciences companies to manage growing complexities in manufacturing while ensuring product quality, patient safety, and supply chain continuity. These latest innovations demonstrate how Sparta Systems is setting the standard for digital quality and moving life sciences companies closer to achieving the goal of proactive quality. Download a PDF of this Press Release About Sparta Systems Sparta’s industry-leading quality management systems bring together an organization’s quality processes in a single place, increasing efficiency and performance while helping to achieve compliance and reduce risk. Sparta is the provider of TrackWise® enterprise QMS software and TrackWise Digital®, a next-generation, cloud, and digital QMS SaaS platform. With nearly a million users in more than 30 countries, companies in life sciences and other industries rely on Sparta’s expertise and solutions to optimize quality and help them deliver safe and effective products to patients and customers. Leading companies who rely on TrackWise Digital include Alkermes, Arbor Pharmaceutical, bioMerieux, Endo Pharmaceuticals, McKesson, Pfizer, Roche Diagnostics, SGS and Thermo Fisher Scientific.