“Enhancing quality management processes with human-driven instruction support reduces complexity, increases operational efficiency and supports compliance.”
The pharmaceutical and biotechnology industries face complex challenges resulting from regulatory scrutiny, mergers and acquisitions, patent expirations, and a myriad of cost-cutting requirements. Companies in these industries require robust information and quality management systems to stay competitive and foster growth in the highly volatile global marketplace.
Sparta’s TrackWise Digital, a pharmaceutical Quality Management Software, supports centralized and consolidated tracking, workflow management, and regulatory reporting for all critical business processes affecting pharma and biotech manufacturing operations across the globe. It leverages best practices from hundreds of pharma and biotech companies that enable your company to comply with 21 CFR Part 11, GMP, GLP, GCP, and other industry standards.
TrackWise Digital, a Sparta Systems solution, is the first 100% cloud-offered electronic Quality Management System (eQMS) available in the market. The software is available on a subscription basis and includes a full Quality, Complaints, Training Management and Document Management solutions. The system is 21 CFR Part 11 compliant (Including 820, 821, 210, and 211) and is offered on the state-of-the-art Salesforce.com platform delivered as an on-line web application, fully mobile and have offline capabilities. [ width=”1/2″ css=”._1550727596283{margin-left: 0px !important;border-left-width: 0px !important;padding-left: 0px !important;}”]
TrackWise Digital is the only solution to combine instant, out-of-the-box compliance with the ease and cost-effectiveness of the cloud. Dana Jones is Chief Executive Officer and a member of the board of directors for Sparta Systems. “Enhancing quality management processes with human-driven instruction support reduces complexity, increases operational efficiency and supports compliance. This helps our clients reduce human error and foster a ‘right-first-time’ culture of quality,” says Dana.
Being able to support a wide range of business functions—including sales, customer service/call center, and compliance—on a single, integrated platform is enabling life-science organizations to minimize costs and maximize visibility and control to a degree that is simply not possible with a traditional, in-house software model.
For example, a recent evaluation by CapGemini of the Sparta Systems solution TrackWise Digital, a cloud-based compliance system built on the Salesforce.com platform, demonstrated a significant advantage in terms of up-front and long-term costs, integration, configuration, and a number of other key business requirements. Over the course of five years, the total cost of ownership for compliance software was projected to be more than a third lower for a cloud-based solution.
Better data, deeper insights. When different business processes can’t “talk” to one another by exchanging and aggregating data freely, an organization can only see a piece of the puzzle rather than the whole picture. A cloud ecosystem creates opportunities for game-changing analytics and insights. The true value of cloud computing for life sciences organizations is its ability to support innovation. By providing an environment that is integrated, compatible, and scalable, the cloud removes boundaries and restrictions in key areas such as relationship-building, collaboration, business-process integration, agility, and data access. And because of its multi-platform structure, it delivers these capabilities at a price that’s affordable for organizations of any size.
Siegfried Group is a global life sciences company, headquartered in Switzerland implemented Sparta Systems TrackWise as its QMS system across its global organization. Siegfried is using the TrackWise QMS system to standardize data processes and enable consistent reporting across the entire organization. TrackWise is used to manage deviations, complaints, audits, Change control, CAPA for operations, research and development, project management, quality control and other critical functions of the organization. Siegfried was able to implement TrackWise QMS rapidly with minimal disruption to the business. The company followed a well-defined methodology for implementation, phased through multiple pilots, enabling a smooth, on-time rollout of TrackWise. The software is currently being used by more than 700 Siegfried employees.
