TrackWise Product Life Cycle, Registration and Submission Tracking

TrackWise by Sparta Systems enables companies to significantly reduce efforts, costs, and risks associated with the registration process by improving the management and tracking of submission activities. As a result, regulatory affairs organizations can devote more time to activities that directly contribute to the product approval process and increase their value to the organization. TrackWise improves the management of product life cycle activities for each registration, in each country, and for every dose, indication, and formulation. TrackWise is the only regulatory affairs tracking software system that can effectively manage the highly complex data relationships that are typical of registration data as well as all associated work activities.

Benefits

• Improves cycle time of approvals by ensuring accurate data and streamlined management of all registration data and submission activities
• Re-directs valuable resources to value added activities by reducing manual and administrative tasks
• Improves organization of workload assignment
• Enhances overall collaboration between regulatory affairs and supporting departments
• Improves Product Safety Update Reporting (PSUR) with built-in, enterprise reporting tools
• Streamlines regulatory affairs workflow and improve time to market by providing users with efficient tools to replace manual tracking processes
• Guarantees real-time access to registration and submission status as well as to all related work items, commitments, and tasks
• Provides secure access to source regulatory correspondence documents by integrating with a document management system
• Increases responsiveness and accuracy of registration data for all products, indications, formulations, and health authorities