Product Life Cycle, Registration, and Submission Tracking
Most pharmaceutical and biotechnology companies will agree that managing product registrations and submissions as well as the thousands of action items that accompany them, is a demanding task. Regulatory activities are managed across geographically dispersed operations and must correspond to specific requirements of each health authority. Companies that use home grown databases and spreadsheets to track registrations and submission activities often lose track of submission and commitment status and are often faced with having to correct inaccurate data later.
TrackWise Submission Tracking Solutions
TrackWise software enables pharmaceutical and biotechnology 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.
TrackWise's powerful workflow engine and 24/7 business rules engine streamline the submission tracking process by alerting users when work is required and enabling them to document tasks that have been completed. The system's unmatched reporting tools and built-in dashboards provide up to date status on product registrations, enabling your organization to know exactly where it stands with each submission. TrackWise also integrates with document management systems, or can provide its own document management functionality to link registration documents to related submissions.
Benefits
- Improve cycle time of approvals by ensuring accurate data and streamlined management of all registration data and submission activities
- Re-direct valuable resources to value added activities by reducing manual and administrative tasks
- Improve organization of workload assignment.
- Enhance overall collaboration between regulatory affairs and supporting departments
- Improve Product Safety Update Reporting (PSUR) with built-in, enterprise reporting tools
- Streamline regulatory affairs workflow and improve time to market by providing users with efficient tools to replace manual tracking processes
- Guarantee real-time access to registration and submission status as well as to all related work items, commitments, and tasks
- Provide secure access to source regulatory correspondence documents by integrating with a document management system
- Increase responsiveness and accuracy of registration data for all products, indications, formulations, and health authorities
