Regulatory Affairs

Regulatory Affairs departments are responsible for capturing, managing and tracking all communications, correspondence, product registrations, submissions and commitments to health authorities. Tracking and managing submissions and follow-up activities for multiple products in countries around the world requires a high degree of organization and tracking.

Blood and tissue collection centers and manufacturers need effective management and tracking systems that enable them to manage correspondences, track commitments, and obtain current status on outstanding action items. Many organizations use rudimentary home grown databases, spreadsheets, or paper-based tracking systems.

TrackWise Regulatory Affairs Solutions

TrackWise is an enterprise quality management software system that creates an efficient, cost-effective, global solution for capturing and tracking all required regulatory information, commitments, and tasks pertaining to new products and product lifecycle management.

TrackWise enables your organization to:

• Report on regulatory audits and resulting findings and commitments.
• Manage and track correspondences with health authorities along with resulting commitments and tasks.
• Initiate, track, and manage changes required to meet regulatory guidelines.
• Manage and track regulatory notifications or approvals as a result of change controls initiated by other parts of the organization.
• Manage and track regulatory reporting processes.

Select one of the applications below to learn more about how TrackWise can help improve your regulatory affairs processes.

• Biological Deviation Reporting
• Correspondence & Commitment Tracking