Trackwise enterprise quality management software for regulatory affairs

TrackWise by Sparta Systems offers enterprise quality management software solutions to meet the needs of regulatory affairs departments responsible for capturing, managing and tracking all communications, correspondence, product registrations, submissions and commitments to health authorities. TrackWise offers an efficient, cost-effective, global solution for capturing and tracking all required regulatory reporting information, commitments, and tasks pertaining to new products and product lifecycle management.

Benefits:

• Improves accuracy of registration information
• Tracks and manages all phases of the product life cycle and submission process
• Reports on registration status by country, product type, indication, dosage, or any other classification
• Manages and track correspondences with health authorities along with resulting commitments and tasks
• Initiates, tracks, and manages changes required to meet regulatory guidelines
• Manages and tracks regulatory notifications or approvals as a result of change controls initiated by other parts of the organization
• Manages and track regulatory reporting processes including product safety update reports (PSURs)