Sparta Systems regulatory correspondence tracking solution improves response time and completion of regulatory commitments by providing a rapid and efficient methodology for managing, tracking and responding to regulatory audits and health authority inquiries. The solution offers integration with document management systems to link commitments and action items with the relevant regulatory correspondence.
Regulatory Correspondence Tracking
Providing a robust and flexible workflow management process, Sparta Systems’ Regulatory Tracking Solution manages correspondence, responses, resulting commitments and any action items required to ensure proper closure of outstanding issues for regulatory affairs professionals.
Benefits of Sparta Systems' Electronic Correspondence Tracking System:
- Provides real-time access to relevant health authority correspondence and commitment information to all the individuals involved in answering commitments
- Streamlines regulatory affairs workflow and improves time to market by providing users with efficient tools to replace manual commitment tracking processes
- Ensures faster response time to resolving findings, 483s, or warning letter issues
- Provides access to source regulatory correspondence documents by integrating with a document management system
- Increases speed and accuracy of commitments responses
- Eliminates redundant systems and reduces repetitive and manual data entry in spreadsheets
- Improve control and consistency in the commitment tracking process
- Reduces errors and decrease repeat inquiries from health authorities
- Eradicates the potential of missing action items or forgotten commitments
- Eliminates repeat work by bringing visibility to systematic issues
- Avoid regulatory observations by tracking and managing all correspondences and resulting actions