Automated Tracking for Pharma and Biotech Companies
Sparta's regulatory correspondence tracking solution improves response and completion times for regulatory commitments. It provides a rapid and efficient method for managing, tracking, and responding to regulatory audits and health authority inquiries. The solution integrates with your document management system to link commitments and action items with the relevant regulatory correspondence.
Regulatory Correspondence Tracking
A robust and flexible workflow management process handles correspondence, responses, resulting commitments, and any action items required to ensure proper closure of outstanding issues for regulatory affairs professionals.
Benefits of Sparta's 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 automated tools that 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 decreases repeat inquiries from health authorities.
- Lowers the risk of missing action items or forgotten commitments.
- Eliminates repeat work by bringing visibility to systematic issues.