Regulatory Correspondence, Audits, and Commitment Tracking

Regulatory affairs departments are faced with the challenging task of efficiently managing regulatory correspondence data, and meeting departmental and corporate commitments to health authorities. When a response to a health authority inquiry or commitment as a result of a New Drug Application (NDA) or other submission slips through the cracks, it can delay the approval process as well as impact revenue streams. Companies must also track and manage commitments that result from regulatory audits, 483s, warning letters, and other issues that could lead to critical compliance issues if not resolved quickly and effectively.

TrackWise Regulatory Commitment Management Solutions

TrackWise software is an enterprise quality management tool that improves response time and completion of regulatory commitments. TrackWise provides a rapid and efficient methodology for managing, tracking, and answering regulatory audits as well as health authority inquiries by enabling regulatory affairs professionals to capture, monitor, and complete the activities associated with satisfying commitments.

TrackWise's configurable web-based interface is available to all personnel involved in answering a regulatory request. The system automates workflow as it enables personnel to initiate a commitment based upon a regulatory communication, assign that commitment to a department or resource, and monitor progress. The assigned parties can review all information required to meet the commitment, track their own activities, and track any further related regulatory inquiries.

TrackWise integrates to document management systems to link commitments and action items with the relevant regulatory correspondence. Personalized dashboards and integrated reporting allow users and managers to track and monitor status. Flexible escalations provide e-mail alerts to various levels of management within both regulatory affairs and other departments, helping to ensure that responses are provided on time.

Benefits

• Streamline regulatory affairs workflow and improve time to market by providing users with efficient tools to replace manual tracking processes
• Ensure faster response time to resolving findings, 483s, or warning letter issues
• Provide real-time access to relevant health authority correspondence and commitment information to all the individuals involved in answering commitments
• Provide access to source regulatory correspondence documents by integrating with a document management system
• Increase speed and accuracy of commitments responses
• Eliminate redundant systems and reduce repetitive and manual data entry
• Improve control and consistency in the commitment management process
• Reduce errors and decrease repeat inquiries from health authorities
• Eradicate the potential of missing action items or forgotten commitments
• Eliminate repeat work by bringing visibility to systematic issues
• Avoid regulatory observations by tracking and managing all correspondences and resulting actions