Corrective and Preventive Action Tracking Software (CAPA)

Corrective Action and Preventive Action (CAPA) management is the main hub of an organization's quality management system (QMS). FDA, ISO, EMEA, and other regulations and standards expect a systematic approach to managing CAPAs. Organizations must log events and problems, investigate them to determine root cause, propose corrective and preventive action plans, track and manage individual actions, and measure effectiveness to ensure the root cause has been eliminated.

Managing a CAPA program as part of the broader quality management system improves the tracking and trending of key quality drivers and resulting actions. While many organizations strive to implement this approach, only those with an effective quality management software system that implements a holistic CAPA approach are able to truly do so.

TrackWise Corrective & Preventive Actions (CAPA Solutions)

TrackWise software enables companies to improve quality, reduce costs, and meet compliance requirements by automating and centralizing the CAPA process using an enterprise approach. TrackWise manages CAPAs originating from any source, and enables organizations to integrate and relate investigation and corrective action processes.

The flexible TrackWise architecture enables your organization to log any problem and manage all related investigation tasks and actions. Investigation "tasks" are assigned to investigators who access and update them from their personalized dashboards. TrackWise improves the collaboration process by enabling investigation teams to share results and use drill-down selection tools to walk through root cause analysis steps. Electronic workflow management controls the process and improves timeliness of all CAPA plan development, approval, implementation, verification and effectiveness.

TrackWise's patented 24/7 business rules engine monitors key milestone dates to ensure investigations and CAPAs are closed on time and escalates latent issues based on simple to complex conditional logic. The system also improves the reporting and trending processes with built-in, easy-to-use search tools and integrated enterprise reporting that provides managers the critical quality information necessary to make confident GMP decisions.

Benefits

• Lower costs by consolidating redundant systems and enhancing collaboration, fueling cost-savings, and increasing ROI.
• Eliminate repeat problems by improving the investigation and root cause analysis processes.
• Eliminate the potential of lost information by electronically and securely managing all information in a scalable and reliable system.
• Ensure compliance with industry regulations and ISO standards.
• Implement a closed-loop CAPA process with electronic workflow and built-in effectiveness checks.
• Implement a holistic approach to your CAPA system by managing and tracking CAPAs resulting from all sources in one centralized database.
• Improve quality trending and management reporting through integrated search tools, reporting functions, and management dashboards.
• Increase accountability as well as collaboration by assigning investigations to responsible parties and monitoring due dates through interactive dashboards.
• Increase visibility and reduce product impact by notifying other departments and sites automatically when problems occur.
• Increase visibility and transparency with personalized dashboards, integrated reporting tools, and automatic report distribution to management.
• Reduce costs and risks by eliminating redundant and ineffective paper-based systems, hybrid, and legacy systems.
• Reduce risk by enforcing consistent and harmonized processes and procedures across the organization.
• Release product faster by shortening investigation cycle times and enabling faster closure of deviations.