Sparta Systems’ offers a corrective and preventive action (CAPA) solution that automates CAPAs precipitated by deviations, complaints and other quality events. The complete CAPA solution tracks and manages the process of carrying out CAPA plans, automates verification of CAPA effectiveness over time and provides seamless traceability to related quality CAPA processes, including change control and training.
TrackWise by Sparta Systems is the only enterprise quality and compliance system that makes it possible for your company to take a closed-loop, holistic approach to your CAPA activities. The flexible TrackWise architecture gives your organization the power to log CAPA quality assurance issues originating from any source while its automated workflow engine routes records through the appropriate investigation, root cause analysis, planning, verification and CAPA effectiveness steps.
Benefits of TrackWise CAPA Software Solutions:
- Reduce the risk of lost or incomplete data with closed-loop CAPA management systems
- Facilitate compliance with pharmaceutical and biotech industry regulations including ISO 9001 and 14001; 21 CFR parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards
- Provide a flexible yet controlled environment through fully configurable CAPA process workflows
- Reduce the risk of repeat issues by ensuring that defined CAPA solutions and CAPA processes are followed
- Decrease cycle time and production/operation costs by increasing CAPA process efficiency
- Improve the efficiency of quality and operating processes by integrating your CAPA management software with other enterprise-level control systems such as document management software (DMS), enterprise resource planning (ERP) systems and laboratory information management solutions (LIMS)