CAPA Software with Risk Management by Qualityze

 

Qualityze CAPA Management Software provides a robust and closed-loop system to manage corrective and preventive actions effectively. It enables organizations to systematically identify, investigate, and resolve quality issues to avoid recurrence and noncompliance. The platform supports both proactive and reactive CAPAs, ensuring quality improvement across all functions.

One of the core strengths of Qualityze CAPA Software is its built-in risk management functionality. Before initiating a CAPA, users can conduct risk assessments to evaluate the severity, likelihood, and potential impact of an issue. This helps prioritize actions and resources toward high-risk areas, supporting a risk-based quality approach aligned with ISO and FDA expectations.

The software incorporates industry-standard tools such as 5 Whys and Fishbone diagrams to assist in identifying the root causes of problems. Once causes are established, users can create detailed corrective and preventive action plans. Each action can be linked to risk scores, allowing quality teams to monitor whether implemented actions effectively reduce overall risk.

Qualityze offers a configurable workflow that automates CAPA processes from initiation to closure, ensuring that all steps—including risk evaluation—are completed in a structured and compliant manner. Timely reminders, task assignments, and escalation mechanisms enhance accountability and support adherence to regulatory requirements such as FDA 21 CFR Part 820 and ISO 14971.

The solution provides dynamic dashboards and reporting tools to track CAPA progress and assess residual risk after actions are implemented. Quality teams can use real-time insights to detect patterns, monitor risk trends, and evaluate the effectiveness of preventive actions. This helps foster a culture of continuous improvement and informed decision-making.

Built on the Salesforce platform, Qualityze CAPA with Risk Management easily integrates with other modules like Nonconformance, Audit, and Change Management. This ensures end-to-end visibility and traceability for all quality events, while maintaining data integrity and compliance. The result is a streamlined, risk-aware CAPA process that drives operational excellence.