Qualityze offers a module within its larger EQMS (Enterprise Quality Management System) platform focused on CAPA — i.e., capturing, investigating, implementing corrective and preventive actions, verifying effectiveness, and closing the loop.
Key facts:
It is cloud-based, built on the Salesforce platform, providing scalability, access anywhere, and enterprise-grade infrastructure.
It is designed for regulated industries (life sciences, medical devices, manufacturing) with compliance to standards such as ISO 9001, ISO 13485, 21 CFR Part 11, etc.
The CAPA module is integrated with other modules (nonconformance management, audit management, supplier quality, training, document change control) to support a “closed-loop” quality system.
Key Features & Highlights
Here are the standout features of Qualityze’s CAPA offering:
- Centralized CAPA management
You can capture issues (nonconformances, deviations, audit findings, complaints) and launch CAPA workflows from them. The system acts as a central repository of CAPA events.
- Automated Workflows
Workflows guide the steps: assignment of tasks, responsible persons, deadlines, notifications/alerts, approvals, effectiveness checks. The automation helps reduce delays and ensures accountability.
- Root Cause Analysis Tools
Qualityze provides tools to support structured investigation: methods like 5-Why, Fishbone (Ishikawa) diagrams, FMEA (Failure Modes & Effects Analysis). These help drive from symptomatic issues to root causes.
- Risk-Based Prioritization
A strong point: the system allows CAPA actions to be prioritized based on risk (severity, recurrence probability, detection/ control effectiveness) so that resources can focus on high-impact issues.
- Integration with broader Quality Ecosystem
Because it’s part of a bigger EQMS, CAPA is linked with nonconformance, supplier quality, audits, training, document control, change management. This helps avoid silos and supports “closed-loop” quality improvement.
- Analytics, Dashboards & Reporting
Real-time dashboards, trend analysis, KPIs, audit-trail visibility. These help management review and continuous-improvement activities.
- Compliance & Audit-Readiness
Because the platform is built for regulated industries, you get features like electronic signatures, full audit‐trail, traceability, role-based access, and regulatory standard alignment (ISO, FDA, etc.).
Software Connect
Benefits for Organizations
Here are some of the practical benefits of using Qualityze’s CAPA module:
Faster issue resolution and closure of CAPA cycles thanks to workflow automation + alerts.
Better prevention of issue recurrence because root-cause analysis is enforced and corrective/preventive actions followed through; risk-based prioritization ensures the biggest risks are addressed.
Improved visibility and traceability for audits/regulators and internal management, reducing compliance risk.
Greater alignment between quality events (non-conformance, audit findings, complaints) and preventive actions, enabling proactive rather than purely reactive quality management.
Scalability and flexibility: being cloud based and built on Salesforce supports growth and integration with other systems. Read more - www.qualityze.com/capa-management