CAPA Management System

Safeguard your business with proactive CAPA management software

Complete CAPA Lifecycle Automation

Orcanos enables full automation of the CAPA lifecycle - from initiation to investigation and closure - ensuring compliance with industry regulations such as ISO 13485 and 21 CFR Part 11.

Comprehensive Traceability: Seamlessly link CAPA to other critical processes, such as FMEA, ECO, Complaints, Training, and Verification.

Root Cause & Action Planning: Manage root cause investigations and create actionable plans to address issues.

Prioritization & Risk Management: Ensure the most critical actions are addressed first, based on real-time data and risk prioritization.

Effectiveness Verification: Confirm that corrective actions are effective, closing the loop on your quality processes.

Real-Time Dashboards: Monitor CAPA activities with visual dashboards that provide instant insights into your compliance status and quality metrics.

Built for regulated industries, ensuring compliance with medical device standards and regulations.

Customizable CAPA Forms for Your Workflow

Tailor your CAPA process effortlessly. Our user-friendly interface allows you to configure electronic CAPA forms to meet your organization's specific needs.

Add custom fields to capture the data that matters most to your process.

Set mandatory rules to ensure compliance.

Implement access control to manage user permissions.

Apply traceability rules to maintain strong connections between quality activities.

Configure alerts and notifications to keep your team informed at every step.

Seamless Integration with Orcanos QMS

The Orcanos CAPA Management System integrates flawlessly with our comprehensive QMS (Quality Management System), delivering a complete solution for medical device compliance. With our integrated Traceability Tool, you can connect all relevant artifacts, ensuring thorough impact analysis and accurate tracking of all quality-related processes.

Fully Customized CAPA Solutions Tailored to Your Needs. Click below to know more.

Get a Demo

Trusted by