CAPA Tool

CAPA Tool

Generate comprehensive Corrective Action and Preventive Action (CAPA) plans to address quality issues and prevent recurrence in regulated environments. This tool creates structured reports compliant with industry standards and regulatory requirements.

How It Works

1. Describe the Issue: Provide details about the quality issue or non-conformance.
2. Select Issue Type: Choose the appropriate category for your quality issue.
3. Specify Industry: Select your regulated industry for tailored recommendations.
4. Assess Severity: Rate the impact of the issue on quality, safety, and compliance.
5. Add Additional Context: Include any relevant details that might help with root cause analysis.
6. Generate CAPA Plan: Our AI will create a comprehensive report following industry best practices.

Features

• Structured CAPA Reports: Compliant with FDA, ISO, and other regulatory frameworks.
• Root Cause Analysis: Detailed methodologies including 5-Why, Fishbone, and FMEA approaches.
• Risk-Based Prioritization: Recommendations tailored to severity level and industry context.
• Implementation Timelines: Realistic schedules for corrective and preventive actions.
• Effectiveness Verification: Metrics and methods to confirm CAPA effectiveness.