CAPA Module

Grand Avenue's CAPA Module is a web-based corrective and preventive action management solution designed for life sciences and regulated industries. It supports teams in managing the full CAPA lifecycle — from initial submission and root cause analysis through to action implementation and effectiveness verification — within a single connected system aligned with FDA and ISO 13485 requirements.

The module is intended for quality and compliance teams that need structured, audit-ready processes to resolve non-conformities, reduce recurring issues, and document every step of the CAPA process for regulatory review.

Core Features

• Web-based CAPA submission with built-in validation review
• Root cause analysis and action planning within a single workflow
• Automated due dates, reminders, and task tracking
• Effectiveness verification and follow-up action support
• Real-time CAPA status dashboards and trend reports
• Full audit trails with linked evidence and resolution data
• Integration of both preventive and continuous improvement actions

CAPA Workflow

1. Issue identification and web-based CAPA submission with validation review
2. Root cause analysis conducted within the structured workflow
3. Action planning with assigned responsibilities and automated deadlines
4. Task tracking with real-time updates and escalation when necessary
5. Effectiveness verification through required follow-up tasks and checks
6. Documentation of all steps in an audit-ready format with linked evidence

Reporting and Trend Analysis

• Built-in charts and reporting tools to visualize CAPA data
• Ability to group CAPAs by source for pattern identification
• Monitoring of resolution trends over time
• Identification of high-risk areas based on CAPA data

Compliance Support

• Supports compliance with FDA regulations and ISO 13485 standards
• Manages both corrective and preventive actions within the same structured workflow
• Assigns responsibilities and tracks corrective actions through to verified resolution
• Maintains complete documentation of root cause analysis, actions taken, and effectiveness checks to meet regulatory requirements

Grand Avenue's CAPA Module is designed to fit into existing quality management workflows, providing audit trail documentation, regulatory alignment, and visibility into CAPA status across the organisation.