QMS CAPA Software Solution

Overview

The QMS CAPA Software Solution offers a comprehensive approach to managing Corrective and Preventative Actions (CAPA) processes. It is designed to be user-friendly, easy to implement, and highly configurable, catering to both transactional and non-transactional processes such as planning, marketing, customer service, and manufacturing operations.

This system is compliant with ISO9000 standards, 21CFR part 820 for medical devices, and AS9000 standards, ensuring it meets necessary regulatory requirements. It provides a closed-loop CAPA system that is effective, auditable, and traceable.

Key Features

• User-Friendly Interface: The system is easy to use and configure, with built-in error-proof mechanisms to prevent mistakes during operation.
• Secure Access Control: Role-based identification and login ensure secure and convenient access, with tasks and projects not being delayed by individual availability.
• Workflow Management: The workflow inbox offers visibility of notifications, tasks, and projects in one place, showing users only their relevant tasks and notifications.
• Flexible Approval Process: The number of reviewers or approvers can be customized per project, with options to specify departments for reviewers.
• Audit and Traceability: Features include e-signature capability, PDF printing with timestamps, and the ability to attach various file types, including audio and video.
• Enhanced Usability: Drag-and-read text boxes eliminate the need for scrolling, allowing users to view content easily.
• Automated Reminders: Configurable reminders for task and project owners, as well as approvers.
• Reporting and Metrics: Options for creating metrics and reports, with data exportable to Excel for customized reporting.
• Configurable Labels: Text boxes can be labeled according to user preferences, offering flexibility in system operation.

For further information or to arrange a demo and a 30-day free trial, please contact us with your email address and phone number for a prompt response.