As part of supporting ISO 13485, Medical Device companies must have a quality management system in place to ensure they provide medical devices and related services that consistently meet both regulatory and customer requirements, including capabilities for comprehensive management of corrective and preventive action plans. CAPAs must be entered and tracked through closure in this system, with full audit history recorded and available, including links to the source of the CAPA, and links to the resolution, follow up actions, and commitments. CAPAs may originate based on a variety or sources, including audit findings, inspections, complaints, and deviations.
The fully integrated 21 CFR Part 11 compliant CAPA Management solution from QUMAS offers a powerful yet flexible and easy to use solution to address all of these requirements. The system ensures that CAPAs are linked to the identification source of the problem, such as a complaint or deviation, and automatically pulls forward relevant information, reducing transcription errors and eliminating duplication of effort and re-entry. Configurable automated forms, business rules and workflow are delivered with a predefined best practice process configuration. The process supports email notification and a task list of action items, electronic signature, and full audit trail and reporting. The QUMAS Quality Management Solution will ensure that corrective action plans are aligned with the source of the issue, removing the need for duplication of effort.
Automated forms, business rules and a dynamic workflow engine make up the basis of the QUMAS CAPA Management Solution process, allowing for a corrective action plan to be created and executed on. Full audit trail and electronic signature functionality ensures compliance with 21 CFR Part 11. This includes data integrity, traceability, data security and electronic signatures. The system allows you to automate routine operations and enhance efficiency. This automated CAPA Management Solution ensures regulatory compliance across your entire company, which is essential for life science companies operating within strict GxP regulatory environments.
QUMAS preventative action software is designed to enable you to track and action CAPA deviations across multiple plants. The user-friendly interface allows you to create effective CAPA process controls.
For more information on managing CAPAs using the QUMAS solution, download this webinar on Driving Business & Quality Success with an Integrated QMS Platform, which outlines how to take control of your quality processes including CAPAs, Deviations, Change Control and Audits:
- CAPA creation
- Form filling, workflow execution
- Root Cause Analysis
- QA Approval