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Integrated Quality Management System
Orcanos CAPA system is integrated with ORCANOS e-QMS to support Medical device compliance.
Whether it has risk associated, or resolution requires an engineering change, Orcanos links the quality management artifacts using Orcanos Traceability tool and provides impact analysis and better tracking.
Fully Customizable CAPA Form
Customize CAPA process and electronic form in minutes.
- Add custom fields
- Mandatory rules
- Access control
- Traceability rules
- Alerts and notifications
- Automation, e-Sign and workflow
ORCANOS CAPA (Corrective Action and Preventive Action)
As part of Orcanos QMS, ensure regulations compliance, while automating CAPA process completely, from initiation to investigation and closure.
Orcanos CAPA system includes:
- Electronic, secured and centralized web-based system
- Tractability to other quality processes, such as FMEA, ECO, Complaints, Training, Verification etc.
- Corrective and Preventive action management
- Root-cause management and action planning
- Prioritization
- Verification of effectiveness
- Smart dashboards
- Workflow and e-sign automation
- 21 CFR Part 11 compliant
What is CAPA?
Corrective and Preventive Actions (CAPA) refer to the measures taken by an organization to improve its processes and eliminate causes of non-conformities or undesirable situations. CAPA is a crucial component of good manufacturing practices (GMP) and various ISO business standards. The approach emphasizes the systematic investigation of root causes behind identified problems or risks to prevent recurrence through corrective action or avoid occurrence through preventive action.
No More Paper Work
