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
- Verification of Effectiveness
- Smart dashboards
- Workflow and e-sign automation
- 21 CFR Part 11 compliant
What is CAPA?
Corrective and preventive action also called CAPA are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice GMP and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence for corrective action or to prevent occurrence for preventive action
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.
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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