Complete automation of CAPA process in Orcanos QMS
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.
Fully Customizable CAPA Form
Customize CAPA process and electronic form in minutes
No More Paper Work
Combine design control with quality and regulation in a central repository for better collaboration
Easily generate ready for submission documents from your database
Integrated Risk Management
Integrating risk into your development ensures that hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
Define e-sign processes (routing process) for documents apporval, comply with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity), E-signature processes, status flows, mandatory rules and permissions
Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
Alerts come into play when process-critical inconsistencies occur, such as new risk or outdated documents. Alerts are automatically fired once a day/week
- cGMP Part IV
- Project Planning Gantt
- cGMP Part V
- Action Item Management
- Integration with Zapier
- cGMP Part VI
- 21 CFR Part 820
- Customer Related Processes
- Design Review
- Agile Scrum Project Management
- Design Inputs and Desing Output
- cGMP – Validation Master Plan
- 10 Reasons why to use EQMS