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:
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.
combine Design Control with quality and regulation in a central repository for better collaboration
Easily generate ready for submission documents from your database
Integrate risk into your development, ensures 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-sign 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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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