Orcanos Nonconformance Management Software allows easy recording, assessing, and investigation of your product nonconformance.
The fact that Orcanos is an integrated quality management system (e-QMS) allows to natively link nonconformance to other quality processes, such as Audit, CAPA and Risk
Using Orcanos powerful filter module, and the customized dashboard, allows better tracking of your Nonconformance records, and the electronic signature enables signing a Nonconformance upon completion.
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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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