Get better prepared for your next audit or inspection
Orcanos Audit Management System allows preparing and managing audits electronically. Conducting periodic audits based on your industry is crucial in order to comply with regulations and to ensure product safety and quality. Each audit can have audit checklist to specify the topics under audit, and then link to audit findings based on the findings.
The Orcanos Electronic Audit Management System includes the following capabilities: Secured electronic, and centralized web-based system; Tractability to other quality processes, such as Nonconformance, FMEA, Training, Verification, Complaints, CAPA, etc; Smart dashboards; Workflow and e-sign automation etc.
Use Orcanos alert engine to assure no audit finding is overlooked.
Use Orcanos Regulations Compliance engine in order to automate your audit in one click, before the audit occurs
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Alerts come into play when process-critical inconsistencies occur, such as new risk or outdated documents.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