Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records
Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.
Ensures hazards are mitigated and prevents failure from happening
Generate Risk Management File in just one-click
ISO 14971 Compliance
Replace paper-based QMS with Orcanos electronic forms, and achieve higher productivity and efficiency
“ORCANOS Medical provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks Management and Traceability in a highly regulated environment…”
Technical Program Manager, Fio
“Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…”
Co-Founder, Mazor Robotics
CEO, Upnride
“…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…”
Industry Based
Combine Design Control (ALM) with quality management system and regulation in a central repository
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 electronic signature process for a complete documents approval lifecycle
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions
Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, 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Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents.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
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8 Tozeret Ha'aretz Street
Tel Aviv, Israel
+972-3-5372561
info@orcanos.com
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