Orcanos Software combines ALM with quality and industry-based regulations. Perfect for medical, software, automotive, embedded, financial, and government
ALM And QMS
Collaborative ALM and Quality Management system that supports Requirements Management, Test Management, Document Control, CAPA, Risk Management, Complaints.
Using Orcanos will reduce the risk of your next audit and assure a better product delivery
Modules And Compliance
ALM/ DESIGN CONTROL
Requirements Management
Test Management
Defect Tracking
Customer Service
QUALITY MANAGEMENT
Document Control
CAPA Management
Complaints
Change Management
Training
Non-Conformities
REGULATIONS
21 CFR Part 11
FDA 21 CFR Part 820
ISO 14971
ISO 13485:2016
IEC 62304
Regulation Compliance Engine
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Our Clients Testimonials
“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…”
Igor Stankovski
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…”
Eli Zehavi
Co-Founder, Mazor Robotics
Oren Tamari
CEO, Upnride
“…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…”
Integrating To 750+ Applications with Zapier
Key Features
ALM+QMS
Combine Design Control (ALM) with quality management system and regulation in a central repository
Document Generator
Easily generate ready for submission documents from your database
Integrated Risk Management
Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
21 CFR Part 11 Compliance
Define electronic signature process for a complete documents approval lifecycle
Easy Customization
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions
Dashboards And Analytics
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
End To End Traceability
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
Realtime Alerts
Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week
