
A unified ALM & QMS platform reimagined for effortless compliance, accelerated workflows, and AI-powered traceability.
ISO 13485 Ready | FDA 21 CFR Part 11 Compliant.

Regulatory processes suffer from fragmented tools, manual workflows, and lengthy audits. Teams waste time switching systems just to maintain compliance.
A unified platform for regulated businesses, allowing your team to concentrate on innovation rather than administrative tasks.
Gain real-time visibility into your project’s compliance status. Instantly view risk levels, audit readiness, and regulatory progress across all departments without switching tools or hunting for data. Color-coded dashboards flag issues early, helping teams act fast and stay aligned with standards.


Perform key actions like status changes, PDF previews, or record updates instantly from one unified interface. No more scrolling, reloading, or switching windows. This streamlined experience reduces errors, saves time, and keeps your team focused on progress, not process.
Automatically generate traceable documents, test cases, and risk assessments in minutes, not days. The system links requirements, tests, and risks to ensure full coverage and audit readiness. By reducing manual work, your team can focus on analysis and decisions—accelerating delivery while improving accuracy and compliance.


Reclaim valuable hours every week with a workspace built for speed, clarity, and efficiency. Intuitive layouts, smart shortcuts, and organized dashboards help your team navigate tasks effortlessly, reducing time spent on repetitive actions. By minimizing distractions and streamlining workflows, employees can focus on meaningful work that drives results.
This optimized environment not only boosts productivity but also promotes a more satisfying and stress-free work experience.
Explore the new intuitive interface designed for faster navigation, real-time visibility, and more innovative compliance management.

Learn how Orcanos 6.0 can streamline compliance
and accelerate your product lifecycle.

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