orcanos.com

{
  "@context": "https://schema.org",
  "@type": "SoftwareApplication",
  "name": "Orcanos QMS & ALM",
  "url": "/",
  "logo": {
    "@type": "ImageObject",
    "url": "https://cdn.prod.website-files.com/6474afeeb40eaf59586560eb/6690124278a1b26032dd0183_Orcanos%20logo_p.svg"
  },
  "description": "Orcanos is an integrated ALM and QMS platform for the medical device and life sciences industries. It automates compliance with ISO 13485, FDA 21 CFR Part 11, and EU MDR through a single traceability repository.",
  "featureList": [
    "ISO 13485 & ISO 14971 Compliance",
    "FDA 21 CFR Part 11 Electronic Signatures",
    "Integrated Risk Management (FMEA)",
    "CAPA and Complaint Handling",
    "Automated Document Control",
    "Design Control & Traceability Matrix",
    "Ask Paul - AI Compliance Assistant"
  ],
  "sameAs": [
    "https://www.youtube.com/@OrcanosMedical",
    "https://www.facebook.com/orcanos",
    "https://www.linkedin.com/company/orcanos/mycompany/"
  ],
  "aggregateRating": {
    "@type": "AggregateRating",
    "ratingValue": "4.8",
    "reviewCount": "50",
    "bestRating": "5"
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}

{
  "@context": "https://schema.org",
  "@type": "FAQPage",
  "mainEntity": [
    {
      "@type": "Question",
      "name": "What is Orcanos used for?",
      "acceptedAnswer": {
        "@type": "Answer",
        "text": "Orcanos is an integrated QMS and ALM platform built for medical device and life sciences companies. It centralizes Design Control, Risk Management (ISO 14971), Document Control, CAPA, and Audit Management in a single validated repository, enabling ISO 13485, IEC 62304, and FDA 21 CFR Part 11 compliance."
      }
    },
    {
      "@type": "Question",
      "name": "How is Orcanos different from standalone QMS tools like Qualio or Greenlight Guru?",
      "acceptedAnswer": {
        "@type": "Answer",
        "text": "Unlike pure QMS tools, Orcanos natively unifies ALM (Application Lifecycle Management) and QMS in one repository. This means R&D artifacts - requirements, tests, defects - are automatically linked to quality artifacts like risks, CAPAs, and design history files, eliminating traceability gaps that occur when the two systems are separate."
      }
    },
    {
      "@type": "Question",
      "name": "How long does it take to implement Orcanos?",
      "acceptedAnswer": {
        "@type": "Answer",
        "text": "Orcanos customers go live in as few as 14 days, compared to 3-month implementation cycles typical of legacy QMS providers. The platform includes pre-built ISO 13485 best-practice templates and expert data migration support."
      }
    },
    {
      "@type": "Question",
      "name": "Does Orcanos support FDA 21 CFR Part 11 electronic signatures?",
      "acceptedAnswer": {
        "@type": "Answer",
        "text": "Yes. Orcanos provides a fully validated environment with native 21 CFR Part 11 compliance including electronic signatures, audit trails, and access controls for every document, record, and approval workflow."
      }
    },
    {
      "@type": "Question",
      "name": "What is the Ask Paul AI assistant in Orcanos?",
      "acceptedAnswer": {
        "@type": "Answer",
        "text": "Ask Paul is Orcanos' built-in AI compliance assistant. It helps quality and R&D teams navigate regulatory requirements, interpret standards like ISO 13485 and FDA 21 CFR Part 820, and find the right workflows inside the platform - reducing the time teams spend searching documentation."
      }
    }
  ]
}