Streamline Your Document Control with Orcanos
Centralize all your SOPs, policies, work instructions, and key design files into one secure, compliant repository, no scattered folders, no version chaos.
Built for ISO 13485 and FDA Compliance
Orcanos DMS provides revision control, electronic signatures, and transparent approval workflows required to meet ISO 13485 and FDA 21 CFR Part 11. With a centralized, audit-ready system, your team always works on the correct version and stays fully compliant.
Introducing Orcanos DMS
Orcanos’ Document Control Management System (DMS) is purpose-built to handle every phase of your document lifecycle: from creation and review to approval, training, and archival. With Orcanos, you get a centralized, cloud-based solution so your team can collaborate efficiently while staying audit-ready and fully traceable. Our system supports all types of regulated documents, including SOPs, design history files (DHF), policies, work instructions, and more.
Document Control, Centered Around Your Compliance
Orcanos unifies document management, training, and compliance in a single platform, tightly integrated with your quality processes and product records. From creation to approval, revision, and archival, ensure full traceability across every document with automated workflows, audit-ready records, and a single source of truth for your team.
Experience Audit-Ready Quality, Book Your Orcanos Demo Today!
Flexible Import & Scalability
Moving from a legacy system? No problem. Orcanos supports simple drag-and-drop importing, so you can migrate entire folder structures into your DMS in minutes. Every new file imported is assigned an initial revision (e.g., “A.1”), and from there, the system supports robust version control. As your company grows, you can scale your DMS without adding complexity — Orcanos has no file number limit, and permissions are fully configurable to match your structure and security needs.
What our clients say about us
"An efficient system tailored perfectly to our operations."
We began our journey with Orcanos four years ago, starting from scratch. From day one, the Orcanos team took the time to understand our business model and our unique needs. Their expertise and guidance helped us set up a robust and efficient system tailored perfectly to our operations. The experience has been nothing short of excellent - marked by professionalism, responsiveness, and smart, practical solutions. We're grateful for the partnership and look forward to the road ahead.
"We obtained CE certification and FDA clearance with Orcanos."
We were impressed by Orcanos' attention and expertise in the medical device industry, and we felt it was the right choice for us. Having obtained both CE certification and FDA clearance with Orcanos, we are confident that we made the right choice for ZygoFix.
Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!
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