Orcanos Document Control Management System: Audit-Ready, Automated, Built for Medical Device.

Transform manual friction into fully automated system
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Stop 'Preparing' for Audits. Live in a Constant State of Readiness.

To maintain a constant state of inspection-readiness, the system features an Online Audit module designed to streamline both internal and external evaluations. This functionality transitions the audit process from a reactive, paper-heavy event to a proactive, digital workflow.
‍Virtual Auditor: A real-time monitoring engine that scans the document database to identify gaps, such as expired SOPs or missing training records, before they become non-conformities.
‍Instant Traceability: During a live audit, users can instantly pull full revision histories, e-signature logs, and linked CAPAs, eliminating the need to manually search through physical binders.
‍Integrated Findings Management: Observations and findings are logged directly within the system, automatically triggering corrective actions (CAPA) or document change requests where necessary.

Orcanos was designed with a single mission: to automate the complexity of Medical Device compliance so you can focus on the product, not the paperwork.

If your change control process is in a slow-motion

We replace chaos with compliance. By leveraging Orcanos’ integrated Electronic Change Order (ECO) system, you can enforce structured workflows that route documents for approval instantly. Plus, we fully automate the batch release of related documents, ensuring that every connected SOP, work instruction, or drawing is up-to-date simultaneously, saving weeks of manual effort.

If you still manage spreadsheet-based training matrixes

Orcanos bridges the gap between document revision and training. The moment a new document is approved, the system automatically triggers training tasks for all required stakeholders. There is no manual matrix to maintain. Employees receive instant notifications, can complete training with a click, and the system creates a bulletproof, real-time electronic training record that is always "audit-ready."

When approval workflows are a rigid 'one-size-fits-none' system

We put control back in your hands. You can easily design and implement dynamic, custom workflows that route different types of documents through different approval stages based on their risk or complexity. Whether it’s a simple update or a major revision, Orcanos uses seamless, secure electronic signature modules to move approvals forward instantly and securely from any device.

When the thought of an FDA audit gives you anxiety

We don't just "support" 21 CFR Part 11; we build our entire platform around it. You get absolute certainty that your electronic records, audit trails, and digital signatures meet every regulatory requirement. We provide a validated, compliant environment that provides an immutable history of who did what and when, letting you walk into any audit with confidence.

Secure, Automated PDF Publishing

All approved documents are automatically published as PDFs with a secure watermark and stored indefinitely in a protected vault. When new revisions are released, previous versions are marked as obsolete, ensuring your team always works with the latest information.

Lightning-Fast System Launch

We replace months of implementation with days of action. Leverage Orcanos' "instant-on" platform and effortless migration tools. Your entire existing file repository is centralized and structured, allowing your team to go live with a fully compliant system in less than one week.

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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An auditor asks you for the "Design History File for Project X, Revision 2."

Instant Digital Traceability. One search, one click. Every version, every signature, and every related record is linked and retrievable in seconds—no matter where your team is located.
Visual Workflow Dashboards. See exactly where every document is stalled. Automated escalations and "nag" notifications move the process forward without you having to play "document police."

Bulletproof Revision Control—Fully Automated, Fully Compliant

Do you feel like you spend 80% of your time chasing people for signatures rather than improving quality?
Manual revision control is a high-wire act. One missed watermark, an outdated training record, or a "ghost" signature can tank an entire audit.
We can give you your time back:

No More Manual Versioning: The system auto-increments revisions and updates effective dates instantly.

Ghost-Free Signatures: Electronic signatures are permanently bound to the record—no more chasing ink.

Instant Obsolescence: The moment "Revision B" is live, "Revision A" is digitally shredded and archived across the entire company.

Zero-Gap Training: Approving a document automatically "fires" training tasks to the right people. No gaps, no excuses.

Integrated Engineering Change Control: We bridge the gap between the "Change Request" and the "Document Update." Every revision is digitally tethered to its formal Change Order (ECR/ECN).

Intelligent Structure & Submission-Ready Export

Most systems are just a "digital dump" of files. You waste hours searching through folders, and when it’s time for a 510(k) or CE Mark submission, the nightmare of manually collecting, naming, and sequencing hundreds of PDFs begins. One missing document can delay your market entry by months.

‍The Orcanos Solution: We bring logical order to regulatory chaos. Our system allows you to organize your documents in a multi-level, hierarchical tree that mirrors your actual DHF or Technical File structure.
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‍Intuitive Classification: Drag-and-drop documents into a familiar folder-based hierarchy that enforces consistent naming and metadata.

One-Click Submission Export: When you are ready for a regulatory filing, simply select your "Submission Set." Orcanos automatically compiles the latest approved versions into a clean, structured package—complete with a table of contents—ready for the FDA or your Notified Body.

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FAQ

Questions teams ask before choosing Orcanos

Everything you need to know about our platform, compliance coverage, and getting started.

What is medical device document control software?

Document control software manages the full lifecycle of controlled documents, from drafting and review through approval, release, revision, and obsolescence, with a complete audit trail. Orcanos automates that lifecycle for SOPs, work instructions, specifications, and DHF records, so the version people can access is always the current one.

Why do medical device companies need document control?

Because regulators require evidence that the right people approved the right version, and that staff were trained on it. Uncontrolled documents are among the most common audit findings. Orcanos enforces approval routing, revision control, and training assignment automatically, instead of relying on folder discipline.

How does Orcanos ensure 21 CFR Part 11 compliance?

Orcanos is built around Part 11: electronic signatures are permanently bound to the record, every action is captured in an immutable audit trail, and access is controlled by role. Approved documents publish as watermarked PDFs to a protected vault, with prior revisions automatically marked obsolete.

How does document control support medical device compliance?

It supplies the objective evidence behind almost every ISO 13485 and FDA requirement - approved procedures, current revisions, trained staff, and full change history. Orcanos links documents to training tasks, change orders, and quality records, so compliance becomes a by-product of normal work.

Can Orcanos automate medical device regulatory compliance?

Much of it, yes. Orcanos automates approval routing, revision numbering, effective dates, training assignment, PDF publishing, and obsolescence. Its Virtual Auditor continuously scans the document database for gaps such as expired SOPs or missing training records, flagging them before they become non-conformities.

How does document control improve audit trail traceability?

Every action - draft, review, signature, revision, release - is time-stamped and attributed to a named user. In Orcanos, an auditor's request for a specific document revision returns the full history, e-signature log, and linked CAPAs or change orders in a single search.

How are document approvals tracked for compliance?

Through configurable workflows that route each document type to the right reviewers, in sequence or in parallel, using 21 CFR Part 11 electronic signatures. Orcanos dashboards show exactly where a document is stalled, and automated escalations move approvals along without anyone chasing signatures.

Can document control integrate with existing business tools?

Yes. Orcanos provides REST and SOAP APIs plus a Zapier connector reaching more than 1,000 applications, including Jira, Microsoft Teams, and Salesforce. Documents and quality records flow between Orcanos and the systems your engineering, operations, and support teams already run.

How fast can teams launch Orcanos document control?

Less than one week for most teams. Orcanos migration tools import and structure your existing file repository, and configurable workflows mean there's no lengthy custom build, so you go live on a compliant, Part 11-ready system in days rather than months. Covaris' Director of Quality and Regulatory described going from onboarding to four days of live auditing in a week and a half, without a back room or binders.

Does Orcanos work like Greenlight Guru or Qualio for document control?

Similarly in setup speed, differently in ceiling. Greenlight Guru and Qualio are both fast to implement and built for early-stage, FDA-focused medtech startups, but companies commonly outgrow their more rigid workflows at multi-product or EU MDR scale. Orcanos matches the fast go-live and stays configurable as document volume, product lines, and regulatory scope grow.