Document Control Software

Supports Lifescience Companies In Regulation Compliance

Cloud Document Control Software System (DMS), satisfies ISO 13485 and 21 CFR Part 11

gohnson & gohnson
Mazor Robotics
Biosense Webster
Fio Corporation

Top DMS Features

Automated Document Control and Management

Automation of your documents lifecycle, such as Import, approve, distribute, and obsolescence. By automating document workflow, such as routing, approval, and distribution, you can assure that no task is overlooked, and document cycle time is reduced significantly while assuring compliance with regulations.

Web based User-Friendly Interface

Orcanos uses Google Material Design guidelines to assure the best user experience. Orcanos Document Control is structured hierarchically so it is similar to windows explorer layout. You can easily switch between a hierarchic view to the listview, with may navigations capabilities, such as search inside the tree, designate favorite items, last viewed items and more, using responsive uI, which fit the screen you're using, both for desktop, mobile, and tablets.

Workflows Automation End Electronic Signature

Orcanos online Document Management Software System will automate your workflows, route e-sign to the next signers, and provide real-time alerts

PDF Publishing On Signoff

Approved document is published to PDF, While Orcanos generates cover letter and adds watermarks to each page. While new revision is generated, previous revision is set to Obsolete. This enables users to preclude unauthorized printing, saving or copying of the documentation.

Quick Import Of Your Repository

Orcanos Document Management Software system import tool allows importing your entire file system into Orcanos central repository, in just a few clicks, so you can start working immediately.

Automated Revision Control

Orcanos Document Management System manages revisions based on routing status, makes previous revisions obsolete and publish approved documents to PDF, while generating effective date and notify stakeholders

21 CFR Part 11 Compliance

Develop Medical Device? Orcanos DMS Online fully satisfies FDA 21 CFR Part 11 for electronic records and electronic signature

Simple Configuration

Orcanos Document Control Software system allows you to set up dynamic routing process (workflow), forms layout, fields and sections, roles & permissions, with just few clicks, no programming or special skills are required

Custom DMS Dashboards And Analytics

Orcanos Document Control Analytics Engine enables building multiple dashboards and dashboard panels, to increase transparency.

Single Centralized ALM And QMS Repository

All departments, such as R&D, QA and RA login to a single centralized location for all documents and R&D information

This is the moment when you
choose your way to succes.

After working with the Orcanos team on optimizing our development process, we often get them involved strategically, when we are about to start a new project, or when we assemble a new team. Our experience taught us that it is better to start on the right foot than try to fix things later.

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Mazor Robotics

Orcanos Medical ALM Solution provides a platform to easily deal with complexities entailed in capturing and managing product requirements (system, software, hardware, mechanical, etc), risk management and traceability in a highly regulated environment.

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Traceability from the cradle to the grave is the key to quality in our development of the most advanced Oncotherapy. Orcanos serves us this tracking ability and gives us high flexibility, comprehensive reports and good office collaboration world wide on top of our existing disjoint systems. This enables us at the AVO-ADAM to live our workflow.

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Start in 5 steps

document management software system

Define Users And Roles

Build users and groups, assign roles and permissions for document authors and signers

Build routing process

Build routing process, workflows for documents approvals and signoff (Part 11 Compliant e-sign)

Import Your Documents

Use Orcanos Import tool to get all your existing repository in one click, to create your baseline

Create Baseline

All documents get an initial baseline - start routing and change management

Start Working

Get started with Orcanos DMS first time tutorial

Dramatically Increase Your Employee Engagement & Productivity

No more paper work


Combine design control with quality and regulation in a central repository for better collaboration

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrating risk into your development ensures that hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

Electronic Signature

Define your e-sign processes (routing process) for documents approval, complying with 21 CFR Part 11.

Fully Customizable

Powerful customization tools to customize your quality forms (CAPA, ECO, non-conformity…), e-sign processes, status flows, mandatory rules and permissions 

Personal Dashboards

Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more


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

Manage Your QMS From Start To Finish


8, Beit Oved Street
Tel Aviv


Huizingalaan 69
3572LJ Utrecht
+31 85 1046614



8Beit Oved Street
Tel Aviv, Israel

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