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What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

What is Clearlane Controlled Documents?

Clearlane Controlled Documents provides a specialized document control system tailored for quality management frameworks within Confluence Cloud, effectively converting standard documentation such as SOPs, work instructions, and policies into regulated entries. Each document revision is verified by designated approvers who employ a distinctive personal signing password; this electronic signature is meticulously connected to the document content via a SHA-256 fingerprint, guaranteeing that any modifications during the review process will render the signature invalid. Upon securing the final signature, the revision is recognized as effective and is assigned a future review date. Readers can confirm that they are viewing the latest revision, and regular reviews trigger reminder notifications, while a comprehensive register tracks all documents within each designated space. Users can also generate a detailed evidence PDF, which encompasses signatures, revision histories, read confirmations, and an audit trail. This solution is ideal for teams operating in the pharmaceutical, biotech, medtech, and ISO 9001 quality sectors, and it is offered in English, French, and German. Furthermore, it supports compliance with regulations such as 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 standards. Built on the Atlassian Forge platform, it ensures that data is securely stored within the client’s Atlassian environment, thus maintaining both compliance and data integrity. The application also features a user-friendly interface that facilitates the management of controlled documents for users in a variety of industries, making it an invaluable tool for maintaining regulatory standards and improving organizational efficiency.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Atlassian Rovo
Confluence

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$0
Free for up to 10 users. Larger teams pay per user, billed by Atlassian through the Marketplace.
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Clearlane Apps

Date Founded

2026

Company Location

France

Company Website

clearlaneapps.com/controlled-documents/

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

Categories and Features

Document Control

Not specified

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