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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 Elyse?

Elyse® is a high-integrity controlled document management system. Designed from the ground up to serve the people who use it, Elyse has a User-Centric data architecture that carefully mirrors the real world experience of how users expect controlled document management systems to behave. The result is: Users find what they need faster and experience less frustration. Administrators spend less time maintaining the system because there are fewer workarounds and customizations. Auditors have stronger evidence because foundational rules are hard wired. Organizations have a platform that is easier to validate and extend because it doesn't need program code to compensate for highly abstracted data. The protection of your data is ensured through fully ACID-compliant storage, accompanied by an advanced security framework. This system incorporates role-based access control and comprehensive data permissions, making it ideal for large-scale enterprises. Additionally, the unique document identifier namespace guarantees that all document IDs are distinct from the very beginning, while its format-agnostic nature allows for seamless migration from older systems. For organizations deploying in multi-user production settings, the licensing model is designed to be straightforward, providing a trust-based perpetual license for each database instance without imposing any ongoing subscription or upgrade costs. In contrast, the platform remains free for individual users or non-production purposes, offering full functionality. Elyse is designed for any organization that needs to manage controlled documents such as procedures, standards, SOPs, work instructions, quality plans, manuals and engineering drawings. It is fully configured and ready to use out of the box and does not require a team of deployment specialists.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$3,500
For multi-user production environment deployment the license is a low friction trust-based per-database instance perpetual license. There are no recurring subscriptions or upgrade fees. For single user or non-production use the product is free and fully featured.
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

Windows
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

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

Silkwood Software

Date Founded

2009

Company Location

Australia

Company Website

silkwoodsoftware.com

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

Archiving & Retention
Compliance Management
Periodic Review
Version Control

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