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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 Lyons QMS Audit Pro?

QMS Audit Pro is a web-based solution designed for capturing issues, conducting audits, and implementing corrective actions, with usage exceeding 15,000 instances monthly. This platform empowers your team to gather uniform data, streamline processes, and generate reports while facilitating the identification and resolution of issues. Remarkably, it is offered completely free of charge, without any contracts or obligations, allowing users the flexibility to cancel whenever they choose. Users can create comprehensive Audit Plans, execute Audits, and monitor non-conformances, all within a single tool, ensuring complete traceability from start to finish. The platform also enables the development of reusable audit and checklist templates applicable across the organization. Additionally, users can generate detailed audit reports that highlight essential details like audit summaries, identified nonconformances, and the participants involved, with customization options tailored to organizational requirements. By integrating data from various sources into dynamic dashboards, decision-making becomes swift and informed, enhancing the overall audit process. This comprehensive approach not only simplifies audits but also fosters a culture of continuous improvement within the organization.

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

Pricing not provided

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS

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

Not specified

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Lyons Information Systems

Company Location

United States

Company Website

www.lyonsinfo.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

Audit

Not specified

CAPA

Not specified

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