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What is QIT Enterprise Quality Management?

Companies that are progressing must quickly adjust to the ever-changing market dynamics. Both customers and suppliers expect immediate answers to critical questions, and those businesses that fail to keep pace risk experiencing a decline in revenue. As a result, implementing a management software suite has become vital for any organization striving to make a notable mark in its industry. A Quality/Assurance Management System (QMS) encompasses a variety of business processes designed to achieve quality objectives and meet customer expectations. Developed by skilled quality consultants and ISO auditors, QIT Consulting’s Enterprise Quality Management Software provides a web-based, customizable solution for quality management. We are committed to offering exceptional software products that deliver greater value than their cost. If for any reason you are dissatisfied, simply contact us within 60 days of your purchase, and we will cheerfully refund the full amount, no questions asked. Our unwavering dedication to customer satisfaction is essential, and we firmly believe that trust is established through consistent and dependable service. By prioritizing your needs and feedback, we aim to foster long-lasting relationships built on mutual respect.

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.

Media

Media

Integrations Supported

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

QIT Consulting

Date Founded

2002

Company Location

United States

Company Website

www.qitconsulting.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Aviation

Not specified

Document Control

Not specified

Quality Management

Audit Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management

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

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