Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Ratings and Reviews 0 Ratings

Total
ease
features
design
support

This software has no reviews. Be the first to write a review.

Write a Review

Alternatives to Consider

  • isoTracker Quality Management Reviews & Ratings
    19 Ratings
    Company Website
  • Intelex Reviews & Ratings
    180 Ratings
    Company Website
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    66 Ratings
    Company Website
  • HSI Donesafe Reviews & Ratings
    176 Ratings
    Company Website
  • SBS Quality Management Software Reviews & Ratings
    7 Ratings
    Company Website
  • AlisQI Reviews & Ratings
    108 Ratings
    Company Website
  • Certainty Software Reviews & Ratings
    93 Ratings
    Company Website
  • Hyperproof Reviews & Ratings
    350 Ratings
    Company Website
  • Qualio Reviews & Ratings
    919 Ratings
    Company Website
  • Predict360 Reviews & Ratings
    18 Ratings
    Company Website

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 Kneat?

Utilize Kneat to effortlessly manage and streamline any validation, commissioning, or qualification process. This all-encompassing solution is tailored to meet and adapt to your validation needs across diverse facilities globally. Engineers trust Kneat's paperless validation software to boost their efficiency, liberating them from tedious paperwork, while Managers leverage it to implement, uphold, and monitor best practices. Quality Directors gain from Kneat by guaranteeing quality oversight and upholding compliance, with CIOs being empowered to advance digital transformation efforts. Featuring a secure cloud-based platform, Kneat enables teams to collaborate effortlessly from anywhere in the world. The platform ensures that all documents are live, up-to-date, and easily accessible, thus removing the necessity for hand-offs, binder compilations, and searching through paper records. By promoting quicker and smarter collaboration, Kneat not only conserves valuable time and resources but also strengthens quality and compliance protocols, allowing organizations to function efficiently and effectively. As you adopt Kneat, you will revolutionize the validation process, enhancing your team's productivity and reliability. Experience the transformation in how your organization manages validation tasks and unlock new levels of operational excellence.

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

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

Kneat

Date Founded

2006

Company Location

Ireland

Company Website

kneat.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 Management

Not specified

Popular Alternatives

Modern Requirements4DevOps Reviews & Ratings

Modern Requirements4DevOps

Modern Requirements

Popular Alternatives

DigiSign Reviews & Ratings

DigiSign

Digio
aligned elements Reviews & Ratings

aligned elements

Aligned AG
FileDirector Reviews & Ratings

FileDirector

Spielberg
Dot Compliance QMS Reviews & Ratings

Dot Compliance QMS

QMS for Life Sciences
RegDoc eSafe Reviews & Ratings

RegDoc eSafe

MedPoint Digital