Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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

Write a Review

Ratings and Reviews 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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

Write a Review

Alternatives to Consider

  • isoTracker Quality Management Reviews & Ratings
    4.6 out of 5 stars 19 Ratings
    Company Website for isoTracker Quality Management
  • Intelex Reviews & Ratings
    4.2 out of 5 stars 193 Ratings
    Company Website for Intelex
  • Interfacing Integrated Management System (IMS) Reviews & Ratings
    4.6 out of 5 stars 66 Ratings
    Company Website for Interfacing Integrated Management System (IMS)
  • SBS Quality Management Software Reviews & Ratings
    5.0 out of 5 stars 7 Ratings
    Company Website for SBS Quality Management Software
  • HSI Donesafe Reviews & Ratings
    4.7 out of 5 stars 176 Ratings
    Company Website for HSI Donesafe
  • AlisQI Reviews & Ratings
    4.5 out of 5 stars 108 Ratings
    Company Website for AlisQI
  • Certainty Software Reviews & Ratings
    4.5 out of 5 stars 93 Ratings
  • Hyperproof Reviews & Ratings
    4.6 out of 5 stars 350 Ratings
    Company Website for Hyperproof
  • Qualio Reviews & Ratings
    4.4 out of 5 stars 919 Ratings
    Company Website for Qualio
  • Jama Connect Reviews & Ratings
    4.3 out of 5 stars 416 Ratings
    Company Website for Jama Connect

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 FORM OpX?

Software designed for regulatory compliance is essential for organizations like Fannie Mae, Wendy's, and Walmart, who rely on a top-tier mobile inspection and audit platform. By utilizing such tools, you can significantly enhance both safety and accuracy within your operations. FORM OpX stands out as the leading field management platform, revolutionizing the way teams interact with Excel, paper, and digital processes. It integrates sophisticated data collection alongside customizable workflows, offering vital operational insights that boost real-time compliance. To promote adherence to regulations, you have the option to implement audits, inspections, or tailored workflows. With digital forms, data can be captured effectively while steering teams toward appropriate actions. Automated alerts can be configured to escalate issues, ensuring timely corrective measures are taken when necessary. Through the creation of personalized workflows, you can streamline processes, enhance compliance, and minimize errors, ultimately saving both time and resources. This approach not only fosters a culture of accountability but also empowers teams to operate with greater efficiency.

Media

Media

Integrations Supported

Salesforce
Jira
Microsoft 365

Integrations Supported

Salesforce
Qlik Cloud Analytics

API Availability

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

FORM.com

Date Founded

2002

Company Location

United States

Company Website

form.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

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

CAPA

Audit Management
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
OSHA Compliance
Risk Management
Surveys & Feedback
Workflow / Process Automation

Forms Automation

Approval Process Control
Archiving & Retention
Collaboration
Drag & Drop
Full Text Search
Remote Document Access
Rules-Based Workflow
Text Editing
Version Control

Inspection

Appointment Management
Customer Database
Dispatch Management
Equipment Tracking
Photos In Reports
Print on Site
Report Templates
Speech Recognition

Quality Management

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

Sustainability

Audit Management
Benchmarking
Corrective Actions (CAPA)
Employee Training
Incident Management
Performance Metrics
Supplier Management

Popular Alternatives

Modern Requirements4DevOps Reviews & Ratings

Modern Requirements4DevOps

Modern Requirements
5.0 out of 5 stars

Popular Alternatives

Alpha Anywhere Reviews & Ratings

Alpha Anywhere

Alpha Software Corporation
4.5 out of 5 stars
SmartCompliance Reviews & Ratings

SmartCompliance

4.0 out of 5 stars
Incident Tracker Reviews & Ratings

Incident Tracker

4.3 out of 5 stars
aligned elements Reviews & Ratings

aligned elements

Aligned AG
Safefood 360° Reviews & Ratings

Safefood 360°

4.3 out of 5 stars
Dot Compliance QMS Reviews & Ratings

Dot Compliance QMS

QMS for Life Sciences
Total Lean Management (TLM) Software Reviews & Ratings

Total Lean Management (TLM) Software

Lean & Mean Business Systems
5.0 out of 5 stars