Intact PlatformIntact
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Related Products
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About
The Intact Platform is the leading cloud and on-premise Enterprise Resource Planning (ERP) solution for audits, assessments, certification, accreditation, and standards worldwide. It goes beyond other audit collection tools on the market with a full solution approach that helps you manage communications, business goals, and personnel. The Intact Platform is unsurpassed in functionality and features a fully modular end-to-end workflow that is easily scalable.
✓ 34% increase in efficiency on average (up to 60+%)
✓ Unmatched modularity, flexibility, and scalability
✓ All standards and audit services
✓ Digital workflow – no paper
✓ On-site and remote auditing
✓ Non-conformities & corrective actions
✓ Risk-based auditing & planning
✓ Easy client communication
✓ Reporting & business intelligence (BI)
✓ Central data and management hub (incl. full audit trail)
✓ Nonstop innovation
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About
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Certification Bodies, Accreditation Bodies, Standard Setters, Internal and Supplier Audits
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Audience
Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
On request
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationIntact
Founded: 2001
Austria
intact-systems.com
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Alternatives |
Alternatives |
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Categories |
Categories |
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Audit Features
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Quality Management Features
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
Food Traceability Features
CRM
Order Management
Product Lifecycle Management
Production Management
Quality Control
Recall Management
Recipe Management
Traceability
Traceback & Traceforward
Supply Chain Management Features
Demand Planning
Electronic Data Interchange
Import / Export Management
Inventory Management
Order Fulfillment
Order Management
Sales & Operations Planning
Shipping Management
Supplier Management
Transportation Management
Warehouse Management
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Application Lifecycle Management Features
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management Features
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes
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Integrations
Microsoft 365
Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Jira
Pimberly
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Integrations
Microsoft 365
Azure Storage
ComponentOne
Conholdate.Total For .NET
Conholdate.Total for Java
GitHub
Google Maps
Highcharts
Jira
Pimberly
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