Proarc

Proarc

Ascertra
+
+

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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.

About

Proarc Engineering Document Management Software helps teams drive document control best practices that lead to improved design quality, reduced risk, and increased profitability. Proarc is highly configurable and purpose-built to manage engineering documents and provides teams with controlled collaboration tools, automated workflows that support document control best practices, and a central, reliable repository for all project and asset operations documents. This is the perfect solution for companies that need to organize, plan, execute, collaborate, track, and deliver documentation, from the moment a document requirement arises to the handover and operations of the completed facility. Your entire team can deliver on schedule at each milestone and be audit-ready at any time. Proarc EDMS has been successfully used across the industry for nearly 30 years on implementations of all sizes and is designed to scale up to growing requirements.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

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

Audience

Document Management Software for Teams

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Supported
Free Trial Supported

Pricing

Pricing Details Upon Request
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

Ascertra
Norway
www.ascertra.com

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Categories

Categories

Collaboration Supported
Compliance Supported

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Supported
Project Management Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Not Supported
HIPAA Compliance Not Supported
Incident Management Not Supported
ISO Compliance Not Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Supported

Collaboration Features

Brainstorming Not Supported
Calendar Management Not Supported
Chat / Messaging Not Supported
Contact Management Not Supported
Content Management Not Supported
Document Management Supported
Project Management Supported
Real Time Editing Supported
Task Management Not Supported
Version Control Supported
Video Conferencing Not Supported

Document Management Features

Access Controls Supported
Archiving & Retention Supported
Collaboration Tools Supported
Compliance Tracking Supported
Document Archiving Supported
Document Assembly Supported
Document Capture Supported
Document Conversion Supported
Document Delivery Supported
Document Indexing Supported
Document Retention Supported
Electronic Signature Not Supported
Email Management Not Supported
File Recovery Not Supported
File Type Conversion Supported
Forms Management Not Supported
Full Text Search Supported
Offline Access Supported
Optical Character Recognition Not Supported
Print Management Not Supported
Version Control Supported

Integrations

Bentley View Not Supported
IBM Maximo Application Suite Not Supported
Jira Supported
Microsoft 365 Supported
Microsoft Dynamics 365 Not Supported
Oracle Fusion Cloud ERP Not Supported
Oracle Primavera Not Supported
Safran Project Not Supported
Salesforce Supported
SmartPlant Not Supported
Teamcenter Not Supported

Integrations

Bentley View Supported
IBM Maximo Application Suite Supported
Jira Not Supported
Microsoft 365 Not Supported
Microsoft Dynamics 365 Supported
Oracle Fusion Cloud ERP Supported
Oracle Primavera Supported
Safran Project Supported
Salesforce Not Supported
SmartPlant Supported
Teamcenter Supported
Claim Orcanos and update features and information
Claim Orcanos and update features and information
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Claim Proarc and update features and information