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What is Proarc?

Proarc's document management system is specifically crafted to oversee engineering documents effectively. It equips teams with tools that foster controlled collaboration and automated workflows, ensuring adherence to document best practices. Additionally, it serves as a centralized repository for all asset operations and project-related documents. Proarc's EDMS is an ideal solution for organizations that need to plan, execute, collaborate, and monitor documentation from inception to the eventual handover and operation of the completed facility. This platform enables teams to meet deadlines at every milestone while remaining audit-ready at all times. Furthermore, Proarc is highly customizable, allowing it to be adjusted to fit the unique requirements of each project while aligning with the broader policies of the organization. With nearly three decades of successful industry applications, our solutions are proven to be flexible and responsive to changing needs. This adaptability ensures that Proarc remains a valuable asset for companies navigating the complexities of document management.

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

Bentley View
IBM Maximo Application Suite
Microsoft Dynamics 365
Oracle Fusion Cloud ERP
Oracle Primavera
Safran Project
SmartPlant
Teamcenter

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

Has API

API Availability

Pricing Information

Pricing Details Upon Request

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
24 Hour 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
On-Site Training

Company Facts

Organization Name

Ascertra

Company Location

Norway

Company Website

www.ascertra.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Collaboration

Document Management
Project Management
Real Time Editing
Version Control

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Risk Management
Version Control
Workflow / Process Automation

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
File Type Conversion
Full Text Search
Offline Access
Version Control

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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