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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 DocControl?

DocControl is an innovative online platform designed to manage and oversee documents with efficiency and ease. Its intuitive and flexible interface allows for smooth operation across a diverse range of devices. This system fosters collaborative efforts among teams, equipped with a wide array of features including generous storage options, document versioning, electronic signatures, and instant conversion to PDF. Additionally, it adheres to HIPAA regulations and 21 CFR Part 11, which significantly boosts its security compared to other document management systems. Users can effortlessly upload any type of document, which is promptly transformed into PDF format, while its streamlined workflow enhances the editing process by automatically adjusting version numbers with every modification. This solution is especially advantageous for small to medium-sized enterprises that emphasize both document security and teamwork. With an expanding client roster of over 50 corporate partners, DocControl has efficiently handled more than 5,000 documents, generating over 30,000 PDFs, which illustrates its effectiveness and dependability in document management. As businesses strive to optimize their document operations, DocControl emerges as a robust and comprehensive solution tailored to meet their needs effectively. Furthermore, its ongoing updates and feature expansions continue to enhance user experience, making it a valuable asset for any organization.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Puntt AI

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

$49 per month
Free Trial Offered?

Supported Platforms

SaaS
Android
Windows

Supported Platforms

SaaS

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
On-Site Training

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Company Facts

Organization Name

QMS ECommerce Solutions

Date Founded

2000

Company Location

United States

Company Website

www.doccontrol.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 Control

Not specified

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Conversion
Document Indexing
Document Retention
Electronic Signature
File Recovery
File Type Conversion
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

PDF Generators

Not specified

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