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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 DataSnipper?

Boost your organization's expansion and strengthen its resilience with DataSnipper’s AI-driven automation platform, specifically tailored for Excel. By optimizing workflows, you can offer greater value to your clients through enhanced productivity. Evaluate the efficiency of your controls and broaden your tax operations with automated data extraction features. Ensure uniformity in document management and conduct comprehensive audits with complete clarity. Unfortunately, audit and finance teams frequently waste valuable time on monotonous manual tasks while overseeing financial processes, leading to extended turnaround times. The intricate nature of sharing, reviewing, and confirming financial documentation can become chaotic and cumbersome, resulting in lost time and a decline in work quality. Utilizing AI enables the automation of the extraction, cross-referencing, and validation of source documents pertinent to any audit or financial procedure. This not only boosts your productivity but also allows you to retain oversight while significantly minimizing repetitive tasks. By adopting AI, you can effectively tackle new challenges in the rapidly evolving audit and finance landscape, ensuring that you maintain a competitive edge. Moreover, this cutting-edge strategy not only improves operational efficiency but also nurtures a more adaptable approach to the shifting demands of the industry, paving the way for long-term success.

Media

Media

Integrations Supported

Jira
Microsoft 365
Salesforce

Integrations Supported

Microsoft Excel

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

€59 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
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

DataSnipper

Company Location

Netherlands

Company Website

www.datasnipper.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

Not specified

Finance

Not specified

Financial Audit

Not specified

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