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What is TrackMyRisks?

Consolidate all your governance, compliance, and risk management documents in a single accessible platform. You can easily upload and share a variety of file types, including PDFs, Office documents, images, and more. Managing your files is hassle-free with built-in automatic version control, eliminating the need to sift through numerous network folders or overflowing inboxes. Additional beneficial features include reminders for document expiration, unlimited permissioned users, customizable document tagging, and in-system notifications. This ensures you maintain reliable and secure visibility over your documents. Simply having the latest version of a document is insufficient; effective compliance requires diligent version control and meticulous user access tracking. With TrackMyRisks, you can also utilize a comprehensive user activity log, regular backups, virus scanning, and document revision history, along with robust encryption for all your files to enhance security further. These features collectively help streamline your document management and bolster your organization's compliance efforts.

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

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

#10 per month

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Continuity Partner

Date Founded

2014

Company Location

United Kingdom

Company Website

trackmyrisks.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Compliance

Archiving & Retention
Audit Management
Compliance Tracking
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Escalation Management
Periodic Review
Version Control

Document Management

Compliance Tracking
Document Archiving
Document Retention
Version Control

GRC

Auditing
Internal Controls Management
Operational Risk Management
Policy Management

Risk Management

Auditing
Business Process Control
Compliance Management
Dashboard
Internal Controls Management

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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