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About

The Secure Audit, Risk, Compliance & Quality Software. With On-Premise and Cloud-based deployment options. Auditrunner offers granular encryption and role-based access control for audit files and documents at-rest. All data transfers are protected. We have automated 3000+ business processes for enterprises around the world. Our GRC platform modules are just a few of them. Cloud-based or On-Premise, deploy and start using. Hassle-free integration process enables you to enjoy the benefits of the platform within weeks of kickoff . The low-code platform we are built upon is fully customizable and allows for compliance with any standard or regulation. Operate in a responsive manner in today’s fast-moving, ever-changing regulatory environment and comply with multitude of different legislation instantly without the need for assistance. The ease of use we offer is unmatched.

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.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Audit teams of all sizes

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

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

$850/month
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

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

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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
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Auditrunner
Founded: 2016
United States
www.auditrunner.com

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Alternatives

Alternatives

Modern Requirements4DevOps

Modern Requirements4DevOps

Modern Requirements
integrum

integrum

integrum Management Systems
aligned elements

aligned elements

Aligned AG
Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences
Total Lean Management (TLM) Software

Total Lean Management (TLM) Software

Lean & Mean Business Systems

Categories

Categories

Audit Features

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Risk Management Features

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
Internal Controls Management
IT Risk Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Data Privacy Management Features

Access Control
CCPA Compliance
Consent Management
Data Mapping
GDPR Compliance
Incident Management
PIA / DPIA
Policy Management
Risk Management
Sensitive Data Identification

GRC Features

Auditing
Disaster Recovery
Environmental Compliance
Incident Management
Internal Controls Management
IT Risk Management
Operational Risk Management
Policy Management

Application Lifecycle Management Features

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

Requirements Management Features

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Integrations

Microsoft 365
Auth0
Google
Jira
Microsoft Azure
Okta
Power BI Embedded
SAP ERP
Salesforce

Integrations

Microsoft 365
Auth0
Google
Jira
Microsoft Azure
Okta
Power BI Embedded
SAP ERP
Salesforce
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