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Description

Transform your operations into a digital framework that prioritizes security, environmental responsibility, quality, and hygiene within your business. By centralizing, simplifying, and automating processes through a single tool, you can achieve sustainable performance for your organization. The effectiveness and safety of your enterprise hinge on streamlined automated processes, and BlueKanGo presents itself as the comprehensive digital EHSQ solution for managing these essential functions. If you're aiming to tackle societal and environmental challenges, mitigate risks, and enhance operational excellence, trust the platform that over 3,500 customers have relied on for more than 18 years. Embrace the digitization of your quality management, EHS initiatives, and much more, covering aspects like quality audits, employee health and safety, environmental compliance, CMMS, inspections, certifications, standards, corporate social responsibility, regulatory oversight, and strategic planning. Our six key differentiators highlight our strengths in the industry. With over 18 years in the market, BlueKanGo stands as a SaaS platform limited only by your creativity, offering an innovative, scalable, and comprehensive solution designed to adapt to your organization's evolving needs. The future of your business processes starts with a commitment to digital transformation and a partnership with BlueKanGo.

Description

Orcanos is an integrated MedTech software platform built to help medical device companies manage quality, compliance, product development, and regulatory documentation from one connected workspace. It combines electronic quality management, application lifecycle management, design controls, document control, risk management, traceability, and audit readiness. The platform is designed to bridge the gap between R&D and Quality teams by connecting user needs, requirements, hazards, mitigations, tests, validations, complaints, and quality processes. Orcanos supports regulated frameworks and standards such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Its eQMS capabilities include document workflows, PDF publishing, revision control, electronic signatures, training automation, audit trails, CAPA support, and quality process management. ALM and design control features help teams maintain a live digital thread across development artifacts, risk files, verification activities, and design history documentation. Orcanos also offers customizable no-code workflows, configurable fields, granular permissions, and migration support for teams moving from spreadsheets or legacy tools. Its AI-powered assistant, Ask Paul, is positioned to help users navigate operations and improve efficiency. By unifying quality and development data, Orcanos helps medical device organizations stay audit-ready while reducing manual documentation work.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Jira No 
Microsoft 365 No 
Salesforce No 

Integrations

Jira Yes 
Microsoft 365 Yes 
Salesforce Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App Yes 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App Yes 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

BlueKanGo

Founded

1998

Country

France

Website

www.bluekango.com/en/

Vendor Details

Company Name

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com

Product Features

Accreditation Management

Collaboration Yes 
Compliance Management Yes 
Document Management Yes 
Higher Education No 
Requirements Management Yes 
Reviewer Portal Yes 
Self Assessment Yes 
User Access Permissions Yes 
Workflow Management Yes 

Audit

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

Business Process Management

Access Controls / Permissions Yes 
Alerts / Notifications Yes 
Business Process Automation Yes 
Business Rules Management Yes 
Collaboration Yes 
Process Change Tracking Yes 
Process Mapping Yes 
Process Modeling & Design No 
Visual Workflow Management Yes 

CAPA

Audit Management Yes 
CAPA Planning Yes 
Change Management Yes 
Complaint Management Yes 
Incident Management Yes 
Nonconformance Tracking Yes 
Quality Control Yes 
Risk Management Yes 
Root Cause Analysis Yes 
Training Management Yes 

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking Yes 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management Yes 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback Yes 
Version Control Yes 
Workflow / Process Automation Yes 

Document Control

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

Document Management

Access Controls No 
Archiving & Retention No 
Collaboration Tools Yes 
Compliance Tracking Yes 
Document Archiving Yes 
Document Assembly Yes 
Document Capture No 
Document Conversion No 
Document Delivery No 
Document Indexing Yes 
Document Retention Yes 
Electronic Signature Yes 
Email Management No 
File Recovery Yes 
File Type Conversion Yes 
Forms Management No 
Full Text Search No 
Offline Access Yes 
Optical Character Recognition Yes 
Print Management No 
Version Control Yes 

EHS Management

Audit Management Yes 
Corrective / Preventive Actions Yes 
Environmental Management No 
Environmental Risk Assessment No 
Forms Management No 
Incident Management Yes 
Industrial Safety Management Yes 
Injury Reporting No 
Inspection Management Yes 
MSDS No 
OSHA Recordkeeping Yes 
Occupational Health Management Yes 
Safety Risk Assessment Yes 
Training Management Yes 
Waste Management No 

Environmental

Air Management No 
Auditing Yes 
Compliance Management Yes 
Document Management Yes 
Emissions Inventory Yes 
Hazardous Materials Control Yes 
Sustainability Management Yes 
Training Management No 
Waste Management Yes 
Water Management No 

Forms Automation

Approval Process Control No 
Archiving & Retention Yes 
Collaboration Yes 
Document Indexing No 
Drag & Drop Yes 
Full Text Search Yes 
Remote Document Access No 
Rules-Based Workflow No 
Text Editing No 
Version Control Yes 

Inspection

Appointment Management Yes 
Customer Database Yes 
Dispatch Management Yes 
Equipment Tracking Yes 
Photos In Reports Yes 
Print on Site Yes 
Report Templates Yes 
Speech Recognition Yes 
Subcontractor Management Yes 

Quality Management

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

Risk Management

Alerts/Notifications Yes 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management Yes 
IT Risk Management No 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access Yes 
Operational Risk Management Yes 
Predictive Analytics Yes 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

Safety Management

Audit Management Yes 
Corrective / Preventive Actions Yes 
Incident Management Yes 
Injury Reporting No 
Inspection Management Yes 
OSHA Recordkeeping Yes 
Safety Risk Assessment No 
Training Management Yes 

Product Features

Application Lifecycle Management

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

Audit

Alerts / Notifications No 
Audit Planning No 
Compliance Management No 
Dashboard No 
Exceptions Management No 
Forms Management No 
Issue Management No 
Mobile Access No 
Multi-Year Planning No 
Risk Assessment No 
Workflow Management No 

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Document Control

Archiving & Retention No 
Automated Routing No 
Change Management No 
Compliance Management No 
Electronic Signature No 
Escalation Management No 
Periodic Review No 
Version Control No 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) No 
Defect Tracking No 
Document Control No 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA No 
Automated Test Generation No 
Automated Use Case Modeling No 
Change Management Yes 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking Yes 
Summary Reports Yes 
Task Management Yes 
To-Do List Yes 
Traceability Yes 
User Defined Attributes Yes 

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management No 
Corrective Actions (CAPA) No 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management No 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management No 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment No 

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