Average Ratings 93 Ratings
Average Ratings 0 Ratings
Description
Certainty is an enterprise-level auditing and inspection software that can be trusted to help you manage and report on business risk, compliance, and performance metrics quickly and efficiently.
Certainty Software is used by hundreds of thousands of professionals to complete millions of inspections and audits each year. It provides all the tools you need to collect, collate, and report consistent, accurate, and meaningful metrics across your business.
Certainty provides all the tools you need to design, manage, and report on audit/inspection data, as well as help you manage and mitigate any risks, incidents, and issues that may be identified during the audit/inspection process.
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
Yes
API Access
Has API
No
Integrations
ALL In Learning
No
Jira
Yes
Microsoft 365
Yes
Salesforce
Yes
Pricing Details
$18 per user per month
Priced by user and billed annually in advance.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
Yes
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
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Certainty Software
Founded
2010
Country
Canada
Website
bit.ly/4dzwWZg
Vendor Details
Company Name
Orcanos
Founded
2004
Country
Israel
Website
www.orcanos.com
Product Features
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
No
Risk Assessment
Yes
Workflow Management
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
No
Complaint Management
No
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
No
Compliance
Archiving & Retention
No
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
Yes
Risk Management
Yes
Sarbanes-Oxley Compliance
Yes
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
EHS Management
Audit Management
Yes
Corrective / Preventive Actions
Yes
Environmental Management
Yes
Environmental Risk Assessment
Yes
Forms Management
Yes
Incident Management
Yes
Industrial Safety Management
Yes
Injury Reporting
Yes
Inspection Management
Yes
MSDS
No
OSHA Recordkeeping
Yes
Occupational Health Management
Yes
Safety Risk Assessment
Yes
Training Management
No
Waste Management
No
Inspection
Appointment Management
No
Customer Database
Yes
Dispatch Management
No
Equipment Tracking
Yes
Photos In Reports
Yes
Print on Site
Yes
Report Templates
Yes
Speech Recognition
No
Subcontractor Management
Yes
Risk Management
Alerts/Notifications
Yes
Auditing
Yes
Business Process Control
No
Compliance Management
Yes
Corrective Actions (CAPA)
Yes
Dashboard
Yes
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
Yes
Legal Risk Management
No
Mobile Access
Yes
Operational Risk Management
Yes
Predictive Analytics
No
Reputation Risk Management
No
Response Management
Yes
Risk Assessment
Yes
Safety Management
Audit Management
Yes
Corrective / Preventive Actions
Yes
Incident Management
Yes
Injury Reporting
Yes
Inspection Management
Yes
OSHA Recordkeeping
Yes
Safety Risk Assessment
Yes
Training Management
No
Supply Chain Management
Demand Planning
No
Electronic Data Interchange
No
Import / Export Management
No
Inventory Management
No
Order Fulfillment
No
Order Management
No
Sales & Operations Planning
No
Shipping Management
No
Supplier Management
Yes
Transportation Management
No
Warehouse Management
No
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
