SBS Quality Management SoftwareSunday Business Systems
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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.
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About
The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server.
Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user.
The SBS QMS Suite of modules:
SBS Quality Database
- CAPA / 8D with root cause analysis
- Nonconformance management
- Risk analysis (FMEA, SWOT, etc.)
- Audit management
- EHS module
SBS Ground Control
- Employee training management (LMS)
- Document control
SBS Asset Tracking Database
- Calibrated equipment
- Preventive maintenance
SBS Inspection Database
- Data collection / SPC
- Control Plans
SBS Vendor Management
- Approved vendor list / AVL
- Supplier qualification plans
Great product for efficient and affordable QMS Compliance
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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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
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Audience
Companies interested in a powerful QMS suite
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
$4,268 one time fee
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Company InformationSunday Business Systems
Founded: 2004
United States
sundaybizsys.com/products/
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Alternatives |
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Categories |
Categories |
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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
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CAPA Features
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Document Control Features
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
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
Asset Tracking Features
Activity Tracking
Audit Trails
Barcoding / RFID
Checkout / Check-In
Depreciation Tracking
Disposal Tracking
Inventory Management
Location Tracking
QR Codes
Reservations
Service History
Calibration Management Features
Calibration Instructions
Calibration Schedules
Compliance Management
Device History
Due Date Tracking
Gage Management
Label Printing
Measurement Readings
Multi-Station Management
Out-of-Tolerance Notification
Statistical Data Reporting
Learning Management Systems (LMS) Features
Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Corporate / Business
Customizable
eCommerce
eLearning Companies
Gamification
Learner Portal
Mobile Learning
Open Source
SCORM Compliance
Synchronous Learning
Video Conferencing
Preventive Maintenance Features
Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management
SPC Features
Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance
Vendor Management Features
Audit Management
Contact Management
Customer Database
Self Service Portal
Supplier Master Data
Transaction History
Vendor Maintained Profiles
Vendor Managed Inventory
Vendor Performance Rating
Vendor Qualification Tracking
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Integrations
Microsoft 365
Azure SQL Database
Azure SQL Edge
Jira
Salesforce
Sunday Business Systems
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Integrations
Microsoft 365
Azure SQL Database
Azure SQL Edge
Jira
Salesforce
Sunday Business Systems
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