Average Ratings 7 Ratings
Average Ratings 0 Ratings
Description
The SBS QMS Suite consists of 5 software modules that work together for efficient Quality compliance:
1) SBS Quality Database
- CAPA / 8D corrective and preventive actions (CAR) with root cause analysis
- Nonconformance management
- Risk analysis including FMEA, SWOT, interested party risk register
- Internal, customer, and third-party audit management
- Environmental Health and Safety (EHS / HSE) management
2) SBS Ground Control
- Employee training management (LMS)
- Self-Paced training
- Change control
- Document control
3) SBS Asset Tracking Database
- Calibrated equipment control
- Preventive maintenance
- Asset inventory management
4) SBS Inspection Database
- Record incoming material, in process, and final product inspection data
- Generate real time SPC charts
- Inspection plans and Control Plans
- Archive data for further statistical analysis
5) SBS Vendor Management
- Maintain an approved vendor list or AVL
- Develop vendor / supplier qualification plans
- Maintain vendor / supplier qualification history
Modules may be purchased separately or in any combination.
On-premise and cloud-based options are available.
Free demos are available for download or contact us for a cloud-based demo.
Description
SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.
SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.
The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.
SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.
Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Azure SQL Database
Azure SQL Edge
Microsoft Entra ID
Sunday Business Systems
Integrations
Microsoft 365
Azure SQL Database
Azure SQL Edge
Microsoft Entra ID
Sunday Business Systems
Pricing Details
$4,268 one time fee
Free Trial
Free Version
Pricing Details
$13,750/year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com/qms-suite-2/
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Asset Tracking
Activity Tracking
Audit Trails
Barcoding / RFID
Checkout / Check-In
Depreciation Tracking
Disposal Tracking
Inventory Management
Location Tracking
QR Codes
Reservations
Service History
Calibration Management
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
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Learning Management Systems (LMS)
Academic / Education
Asynchronous Learning
Blended Learning
Built-In Course Authoring
Corporate / Business
Customizable
Gamification
Learner Portal
Mobile Learning
Open Source
SCORM Compliance
Synchronous Learning
Video Conferencing
eCommerce
eLearning Companies
Preventive Maintenance
Condition Monitoring
Inspection Management
Maintenance Scheduling
Mobile Access
Predictive Maintenance
Purchasing
Reminders
To-Do List
Vendor Management
Work Order Management
Quality Management
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
SPC
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
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
Product Features
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Quality Management
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