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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.
Description
Founded in 2004, Sunday Business Systems (SBS) specializes in providing quality management software and consulting services that help businesses comply with a range of ISO certifications like ISO 9001:2015 and ISO 13485. SBS’s product suite includes tools for document control, asset tracking, corrective actions, and preventive maintenance. Their cloud-based solutions are designed to simplify and automate key business processes, while their consulting services offer expert guidance for businesses aiming for ISO certification or requiring customized software for manufacturing or compliance needs.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Asset Tracking Database
No
FMEA Database
No
Microsoft 365
Yes
Microsoft Entra ID
Yes
Q-Med Database
No
SBS Ground Control
No
SBS Inspection Database
No
SBS Quality Database
No
SBS Quality Management Software
No
SBS T-Med Database
No
Integrations
Asset Tracking Database
Yes
FMEA Database
Yes
Microsoft 365
No
Microsoft Entra ID
No
Q-Med Database
Yes
SBS Ground Control
Yes
SBS Inspection Database
Yes
SBS Quality Database
Yes
SBS Quality Management Software
Yes
SBS T-Med Database
Yes
Pricing Details
$13,750/year
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial
Yes
Free Version
No
Pricing Details
$295
Pricing varies by product and by the number of concurrent users. See individual product pages for detailed pricing.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Vendor Details
Company Name
Sunday Business Systems
Founded
2004
Country
United States
Website
sundaybizsys.com
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
No
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
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
No
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
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
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
Product Features
Asset Tracking
Activity Tracking
Yes
Audit Trails
Yes
Barcoding / RFID
No
Checkout / Check-In
No
Depreciation Tracking
Yes
Disposal Tracking
No
Inventory Management
Yes
Location Tracking
Yes
QR Codes
No
Reservations
No
Service History
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
No
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Inspection
Appointment Management
No
Customer Database
No
Dispatch Management
No
Equipment Tracking
Yes
Photos In Reports
No
Print on Site
No
Report Templates
No
Speech Recognition
No
Subcontractor Management
No
Manufacturing
Accounting Integration
No
ERP
No
MES
No
MRP
No
Maintenance Management
Yes
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
Yes
Safety Management
Yes
Shipping Management
No
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
Vendor Management
Audit Management
Yes
Contact Management
Yes
Customer Database
Yes
Self Service Portal
No
Supplier Master Data
Yes
Transaction History
Yes
Vendor Maintained Profiles
No
Vendor Managed Inventory
No
Vendor Performance Rating
Yes
Vendor Qualification Tracking
Yes