Average Ratings 1 Rating

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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 

Screenshots View All

Screenshots View All

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 
SBS Training Database No 
SBS Vendor Management 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 
SBS Training Database Yes 
SBS Vendor Management 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 

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd

Alternatives

Intelex Reviews

Intelex

Intelex Technologies
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
SBS Quality Database Reviews

SBS Quality Database

Sunday Business Systems
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
SBS Quality Management Software Reviews

SBS Quality Management Software

Sunday Business Systems
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
QT9 QMS Reviews

QT9 QMS

QT9 Software