SimplerQMS Reviews

SimplerQMS

3.0 out of 5 stars

Average Ratings 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

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

Write a Review

Average Ratings 2 Ratings

Total 3 out of 5 stars
ease 3 out of 5 stars
features 2.5 out of 5 stars
design 2.5 out of 5 stars
support 3.5 out of 5 stars

Description

Enhance your quality compliance management through our secure, cloud-based solutions that streamline every aspect of your audits in a single platform. This includes features such as CAPA follow-ups, auditor CVs, real-time updates on audit statuses, and a comprehensive audit report repository, among other functionalities. Our platform facilitates seamless connections between customers, suppliers, and auditors, enabling centralized control across multiple sites. Gain access to an extensive audit database featuring over 2,300 audits, utilizing our shared audits model and pre-existing reports to eliminate the complexities associated with organizing new audits. Additionally, our supplier directory makes it easy to find both new and backup suppliers from a pool of over 24,000, offering the widest variety of products and services available in the industry. Qualify and choose the best partners effortlessly, with instant access to their most recent audit reports, compliance information, warning letters, and quality ratings. Moreover, experience the fastest onboarding process available in the industry, complemented by our weekly updates on observation ratings and CAPA performance metrics, ensuring you remain informed and compliant at all times. Don't miss out on the opportunity to revolutionize your quality compliance management with our innovative solutions.

Description

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes. The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records. Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards. Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes: • Audit-proven insights • Guidance from compliance specialists • Continuous system validation • User training • 24/7 global support • Smooth implementation and data migration • Dedicated Customer Success Experts With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

API Access

Has API Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 No 
Microsoft Entra ID No 

Integrations

Microsoft 365 Yes 
Microsoft Entra ID Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Qualifyze

Founded

2019

Country

Germany

Website

www.qualifyze.com

Vendor Details

Company Name

SimplerQMS

Founded

2017

Country

Denmark

Website

www.simplerqms.com

Product Features

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 

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 

Alternatives

eAuditor Audits & Inspections Reviews

eAuditor Audits & Inspections

Lyons Information Systems

Alternatives

QEdge Reviews

QEdge

Sarjen Systems Pvt Ltd
Audit Pro Reviews

Audit Pro

Omnex Systems
isoTracker Quality Management Reviews

isoTracker Quality Management

isoTracker Solutions Ltd
4.6 out of 5 stars
Dot Compliance QMS Reviews

Dot Compliance QMS

QMS for Life Sciences
QT9 QMS Reviews

QT9 QMS

QT9 Software
Lyons Quality Audit Tracking LQATS Reviews

Lyons Quality Audit Tracking LQATS

Lyons Information Systems
QualityPro by TecWork Reviews

QualityPro by TecWork

TecWork Global Business Solutions Pvt. Ltd.
5.0 out of 5 stars