Related Products
|
||||||
About
SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process.
What customers appreciate most:
• Compliant processes and fewer manual errors
• Fast implementation and smooth data migration
• User training and 24/7 global support
• Guidance from compliance experts throughout the journey
Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.
|
About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
|
|||||
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
|
Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
|
|||||
Audience
Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO
|
Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
|
|||||
Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
|
Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
|
|||||
API
Offers API
Supported
|
API
Offers API
Not Supported
|
|||||
Screenshots and Videos |
Screenshots and Videos |
|||||
Pricing
$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 Version
Not Supported
Free Trial
Supported
|
Pricing
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Version
Not Supported
Free Trial
Supported
|
|||||
Reviews/
|
Reviews/
|
|||||
Pros & Cons from Real UsersPros
Cons
|
Pros & Cons from Real UsersPros
Cons
|
|||||
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
|
Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
|
|||||
Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
|
Company InformationqmsWrapper
Canada
www.qmswrapper.com
|
|||||
Alternatives |
Alternatives |
|||||
|
|
||||||
|
|
||||||
|
|
|
|||||
|
|
||||||
Categories |
Categories |
|||||
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Not Supported
Training Management
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
Audit Features
Alerts / Notifications
Supported
Audit Planning
Supported
Compliance Management
Supported
Dashboard
Supported
Exceptions Management
Not Supported
Forms Management
Supported
Issue Management
Supported
Mobile Access
Supported
Multi-Year Planning
Not Supported
Risk Assessment
Supported
Workflow Management
Supported
Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Not Supported
Controls Testing
Not Supported
Environmental Compliance
Not Supported
FDA Compliance
Supported
HIPAA Compliance
Supported
Incident Management
Not Supported
ISO Compliance
Supported
OSHA Compliance
Not Supported
Risk Management
Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Not Supported
Version Control
Supported
Workflow / Process Automation
Supported
Document Control Features
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Escalation Management
Supported
Periodic Review
Supported
Version Control
Supported
|
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Not Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
|
|||||
Integrations
Jira
Not Supported
Microsoft 365
Supported
Microsoft Entra ID
Supported
|
Integrations
Jira
Supported
Microsoft 365
Not Supported
Microsoft Entra ID
Not Supported
|
|||||
|
|
|