RegDocs365Court Square Group
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Related Products
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About
Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.
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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.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
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Audience
Pharmaceutical, biotech, life science, medical device vendors, and more
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Audience
Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Not Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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PricingPer user, Per month
Free Version
Not Supported
Free Trial
Not Supported
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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
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationCourt Square Group
Founded: 1995
United States
www.regdocs365.com
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Alternatives |
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Categories |
Categories |
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Clinical Trial Management Features
21 CFR Part 11 Compliance
Supported
Document Management
Supported
Electronic Data Capture
Supported
Enrollment Management
Not Supported
HIPAA Compliant
Supported
Monitoring
Not Supported
Patient Database
Not Supported
Recruiting Management
Not Supported
Scheduling
Not Supported
Study Planning
Not Supported
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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
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
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
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
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
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Integrations
Crow Canyon Contract Management
Supported
Microsoft 365
Not Supported
Microsoft Entra ID
Not Supported
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Integrations
Crow Canyon Contract Management
Not Supported
Microsoft 365
Supported
Microsoft Entra ID
Supported
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