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Average Ratings 1 Rating
Description
The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure, and modify.
AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.
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.
API Access
Has API
Yes
API Access
Has API
Yes
Integrations
Microsoft 365
Yes
Agile CRM
Yes
Blue Link ERP
Yes
Expandable
Yes
JD Edwards EnterpriseOne
Yes
Microsoft Access
Yes
Microsoft Azure
Yes
Microsoft Dynamics 365
Yes
Microsoft Entra ID
No
Oracle BPM Suite
Yes
Integrations
Microsoft 365
Yes
Agile CRM
No
Blue Link ERP
No
Expandable
No
JD Edwards EnterpriseOne
No
Microsoft Access
No
Microsoft Azure
No
Microsoft Dynamics 365
No
Microsoft Entra ID
Yes
Oracle BPM Suite
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
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
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
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)
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
AssurX
Founded
1993
Country
United States
Website
www.assurx.com
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
Yes
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
Yes
Risk Assessment
Yes
Workflow Management
Yes
Complaint Management
Case Management
No
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
Yes
Forms Management
Yes
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
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
Energy Management
Benchmarking
No
Bill Audit
No
Bill Database
No
Bill Importing
No
Budgeting & Forecasting
No
Compliance Management
Yes
Contract Management
No
Cost / Use Reporting
No
Emissions Monitoring
No
Energy Price Analysis
No
Facility Scheduling
No
Greenhouse Gas Tracking
No
Load Control
No
Load Forecasting
No
Meter Tracking
No
Risk Management
Yes
Weather Normalization
No
Manufacturing
Accounting Integration
No
ERP
No
MES
No
MRP
No
Maintenance Management
No
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
No
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
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