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About

The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly 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. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.

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.

Platforms Supported

Windows Supported
Mac Supported
Linux Supported
Cloud Supported
On-Premises Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Supported

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Audience

Pharmaceutical, Biotechnology, Medical Device, High Tech Manufacturing, Energy & Utilities, Food & Beverage, and others.

Audience

Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

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

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

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Reviews/Ratings

Overall 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 5

Pros & Cons from Real Users

Pros

  • The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

Cons

  • In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

AssurX
Founded: 1993
United States
www.assurx.com

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

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QT9 QMS

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Dot Compliance QMS

Dot Compliance QMS

QMS for Life Sciences

Categories

Categories

Audit Supported
CAPA Supported
Compliance Supported
Document Control Supported
ISO Compliance Supported
Quality Management Supported

Audit Features

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Exceptions Management Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Multi-Year Planning Supported
Risk Assessment Supported
Workflow Management Supported

Compliance Features

Archiving & Retention Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Supported
Environmental Compliance Supported
FDA Compliance Supported
HIPAA Compliance Supported
Incident Management Supported
ISO Compliance Supported
OSHA Compliance Supported
Risk Management Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback 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

Complaint Management Features

Case Management Not Supported
Complaint Classification Supported
Corrective Actions (CAPA) Supported
Customer Complaint Tracking Supported
Feedback Management Supported
Forms Management Supported
Issue Tracking Supported
Quality Assurance Management Supported
Routing Supported
Self Service Portal Not Supported
Social Media Monitoring Not Supported
Survey Management Not Supported

Energy Management Features

Benchmarking Not Supported
Bill Audit Not Supported
Bill Database Not Supported
Bill Importing Not Supported
Budgeting & Forecasting Not Supported
Compliance Management Supported
Contract Management Not Supported
Cost / Use Reporting Not Supported
Emissions Monitoring Not Supported
Energy Price Analysis Not Supported
Facility Scheduling Not Supported
Greenhouse Gas Tracking Not Supported
Load Control Not Supported
Load Forecasting Not Supported
Meter Tracking Not Supported
Risk Management Supported
Weather Normalization Not Supported

Manufacturing Features

Accounting Integration Not Supported
ERP Not Supported
Maintenance Management Not Supported
MES Not Supported
MRP Not Supported
Purchase Order Management Not Supported
Quality Management Supported
Quotes/Estimates Not Supported
Reporting/Analytics Not Supported
Safety Management Supported
Shipping Management Not 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

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

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

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

Integrations

Microsoft 365 Supported
Agile CRM Supported
Blue Link ERP Supported
Expandable Supported
Microsoft Access Supported
Microsoft Azure Supported
Microsoft Cognitive Toolkit Supported
Microsoft Dynamics 365 Supported
Microsoft Entra ID Not Supported
NetSuite Supported
Oracle BPM Suite Supported
Oracle Business Intelligence (OBIEE) Supported
Oracle Cloud Infrastructure Supported
Oracle PeopleSoft Supported
QAD Adaptive ERP Supported
QUMAS EQMS Supported
SAP Analytics Cloud Supported
SAP BusinessObjects Business Intelligence Supported
SAP Crystal Reports Supported
Tech Cloud ERP Supported

Integrations

Microsoft 365 Supported
Agile CRM Not Supported
Blue Link ERP Not Supported
Expandable Not Supported
Microsoft Access Not Supported
Microsoft Azure Not Supported
Microsoft Cognitive Toolkit Not Supported
Microsoft Dynamics 365 Not Supported
Microsoft Entra ID Supported
NetSuite Not Supported
Oracle BPM Suite Not Supported
Oracle Business Intelligence (OBIEE) Not Supported
Oracle Cloud Infrastructure Not Supported
Oracle PeopleSoft Not Supported
QAD Adaptive ERP Not Supported
QUMAS EQMS Not Supported
SAP Analytics Cloud Not Supported
SAP BusinessObjects Business Intelligence Not Supported
SAP Crystal Reports Not Supported
Tech Cloud ERP Not Supported
Claim AssurX and update features and information
Claim AssurX and update features and information
Claim SimplerQMS and update features and information
Claim SimplerQMS and update features and information