AssurX Inc.

One Quality Management Software System (QMS) Delivers Every Solution for Medical Device Manufacturing

The AssurX quality management system (QMS) software platform offers an easy-to-use, flexible, integrated set of quality management system (QMS) software solutions designed for FDA-regulated manufacturers. With one system you can improve quality and compliance, streamline workflow, control risk and better manage your enterprise. No other automated quality management system (QMS) is easier to deploy, use and modify.

Using AssurX quality management software, you not only know immediately when an issue arises (from any source: customer, supplier, internal), all relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem.

The AssurX Automated Quality Management System

SINGLE PLATFORM
One system of seamlessly connected solutions to improve quality, ensure compliance, manage risk and streamline workflow.

COMPLIANCE BUILT-IN
Every solution built for FDA, ISO and cGXP. Seamlessly integrated electronic medical device reporting (eMDR).

STREAMLINED ACTIVITIES
Automatically orchestrate and track activities, share data and communicate information to the appropriate parties.

COMPLETE TRANSPARENCY
Dashboards provide live, clear views of coordinated activities and information across all areas of the business.

THE EFFICIENT MANAGER
Manage operations while detecting, correcting and preventing potential issues.

EFFORTLESS STABILITY
Simple to deploy, configure, use and modify.

COMPLETE ANALYTICS
Powerful real-time trending and analytical tools.

SERVICE DELIVERED
Available as either traditional OnPremise (licensed software) or OnDemand (cloud-based SaaS).

QUALITY MANAGEMENT SOFTWARE SOLUTIONS | Included in the AssurX Platform
Ready-to-use quality and compliance software solutions are part of the core AssurX quality management system (QMS) platform and work together seamlessly—sharing a single source of data and informing one another. With the AssurX quality management system (QMS) platform you can start with just the solutions you need, then easily bring new quality and compliance processes online as you’re ready.

AssurX’s closed-loop solutions deliver fully FDA-compliant processes for integrated, corrective and preventive action (CAPA), complaints management, supplier quality management, document management, risk management, training management, change management, audit management, overall product quality management, electronic medical device reporting (eMDR) and more, while a state of control and proof of compliance is maintained continuously in one central, securely accessible system.

Audit Management
Change Management
Compliance Management
Corrective and Preventive Action (CAPA)
Complaints Management
Customer Quality Management
Document Management
eMDR (Electronic Medical Device Reporting)
Manufacturing Quality Management
Risk Management
Supplier Quality Management
Training Management

LEARN MORE ABOUT THE ASSURX QMS PLATFORM AND INCLUDED SOLUTIONS

AssurX Clients + Testimonials
We’re proud to keep good company. Medical device companies of every size—that’s 10s of 1000s of users worldwide—rely on us each day. AssurX is an ideal partner for medical device companies looking for better operational control and efficiency while staying compliant.

SEE MORE ASSURX CLIENTS  |  ACCESS THE ASSURX CLIENT TESTIMONIALS  |  READ CUSTOMER CASE STUDIES

WEBCAST LIBRARY | Quality Management System (QMS) Best Practices
Audit Management Best Practices
Automating Your QMS: Pitfalls To Avoid & Essential Strategies For Success
Complaints Handling for Life Science Companies
Corrective and Preventive Action Automation Best Practices
Document Management Best Practices for Life Science
Electronic Medical Device Reporting (eMDR)
Training Management Best Practices

EXPLORE ALL ASSURX WEBCASTS

WHITEPAPER RESOURCE LIBRARY | Quality Management System (QMS) Best Practices
Automating Your QMS: Pitfalls and Essentials
The Importance of an Enterprise-wide Quality Management System
7 Integration Methods for Connecting Your AssurX System With Other Systems
Benefits of Cloud Computing in Life Sciences Industry
The Zero Client Validation Breakthrough for FDA regulated systems
Taking the Complexity out of Computer System Validation
How AssurX Uses Web Services Technology—An in-depth technical discussion
Tips for efficiently controlling records for Compliance & Security
FDA Part 820 Quality System Regulation for Medical Devices
eMDR eBook – 3rd Edition
FDA 21CFR Part 11 Compliance Bulletin
An FDA Look at CAPA and Quality Systems
Complaint Handling and Regulatory Reporting System Requirements Matrix
FDA Importer Guidance For Medical Devices
How to Respond to an FDA Warning Letter or 483 Observation

EXPLORE ALL ASSURX WHITE PAPERS

INDUSTRY INSIGHTS | Popular AssurX QMS Blog Posts
Special QMS Automation Blog Series – Part 1 | Avoid QMS Automation Failures With The Right Implementation Team
Special QMS Automation Blog Series – Part 2 | Successful QMS Implementation Requires Clearly Defined Processes
Special QMS Automation Blog Series – Part 3 | Prioritize QMS Process Automation Or Risk Failure
FDA Warning Letters: First Half of 2017 Trends
No Apps Needed! Mobile Website Optimization for QMS
Configuration vs. Customization For Enterprise QMS Software
Five Form Design Mistakes To Avoid When Automating Your QMS
Medical Device Manufacturers Warned For CAPA Non-Compliance
Disciplined Patch Management Is Essential: Take Note From The Energy Industry
FDA Enforcement Trends: Pharmaceutical Manufacturing Quality Focus
How Will Real-World Evidence Impact 2017 FDA Guidances?
CDRH Report: Quality Management Insights For Medical Device Manufacturers
China Addresses Life Sciences Regulatory Compliance Concerns
FDA Warning Letters Emphasize Document Control System Compliance
FDA States Clear CGMP Expectations For Combination Products
Cybersecurity Management Expectations Clarified By FDA
Increased QMS Compliance Inspections For International Life Science Manufacturers
Document Management + CGMP Compliance
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Risk Management Best Practices for Cybersecurity Compliance
Quality Management Efforts: 2017 CDER Guidance Agenda Impact
Document Management + CGMP Compliance
Increased QMS Compliance Inspections For International Life Science Manufacturers
Cybersecurity Management Expectations Clarified By FDA
Tougher Quality Management Enforcement By FDA In 2017
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Corrective and Preventive Action (CAPA) + Document Management Citation Trends
Document Management Problems Threaten Pharmaceutical Manufacturers
Risk Management + Adverse Event Reporting: FDA Guidance
Weak Corrective and Preventive Action (CAPA) Programs Hit Globally By FDA Warnings
Is Your Change Control Program Ready for FDA 510(K) Scrutiny?
What You Need To Know About The FDA’s Mixed Medical Device PMA Approval Report Card
How Strong Is Your QMS Program? New International Medical Device Rules Challenge Complacent Organizations
Cloud for Quality and Compliance Management: A Primer for Life Sciences

ASSURX BLOG | QMS STRAIGHT TALK FOR FDA REGULATED INDUSTRIES

Quality Management Software Built for Medical Device Regulatory Compliance System

AssurX quality management system (QMS) software is designed to support requirements and standards for the FDA regulated medical device manufacturing industry.

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards regulatory requirements. In addition to FDA’s stringent 21 CFR Part 11 and 21 CFR Part 820 and CGXP requirements, medical device companies also face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon medical device manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it.

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