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Quality Management System

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

17 06, 2025

QMS Software: When to Configure and When to Customize
QMS Software: When to Configure and When to Customize

QMS Software: When to Configure and When to Customize

By Stephanie Ojeda|2025-06-17T15:25:23+00:00June 17th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

When it comes to managing quality and compliance in today’s regulated industries [...]

10 06, 2025

Why QMS Software Is No Longer Optional in Regulated Industries
Why QMS Software Is No Longer Optional in Regulated Industries

Why QMS Software Is No Longer Optional in Regulated Industries

By Stephanie Ojeda|2025-06-10T17:42:50+00:00June 10th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Many companies are still clinging to paper-based and unconnected electr [...]

21 05, 2025

Human Factors in CAPA Part III: How To Secure Management Commitment
Human Factors in CAPA Part III: How To Secure Management Commitment

Human Factors in CAPA Part III: How To Secure Management Commitment

By Stephanie Ojeda|2025-05-21T13:32:55+00:00May 21st, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the third and final part of our Human Factors in CAPA series, we’re tackling [...]

14 05, 2025

Human Factors in CAPA Part II: How to Improve CAPA Accountability
Human Factors in CAPA Part II: How to Improve CAPA Accountability

Human Factors in CAPA Part II: How to Improve CAPA Accountability

By Stephanie Ojeda|2025-05-19T18:44:35+00:00May 14th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In Part I of our Human Factors in CAPA series, we talked about employee engagem [...]

7 05, 2025

Human Factors in CAPA Part I: How to Improve Employee Engagement
Human Factors in CAPA Part I: How to Improve Employee Engagement

Human Factors in CAPA Part I: How to Improve Employee Engagement

By Stephanie Ojeda|2025-05-07T15:05:26+00:00May 7th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

At its core, corrective and preventive action (CAPA) is about systematically ev [...]

17 04, 2025

Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing
Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing

Mastering the 8D Problem-Solving Methodology: A Guide to Root Cause Analysis in Manufacturing

By Stephanie Ojeda|2025-04-17T12:50:31+00:00April 17th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Every day, quality leaders face a variety of production and process issues. Whi [...]

24 03, 2025

Understanding the Differences Between Deviation vs. Nonconformance
Understanding the Differences Between Deviation vs. Nonconformance

Understanding the Differences Between Deviation vs. Nonconformance

By Stephanie Ojeda|2025-04-04T02:10:09+00:00March 24th, 2025|Deviation, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The pharmaceutical industry and the medical device industry have unique ways of [...]

13 03, 2025

How to Use a Risk Matrix to Ensure Effective Risk Management
How to Use a Risk Matrix to Ensure Effective Risk Management

How to Use a Risk Matrix to Ensure Effective Risk Management

By Stephanie Ojeda|2025-05-07T15:08:38+00:00March 13th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In manufacturing and in life, we can never completely eliminate risk. What matt [...]

10 03, 2025

3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI
3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI

3Analytics Partners With AssurX to Revolutionize IMDRF Coding Using AI

By Tamar June|2025-03-18T08:55:18+00:00March 10th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

The IMDRF Coding solution integrates seamlessly into AssurX EQMS, ensuring comp [...]

27 02, 2025

Enhancing Compliance Through Quality Risk Management
Enhancing Compliance Through Quality Risk Management

Enhancing Compliance Through Quality Risk Management

By Stephanie Ojeda|2025-10-03T03:46:17+00:00February 27th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Quality risk management (QRM) has become a crucial tool for ensuring regulatory [...]