Enterprise Quality Management Software by AssurX

AssurX’s Enterprise Quality Management Software (EQMS) automates and harmonizes quality processes on a secure platform. Our EQMS adapts to evolving business needs, providing a comprehensive solution for managing compliance and quality issues across industries. Benefit from seamless integration, flexibility, and scalability to improve operational efficiency and regulatory adherence.

9 07, 2025

QMS Validation: How CSA Reduces Documentation Without Increasing Risk
QMS Validation: How CSA Reduces Documentation Without Increasing Risk

QMS Validation: How CSA Reduces Documentation Without Increasing Risk

By Victoria Alestra|2025-07-08T20:34:27+00:00July 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Documentation has long been at the heart of quality management system (QMS) val [...]

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 [...]

5 12, 2024

AI in Medical Device Manufacturing: How It’s Transforming an Industry
AI in Medical Device Manufacturing: How It’s Transforming an Industry

AI in Medical Device Manufacturing: How It’s Transforming an Industry

By Stephanie Ojeda|2025-04-04T01:31:15+00:00December 5th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]

21 11, 2024

FDA Inspection Expectations in 2025
FDA Inspection Expectations in 2025

FDA Inspection Expectations in 2025

By Stephanie Ojeda|2025-04-04T02:22:07+00:00November 21st, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The U.S. Food and Drug Administration (FDA) has been ramping up on-site inspect [...]

14 11, 2024

Critical Aspects of Quality Management Systems: Focusing on the Validation Process
Critical Aspects of Quality Management Systems: Focusing on the Validation Process

Critical Aspects of Quality Management Systems: Focusing on the Validation Process

By Victoria Alestra|2025-04-04T02:21:19+00:00November 14th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In regulated industries like pharmaceuticals, medical devices, and food manufac [...]

30 10, 2024

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

By Stephanie Ojeda|2025-04-04T02:28:32+00:00October 30th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]

24 10, 2024

5 Places to Use a FMEA in Your Quality Process
5 Places to Use a FMEA in Your Quality Process

5 Places to Use a FMEA in Your Quality Process

By Stephanie Ojeda|2025-04-04T01:32:06+00:00October 24th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Before any road trip, it makes sense to check your tire pressure along with lev [...]