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.

What the Yellow Book Updates for 2025 Means for Auditing Organizations
What the Yellow Book Updates for 2025 Means for Auditing Organizations

What the Yellow Book Updates for 2025 Means for Auditing Organizations

Stephanie Ojeda2026-01-29T15:08:46+00:00January 29th, 2026|

The U.S. Government Accountability Office (GAO) issued the 2024 revision of Gov [...]

Preparing for the FDA’s Quality Management System Regulation (QMSR): A Guide for Life Science Manufacturers
Preparing for the FDA’s Quality Management System Regulation (QMSR): A Guide for Life Science Manufacturers

Preparing for the FDA’s Quality Management System Regulation (QMSR): A Guide for Life Science Manufacturers

Stephanie Ojeda2026-01-22T14:06:58+00:00January 22nd, 2026|

As the life sciences industry evolves, regulatory bodies like the U.S. Food and [...]

Building a Strong EQMS Foundation: Why Document Control and Training Come First
Building a Strong EQMS Foundation: Why Document Control and Training Come First

Building a Strong EQMS Foundation: Why Document Control and Training Come First

Stephanie Ojeda2026-01-15T20:36:30+00:00September 22nd, 2025|

When organizations implement an enterprise quality management system (EQMS), th [...]

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations

Stephanie Ojeda2026-01-15T20:53:07+00:00August 5th, 2025|

The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]

Why Quality Audits Are Critical for Compliance in FDA and ISO Environments
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments

Why Quality Audits Are Critical for Compliance in FDA and ISO Environments

Stephanie Ojeda2026-01-29T16:38:51+00:00July 23rd, 2025|

Quality audits are a cornerstone of compliance in FDA and ISO-regulated environ [...]

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

Victoria Alestra2026-01-29T18:37:03+00:00July 9th, 2025|

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

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

Stephanie Ojeda2026-01-29T20:15:01+00:00May 21st, 2025|

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

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

Stephanie Ojeda2026-01-29T20:08:54+00:00May 14th, 2025|

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

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

Stephanie Ojeda2025-05-07T15:05:26+00:00May 7th, 2025|

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

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

Stephanie Ojeda2026-01-29T20:38:17+00:00April 17th, 2025|

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