Quality Process Automation Archives | EQMS

Explore the transformative power of Quality Process Automation with AssurX. Discover how automating quality management processes can maximize efficiency, enhance compliance, and drive continuous improvements across manufacturing sectors. Dive into insights, best practices, and real-world applications of AssurX to streamline your operations and elevate your quality standards.

The Invisible Cost of “Good Enough” QMS Tools
The Invisible Cost of “Good Enough” QMS Tools

The Invisible Cost of “Good Enough” QMS Tools

Stephanie Ojeda2026-03-19T18:31:22+00:00March 19th, 2026|

It’s not always obvious when a quality management system (QMS) is underperformi [...]

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 [...]

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 [...]

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

Stephanie Ojeda2026-01-29T21:50:00+00:00December 5th, 2024|

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

FDA Inspection Expectations in 2025
FDA Inspection Expectations in 2025

FDA Inspection Expectations in 2025

Stephanie Ojeda2025-04-04T02:22:07+00:00November 21st, 2024|

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