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.

5 08, 2025

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

By Stephanie Ojeda|2025-08-05T13:51:41+00:00August 5th, 2025|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

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

23 07, 2025

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

By Stephanie Ojeda|2025-07-23T14:48:04+00:00July 23rd, 2025|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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

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 [...]