Quality Management

The “Quality Management” category at AssurX provides a comprehensive look into effective strategies and tools for optimizing quality processes. This section covers essential topics such as process improvement, compliance integration, and performance measurement. By leveraging these resources, organizations can enhance their quality management systems, ensuring consistent product quality and operational efficiency. AssurX offers the expertise and solutions necessary to drive continuous improvement and maintain high standards across industries.

Why Consider a Cloud QMS for FRACAS Automation?
Why Consider a Cloud QMS for FRACAS Automation?

Why Consider a Cloud QMS for FRACAS Automation?

AssurX Blog2020-08-04T05:30:39+00:00August 4th, 2020|

Authors: Sal DiIorio, Principal Consultant, Semi-Tech Group Dave Vadas, VP of Sp [...]

Prioritize QMS Process Automation or Risk Failure
Prioritize QMS Process Automation or Risk Failure

Prioritize QMS Process Automation or Risk Failure

AssurX Blog2020-07-28T07:50:20+00:00July 28th, 2020|

This blog is part of a three-part series on proven strategies to help avoid QMS [...]

A Successful QMS Implementation Requires Clearly Defined Processes
A Successful QMS Implementation Requires Clearly Defined Processes

A Successful QMS Implementation Requires Clearly Defined Processes

AssurX Blog2023-09-28T21:18:36+00:00July 13th, 2020|

This blog is the second of a three-part series on QMS implementation best practi [...]

Avoid QMS Implementation Failures with the Right Team
Avoid QMS Implementation Failures with the Right Team

Avoid QMS Implementation Failures with the Right Team

AssurX Blog2025-01-01T00:06:50+00:00July 13th, 2020|

This blog it the first of a three-part series on QMS implementation best practi [...]

How Risk-Based Testing is Revolutionizing Computer System Validation
How Risk-Based Testing is Revolutionizing Computer System Validation

How Risk-Based Testing is Revolutionizing Computer System Validation

AssurX Blog2024-01-13T02:37:12+00:00June 1st, 2020|

We live in a world where speed is vital to success. Patients and consumers expec [...]

Effectively Managing Data Integrity for CGMP
Effectively Managing Data Integrity for CGMP

Effectively Managing Data Integrity for CGMP

AssurX Blog2024-01-13T02:40:15+00:00May 14th, 2020|

Data integrity is a key component in making informed decisions within any organi [...]

5 Commonalities of Enterprise Supplier Quality Management Systems
5 Commonalities of Enterprise Supplier Quality Management Systems

5 Commonalities of Enterprise Supplier Quality Management Systems

AssurX Blog2025-05-19T18:50:33+00:00April 7th, 2020|

Global-scale events have tested the bounds of a supply chain system. The coronav [...]

Don’t take your foot off the gas on EU MDR implementation
Don’t take your foot off the gas on EU MDR implementation

Don’t take your foot off the gas on EU MDR implementation

AssurX Blog2020-04-03T15:31:23+00:00April 3rd, 2020|

The coronavirus has had a massive impact on the medical device industry. As a c [...]

The Six C’s of a Modern Complaint Management System 2020
The Six C’s of a Modern Complaint Management System 2020

The Six C’s of a Modern Complaint Management System 2020

AssurX Blog2020-03-10T07:15:08+00:00March 10th, 2020|

Regulators such as FDA, European Commission (EC), ISO 13485 require a product c [...]

Human Error is a Precipitator for Root Cause Analysis, Not Blame
Human Error is a Precipitator for Root Cause Analysis, Not Blame

Human Error is a Precipitator for Root Cause Analysis, Not Blame

AssurX Blog2024-06-03T13:33:05+00:00February 21st, 2020|

Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]