Quality Management System Solutions by AssurX

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

3 01, 2024

The Top 3 Technology Trends Transforming Manufacturing Quality in 2024
The Top 3 Technology Trends Transforming Manufacturing Quality in 2024

The Top 3 Technology Trends Transforming Manufacturing Quality in 2024

By Stephanie Ojeda|2025-03-18T09:28:59+00:00January 3rd, 2024|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

As manufacturers face increased pressure to optimize their quality management pr [...]

5 12, 2023

Top 10 EQMS Attributes for Comprehensive Control and Rapid Deployment
Top 10 EQMS Attributes for Comprehensive Control and Rapid Deployment

Top 10 EQMS Attributes for Comprehensive Control and Rapid Deployment

By Stephanie Ojeda|2025-03-18T09:29:11+00:00December 5th, 2023|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

With an unprecedented level of challenge and change in manufacturing, there is t [...]

20 11, 2023

Benefits of Document Management System
Benefits of Document Management System

Benefits of Document Management System

By Stephanie Ojeda|2025-03-18T09:29:20+00:00November 20th, 2023|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

There’s an old saying in regulated industries: if it isn’t documented, it didn’ [...]

17 08, 2023

Aligning Incident Management with ISO 45001 Requirements
Aligning Incident Management with ISO 45001 Requirements

Aligning Incident Management with ISO 45001 Requirements

By Stephanie Ojeda|2025-03-18T09:29:45+00:00August 17th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2 [...]

8 08, 2023

EHS Incident Management and Root Cause Analysis
EHS Incident Management and Root Cause Analysis

EHS Incident Management and Root Cause Analysis

By Stephanie Ojeda|2023-08-08T16:57:29+00:00August 8th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

Workplace safety incidents are a key driver of risk in manufacturing organizatio [...]

26 07, 2023

Risk Management in ISO 13485
Risk Management in ISO 13485

Risk Management in ISO 13485

By Stephanie Ojeda|2024-06-03T14:04:45+00:00July 26th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management, Risk Management|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]

12 07, 2023

SOP in QMS
SOP in QMS

SOP in QMS

By Stephanie Ojeda|2025-03-18T09:37:38+00:00July 12th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Mistakes around standard operating procedure (SOP) management are widespread an [...]

6 06, 2023

Linking Design Controls and Risk Management in the QMS
Linking Design Controls and Risk Management in the QMS

Linking Design Controls and Risk Management in the QMS

By Stephanie Ojeda|2024-03-12T13:25:01+00:00June 6th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

Design controls are a frequent citation in 483 observations and warning letters [...]

30 05, 2023

Complaint Management for Life Sciences with an Automated QMS
Complaint Management for Life Sciences with an Automated QMS

Complaint Management for Life Sciences with an Automated QMS

By Stephanie Ojeda|2025-05-07T23:01:07+00:00May 30th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Effective complaint handling is fundamental to life sciences quality management [...]

27 04, 2023

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

By Tim DeMuth|2025-05-07T23:05:35+00:00April 27th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]