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.

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|2024-06-03T13:17:16+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|2025-03-18T09:38:24+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 & [...]

25 04, 2023

Update: EU Medical Device Regulation Deadlines Extended
Update: EU Medical Device Regulation Deadlines Extended

Update: EU Medical Device Regulation Deadlines Extended

By Stephanie Ojeda|2024-03-04T21:19:23+00:00April 25th, 2023|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]

6 04, 2023

Key Priorities for Proactive EHS Risk Management
Key Priorities for Proactive EHS Risk Management

Key Priorities for Proactive EHS Risk Management

By Stephanie Ojeda|2024-03-12T13:26:55+00:00April 6th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted [...]

4 04, 2023

7 Ways to Enhance Quality Management Training
7 Ways to Enhance Quality Management Training

7 Ways to Enhance Quality Management Training

By Stephanie Ojeda|2024-06-26T08:12:15+00:00April 4th, 2023|Document Management, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

In regulated environments, quality management training is a requirement for goo [...]

23 03, 2023

Understanding OSHA Form 300
Understanding OSHA Form 300

Understanding OSHA Form 300

By Stephanie Ojeda|2023-03-23T14:59:55+00:00March 23rd, 2023|Document Management, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Based on OSHA Form 300 data, the U.S. Bureau of Labor Statistics reported 2.6 mi [...]

14 03, 2023

Why Manufacturers are Integrating EHS and Quality
Why Manufacturers are Integrating EHS and Quality

Why Manufacturers are Integrating EHS and Quality

By Stephanie Ojeda|2024-12-31T23:53:47+00:00March 14th, 2023|Document Management, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

Quality management and environmental, health, and safety (EHS) have traditionall [...]

7 03, 2023

FDA Warning Letters Show Document Management System Issues in Food Industry
FDA Warning Letters Show Document Management System Issues in Food Industry

FDA Warning Letters Show Document Management System Issues in Food Industry

By Stephanie Ojeda|2024-12-31T23:17:09+00:00March 7th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Quality Management|

Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]