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.

ISO 9001:2026 Elevates Risk-Based Thinking: Building a More Resilient Quality Management System
ISO 9001:2026 Elevates Risk-Based Thinking: Building a More Resilient Quality Management System

ISO 9001:2026 Elevates Risk-Based Thinking: Building a More Resilient Quality Management System

Stephanie Ojeda2026-07-20T21:28:59+00:00July 21st, 2026|

The upcoming ISO 9001:2026 revision continues the evolution of quality manageme [...]

Why Risk-Based Supplier Audits Are Replacing Calendar-Based Audits
Why Risk-Based Supplier Audits Are Replacing Calendar-Based Audits

Why Risk-Based Supplier Audits Are Replacing Calendar-Based Audits

Stephanie Ojeda2026-06-03T14:21:36+00:00June 3rd, 2026|

In the larger organizations I worked for as a quality leader, supplier auditing [...]

Why AI in Manufacturing Requires Caution
Why AI in Manufacturing Requires Caution

Why AI in Manufacturing Requires Caution

Stephanie Ojeda2026-06-09T20:43:46+00:00April 29th, 2026|

The FDA warning letter to Purolea Cosmetics Lab is the first in U.S. drug cGMP [...]

Scaling Without Breaking: How EQMS Helps FDA-Regulated Teams Grow
Scaling Without Breaking: How EQMS Helps FDA-Regulated Teams Grow

Scaling Without Breaking: How EQMS Helps FDA-Regulated Teams Grow

Stephanie Ojeda2026-04-08T19:23:20+00:00April 8th, 2026|

Growth has a way of outpacing the quality systems built to support it. More pro [...]

Where Manufacturers Are Getting EHS Wrong
Where Manufacturers Are Getting EHS Wrong

Where Manufacturers Are Getting EHS Wrong

Stephanie Ojeda2026-03-25T19:23:54+00:00March 25th, 2026|

Part 1 of a 2 blog series Despite the critical role EHS management plays in saf [...]

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 [...]

The Importance of Integrating EHS and Quality Management Systems for Manufacturers
The Importance of Integrating EHS and Quality Management Systems for Manufacturers

The Importance of Integrating EHS and Quality Management Systems for Manufacturers

Stephanie Ojeda2026-02-11T18:25:56+00:00February 11th, 2026|

In today's manufacturing landscape, integrating EHS (Environmental, Health, and [...]

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 [...]

Meet Stephanie Ojeda, AssurX’s New VP of Product Management, Life Sciences and Manufacturing
Meet Stephanie Ojeda, AssurX’s New VP of Product Management, Life Sciences and Manufacturing

Meet Stephanie Ojeda, AssurX’s New VP of Product Management, Life Sciences and Manufacturing

AssurX Blog2026-01-19T21:05:53+00:00January 20th, 2026|

AssurX recently welcomed Stephanie Ojeda as its new Vice President of Product M [...]