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.

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 [...]

Why Life Sciences Companies Choose CDMOs with a Digital QMS
Why Life Sciences Companies Choose CDMOs with a Digital QMS

Why Life Sciences Companies Choose CDMOs with a Digital QMS

Stephanie Ojeda2025-12-04T22:12:09+00:00November 20th, 2025|

When I worked as a supplier quality team lead, I spent a lot of time auditing s [...]

Improving the Supplier Corrective Action Request Process with the QMS
Improving the Supplier Corrective Action Request Process with the QMS

Improving the Supplier Corrective Action Request Process with the QMS

Stephanie Ojeda2026-01-15T16:37:08+00:00November 11th, 2025|

When I first started developing supplier quality management programs in pharma m [...]

AssurX Promotes Stephanie Ojeda to Vice President, Product Management, Life Sciences and Manufacturing
AssurX Promotes Stephanie Ojeda to Vice President, Product Management, Life Sciences and Manufacturing

AssurX Promotes Stephanie Ojeda to Vice President, Product Management, Life Sciences and Manufacturing

Tamar June2026-01-29T20:22:58+00:00November 4th, 2025|

Reno, NV – November 4, 2025 – AssurX, a leading provider of quality management [...]

The Hidden Cost of Fragmented QMS Systems in Life Sciences
The Hidden Cost of Fragmented QMS Systems in Life Sciences

The Hidden Cost of Fragmented QMS Systems in Life Sciences

Stephanie Ojeda2026-01-15T16:59:06+00:00October 22nd, 2025|

Implementing a new quality management system (QMS) is no small task, especially [...]

5 Benefits of Quality Risk Management in the EQMS
5 Benefits of Quality Risk Management in the EQMS

5 Benefits of Quality Risk Management in the EQMS

Stephanie Ojeda2026-01-15T20:27:30+00:00October 16th, 2025|

Regulators and standards organizations are increasingly requiring manufacturers [...]

Building a Strong EQMS Foundation: Why Document Control and Training Come First
Building a Strong EQMS Foundation: Why Document Control and Training Come First

Building a Strong EQMS Foundation: Why Document Control and Training Come First

Stephanie Ojeda2026-01-15T20:36:30+00:00September 22nd, 2025|

When organizations implement an enterprise quality management system (EQMS), th [...]

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

Stephanie Ojeda2026-01-15T20:53:07+00:00August 5th, 2025|

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