What the Yellow Book Updates for 2025 Means for Auditing Organizations
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
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
AssurX recently welcomed Stephanie Ojeda as its new Vice President of Product M [...]
Why Life Sciences Companies Choose CDMOs with a Digital QMS
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
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
Reno, NV – November 4, 2025 – AssurX, a leading provider of quality management [...]
The Hidden Cost of Fragmented QMS Systems in Life Sciences
Implementing a new quality management system (QMS) is no small task, especially [...]
5 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
FSVP Violations Under Fire: FDA’s 2025 Warning Letters and the Listeria Outbreak Exposing Global Food Supply Chain Risk
In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdow [...]
Building a Strong EQMS Foundation: Why Document Control and Training Come First
When organizations implement an enterprise quality management system (EQMS), th [...]
