Recent FDA Warning Letters Highlight Gaps in Supplier Quality
FDA has been drawing a sharp line over the past year when it comes to supplier [...]
Preparing for ISO 14001:2026: What Organizations Need to Know
Environmental management continues to evolve as organizations face growing expe [...]
Why Risk-Based Supplier Audits Are Replacing Calendar-Based Audits
In the larger organizations I worked for as a quality leader, supplier auditing [...]
Why AI in Manufacturing Requires Caution
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
Growth has a way of outpacing the quality systems built to support it. More pro [...]
The Invisible Cost of “Good Enough” QMS Tools
It’s not always obvious when a quality management system (QMS) is underperformi [...]
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 [...]
