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 [...]
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 [...]
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]
QMS Validation: How CSA Reduces Documentation Without Increasing Risk
Documentation has long been at the heart of quality management system (QMS) val [...]
Why QMS Software Is No Longer Optional in Regulated Industries
Many companies are still clinging to paper-based and unconnected el [...]
Human Factors in CAPA Part III: How To Secure Management Commitment
In the third and final part of our Human Factors in CAPA series, we’re tackling [...]
