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 [...]
20
11, 2025
4
11, 2025
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 [...]
22
10, 2025
The Hidden Cost of Fragmented QMS Systems in Life Sciences
Implementing a new quality management system (QMS) is no small task, especially [...]
16
10, 2025
5 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
9
10, 2025
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 [...]
5
08, 2025
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
The U.S. Food and Drug Administration (FDA) released an updated guidance docume [...]
23
07, 2025
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments
Quality audits are a cornerstone of compliance in FDA and ISO-regulated environ [...]
9
07, 2025
QMS Validation: How CSA Reduces Documentation Without Increasing Risk
Documentation has long been at the heart of quality management system (QMS) val [...]
10
06, 2025
Why QMS Software Is No Longer Optional in Regulated Industries
Many companies are still clinging to paper-based and unconnected electr [...]
21
05, 2025
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 [...]
