Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

2210, 2025

The Hidden Cost of Fragmented QMS Systems in Life Sciences

October 22nd, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. E [...]

1610, 2025

5 Benefits of Quality Risk Management in the EQMS

October 16th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

Regulators and standards organizations are increasingly requiring manufacturers to incorporate a risk-based approach into their quality processes. For instance, ISO 9001 replaced prev [...]

910, 2025

FSVP Violations Under Fire: FDA’s 2025 Warning Letters and the Listeria Outbreak Exposing Global Food Supply Chain Risk

October 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdown on Foreign Supplier Verification Program (FSVP) violations, issuing multiple warning letters to food i [...]

2209, 2025

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

September 22nd, 2025|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) [...]

2208, 2025

Why Automating the Audit Preparation Package Matters for Utilities and NERC Regions

August 22nd, 2025|Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

What Is the Audit Preparation Package?  For utilities, the Audit Preparation Package is the starting point of the compliance audit process. Issued by NERC Regional Entities, the provi [...]

Go to Top