AssurX Blog
Straight talk for regulated industries.
5 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers to incorporate a risk-based approach into their quality processes. For instance, ISO 9001 replaced prev [...]
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 crackdown on Foreign Supplier Verification Program (FSVP) violations, issuing multiple warning letters to food i [...]
Building a Strong EQMS Foundation: Why Document Control and Training Come First
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) [...]
Why Automating the Audit Preparation Package Matters for Utilities and NERC Regions
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 [...]
NERC Audit Fundamentals
A NERC audit is more than just paperwork—it’s an evaluation of how well you safeguard the bulk power system. In simple terms, auditors review your internal controls, processes, and cu [...]
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
The U.S. Food and Drug Administration (FDA) released an updated guidance document in June 2025, titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of [...]
