AssurX Blog
Straight talk for regulated industries.
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 [...]
5 Essential Elements Shared by Leading Supplier Quality Management Systems
Global-scale events have tested the bounds of a supply chain system. The coronavirus, for example, has made it clear how critical an efficient supply chain is for continuity and surviv [...]
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments
Quality audits are a cornerstone of compliance in FDA and ISO-regulated environments, ensuring that procedures, records, and activities align with stringent regulatory standards. Thes [...]
QMS Validation: How CSA Reduces Documentation Without Increasing Risk
Documentation has long been at the heart of quality management system (QMS) validation, particularly in regulated industries such as pharmaceuticals and medical devices. In environmen [...]
