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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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-v [...]
Why Automating the Audit Notification Package (ANP) Matters for Utilities and NERC Regions
What is the Audit Notification Package (ANP)? For utilities, the Audit Notification Package is the starting point of th [...]
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 [...]
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 i [...]
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 [...]
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 [...]
