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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 Progr [...]
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 [...]
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 indus [...]
Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking
Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates [...]
