AssurX’s FDA Compliance Software automates quality management processes, ensuring adherence to FDA regulations like 21 CFR Part 11. Our platform integrates with enterprise systems, enhancing visibility and control over compliance activities. Experience streamlined workflows and real-time insights to maintain high compliance standards.
Look through even a few FDA warning letters, and you’re likely to find violation [...]
Change is a constant in manufacturing, and is both necessary for innovation and [...]
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
Companies marketing devices in the European Union are facing a perfect storm of [...]
From Listeria in ice cream to E. coli in lettuce, there’s one central question i [...]
Software validation is historically one of the most difficult compliance activit [...]
As innovation in medical technology increases, potential cybersecurity threats a [...]
When evaluating an automated QMS, the question to invest in configuration vs. ou [...]
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