Compliance Background

The FDA 21 CFR 211.25(a) regulation requires that every individual involved in the manufacturing, processing, packing, or holding of drug products must have the proper education, training, and experience to perform their assigned functions.

Over the past five years, the FDA has issued hundreds of 483 observations linked to training deficiencies — making inadequate training one of the most common causes of non-compliance.

ComplyIQPro™ was designed to eliminate these challenges by ensuring continuous, documented, and measurable competency across your GMP workforce. Our platform helps organizations maintain inspection readiness, prevent avoidable citations, and demonstrate compliance with complete confidence.