FDA Six-systems
FDA Six-Systems
Understand FDA’s six-system inspection model with compliance metrics and risk assessments to identify gaps, mitigate risks, and enhance regulatory compliance.
Quality Unit
Total Sub-Systems 15
Encompasses quality management, documentation, and quality control procedures
Packaging and Labelling
Total Sub-Systems 12
Encompasses quality management, documentation, and quality control procedures
Production
Total Sub-Systems 11
Manufacturing operations, process controls, and validation procedures
Material
Total Sub-Systems 5
Material handling, storage, and inventory management procedures
IT/ Data Management
Total Sub-Systems 4
Data integrity, computer system validation, and electronic records management
Laboratory
Total Sub-Systems 9
Covers testing procedures, specifications, and laboratory data management
Facilities and Equipment
Total Sub-Systems 14
Facility maintenance, equipment qualification, and environmental controls
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