An expectation of the FDA during site inspection (Pre-Approval Inspection or routine cGMP inspection) is evidence of a mature Pharmaceutical Quality System (PQS). During the inspection, FDA investigators will evaluate the processes for continual quality system improvement.

The CQSA framework will provide a company with ongoing feedback concerning the health of their quality systems. This is essential input to Management Review and will identify areas where improvement is required.

The benefits of CQSA include:

• Maintain a state of inspection readiness
• Avoid systemic risks across a network of sites
• Reduce compliance and business risk
• Demonstrate continual improvement
• Provide a key input to Management Review