Commissioning, Qualification & Validation (CQV)

Commissioning, Qualification, and Validation (CQV) ensure that facilities, utilities, and equipment are designed, installed, and operate in accordance with regulatory and quality requirements. CQV activities support compliant manufacturing and laboratory operations throughout the product lifecycle.

Engineering-led CQV focuses on confirming that systems perform as intended while integrating with quality systems and change control processes. Well-planned CQV programs help organizations achieve operational readiness without compromising compliance.

CQV is a foundational element of FDA inspection readiness for regulated manufacturing environments.

Engineering CQV activities commonly include:

• Commissioning planning and execution

• Installation, operational, and performance qualification (IQ/OQ/PQ)

• Equipment and utility qualification

• Documentation development and review

• Integration with quality and change management systems