Commissioning, Qualification & Validation (CQV)

Ensuring that your systems meet the highest standards of compliance.

Commissioning, Qualification & Validation (CQV)

Our CQV services ensure that your systems and equipment are designed, tested, and validated to meet the necessary regulatory and operational standards. We specialize in:

System Build Lifecycle Participation:

Active participation in the system build lifecycle.
Applying principles from the ISPE Commissioning & Qualification (C&Q) Guide 2.0: Good Practice Guide
Reviewing key documentation such as User Requirement Specifications (URS), P&ID (Piping and Instrumentation Diagrams), Isometric Drawings, 3D walkdowns and General Arrangement (GA) to identify and resolve potential issues early in the lifecycle.

Risk-based CQV:

Implementation of risk-based approaches as per ASTM E2500 and ICH Q9 guidelines.
Thorough risk assessment and mitigation strategies.
Leveraging existing testing and data for efficient validation.

Mechanical Completion and Commissioning:

Performing thorough mechanical completion checks to verify that all components are correctly installed and ready for testing.
Conducting commissioning activities, including system testing and readiness
checks.

Qualification & Documentation:

Developing and Reviewing Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ) documentation for validation.
Ensuring systems meet the compliance and operational standards required for regulated environments.