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Commissioning, Qualification and Validation (CQV) activities play a crucial role in delivering operationally effective, compliant facilities, utilities, equipment and process.

We support our clients throughout the full CQV lifecycle.  We are engaged in the process from early stage of user requirements gathering to start-up and operations handover.  A comprehensive approach is taken together with the client’s interdisciplinary team during CQV process to facilitate a timely and cost-effective solution.  During the course of our engagement, we continually educate your team, to facilitate knowledge transfer and ensure long-term sustainability.

Experienced in the vertical take-off after construction completion, we deliver value to your projects through our CQV services:

  • Establish basis and optimize CQV processes at regulated facilities
  • Attain quality compliance to regulatory requirements and alignment with business goals
  • Achieve technical assurance for the impacted systems and processes
  • Ensure operational readiness for turnover
  • Deliver project with high quality on-time & on-budget
  • Validation Project Scoping
  • Risk Assessment
  • Execution Strategy Development
  • Resource Strategy Development
  • Project Status Monitoring & Reporting
  • Change Request Management
  • Performance Management
  • Commissioning, Qualification & Validation Planning
  • Validation Master Plan Development
  • Requirements Traceability
  • Design Qualification (DQ) Development/Execution
  • Commissioning (FAT, SAT) Development
  • Installation, Operational, Performance Qualification (IQ/OQ/PQ) Execution
  • Process Validation (PV)
  • Computer System Validation (CSV) Compliant to Data integrity and 21 CFR Part 11
  • Automation System Validation
  • Sterilization Validation
  • Cleaning Validation (CV)
  • Media Fill Validation
  • Laboratory Equipment Validation
  • Analytical Method Validation
  • Environmental Monitoring