At CellSpark Consulting, we provide end-to-end Commissioning, Qualification, and Validation (CQV) services tailored for pharmaceutical, biotechnology, and cell & gene therapy facilities. Our approach aligns with ISPE, GAMP 5, and global GMP standards to ensure all systems are qualified, compliant, and ready for commercial operation.

We also offer dedicated CQV project supervision and oversight, ensuring seamless coordination between stakeholders, clear communication, and disciplined execution throughout the project lifecycle.

CQV Project Management & Supervision

• Oversight of commissioning and qualification activities from design through final reporting
• Interface with client teams, contractors, QA, validation, and engineering
• Timeline tracking, critical path coordination, and resource alignment
• Daily/weekly progress reporting, issue tracking, and resolution follow-up
• Vendor coordination and site execution supervision
• GMP readiness oversight during construction and startup

Validation Master Planning & Strategy

• Development of Validation Master Plan (VMP) and risk-based qualification strategy
• Planning of C&Q lifecycle documentation in alignment with regulatory requirements
• Scope definition and coordination with QA and project stakeholders