Commissioning, Qualification & Validation (CQV)

Commissioning, Qualification, and Validation (CQV) confirm that facilities, utilities, and equipment are designed, installed, and operate as intended under GMP. The work runs from design review and commissioning through installation, operational, and performance qualification (IQ, OQ, and PQ). Done well, CQV ties engineering evidence to quality system expectations so manufacturing and laboratory operations can start in a controlled state and stay there when something changes later.

Viltis engineers build CQV plans matched to process risk rather than a generic protocol library. We coordinate commissioning execution with validation protocols, discrepancy handling, and change control so turnover packages stay inspection-ready. That includes URS and design qualification alignment, FAT and SAT support when vendors are involved, and clear ownership between site engineering, quality, and operations. We also help sites decide what belongs in commissioning versus formal qualification so teams do not duplicate tests or leave critical checks undocumented.

Risk-based CQV also means knowing when to stop testing. We help sites set acceptance criteria that reflect process criticality, document justified use of vendor documentation where allowed, and keep commissioning evidence linked to the same requirements used in IQ and OQ. That discipline prevents both under-testing of critical systems and endless retesting of low-risk utilities that already proved themselves during commissioning.

CQV work we typically support

• Commissioning plans linked to URS and design docs
• IQ, OQ, and PQ protocol writing and execution support
• Utility and equipment qualification packages
• Traceability from requirements to test evidence
• Deviation and discrepancy close-out during CQV
• Handover packages for quality and operations
• Integration with site change control and CAPA

CQV should leave you with a system that runs to specification and a file that shows why the tests were chosen. We help sites finish qualification without burying operators in paperwork they cannot defend later. When start-up reveals gaps, we support targeted retesting and documentation fixes. We also stay available for requalification and post-change verification after the initial campaign, when the real operating envelope becomes clearer than the design assumptions. If your site is mid-campaign with open discrepancies, we can prioritize critical path systems first so production readiness does not wait on low-risk paperwork.