Commissioning, Qualification & Validation
We bring equipment and processes to the qualified state, with risk and science.
We plan and execute the equipment and process qualification lifecycle, linking commissioning and qualification (ASTM E2500) to reach a qualified state traceable to user requirements.
We apply the risk- and science-based approach to focus effort on what impacts product quality and patient safety, avoiding redundant testing.
We integrate commissioning and qualification to cut timeline and rework, leveraging supplier documentation whenever possible.
Deliverables cycle
Validation Master Plan (VMP)
Strategy, scope and schedule of the equipment and process qualification program.
DQ · Design Qualification
Documented verification that the proposed design meets the defined requirements.
IQ / OQ / PQ
Installation, operation and performance documented, approved and traced to requirements.
Traceability Matrix
Requirement, specification and test linked end to end, easing risk management.
Qualification Report
Consolidation of evidence and formal release of the qualified state.
How we run it
Plan (VMP)
Scope, risk and schedule.
Design (DQ)
Design verification and specifications.
Qualify (IQ/OQ/PQ)
Risk-driven execution.
Release
Report and qualified state.
Applicable standards
Frequently asked questions
How is it different from CSV?
CQV focuses on physical equipment and processes; CSV focuses on computerized systems. They often go together and we cover both.
Do you do thermal mapping or utilities?
Our focus is the equipment and process qualification lifecycle and its documentation. Utility studies are not part of our scope.
Can supplier documents be leveraged?
Yes. We review and integrate manufacturer packages, completing the cycle to the qualified state.