CQV Readiness Assessment
Identify qualification risks before they become execution delays
The CQV Readiness Assessment is a structured review of project evidence, system status, documentation, and execution dependencies. It is intended to identify where a project is prepared to enter qualification and where unresolved gaps may affect schedule, compliance, testing, or turnover.
Who it is for
A defined checkpoint for projects approaching execution
The assessment can be shaped around a facility, workstream, system set, or project transition.
- New facility and expansion projects
- Clinical manufacturing buildouts
- Technology-transfer projects
- Manufacturing scale-up
- Equipment and utility installations
- Projects approaching FAT, SAT, IQ, OQ, or PQ
- Projects experiencing fragmented turnover or documentation gaps
- Organizations preparing to engage external CQV resources
Evidence in scope
What may be reviewed
Review depth and evidence selection are established for the agreed systems, workstreams, project phase, and priorities.
- URSs and design specifications
- System lists and boundaries
- Risk assessments
- Vendor documentation
- FAT and SAT plans
- Qualification plans and protocols
- Construction and installation status
- Calibration and maintenance readiness
- Automation and software dependencies
- Turnover packages
- Deviations, punch items, and open actions
- Requirements traceability
- Roles, responsibilities, and approvals
- Schedule and sequencing assumptions
Assessment process
A four-step path from scope to action
Define scope
Confirm systems, project phase, priorities, and evidence available for review.
Review evidence
Examine project documentation, status information, dependencies, and qualification assumptions.
Evaluate readiness
Identify material gaps, risks, unresolved decisions, and execution constraints.
Prioritize action
Provide recommended actions, owners, sequencing, and escalation considerations.
Typical outputs
Decision-ready findings for the agreed scope
Final outputs depend on the scope agreed for the engagement; not every assessment includes every deliverable.
- Executive readiness summary
- System or workstream readiness view
- Gap and risk register
- Documentation-gap assessment
- Dependency and constraint list
- Prioritized recommendations
- Suggested near-term action plan
- Optional follow-up workshop