Services
CQV and validation support across the project lifecycle
Augmented supports manufacturing organizations from early planning and design review through field execution, qualification closeout, and inspection-readiness activities. Services can be delivered as a focused assessment, a defined work package, or an integrated project engagement.
Service scope
Connected technical support, not isolated deliverables
Each engagement is scoped to the project phase, systems, evidence available, and the decisions the team needs to make.
CQV Strategy and Project Planning
- Validation Master Plans
- Project Validation Plans
- System-level qualification strategies
- System boundaries and system inventories
- Direct-impact and criticality assessments
- Risk-based testing approaches
- Deliverable matrices
- CQV schedules and execution sequencing
- Resource and responsibility planning
Requirements, Design, and Traceability
- User Requirements Specification review
- Design specification review
- Design qualification support
- Requirements rationalization
- Risk assessment
- Requirements-to-test traceability
- Vendor-documentation assessment
- Design and qualification gap identification
Vendor and Acceptance Testing
- Vendor package assessment
- FAT strategy and protocol review
- FAT witnessing
- SAT strategy and execution
- Vendor test leveraging
- Gap testing
- Deficiency and punch-list management
- Turnover-package review
IQ, OQ, and PQ
- Protocol authoring
- Protocol review
- Field execution
- Discrepancy management
- Deviation support
- Data and evidence review
- Summary reporting
- Final protocol closeout
Computerized Systems and Automation
- CSV planning
- GAMP 5-aligned risk assessment
- Functional and configuration review
- Interface and data-flow assessment
- Access and security testing
- Audit-trail testing
- Data-integrity considerations
- Requirements and test traceability
Turnover, Closeout, and Readiness
- Turnover-package reconciliation
- Punch-list and open-item review
- Qualification status tracking
- Requirements closure
- Deviation and discrepancy closure
- Final summary documentation
- Handover to operations
- Inspection-readiness support
Delivery model
Engagement structures matched to the work
Focused advisory support
Targeted senior review, decision support, strategy, or technical guidance for a defined issue.
Defined CQV work package
A bounded scope with agreed systems, deliverables, interfaces, schedule, and closeout expectations.
Embedded project leadership
Integrated leadership across project planning, interfaces, execution, issue resolution, and turnover.
Discuss the scope of your project
Share the facility, systems, project phase, and current challenge to begin a focused conversation.