CQV
Our approach to Comprehensive Equipment Lifecycle Validation (IQ/OQ/PQ/PV) ensures that your critical manufacturing systems meet the most stringent regulatory requirements. We strategically execute and document every phase of qualification to verify operational efficiency and compliance, building a robust foundation for your entire manufacturing lifecycle.
Through detailed Master and Project Validation Plans, our team ensures that all validation activities are structured to meet your specific production and capacity goals. We collaborate closely with your internal quality units and engineering teams to establish phase-appropriate strategies, so your qualification efforts align seamlessly with the overarching project schedule.
We provide end-to-end oversight spanning Facility Validation, including Room Finishes, Environmental Mapping, and Smoke Studies. Acting as a true extension of your team, we verify that your physical manufacturing environment maintains strict environmental control and sterility, ensuring your cleanrooms are fully compliant and operational upon start-up.
- IQ/OQ/PQ/PV/CSV
- Data Integrity
- Master and Project Validation Plans
- Environmental Monitoring
- Smoke Studies
- Change Control Initiation & Execution
- Non-Conformance Resolution
- Deviations and CAPAs
What We Do
- Feasibility Study
- Project Charter
- Proposal
- Kickoff Meeting
- Project Execution Plan
PLAN
- Gantt Chart
- User Requirements Specification (URS)
- Budget
- Project Validation Plan
- Trace Matrix
- Assessments
- Stakeholder Engagement
- Equipment List
- Conceptual Layout
- Flow Diagram
- Resource Schedule
Execute
- Factory Acceptance Testing (FAT)
- Pre-Delivery Inspection (PDI)
- Vendor Coordination
- Change Control
- Site Acceptance Testing (SAT)
- Equipment and Facility Qualification (IQ/OQ/PQ)
- Pre-Start Health and Safety Review (PSHSR)
- Standard Operating Procedures (SOP)
- Document Post-Approval
- Project Punchlist
- Remediation
- Change Control Close
- Handover Documents/Packages
- PQ Readiness
