Scope of CQV Services
Commissioning
FAT/SAT Support & Execution
System Turnover & Turnover Package Review
Commissioning Protocol Development & Execution
Coordination with OEMs, Vendors, & Contractors
Qualification
Protocol Authoring & Review (risk-based approach)
Installation Qualification (IQ) Execution
Operational Qualification (OQ) Testing & Challenge Conditions
Performance Qualification (PQ) Aligned With Process Requirements
Data Collection, Analysis, and Summary Reporting
Deviation, CAPA & Compliance Management
Deviation Investigation & Resolution
CAPA Development & Closure
Change Control Support
Audit-Ready Documentation Alignment
Validation Strategy & Planning
Validation Master Plans (VMP)
Validation Plans & Project-Specific Strategies
Risk Assessments
Traceability Matrix Development
Automation & Computer System Validation (CSV/CSA)
PLC & SCADA System Validation
21 CFR Part 11 Alignment
CSV/CSA Documentation & Execution
System Integration Validation (BMS, Data Historian, MES, etc.)
Approach to CQV Execution
Rapid Assessment: Evaluate system readiness, documentation status, and compliance gaps
Structured Planning: Develop risk-based CQV strategy aligned with project timelines
Execution Discipline: Drive protocol execution, coordinate cross-functional teams, and maintain schedule integrity
Documentation & Closure: Deliver complete, traceable, and audit-defensible validation package
Why Messner Precision Solutions
Direct execution by senior CQV and Validation professional
Deep experience in regulated pharma, biotech, and medical device environments
Strong alignment with FDA, GMP, and GAMP expectations
Ability to lead cross-functional teams across Quality, Engineering, and Operations
Focus on delivering results & compliance; Not just documentation