Commissioning, Qualification & Validation (CQV) Services
AM Technical Solutions provides commissioning, qualification, and validation (CQV) services for complex manufacturing environments, including life sciences and semiconductor manufacturing. Our owner-focused approach combines technical expertise, early planning, and disciplined execution to help clients bring facilities, utilities, equipment, and critical systems online efficiently and reliably.
Through Sequence, our life sciences team, we provide specialized pharmaceutical and biotechnology CQV expertise with a strong understanding of regulatory requirements throughout the project lifecycle.
Hands-On CQV Training & Resource Preparation
A key differentiator is how we prepare our people before they reach the client site. Our dedicated technical training facility allows our resources to receive customized, project-specific training prior to deployment.
Using equipment, utilities, automation, and systems representative of life sciences manufacturing, we reinforce technical skills, safety, documentation practices, and client-specific requirements. This hands-on preparation helps reduce the learning curve so our teams can integrate quickly and contribute effectively from day one.
Risk-Based Commissioning, Qualification & Startup
Our approach integrates early planning, risk-based decision-making, commissioning, qualification, and startup activities to identify issues earlier, reduce rework, and minimize costly project delays.
From new facilities and expansions to retrofits and existing operations, our teams develop scalable execution strategies aligned with system requirements, intended use, quality objectives, and applicable industry and regulatory expectations.
- Commissioning, Qualification & Validation Capabilities
- CQV Program Development and Master Planning
- User and Functional Requirement Specifications (URS/FRS)
- Design Specifications and Design Reviews
- Risk Assessments and Requirements Traceability
- Facility, Utility, and Infrastructure C&Q
- Process Equipment Commissioning and Qualification
- Analytical and Laboratory Equipment Qualification
- Automation and Control System Commissioning
- Computerized System Validation
- Cleaning Development and Validation Support
- Protocol Development and Execution
- Requalification, Revalidation, and Periodic Reviews
- SOP Development and Technical Writing
- Compliance Remediation and Change Management
- Startup and Operational Readiness Support
Process Validation Services
For regulated life sciences operations, a lifecycle approach to process validation provides documented evidence that manufacturing processes are designed, controlled, and capable of consistently meeting established quality requirements.
Process Qualification (PQ) – Confirming that facilities, utilities, equipment, and processes are appropriately qualified for their intended use, including Process Performance Qualification (PPQ) support.
Continued Process Verification (CPV) – Supporting ongoing monitoring to demonstrate that manufacturing processes remain in a state of control and consistently meet established requirements.