The CQV Process
Equipment & Facility CQV Lifecycle Planning Simplified
Commissioning, Qualification, and Validation (CQV) is a process used in the pharmaceutical and life sciences industries to ensure that systems, facilities, and equipment all fit their intended purpose. It’s often used during facility builds, expansions, and equipment upgrades. It’s a comprehensive strategy that combines technical assessment with process documentation, and it’s critical for achieving a compliant, performance-ready system.
At VaLogic, we approach CQV as more than a checklist. It’s a coordinated effort involving multiple services, deliverables, and projects. Below is how we structure CQV:
Strategic Planning and Process Design
Every CQV project from VaLogic Bio starts with smart planning. We begin by defining the scope of work, conducting a thorough risk-based assessment, and developing a CQV Master Plan. This strategic blueprint outlines how CQV will unfold.
Commissioning
Commissioning is a process that verifies all systems and components within a facility or equipment are designed, installed, and tested in accordance with the approved design specifications. It involves inspecting, testing, and preparing mechanical, electrical, plumbing (MEP), HVAC, and utility systems to confirm installation integrity and operational readiness. We work closely with your facility and construction teams to set the stage for success.
Deliverables may include:
- Commissioning Plan
- Design Qualification (DQ)
- Commissioning Protocols (Installation and Functional Verification Tests/Checklists)
- Turn Over Packages
Qualification
Qualification aims to validate that systems perform consistently as expected under both simulated and actual operating conditions. This process includes:
- IQ (Installation Qualification): Confirms that equipment is installed per design specifications.
- OQ (Operational Qualification): Ensures equipment operates within specified parameters.
- PQ (Performance Qualification): Verifies consistent output during normal operating conditions.
We work across a wide range of equipment, including:
- Environmental and temp/RH chambers
- Autoclaves and sterilizers
- Bioreactors
- Cleanrooms and HVAC systems
- Freezers and refrigerators
- Warehouses
Validation & Ongoing Support
Validation establishes documented evidence that a process, equipment, or system consistently delivers a product that meets predetermined quality standards and specifications. We prepare your team for audits with well-organized documentation and provide ongoing support.
Deliverables may include:
- Cleaning Validation
- Computer System Validation
- Periodic Review
- Requalification
- Validation Master Planning
