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Commissioning, Qualification, And Validation

CQV Services

Pharmaceutical and biotechnology manufacturers understand the importance of quality control. A comprehensive approach that covers every aspect of your manufacturing process, from equipment to facilities, is crucial to ensure consistent production of high-quality products that meet industry standards. This is where CQV comes in. Commissioning, Qualification, and Validation are essential for meeting industry standards, and VaLogic’s CQV services provide confidence that your products are of the highest quality.

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Why CQV Matters in Pharma, Biotech & Life Sciences

CQV services are foundational to safety, product quality, and operational continuity. Regulated industries such as pharmaceuticals, biotech, and life sciences must align with regulatory standards, including FDA guidelines, EMA requirements, and ICH Q8, Q9, and Q10 regulatory standards. Beyond compliance, CQV can help improve your process facility and overall reliability.

Here are just some of the benefits of our CQV approach:

  • Reduce operation costs by improving efficiency and reducing downtime
  • Streamlined compliance documentation and reporting support facilities for regulatory inspections.
  • Minimize risk of contamination, equipment malfunctions, and procedural discrepancies
  • Reduces rework and waste by catching design and installation issues early.
  • Meet project deadlines and speed up your timeline with personalized solutions
  • Enhance project quality and patient safety

The CQV Process

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:

Equipment & Facility CQV Lifecycle Planning Simplified

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
VaLogic commissioning and CQV services
VaLogic qualification and CQV services

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 and
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:

VaLogic validation and CQV services

The VaLogic Difference

We don’t just hand off documents and call it a day. VaLogic Bio takes ownership across the entire CQV lifecycle, ensuring every phase is executed with precision and accountability.

  • 20+ years of experience working with over 400 companies in the biotech and life sciences industries
  • Full lifecycle CQV: from planning and risk assessments to revalidation
  • We provide more than just documentation: you can expect full lifecycle ownership, from planning to performance
  • Detail-focused real-time adjustments with cross-disciplinary coordination
    Integration with
  • VaLogic’s broader GxP compliance capabilities
  • Project management expertise embedded in service delivery

Industries We Serve

We provide CQV services tailored to the unique requirements of:

Biotechnology

Pharmaceutical

Diagnostics

Medical Devices

Tailored Support for New and
Existing Facilities

Every facility has different needs, and we meet you where you are. For new facilities, we guide you every step of the way with a coordinated CQV roadmap. For existing sites, we’ll execute our CQV services with minimal disruption to your day-to-day operations.

Have a question or need a quote? Give us a call!

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