A hands-on approach to CQV
Normec supports the qualification and validation of facilities, equipment, utilities and manufacturing processes, from initial requirements through to verified closure.
Our specialists combine planning with hands-on execution. By staying closely involved throughout the qualification and validation process, issues can be identified and resolved during the study rather than after completion.
Whether you are commissioning a new facility, expanding existing operations or optimising production processes, we help you maintain control over quality, compliance and operational reliability.
Our CQV expertise
Our specialists can support qualification and validation activities across facilities, utilities, equipment and critical GMP processes, including:
- Qualification of facilities, utilities and equipment, including sterile isolators, RABS, fillers, washers, sterilisers and lyophilisers
- Cycle development and execution for CIP, SIP, sterilisation and depyrogenation, including load pattern development and wet load resolution
- Sterile utilities qualification, including clean steam, WFI and PW, compressed air and process gases
- Thermal mapping and periodic requalification of critical GMP equipment
- FAT and SAT witnessing and IQ/OQ/PQ protocol development and execution
- Computer system validation and data integrity in line with GAMP 5, Annex 11 and 21 CFR Part 11
- Deviation and CAPA support, integration testing and close-out documentation
Flexible support throughout your CQV lifecycle
Every project requires a different level of support. You may need end-to-end CQV expertise or additional capacity during a specific project phase.
Normec can support you throughout the lifecycle, including:
- URS
- FAT/SAT
- IQ/OQ/PQ
- Validation
- Deviation & CAPA
- Verified closure
Our specialists can work alongside your internal teams or take responsibility for defined CQV work packages, depending on your project requirements.
From qualification to verified closure
Well-executed CQV is not only about producing compliant documentation. It is about identifying issues early, resolving deviations efficiently and establishing processes that continue to perform reliably in day-to-day production.
With Normec, you can:
- Strengthen compliance with GMP and GxP requirements
- Identify and resolve issues earlier in the qualification process
- Improve control over deviations and CAPAs
- Support inspection and audit readiness
- Establish reliable, documented and maintainable manufacturing processes
Inspection-ready by design, not by rework.
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Frequently Asked Questions about commissioning, qualification, and validation (CQV)
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CQV stands for Commissioning, Qualification and Validation. It covers the testing, qualification and validation of systems, equipment and manufacturing processes within the pharmaceutical and life sciences industries.
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CQV helps organisations ensure the quality, safety and regulatory compliance of production processes, facilities and equipment.
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Commissioning focuses on ensuring that systems are installed and operate as intended. Qualification then demonstrates that those systems consistently perform according to predefined specifications.
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Cleaning and sterilisation validation verifies that cleaning and sterilisation processes are effective, reproducible and compliant with regulatory requirements.
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Yes. We provide support during both Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT).
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A User Requirements Specification (URS) defines the functional and technical requirements that a system or installation must meet.
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We support pharmaceutical companies, biotechnology organisations and other businesses operating within the life sciences and healthcare sectors.