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Designing the laboratory of the future - now
Full gamut of CQV services
Wood has an extensive background in applying regulatory requirements, expectations, and standards on all projects. We provide the full gamut of CQV service offerings from conceptual design through handover and ongoing qualification and validation maintenance.
Our CQV services include:
- Design reviews/ qualification
- Factory acceptance test (FAT)/Site Acceptance Test (SAT)
- CQV document development
- CQV execution
- Current good manufacturing practices (cGMP) audits
Smooth transition from design to CQV
Embedding quality
Our CQV team works closely with engineering, manufacturing, procurement, quality systems, and construction to ensure quality is embedded in the project, user requirements are achieved in the design, regulatory concerns are addressed, and commissioning, and qualification needs are clearly communicated to the entire project team.
Ensuring compliance
We make it a priority to stay aligned with current pharmaceutical regulations, guidelines and client requirements and address them throughout design, construction and CQ phases. Using regular, formal current good manufacturing practice (cGMP) reviews, we document our compliance and prepare to defend regulatory agency submissions and inspections.
Full life cycle CQV approach
Early involvement of our CQV team ensures a smooth transition throughout each project phase. We follow the life cycle approach to commissioning, qualification and validation to define requirements during the earliest project phases, allow for a staged approach to qualification and achieve the best value.
Expertise
Automation and control
Wood's automation and control solutions maximise profitability and safety through innovative technology and global expertise across diverse industries
Active pharmaceutical ingredients
Expert API production services: Safe, efficient, and compliant facilities for small molecule manufacturing. Global expertise, from design to CQV.
Biotechnology & Biologics
Trusted Life Sciences partner with decades of experience in cell culture, single-use systems and process design for drug substance processing
Cell & gene therapy
Accelerate cell & gene therapy market entry with flexible designs, next-generation manufacturing and expert services for advanced-therapy medicinal products
Engineering and construction
Wood engineers creative and innovative solutions which add value to our customers' assets from concept through to operations and decommissioning
Facility automation, robotics and vision
Wood offers experienced engineering and intricate software to provide robotics, special purpose machines and controls for automating manufacturing facilities
Filling & Finishing
Expert filling & finishing solutions for Life Science projects. From design to CQV, we deliver tailored, efficient, and compliant facilities globally
Research & development laboratories
Wood delivers compliant research & development labs, pilot plants and biocontainment facilities (BSL2-4) for universities, healthcare and government
Sustainable design for Life Sciences facilities and processes
Wood offers sustainable design solutions for Life Sciences, balancing cGMP compliance with net-zero goals, delivering expert services throughout
Our services
Delivering the best value and solutions to our clients
Beginning with the end in mind, our team of experts are here to deliver the most complex Life Science projects. From strategy and design, through construction, start-up and CQV, we apply our expertise using the latest digital tools and lean delivery concepts to bring the best value and solutions to our clients.
Providing robust, cost-effective, flexible, and compliant facilities and starting with the end goal in mind:
- Funding and permitting strategy
- Feasibility and investment case
- Site analysis and master planning
- Process definition
- Equipment selection
- Architectural modelling
- Process simulation
- Facility Digitalisation
- Test fits and building capacity assessments
- Code and life safety analysis
- Sustainability/ LEED solutions
Applying proven technology and the latest tools for seamless integrated design:
- Process architecture
- Process engineering
- Mechanical systems and clean utilities
- Instrumentation and control systems
- Electrical engineering
- Piping
- Plumbing
- Structural Engineering
- Fire protection
- 3D Modeling
- Computational flow dynamics
- Automation Engineering
- Sustainability/LEED solutions
Leveraging our global supply chain capability and strong vendor and contractor relationships:
- Procurement Strategy
- Contractor Prequalification
- Contract Negotiation and Administration
- Vendor and Contract Management
- Purchasing
- Expediting
- Material management
- Logistics
- Supplier Quality Surveillance (SQS),
- Subcontracting
Simplifying the complicated:
- World-class safety
- Program integrator
- Integrated Project Delivery
- Start-up strategy
- Pre-construction permitting
- Construction work packages (CWP)/ sequence
- Logistics plan
- Project controls
- Estimating
- Schedule & risk management
- Synchro 4D planning
- Earned value management/ change management
- Start-up & completion
- Digital delivery
Bringing a highly qualified CQV team experienced in multiple types of processes:
- Requirements definition
- Design reviews/ qualification
- Clinical quality management (CQM)/ Validation master planning (VMP)
- Risk assessments
- Program development
- Integrated scheduling
- Factory acceptance test (FAT)/Site Acceptance Test (SAT)
- CQV document development
- CQV execution
- Recertification/periodic review
- Standard operating procedures (SOP) development
- Punch list and deviation remediation and close out
- Corrective and Preventative Action (CAPA) close out
- Staff augmentation
- Current good manufacturing practices (cGMP) audits
- Training
- Decommissioning
