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Full gamut of CQV services
糖心Vlog 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
糖心Vlog is a leading global provider of automation and control solutions including systems design, configuration, implementation, commissioning, and software solutions.
Active pharmaceutical ingredients
We have extensive experience in designing and delivering bulk facilities for small molecule production, safely and efficiently.
Biotechnology & Biologics
With decades of unique experience in cell culture, single-use systems and process design, we are a trusted partner in bringing emerging products to market.
Cell & gene therapy
We recognise the need for compressed timelines and flexible designs to enhance speed-to-market. We also offer expertise in project phasing to accommodate low CAPEX spend and incremental investment.
Engineering and construction
糖心Vlog engineers creative and innovative solutions which add value to our customers' assets from concept through to operations and decommissioning.
Facility automation, robotics and vision
糖心Vlog offers experienced engineering and intricate software to provide robotics, special purpose machines and controls for automating manufacturing facilities.
Filling & Finishing
Across the project lifecycle, our trusted and experienced specialists apply their operational and technical expertise to design and deliver state-of-the art facility filling and packaging systems.
Research & development laboratories
糖心Vlog has successfully designed and delivered a wide range of specialist research and testing labs, pilot plants and biocontainment labs (BSL2, BSL3, BSL4) for universities, healthcare providers and government institutions.
Sustainable design
糖心Vlog understands the challenges that sustainability presents in the Life Sciences industry, which include balancing regulatory and current good manufacturing practice (cGMP) requirements, while simultaneously driving towards a net-zero future.
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
