Our Expertise
4 Pillars of expertise to secure your critical projects
C-Validation offers a complete range of services covering the lifecycle of your critical facilities and systems, from design to operation, ensuring regulatory compliance and operational performance.
Commissioning
Ensuring that your facilities and equipment are designed, installed, tested, and operated according to your operational needs and design requirements.
Our Commissioning Services
- Commissioning Strategy (C&Q)
- Writing and review of URS (User Requirement Specifications)
- Design Qualification (DQ) and design reviews
- Management and supervision of FAT (Factory Acceptance Tests)
- Management and supervision of SAT (Site Acceptance Tests)
- Commissioning and functional testing
- Verification of technical installations
- Coordination with suppliers and installers
Our Qualification & Validation Services
- Validation Master Plan (VMP)
- Risk Analysis (FMEA, HACCP)
- Writing and execution of IQ/OQ/PQ protocols
- Cleaning and process validation
- Computerized System Validation (CSV)
- Maintaining validated state and periodic reviews
- Non-conformance management and CAPA
- Preparation for regulatory inspections
Qualification & Validation
Rigorous validation of your processes and equipment to ensure GMP compliance and guarantee the quality and safety of your products.
Engineering Consultancy
Engineering support for your industrial projects: sizing, integration of automation solutions and ASRS, coordination with project teams and suppliers to secure schedule, costs, and quality.
Our Engineering Services
- Feasibility studies and sizing
- CAPEX projects and expansion coordination
- Automated systems & ASRS integration
- Infrastructure optimization (energy, utilities, flows)
- Technical support during design and construction phases
- Coordination with suppliers and integrators
- Schedule, budget and quality tracking
- Managing interfaces between multidisciplinary teams
Our Quality Services
- Audits & gap analysis (GMP, GAMP, 21 CFR Part 11)
- QMS strengthening and optimization
- CSV (Computerized System Validation)
- Data Integrity implementation (ALCOA+)
- Inspection preparation (ANSM, EMA, FDA)
- Change control support and deviation management
- Document review and procedure harmonization
- Quality team training and coaching
Quality & Compliance
Strengthening your Quality systems: compliance reviews, internal audits, gap analysis, support for Data Integrity and CSV implementation, inspection preparation.
Field-Proven Expertise
Our management team combines decades of experience on critical projects, ensuring flawless technical and operational mastery.
- •CAPEX Project Manager
- •Qualification & Validation Consultant (CQV)
- •Process Engineer / Pharma Process Consultant
- •Methods Engineer / Installation Engineer
- •Automation & CSV Consultant (Computer System Validation)
- •HVAC / Utilities / Clean Utilities Engineer
- •Cost Engineer / Project Controller
- •Quality Specialist / Project Quality Assurance
- •HSE Consultant / Environmental Qualification
Recognized Expertise
A team with over 15 years of combined project experience in Commissioning, Qualification, Validation, and engineering for Life Sciences and critical industries.
Need tailored support?
Our experts analyze your needs and offer you the most suitable solution.
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