Pillar 03
CSV & C&Q
CSV & C&Q
Scope of service
- Computer system validation
- Commissioning & qualification
- Data integrity gap assessment
- Lifecycle CSV services
Typical deliverables
What you receive
- Validation master plan (VMP)
- IQ / OQ / PQ protocol and execution
- CSV assessment and testing (GAMP® 5)
- Traceability matrix and final reports
15+
CSV / compliance specialists
Automation, IT and validation expertise
50+
GxP validated systems
URS through regulatory acceptance
3
Regulatory frameworks
NMPA · FDA · EMA
100%
GAMP® 5 aligned
Risk-based, lifecycle CSV
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Related capabilities
Pillar 01
Design & Consultancy
Digital roadmap & DIP™ planning, feasibility study (FES), concept / basic / detailed design (CD / BD / DD), WEF Lighthouse assessment and energy & sustainability.
Pillar 02
System Solution
MES / PCS / SCADA / DHS, data historian & IoT backbone, production simulation and GMP critical systems.
Pillar 04
Operation Support
Plant digital uplift & OEE, predictive maintenance, OT security & compliance and site support & maintenance.
Pillar 05
Expert Advisory
Automation, IT and CSV subject matter expert (SME), project manager (PM) and engineer & specialist support.
Discuss your commissioning & qualification requirement
Send us the project context — site, phase, scope — and we will come back with the right specialist team.