Our Computerized System Validation Service
Validate your GxP systems with a risk-based approach
We secure the validation of your computerized systems, from CSV/CSA strategy to go-live and maintaining the validated state.
Our Computerized System Validation Service
We secure the validation of your computerized systems, from CSV/CSA strategy to go-live and maintaining the validated state.
Deploying a new system
Evolving an existing system
Revisiting historical validation
Adopting a Cloud or SaaS solution
Define a CSV/CSA approach suited to the system's criticality, use and lifecycle.
Identify critical functions and scale validation effort to GxP risk.
Structure requirements and demonstrate their coverage through to verification evidence.
Design, run or review testing targeted at critical processes and functions.
Integrate change management, periodic reviews and incident tracking into the lifecycle.
An effort level matched to the system's risk and use.
Consistent, traceable deliverables, ready to use.
Controls embedded into the lifecycle and routine activities.
Scope, roles and strategy.
Risks, requirements and controls.
Tests, gaps and evidence.
Decision and maintaining the validated state.
An initial conversation helps define the right approach for your system and risks.
Schedule an initial conversation