Computer System Validation
GAMP 5 category 4 quality management computer systems validation services
A thorough validation service
Our validation services are a 5-part process:
- Plan: Involves building / updating the user requirements specification (URS), functional specification and supplier assessment.
- Build: The Installation Qualification (IQ)
- Configure: The Configuration Specification (CS) and configuration plans.
- Test: The Operation Qualification (OQ), includes administrator training, user training and on-boarding plans.
- Review: The Performance Qualification (PQ), Standard Operating Procedure (SOP) review and change control.
Our validation services
- Dedicated support
- Less internal resource
- Become an expert
- Confidence in your approach
- Best practice implementation
- Reduce compliance burden
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