SERVICES
CSV & CSA
BRIEF
Overview
At Validation Solutions, our CSV & CSA programmes ensure that every GxP critical system is validated to the highest regulatory and data-integrity standards.
We use a modern, risk-based approach built on GAMP 5 (2nd Edition), ICH Q9(R1), and FDA CSA principles, enabling efficient, science-driven validation with reduced documentation burden. We support the full digital lifecycle, from system classification and requirements definition to configuration verification, data-integrity controls, and periodic review. Our strategies align with 21 CFR Part 11, Annex 11, MHRA guidance, and emerging Annex 22 expectations for automated and AI-driven systems, delivering a future-proof, inspection-ready validation framework that ensures lasting compliance.
DELIVERABLES
What's Included?
GxP impact assessment and system classification
User, functional, and configuration requirements
Supplier assessment and documentation leverage
Configuration review and data-flow verification
Risk-based CSA/GAMP 5 test strategy
Development of scripted, unscripted, and exploratory test scripts
Data-integrity, security, and audit-trail controls
Traceability, evidence capture, and validation reporting
Release, deployment, and ongoing lifecycle review
Other services
• GxP impact assessment and system classification
• User, functional, and configuration requirements
• Supplier assessment and documentation leverage
• Configuration review and data-flow verification
• Risk-based CSA/GAMP 5 test strategy
• Development of scripted, unscripted, and exploratory test scripts
• Data-integrity, security, and audit-trail controls
• Traceability, evidence capture, and validation reporting
• Release, deployment, and ongoing lifecycle review