Computerized System Validation (CSV)
CSV that ensures software and digital systems are inspection-ready
Deliverables:
- CSV strategy and risk assessment (GxP applicability and criticality)
- Requirements and functional specifications (URS/SRS)
- Validation plans, test scripts, and execution evidence (IQ/OQ/PQ for systems)
- Traceability matrices and final validation report
- Change control and periodic review support for cloud and SaaS systems
