Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable). Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.