Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA+ principles, metadata management, audit trails, system-to-system data transfer checks, and dataflow mapping) are embedded across the full data lifecycle. GxP System & Technology Compliance * Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and internal digital governance requirements. * Maintain and evolve the compliance framework for GxP-relevant systems (policies, SOPs, guidance). * Provide QA insight during system selection, onboarding, validation, and ongoing oversight. * Support investigations, deviations, CAPAs, and inspection-readiness activities related to DI or system failures, ensuring completeness and alignment with regulatory expectations. External System Oversight (CRO / Vendor Systems)
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