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A Risk-Based Approach to Implement Audit Trail Review and Inspection Readiness Plans in a Data Integrity Conscious World
Session Chair(s)
Paula Horowitz
Program Manager, QA, GCP Software Validation
AbbVie, United States
Given the current regulatory landscape, we will focus on what each organization should consider using a risk-based approach to be inspection ready, specifically regarding audit trail review and compliance with data integrity.
Learning Objective : Define GCP for data quality and data integrity specific to audit trail generation and review. Describe the current regulatory framework for organizational data governance, data integrity, audit trail review and inspection readiness within this framework.
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