Risk Management Shapes FDA Policies and Practices
In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.
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A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
