ePT--the Electronic Newsletter of Pharmaceutical Technology
US District Court for the Eastern District of New York Magistrate Judge A. Kathleen Tomlinson's Nov. 30 2006 "Report and Recommendation" supporting a preliminary injuction requested by the plaintiffs in RxUSA Wholesale, et al v. FDA.
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.