Quantitative open-access HPLC analysis: a new calibration approach
Pharmaceutical Technology Europe
A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.
A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high‑performance liquid chromatography without having to prepare standards. The authors discuss the approach taken to develop the tool, its associated protocols and how it can be used to calculate data.
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.
