A Quality-by-Design Approach to Optimize In-Process Curing of EUDRAGIT NM 30 D
A study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.
Previous studies with EUDRAGIT NM 30 D showed that storage stability can be achieved with in-process curing at specific conditions. The aim of this study was to identify and investigate the influence and correlation of critical process parameters for the optimization of in-process curing.
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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.
