Laser Diffraction Software Supports Analytical QbD
Laser Diffraction Software Supports Analytical QbD
A software upgrade for the Mastersizer 3000 laser diffraction particle size analyzer from Malvern Instruments decreases the analytical workload associated with developing and validating particle sizing methods. New operational features, such as an Optical Property Optimizer (OPO ), simplify the process of method development. The new OPO tool enables the identification of appropriate refractive index and absorption values for the analysis of any given sample. It also allows analysts to research the impact of optical properties on reported particle size, in real time, using an intuitive point-and-click tool. According to the company, this helps exploration of the operating space in which robust measurements are assured, to define the method operable design region for a particle size analysis method.
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.
