Diana Russo has more than 20 years of experience in the pharmaceutical industry. She has built her career in the areas of computer system validation, IT quality, and computer systems quality assurance. And while her current role focuses on data integrity, DI has been an important driving force throughout her entire career. She is an audit trail review subject matter expert, a leader in process improvement, and happily challenges the status quo.
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.