Digital transformation of analytical processes requires suppliers to design and implement audit trail(s) (AT) that are fit for intended use in a regulated laboratory. In addition, second person review ...

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data. Audit trail review (ATR) is a mechanism to detect potential ...

Eli Lilly's enhanced ATR process reduces the burden on laboratories and manufacturing spaces while meeting regulatory expectations. A centralized data management team ensures sustainable DI processes, ...