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 ...

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, ...

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 ...

The CA Institute has issued Frequently Asked Questions (FAQs) to assist its members in handling various practical situations arising from Government norm requiring companies to use only accounting ...