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 ...

Transparency has become more than just a business buzzword — it’s a major operational movement across companies. Take the concepts of workflow management and automation, for example. They’ve become ...

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 ...