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 ...

For example, chromatographic data should be saved to durable media upon completion of each step or injection (e.g., peak integration or processing steps; finished, incomplete, or aborted injections) ...

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 ...