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 ...

Until specific audit trail requirements are available from the US Food and Drug Administration, manufacturers must define their own parameters for software system compliance and decide for themselves ...

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 ...