Application note: A CMC Development Decision Support Tool for Batch Genealogy Management

Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.

The numerical and non-numerical information compiled may be scattered amongst the project team: in disparate emails, chromatography data systems (CDS), analytical electronic laboratory notebooks (ELNs), and chemistry ELNs. While scientists have developed practices to gather this data, it remains a tedious manual process that often causes simple questions to become difficult to answer.