Fig. 3

Structured content and data library for stability data. An overview of a structured content and data library housing stability information is depicted. Each black box constitutes a “content block” that is attributed to a specific lot. Inside each content block, information such as test method, acceptance criteria, and timepoints are accessible. Data is imported into the library directly from the data source (ex. LIMS, eLN). Over time, as development progresses, stability data continually accumulates across lots and, additionally, new lots are developed as the manufacturing process is optimized. Content blocks data elements are updated in real time as new data points become available from data sources. Content blocks and data elements can be “pulled” from the library to auto-populate module 3 CTD sections to prepare for submission