Darwin is a commercial-off-the-shelf LIMS for pharmaceutical development and quality control, which is powered by SampleManager and supports complex pharmaceutical testing and regulatory compliance. The system handles comprehensive batch/lot management and tracking of dissolution, stability, environmental monitoring and other experiments specific to manufacturing R&D and QC. This LIMS addresses the specific workflows of one pharmaceutical company compared with another. For example, users can modify screens and develop reports that suit their needs without custom coding or IT involvement. For FDA and ICH regulatory compliance, there are activity- and event-based system privileges to correspond with users’ work responsibilities. Data and objects can be designated non-GMP for analytical development, allowing researchers flexibility during exploratory work, while quality control data can be designated GMP to enforce adherence to company SOPs and regulatory guidelines. It also features systems and instrument interfacing with other database systems such as SAP, and allows interactions with other data treatment applications. Instrument integration includes instrument tracking, maintenance and calibration and comes preconfigured to integrate with proprietary systems.