SLIM (Stability Lab Information Manager) is a fully validated LIMS designed for complete management of drug stability programs — from the design of stability study protocols to statistical analyses and presentation of final data for regulatory, e.g., FDA, submission. Features include a stability (including extensive formulation capabilities) database; data entry via WYSIWYG forms or spreadsheet mode, as well as automated methods; flexible calendar functionality, including e-mail notification; complete inventory management; resource scheduling; shelf life prediction according to Q1E ICH guidelines; OOT detection/trend snalysis using CI, PI, or StdDev of residuals; and fully Integrated 21 CFR Part 11 compliant features. The software can manage thousands of stability studies operating on a stand-alone PC, a local area network (LAN), or wide area networks (WAN) such as a terminal server or Citrix.