iStudyReporter™ (iSR) is a regulatory standards based pharmaceutical stability reporting tool to be used with any existing stability LIMS.

The supplied MS-Word templates cover different regulated targets like the well defined stability tables and shelf life calculations, certificate of analysis, in depth batch analysis, the Annual Product Review (FDA) and the Product Quality Review (EMEA).

Based on user defined filters, iSR extracts regulatory and statistical data from LIMS and Batch Mgmt. systems, creates protected but amendable MS-Word documents and controls the life-cycle of these documents with e.g. audits and electronic signatures. The filters allow for specification of the included time points, testing methods, etc. , specification assignment and identification of parameters. Based on a filter, iStudyReporter creates a MS-Word document and allows the user to amend this document. At any point, the document can be updated with the most current LIMS information without losing the manual amendments by applying its progressive reporting™ technology. To increase productivity, the data included in any document can be exported either to EXCEL or as HL7 stability data file.

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