iStudyReporter™ Stability is a solution, based on regulatory standards, for the creation of registration relevant stability reports on the basis of data from any Stability-LIMS.

The MS-Word templates integrated in iStudyReporter Stability cover various regulatory required reports, e.g. the Stability Tables or the Shelf-Life based on ICH Q1E. Moreover, our solution provides you with an certificate of analysis, a comprehensive Batch-Analysis, the “Annual Product Review” (FDA) and the “Quality Product Review” (EMEA).

Based on user-defined filter criteria, iStudyReporter Stability extracts regulatory and statistical data from the respective Batch Administration or LIM-Systems. A protected but comments capable MS-Word report is then produced from this data. Its lifecycle can be completely controlled with the help of electronic signatures and audits. The filter criteria enable a detailed determination of particular varieties of data, e.g. storage times and methods, or also the determination of report specifications and test parameters.

In this way, scientific comments can be made on the Word documents. At any point in time the reported data can be updated with the latest data from LIMS, whereby the added comments as well as their relation remain intact. This is made possible on the basis of the technology “Progressive Reporting” developed by up to data. Naturally, all data contained in a report can also be exported to EXCEL or to a “HL7 Stability Data File”.