iStudyReporter™ LabOne is a pharmaceutical stability data management and reporting tool based on regulatory standards. It’s positioned for labs that see the need for regulatory data management but don’t want to introduce a LIMS.

Stability study related information like products, lots, studies or product specifications can be entered to the system by using user configurable MS EXCEL sheets. Result entry worksheets are generated based on user defined templates and include a specification check and may make use of any other kind of calculation (e.g. dissolution worksheets). A sophisticated little impact workflow for regulated labs already working with EXCEL guarantees the validity of this data. In this way iStudyReporter™ LabOne is tailored for smaller pharmaceutical units like separated labs or small and midsized pharmaceutical companies.

The included iStudyReporter™ reporting engine allows high sophisticated reporting and data analysis like batch analysis or shelf life calculations.

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