iStudyReporter™ LabOne is a data management and reporting tool for Life Science companies which is based on regulatory standards.

Target users are laboratories and company departments that are aware of their need for regulated data management but do not wish to introduce a LIMS.

The advantage of iStudyReporter begins where customary data management solutions end: with the production of registration relevant stability studies.

The user loads study relevant data, such as products, batches, protocols and product specifications into the system by means of an individually configurable MS-Excel-Data Sheet. Research results are entered into system-generated Excel-Sheets that can be configured to meet individual requirements but can, nevertheless, also contain diverse calculations (e.g. dissolutions) and specification tests.

The resulting workflow has no negative impact on laboratories that already use MS-Excel; on the contrary, it guarantees data integrity and validity.

In other words, iStudyReporter™ LabOne is the first tailor-made data management solution for independent laboratories that work mainly with a simple regulatory mechanism.

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