Our iStudyReporter™ LabOne package is a data management and reporting system based on regulatory standards designed specifically for companies in the Life Science.
This package is aimed at labs and business units that have found a need regulated data management but try to avoid to introduce a complex LIMS to this end.
The advantage of iStudyReporter LabOne is obvious – a combined solution designed for medium-sized companies and laboratories consisting of a versatile stability data management system together with a fully automated reporting process.
Previous laboratory workflows are left virtually unchanged while implementing iStudyReporter LabOne, keeping the project's implementation effort down to a manageable level. MS Excel data sheets are generated using the solution, and distributed to labs for data collection. The MS Excel data recorded is then extracted into a database structure for verification with a special Certificate of Analysis (CoA). This provides you with a complete and valid set of stability data.
Our iStudyReporter LabOne package gives you the benefits of a transparent stability data management system without the expensive and time-consuming implementation of a complex LIM Solution. Processing all parameters within the database gives you diverse monitoring and notification functions; features such as study design, variable specification handling, storage management, sampling lists, messaging modules are included as standard.
The database with its validated data gives you the major benefit of a fully automated reporting process that will satisfy regulatory requirements, giving you stability data that can be processed into various reports (see also iStudyReporter Stability). This completely frees you from the otherwise tedious manual work involved in report writing manually. The streamlined lab process despite unaltered workflows in combination with the automated study reporting creation including graphical and statistical presentation will result in a procedure of minutes.