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iStudyReporter Stability

Report generation usually plays a rather minor role as the end of the lab process in classical LIMS implementation projects. Most labs working in a regulatory environment use traditional standard solutions such as Crystal Reports™ to draw up their reports. However, the effort needed in customising reports for LIMS structures and implementing individual requirements is often underestimated. In addition, you'll usually find that these reporting tools rapidly reach their limits with complex regulatory study reports – such as complete stability study reports including graphical and statistical treatment as well as APR and PQR. Study leaders mostly have to compile these reports manually, a tedious process that ends in additional "recheck" procedures to validate your data.

Our iStudyReporter Stability package is based on regulatory standards for preparing complex stability study reports for approval as based on data from any stability LIMS, and covers various regulatory reports out of the box to eliminate costly customisation; all that's left is to configure the output formats together with the customer. The package comes with sophisticated template management, making it easy and safe for users to store different templates for different clients, for example.
This solution provides features such as classical stability tables, Certificate of Analysis (CoA), shelf-life calculations based on ICHQ1E, complex trend analysis with corresponding statistical treatment, and APR and PQR.

The iStudyReporter Stability package extracts regulatory and statistical data from the underlying batch and/or LIM systems based on filter criteria. From the data, the system generates a report with a write-protected table part and a space below for you to add comments within a MS Word format, with complete life-cycle revision control by using auditing and electronic signatures. The filter criteria allows detailed definitions of individual data points such as storage times and methods or selecting specification criteria in variance to the LIMS specification if necessary, as well as test parameter identification.
Naturally, you can add your scientific comments to the stability documents generated. Additionally, you can add to or update the data in your report with data from your LIMS at any time. Any comments you have added and their referencing will remain untouched since only the tables are updated. This works on Progressive Reporting Technology developed by up to data. Naturally, you can export all of the report's data to MS Excel or to an HL7 stability data file.
If necessary, you can file your reports directly into the document management system or print them out in PDF format.

iStudyReporter Stability Flyer
WRIB (Workshop on Recent Issues in Bioanalysis) 2017
03.04.2017, Los Angeles, USA