GxP-compliant stability reports within minutes without a need for data revalidation

StudyGen 360 Reporter Stability

StudyGen Reporter Stability provides a variety of pre-configured reports for regulatory submissions, eliminating the need for complex and time-consuming customization. The solution offers formats and reports such as classic stability tables, certificates of analysis (CoA), shelf life calculations based on ICH Q1e, complex trend analyses with corresponding statistical processing, and APR and PQR. A full-featured template management system ensures efficient work with a wide range of stored templates.

Achieve data integrity in reporting by the push of a button.


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The perfect reporting Add-on for your Stability LIMS

Leverage your Stability LIMS in QC and CMC departments by using an established solution to generate your complete stability reports for submission. No more tedious LIMS implementation projects with customized individual reports for regulatory approval. By making use of StudyGen Reporter Stability you get a solution that integrates seamlessly with your LIMS and generates stability reports in the shortest time based on regulatory requirements.

StudyGen Reporter Stability comes with a set of predefined and customizable interfaces to all common LIM systems such as SampleManager LIMS™,, LabWare LIMS or LabVantage or Lab notebooks. Data from several systems can also be merged, e.g. from a legacy system and a current system.

Pre-qualified table representations can be used in custom Word templates. Templates can be configured for a wide variety of purposes – whether initial approval, ongoing stability or PQR and APR. During generation, relevant issues such as unknown impurities, spelling errors in parameter frames, changed method definitions or the use of country-specific product specifications can be addressed and mapped easily.

Sophisticated statistical analyses that can otherwise only be implemented in separate packages with loss of data integrity are already included in StudyGen Reporter Stability. This eliminates the need for external programs, service providers and the time-consuming revalidation of reports.

TOP studygen functions for stability

Predefined report types

  • INDA

  • NDA

  • Annual Reports and PQR/APR

Supported stability systems

  • up2Lims

  • Thermo Scientifc SampleManager

  • LabWare LIMS

  • LabVantage

ICH Q1e based data analysis

  • Poolability analysis

  • Shelf-life statements

  • Transparency of all statistical parameters

Your advantages


Established solution from the specialist based on 25 years of experience with stability systems

Simple integration

Supports all common stability LIMS, especially Thermo Scientific SampleManager, LabWare LIMS or LabVantage

Access to LIMS data in real time

Connection to all available LIMS systems that can map stability studies

Predefined tables and graphics

For all areas of the stability reports

Poolability analysis according to ICH Q1e

Shelf life calculation, shelf life plots and poolability analysis according to ICH Q1e, no manual creation in external software (SAS, SPSS) necessary

Ensured data integrity

Combines different simultaneous data sources (LIMS, ELN, old LIMS)

Supported guidelines

Aligned with current guidelines in research and development, StudyGen Reporter Stability complements the digitalization initiatives of the pharmaceutical industry, for a secure and fast time-to-market of your products.

  • Stability data evaluation: ICH Q1e Evaluation of stability data

Your contact person

Debbie Schmidt
Customer Engagement Manager studygen

t + 1 732 417 3601  
e sales@uptodata.de