The iStudyReporter Stability solution

iStudyReporter Stability generates comprehensive stability reports for drug and product approval using regulatory and statistical data based on filter queries to extract batch and LIMS data such as SampleManager, LabWare, and LabVantage and SAP.

iStudyReporter Stability provides a variety of preconfigured reports for official submission, eliminating the need for complex and time-consuming adaptation. This solution provides formats and reports 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. Fully featured template management ensures efficient procedures using a variety of stored templates.

Benefits of iStudyReporter Stability

For decision makers

  • Fully automated generation of complex reports and approval documents including graphics and statistical analyses within minutes at the click of a mouse.
  • Streamlined lab processes with standardised report creation and increased efficiency in the approvals process.
  • Increased number of reports generated together with substantial time savings and increased productivity.
  • Risk minimisation by eliminating potential sources of error inherent to manual regulatory report preparation, eliminating the need for double-checking according to the four-eyes principle.
  • Simple generation of ongoing stability reports together with automated trend report generation.
  • Structure oriented towards real-life application with an intuitive user interface.
  • Interfacing to any LIMS or other DBMS.
  • Fast customised implementation and seamless integration into existing IT environments with little need for configuration.
  • Decreasing costs per approval report – amortisation within a few years.

For report writers

  • Fully automated generation of complex reports and approval documents including graphics and statistical analyses within minutes at the click of a mouse.
  • Simpler and more rapid reporting processes together with increased data security.
  • Substantial time savings and relief for report writers.
  • Reports with version management without data loss or the need for double-checking.
  • Simple generation of ongoing stability reports.
  • Report-specific approval specification selection.
  • Structure oriented towards real-life application with an intuitive user interface.
  • Validated data transfer from the LIMS into reports.
  • Fast implementation and seamless integration into existing IT environments.
  • Concurrent users towards reducing licensing costs.

Do you have any questions about iStudyReporter?

Need more information, or would you like to arrange a meeting with us?

We would be pleased to help you out, and would welcome the opportunity to talk to you.