Use of iStudyReporter for creation of long term archiving of study data in human readable form

The FDA requires electronic data to be long term available also in human readable form, for audit purposes. Most LIMS, like Watson, do not support this specific requirement. The iStudyReporter now supports this requirement by introducing a new module, allowing creation of archive files covering all study information and data retrieved from a local LIMS.

For example, Watson LIMS is capable of creating a study archive, but this is not in human readable format. The US FDA Guidance for Industry: „21 CFR Part 11; Electronic Records; Electronic Signatures; Maintenance of Electronic Records“ requires in Section 11.10 (b): “The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying by the agency.“1 The well established CDISC standards are not helping in solving this task, since they do not cover all of the relevant bioanalytical data, e.g. from validation studies.

1
[21CFR11, Code of Federal Regulations,Title 21, Volume 1, Revised as of April 1, 2018]

Solution

A new iStudyReporter module generates a complete set of human readable study data documents in PDF/A format from the Thermo Watson study database. The resulting structured documentation is viewable without any knowledge of Watson or iStudyReporter. The documentation comes with a full set of supplemented CSV and XML files with the exported study data for further processing and future analysis, without reliance on any specific tool. The module supports attaching other files to the archive before transfer to a long-term corporate document archiving solution. As an example, the Thermo Watson exports Sciex Analyst files and any other study-relevant information for inclusion in the generated study archive. Apart from long-term study data archiving, this archiving module provides an ideal solution for CRO´s to submit study data to a study sponsor.

Worklist

The modul shlashes processing times by eliminating almost all manual activities in creating archives, including hardcopies, consistency checks with study submissions already created, and manually compiling the resulting documents. The Watson study data archiving module was developed in close cooperation with global pharmaceutical corporations based on regulatory requirements. The modules large number of interfaces allows for integration into any existing IT environment, while supporting major systems such as LIMS, ELN, SAP, SDMS, and legacy systems. This way, a study archive can be created in a human readable format for fast review without addtl. Software, that is satisfying regulatory requirements for study reviews. It ensures consistency with prior submission documents (statistics, comments, ...) and makes data accessible for futher processing without knowledge of Watson or iStudyReporter.

Raw data

Features of iStudyReporter

  • Supports Thermo Scientific™ Watson LIMS

  • Cover requirements of 21 CFR Part 11 (11.10 (b) and 11.50)

  • Complete human-readable study data documentation in PDF/A format

  • No knowledge of Thermo Scientific™ Watson LIMS™ or iStudyReporter required for review

  • Supplementary CSV and XML file sets for further processing

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