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]