Softwaren Validierung Transparenz
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Transparency

The quality standards in the GLP regulated field are high.
The process from the raw data to evaluation and then finally to the report has to be unalterable, testable and reproducible.

Unalterable.

The raw data entered is processed exclusively by ToxRat internally. Raw data tables, results tables and graphics are produced. From these, the so-called primary report is generated (as rtf or pdf).
In principle, the primary report may only be generated by means of an immediately preceding evaluation. This means that it is always produced from an internal original copy of the results. Any changes carried out to the results during a program session are not transferred. Consequently, it is not possible to change results tables before they are included in the report.

The primary report can be saved and, if the rtf format has been selected, it can of course be edited. However, the directly printed primary report is visually different in appearance to an archived report (which may have been edited).   

If desired, the report includes details of the ToxRat version used, the raw data file name, the date of evaluation, the computer name, user name etc.

Testable.

The algorithms and statistical methods used in ToxRat have been tested. A validation document is included with the delivery, which explains all the methods and procedures used in the program including the formulas they are based on. Moreover, all mathematical and statistical procedures have been applied to standardised test data sets and the results have been verified through comparison with independent calculations (for example  MS-Excel) and reference data.

Reproducible.

The test data sets are included with the software so that you as the user can reproduce this quality control step yourself and, furthermore, can check locally whether the software also supplies the results stated in the validation document for your individual configuration.