The quality standards in the GLP-regulated field are high.
The process from raw data to evaluation and finally to the report must be unalterable, verified and reproducible.
The raw data entered is further processed exclusively within ToxRat. Raw data tables, result tables and graphics are generated. From this, the so-called primary report is generated (as rtf or pdf).
The primary report can only be generated on the basis of an immediately preceding evaluation, i.e. it is always generated from an internal original copy of the results. Changes made to the results in the course of a program session are not adopted. This means that it is not possible to modify result tables before they are transferred to the report.
The primary report can be saved and - if format rtf is selected - edited, of course. However, the directly printed primary report is visually different from an archived (and, if necessary, edited) report.
If desired, the report contains information about the ToxRat version used, raw data file name, evaluation date, computer name, user name, etc.
The algorithms and statistical procedures used in ToxRat have been validated. This includes a validation document explaining all methods and procedures used in the program, including the underlying formulas. In addition, all mathematical and statistical procedures are applied to standardized test data sets and the results are verified by comparison with independent calculations (e.g. MS-EXCEL ) and literature data.
The test data sets are part of the scope of delivery of the software, so that you can reproduce this step of the quality control yourself and also check on site whether the software also delivers the results specified in the validation document in your individual configuration.