Instructions for installing the eValidator 24.1

The following basic requirements must be met:

• administrator privileges
• Microsoft Windows Installer 3.1
• Microsoft .NET Framework 4.5 or higher

The following two applications can be downloaded from the following links:

• Microsoft Windows Installer 3.1
• Microsoft .NET 4.5

installation

• Close all programs before starting the installation.
• Download the "AGES_e_Validator_24.1.zip" at the bottom of the page.
• Extract the file to any folder on your desktop, for example.
• Change to the folder where you saved the downloaded file. Press the right mouse button, select "Extract All" and follow the instructions that follow.

Hint:

Please note that there may be updates of this eValidator at irregular intervals.

Please make sure that you are using the latest version.

After successful completion you should find the following files and folders in the folder:

• Double-click on to open the installation folder. Run the Setup.msi and follow the instructions.
• After successful installation you will find a new icon (fig. according to PDF at the bottom of the page) on your desktop.

Guidance for the technical validation of eCTD, NeeS and VNeeS submissions

• Double-click on the symbol to start the e_Validator. The registration screen, which only appears on the first access, can be cancelled with "Skip Registration". Then the e_Validator interface appears automatically.
• Before the validation can be started, the report output directory and the language must be selected under "Settings". All other settings must not be changed. The report output directory is the storage location for the validation log.
• Please note that the validation protocol is not stored in the sequence to be validated, as it will be shown as an error during the new validation.
• The validation protocol must be stored in a separate folder outside the sequences at eCTD or NeeS. This folder must be sent with the submission.
• In this case the drive "D" with the folder "Protocols" has been selected. Return to the validation using the "Rules" button.
• Depending on whether you want to validate "eCTD" or "NeeS", change the rule category to the appropriate format. In this example "eCTD" was selected. This can be selected in the drop down window.
• After you have pressed the "Validate" button, the validation process begins and the entire interface is blocked for access. Two bars now appear at the bottom left. The upper one shows the current checks, the lower one the total progress. Now select the Index.xml file in the sequence to be validated. You can also drag and drop the Index.xml file directly from the Windows Explorer into the input field.

Hint:

All illustrations and the complete installation instructions are available for download in this document.

feedbacks

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Validation criteria for the technical validation of eCTDs

The BASG / AGES Medizinmarktaufsicht uses the published validation criteria, which are available below.

Here you will find the FAQ Electronic submission