1. Connections

There is a role-based, central authentication and registration for the access to applications.

The roles differentiate between the administrator in the higher federal authorities, the main user in a company or an authority and other users in a company (user).

The administrator can provide the main users with rights. The main user in a company or an authority, can create other users (user).

Below the editing options of an administrator of a federal authority are described.

2. Administration by the administrator in the higher federal authorities

Navigation points for the Administration:

• Input - new registrations
• Active - users with state "active"
• Changes - Here you will find those users who have modified their personal data (not the certificate)
• Deactivated - users with state "deactivated"
• New certificates - here you will find changes associated with the certificate

All options in the main part of the page display a table with the users of this category. You can always call the data of the user to edit by clicking on the writing icon.

By clicking on the remove icon the account can be disabled.

Immediately after calling the user administration by the administrator in the federal authority a screen with all the new inputs appears.

3. Activating new registrations

Customer data appear editable. Status is defaulted with "ACTIVE". The applied technical applications with the associated roles are shown and can be selected.

Underneath information about the certificate is displayed. When a certificate is presented, this must be checked. The certificate is the user's personal identification that has the function of an identity card. From the information in the certificate should indicate which person it identifies.

The administrator in the federal authority now must verify the registration of the main user to be activated in a company or an authority.

After clicking on "Activate", the registration of the main user is activated in a company or a public authority and then again the screen of the registration inputs is shown.

If during the registration applications were chosen that fall into different BOB responsibility, they must be activated individually. E.g. a user has selected the applications "Chargenfreigabe" and "Änderungsanzeigen " in the registration. For "Chargenfreigabe" PEI, for "Änderungsanzeigen" BfArM is responsible. Competent administrators are notified by mail that there is a registration and with this information they go in the user management. You can assign and activate permissions / roles for applications falling within your competence.

Already after the first treatment (= activation) the user can use his Account for user self-administration and the previously activated applications use even if not all applications are "allowed", that is, the associated rolls are awarded.

4. Activation by several federal agencies

If during the registration applications were chosen that fall into different higher federal authorities’ responsibility, they must be activated individually. A user has e.g. in the registration selected the applications "Chargenfreigabe" and "Aenderungsanzeigen". Responsible for "Chargenfreigabe" is PEI, for "Aenderungsanzeigen" BfArM is responsible. Competent administrators of the higher federal authorities are notified by mail about the registrations and with this information start the user management. They can assign and activate permissions / roles for applications falling within its competence.

The user who signed up, can already after the first treatment (= activation) use his account for user self-administration and the previously activated applications use even if not all applications "allowed", that is, the associated rollers are awarded.

5. Request for further applications

The main users have the possibility to apply via the "Login for more applications' access for other applications. You the administrator will receive an email with the reference to this application and can call the screen for editing the data of the user and assign the roles for the requested applications as in the initial registration by clicking on the Write icon.

6. Processing of new certificates

Under "New Certificates" users are shown, who uploaded a certificate, which is formally correct, but in which the identity of the certificate holder must be confirmed. The certificate is the user's personal identification that has the function of an identity card. The information in the certificate should indicate which person it identifies.

Via "Edit" and subsequent clicking on "Certificate ok" you confirm the identity of the certificate holder. If you cannot confirm the identity, click on "Certificate not ok". The state of the user does not change and he can use his old certificate until further as it is still valid.

You receive the message "The renewed certificate of users ... with CNR ... was rejected. The user has received an e-mail concerning this matter."

The user receives an email with the following content: "Dear ..., your renewed certificate was rejected. Please contact your administrator. <Name and phone number of the administrator>"

7. Transfer of responsibility

The main users in pharmaceutical companies or authority is responsible for the user's self-government set up by himself. The administrator in the federal authority may delegate the responsibility for users of a main user to another main users. This can e.g. be necessary if an employee leaves. In this case. The main user must get in touch with the responsible administrator of the federal authority.

Contact

Helpdesk Technik
Telephone: +49 (0)228 99 307-4949
E-Mail: helpdesk-technik@bfarm.de