Memmert AtmoCONTROL FDA Version 2.X.X Manual de usuario descargar pdf (Pagina 34)

D30396 | Date 09/2014

AtmoCONTROL FDA Version

Here, you can:

►

add new users

►

change existing user passwords

►

assign and remove user rights

►

remove users

The user management can only be accessed by users the administrator has assigned the

right to do so.

9.2

Changing the user password and user

Via the menu item “Security”

→

”Change password”, the

user currently logged in can change his/her password.

Via the menu item “Security”

→

”Change user”, a differ-

ent user than the one currently logged in can log on. The

user currently logged in is visible in the status bar of the

software:

9.3

Signing a document

With the function “Security”

→

”Sign document”, you can

electronically sign a programme or protocol. For this

purpose, it has to be opened (visible on the monitor). For

protocols, time ranges can be selected using two calen-

dars. Existing ranges are selectable in the lower pane for

additional signatures.

A signature once given cannot be changed or removed

later on and a signed programme cannot be changed any

longer. Each signature is documented by an entry in the

audit trail file (see next chapter).

Using an electronic signature in the sense of 21CFR11

requires additional notification of the responsible

authority in accordance with 11.110(c).

The user rights assigned by the administrator define the

type of signature a user is allowed to provide. The

signatures are divided in the roles “created”, “seen”,

“checked”, “approved” and “responsible”.

A user can also sign with several roles, however only with

the corresponding rights. A role can in turn also be signed

by several users with the right to do so.

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Memmert AtmoCONTROL FDA Version 2.X.X Manual de usuario Pagina 34

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