Memmert AtmoCONTROL FDA Version 2.X.X - Manual (Page 34)

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.