Milestone Ethos EZ - Page 93

MILESTONE
USER MANUAL
Ethos EZ User manual MA073-006
- 87 -
recording of changes on
the system
changes on the system and for the parameter
settings.
The Process Report includes date, time, user
name and access level and the kind of action that
was accomplished.
11.10 (f) System checks for the
restriction to certified
operating procedures.
Comment no. 59 of the Preamble of the rule
indicates that the use of operational checks is not
required in all cases.
Comment no 79 additional indicates that the
checks do not have to be executed outside of a
predefined order, established by the organization.
Such checks are not appropriate for the operation
of the easycontrol software and therefore can not
be used.
11.10 (g) Use of authority checks The microwave system with controller and
easycontrol software fulfills the requirements of a
"closed System". The access to the system is
divided in 3 levels
- Supervisor + Service
- Administrator
- User
The access to the appropriate level is possible
only by the identification over a write-protected
memory card and an additional password.
Every level has different rights on the system and
control parameters which cannot be modified.
11.10 (h) Control of the validity of
the system for the
generation of data.
The system consists of a microwave system, a
controller terminal and a dedicated controller
software. There are no other data sources except
this system configuration. For this reason this
control is not necessary.
There are no other data sources except this
system configuration. For this reason this control
is not necessary.
11.10 (i) Training of the persons
according to their
assigned access
authorization.
All persons with the access authorization for
service and/or supervisor have received and
acquired an appropriate training by the
manufacturer.
The training and briefing of the operators
(administrator and user) take place in the frame
of an on-site training after the installation of the
system.
The training of further persons on the system is
responsibility of the user company.
For the training of additional users - on request -
special training courses are offered by the
manufacturer.
11.10 (j) Responsibility for the
execution of electronic
The organization of the user must guarantee that
the persons are responsible for all actions that