Milestone ultraWAVE 3 - Page 147

Milestone Srl MA245-001 – ultraWAVE 3 – User Manual
145
The organization of the user must produce procedures for
defining the retention period and for the secure back up
of the data copies during that time.
11.10 (d)
Limiting system access to
authorized individuals.
The physical access to the system and to the area where
this is installed must be regulated and it is under the
responsibility of the organization of the user.
11.10 (e)
Use of secure, computer-generated,
time-stamped audit trails to
independently record the date and
time of operator entries and actions
that create, modify, or delete
electronic records. Record changes
shall not obscure previously
recorded information. Such audit
trail documentation shall be
retained for a period at least as long
as that required for the subject
electronic records and shall be
available for agency review and
copying.
A Process Report (Trail) records all the relevant events
including:
- software accesses (including failed)
- settings modification
- methods modification
- cycles execution
- users management
- errors
For each recorded event the following information are
stored:
- date and time
- user name and access level
- details of the action
- both previous and new value (in case of data
modification)
The Trail file cannot be modified or imported on
easyCONTROL software. It can be exported, saved and
printed on readable format file.
The organization of the user must produce procedures
for: defining the retention period (which as to be at least
longer as the data records), the backup of the Trail during
that time, managing the copy of the Trail file in order to
avoid deletion or alteration of the same, linking the
account name to the related person, managing the
eventual change of local time mode (solar-legal).
11.10 (f)
Use of operational system checks to
enforce permitted sequencing of
steps and events, as appropriate
The easyCONTROL software does not allow to start a run
if each critical parameter has not been properly entered or
if all the operation and safety checks (e.g. door closed)
have not been confirmed from the related detection
device.
For critical editable parameters the software does not
allow to enter data out of the defined range.