Milestone DMA-80 evo - Page 164

Milestone Srl MA213-003 – DMA-80 EVO – User Manual
162
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.
- 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 DMA
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 DMA software does not allow to start a run if each
critical parameter has not been properly entered or if all
the operations (e.g. file saving) 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.
The software does not allow the modification of the control
parameters during the execution of a program.
11.10
(g)
Use of authority checks to
ensure that only authorized
individuals can use the system,
electronically sign a record,
access the operation or
computer system input or output
device, alter a record, or perform
the operation at hand.
The access to the system is divided in 5 levels
- Supervisor
- Service
- Administrator
- Manager
- User
The Supervisor and Service levels are reserved to
Milestone organization personnel.
The access to the software can be further secured by the
use of individual and electronically signed USB sticks
(only for terminal, not PC software package).
At total, it is possible to create up to 16 login accounts
with Administrator, Manager and User rights.
The software does not allow to set simultaneously two
accounts with the same name and it is possible to define
an expiration time for the passwords.
It is not possible to use the same password immediately
after the expiration of the previous.
Password must have a minimum length of 5 digits and
must be modified at the first access of a new account.
After 3 consecutive failed unsuccessful attempts from the
same account, this is blocked. The release of a blocked
account can only be authorized from the following login
from a superior level or automatically after 24 hours.
11.10
(h)
Use of device (e.g., terminal)
checks to determine, as
The mercury analyser with terminal and dedicated DMA
software are a “Closed System”. The input of data on the