Milestone Srl MA213-003 – DMA-80 EVO – User Manual
163
appropriate, the validity of the
source of data input or
operational instruction.
terminal from the user can be done via touch screen,
keyboard or mouse.
The software recognizes the validity of the entered data
and immediately notifies the user in case of invalidity or
the same.
There is not any other external data source except this
means
11.10 (i)
Determination that persons who
develop, maintain, or use
electronic record/electronic
signature systems have the
education, training, and
experience to perform their
assigned tasks.
The organization of the user must define adequate
training procedures for all persons involved in using and
maintaining the DMA software but also the generated data
records and trail.
Milestone personnel involved with software developments
and support are trained and qualified to perform their
tasks.
11.10 (j)
The establishment of, and
adherence to, written policies
that hold individuals accountable
and responsible for actions
initiated under their electronic
signatures, in order to deter
record and signature falsification
The organization of the user must guarantee that the
persons are responsible for all actions that have been
implemented with their electronic signatures to prevent
any abuse. This also includes procedures for linking the
account name to the related person.
While on standby mode, the software automatically
logouts if for 10 consecutive minutes any interaction from
the user has been noted.
11.10
(k)
(k) Use of appropriate controls
over systems documentation
including:
(1) Adequate controls over the
distribution of, access to, and
use of documentation for system
operation and maintenance.
(2) Revision and change control
procedures to maintain an audit
trail that documents time-
sequenced development and
modification of systems
(1) The organization of the user must guarantee that the
documentation received with the system (e.g. user
manual) is properly distributed, made accessible and
used.
(2) The organization of the user must maintain audit
minutes of the changes in the documentation for the
system. Milestone will produce and make available in
each case the updated documentation of the system also
through Milestone Connect website.
11.30
Controls for Open system The mercury analyzer with terminal and dedicated DMA
software are a “Closed System”.
11.50
(a)
Signed electronic records shall
contain information associated
with the signing that clearly
indicates all of the following:
(1) The printed name of the
signer;
(2) The date and time when the
signature was executed; and
(3) The meaning (such as
review, approval, responsibility,
or authorship) associated with
(1) While signing a method or a calibration or a run on
DMA software, the name of the signer can be entered
manually or automatically if this is used as account name.
(2) Actual date and time are automatically recorded.
(3) The account level is automatically recorded while other
signing meaning information can be entered in to the free
editable “Function” field while signing.
11.50
(b)
The items identified in
paragraphs (a)(1), (a)(2), and
(a)(3) of this section shall be
subject to the same controls as
for electronic records and shall
The above electronic signature information is permanent
and unalterable part of the data record and therefore
undergoes the same controls as the data records
themselves, including printing or saving on the final report.
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