Milestone ultraWAVE 3 - Page 149

Milestone Srl MA245-001 – ultraWAVE 3 – User Manual
147
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 easyCONTROL 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 documentation.
(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 Systems
N/A
The microwave system with terminal and dedicated
easyCONTROL 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 the
signature.
(1) While signing a method or a run on easyCONTROL
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
The above electronic signature information is permanent
and unalterable part of the data record and therefore