Milestone ultraWAVE 3 - Page 150

Milestone Srl MA245-001 – ultraWAVE 3 – User Manual
148
section shall be subject to the same
controls as for electronic records
and shall be included as part of any
human readable form of the
electronic record (such as electronic
display or printout).
undergoes the same controls as the data records
themselves, including printing or saving on the final
report.
11.70
Electronic signatures and
handwritten signatures executed to
electronic records shall be linked to
their respective electronic records to
ensure that the signatures cannot
be excised, copied, or otherwise
transferred to falsify an electronic
record by ordinary means.
The electronic signature is permanent and unalterable
part of the data record and cannot be separated from
this.
11.100
(a) Each electronic signature shall
be unique to one individual and
shall not be reused by, or
reassigned to, anyone else.
(b) Before an organization
establishes, assigns, certifies, or
otherwise sanctions an individual's
electronic signature, or any element
of such electronic signature, the
organization shall verify the identity
of the individual.
(c) Persons using electronic
signatures shall, prior to or at the
time of such use, certify to the
agency that the electronic
signatures in their system, used on
or after August 20, 1997, are
intended to be the legally binding
equivalent of traditional handwritten
signatures.
(a) Each user must identify himself by his own account
name and password.
The easyCONTROL software does not allow the repeated
use of the same account name for different users but the
organization of the user must implement procedures so
that an existing access authorization cannot be reused by
or reassigned to anyone else.
The access to the software can be further secured by the
use of individual account.
(b)The organization of the user must implement
procedures so that an existing access authorization is
clearly linked to a person and cannot be reused by or
reassigned to anyone else.
At the first access to the easyCONTROL software of a new
account, the default password has to be modified from
the person to who that account name has been assigned.
(c)The organization of the user is responsible for
certifying that the electronic signatures are intended to be
handled as the legal equivalent of traditional handwritten
signatures.
11.200
a) Electronic signatures that are not
based upon biometrics shall:
(1) Employ at least two distinct
identification components such as
an identification code and
password.
(i) When an individual executes a
series of signings during a single,
continuous period of controlled
system access, the first signing shall
be executed using all electronic
a)(1) The unique combination of username and password
achieves the function of two identification components.
The access can be further secured by the use of individual
and electronically signed USB sticks.
While on standby mode, the software automatically
logouts if for 10 consecutive minutes any interaction from
the user has been noted.