Milestone Srl MA213-003 – DMA-80 EVO – User Manual
164
be included as part of any
human readable form of the
electronic record (such as
electronic display or printout).
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
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 DMA 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 DMA 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 signature
components; subsequent
signings shall be executed using
at least one electronic signature
component that is only
executable by, and designed to
be used only by, the individual.
(ii) When an individual executes
one or more signings not
performed during a single,
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.
a)(2) The organization of the user is responsible for
implementing procedures to ensure that electronic
signatures are exclusively used by the owner of the
account.
The system prevents the repeated use of the same
account name for different users.
The access to the software can be further secured by the
use of individual account password.
a)(3) The organization of the user is responsible for
implementing procedures to ensure that any attempt to
use the electronic signature of someone other than the
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