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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. |
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Signed
electronic records contain
the User ID, full printed
name of signer, date/time
when the signature was
executed, the meaning of
signature, and a Reason
field.
Electronic signatures can be
configured for automatic
enforcement with any cell
changes and can also be
executed manually at any
time (eg. after completion
of specific steps).
The Review Changes command
provides an e-signature that
can be used for final review
and sign-off. Access to this
command can be restricted to
authorized users.
The system administrator can
configure various
e-signature meanings (roles)
such as Data Entry, Edit,
Review and Approve. These
are available as a pick-list
to define the meaning of the
e-signature at the time of
signing.
The Reason field can be
configured as Optional or
Required. |
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