MILESTONE
USER MANUAL
Ethos EZ User manual MA073-006
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signatures. have been implemented with their electronic
signatures to prevent any abuse.
11.10 (k)(1) Control of distribution and
access of the system
documentation.
The organization of the user must guarantee that
the documentation for the system (manual and
service documentation) is properly distributed,
made accessible and used.
11.10 (k)(2) Audit-Report for
modifications in the
system documentation
The organization of the user must maintain audit
minutes of the changes in the documentation for
the system. The manufacturer will produce and
make available in each case the updated
documentation for the system.
11.50 - Signature manifestations
11.50 (a)(1) Data records with
electronic signature must
show the complete,
printed names.
Together with the signature the complete
name/identification of the person is printed out.
11.50 (a)(2) Data records with
electronic signature must
include the date and the
time of the execution of
the signature.
Together with the signature the time and the date
of the execution of the signature are printed out.
11.50 (a)(3) Data records with
electronic signature must
contain the meaning of
the signature.
Together with the signature the meaning of the
signature is printed out.
11.50 (b) For the electronic
signature the same
controls as for electronic
data records must be
applied.
The electronic signature is part of the data record
and therefore undergoes the same controls as
the data records themselves.
11.70 - Signature / record linking
11.70 Secure linking of the
signature with the data
record
The electronic signature is part of the data record
and cannot be separated from this.
Chapter C Electronic Signature
11.100 (a) Unique identification of
each Person
The system prevents the repeated use of the
same password for different users.
Each user must identify himself by his memory
card and a password.
11.100 (b) Verification of the identity
of the signature
The organization of the user must guarantee that
an existing access authorization is clearly linked
to a person
11.100 (c) Equality of electronic and The organization of the user must clearly point
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