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FI002K0018v1530hUK – THS/21 Instruction manual for installation, use and maintenance
INSTALLAZIONE
144 ORIGINAL
INSTRUCTION
3.13 Settings for CFR21 Standards
3.13.1 General information
The U
.S. Code of Federal Regulations, CFR Title 21, Volume 1 – Part 11 “
Electronic Records;
Electronic Signatures
”
contains the requirements for the secure and reliable management of
electronic records, electronic signatures and for accessing and reading the stored data.
The requirements contained in the Regulation are grouped into two categories:
- Requirements applicable to the intrinsic operation and to the programming of the System
under test.
- Requirements that govern correct management and control actrivity by the Customer, so as
to guarantee complete compliance with the Regulation.
The respect of all requirements guarantees the complete compliance with the Regulation.
3.13.2 Metal Detector settings requirements
All Users working with the Metal Detector must access to programming with
Username and
Password
. Direct access, without a password (user 000000), must not be available.
It is up to the Administrator to:
- Activate the monitoring of any unauthorized attempts to access programming (FLR=ON).
- In the case of remote connections, check that the access will be treated as per local
programming (RM=NULL or AURM=NULL depending on the connection used).
- In presence of an IXC board, the access to the web server allows, in addition to data storage,
also other network board and System configuration functions. It is therefore recommended to
enable access to Users who, even in local programming, are enabled for similar functions.
- Enable the monitoring of the memory full event (FB=ON), to avoid to overwrite stored data not
yet printed or saved.
- All production data must be printed and/or saved and stored separately, on a regular basis
and managed according to CFR21 standards. This can be automatically performed using
CEIA
THS Production
software.
In Countries where DST is in effect, verify the correct setting to always ensure proper data
traceability. With CEIA THS Production software the time of all connected Metal Detectors is
automatically synchronized with the PC server where the software is installed.
