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FI002K0018v1100UK – THS/21 Instruction manual for installation, use and maintenance
USE OF THE DEVICE
138 ORIGINAL INSTRUCTIONS
4.9 Settings for CFR21 Standards
4.9.1 General information
The U.S. Code of Federal Regulations, CFR Title 21, Volume 1 – Part 11 “Electronic Records;
Electronic Signatures” contains a series of requirements for the secure and reliable management
of electronic records, electronic signatures and for accessing, reading and processing the stored
data.
The requirements contained in the regulation can be grouped into two categories:
- Requirements applicable to the intrinsic operation and to the programming of the equipment
under test (in this case the Pharmaceutical Metal Detector THS/PH21N
®
).
- Requirements that govern correct management and organization by the user, so as to
comply completely with the regulation in question.
The complete range of procedures applied by the user and applied to the operational
characteristics of the Metal Detector must guarantee complete compliance with the regulation.
4.9.2 Metal Detector settings
In order to ensure compliance with CFR21 standards you should note the following:
- All users working with the Metal Detector must have their own
username and password
.
This management shall be performed according to CFR21 standards. Direct access to any of
the programming menus, without a password (user 000000), must not be available.
The Administrator must periodically change the passwords of all operators.
- Set the
Restricted access
(FLR) parameter to ON, to prevent any access by unauthorized
personnel.
- In the case of remote programming, without the IXC card, check that the way to access
remote programming will be treated as per local programming, setting
RS232Password
(RM) and
AuxRS232passw
(AURM) to “NULL”. Also check that the automatic exit from
remote programming is set (RPTO = ON).
- Set the
Event buffer fault
parameter (FB) to ON, to prevent loss of stored data and events
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 easily performed using
THS
Production
software.
- The saved data can be validated using the THS Production software, or by connecting to the
site
http://www.ceia.it/cfr21validation
, selecting the file to be analysed and pressing the
“Check Digital Signature” button.
If the file is not valid (incomplete data or data partially modified), the message “Invalid Digital
Signature” is shown: in this case, the relevant data needs to be saved again.
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