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RIDA qLine® autoBlot | User manual
19.3 Appendix III – Cyber Security Statements
Network Security
1. The INSTRUMENT supports the exchange of electronic data over a wired medium,
pecifically over an Ethernet connection. The supported use case is that a laboratory
configured computer is connected to the instrument using CAT5-CAT7 Ethernet
cables. Validated software that implements the communication protocol will be
installed on the laboratory configured computer and exchange messages with the
control software installed within the INSTRUMENT.
2. R-Biopharm AG anticipates that laboratories have network technicians who configure
the buildings to only have specific internet access points. As such, it’s our
recommendation that the INSTRUMENT never be connected to the internet where it
could potentially be exposed to viruses – although no part of the INSTRUMENT
operating system or control software is configured to download anything from remote
sources. Following this recommendation, the INSTRUMENT does not therefore come
with any pre-installed ANTI-VIRUS software. It’s left up to the specific laboratory
technicians to install their own licensed software. It should be noted that it’s not
recommended to connect the instrument to an internet access point, as a local-area
connection (LAN) is the only expected use. Since networks themselves can be a point
of vulnerability to viruses, the INSTRUMENT control software comes with a firewall
implementation that should block the transfer of rogue software over the network.
User Access Controls
1. Access to an INSTRUMENT is first and foremost restricted behind access to a laboratory,
where it is standard practice to have restricted personnel policies. After this point,
access to the instrument software to be allowed to initiate a test is unrestricted.
2. Specially trained service engineers are provided with passwords and knowledge on
how to access specialist tools that allow them to change the instrument configuration.
These tools typically involve calibration routines to ensure the instrument is running
with optimum performance.
