User's Manual

1-26 KleeYa - User Manual - Version 2
INTRODUCTION
CYBERSECURITY
Additionally updates of the antivirus software might affect the
performance of the computer of the KleeYa System negatively, leading
to a disruption of timing and failures in the subsequent data analysis
processes.
d. STRATEC is not the manufacturer of the antivirus software and cannot
predict the effects updates would have on the functionality and
performance of the KleeYa System. Therefore, STRATEC would need to
update verification and validation of the complete KleeYa System
continuously with each virus update in order to ensure a validated
environment, which is not feasible.
STRATEC strongly recommends not to install additional firewalls and antivirus
software on the KleeYa System!
For end-users (laboratory operators), the following approach has been realized:
1. Operating System service and ports, not being mandatory for the validated
applications in regards to the intended use of the KleeYa System will be
blocked.
2. Operating System integrated firewall is activated and configured such that all
remote access to the system is denied. Additionally, a whitelisting program
(Applocker) is installed avoiding unauthorized access.
3. On the Operating System, the AutoRun for all USB storage devices will be
disabled. The end-user will only have the option to open files stored on a USB
stick for the import and export of data in regards to the intended use of the
KleeYa System. If a USB stick is inserted the end-user assumes full
responsibility that the stick is not infected with viruses, Trojans or spyware.
In case it is urgently necessary to install laboratory specific firewall or antivirus
software on the KleeYa System, access to the Operating System might be generated
for network administrators of the laboratory via dedicated access pathway.
However, it needs to be clearly understood that the aforementioned risk will appear
and STRATEC cannot take over any responsibilities for a system, which has left the
validated environment.
If you believe that additional firewall or antivirus software is necessary for you,
please contact your distributor directly to discuss further steps.
1.7.9 SECURITY UPDATES OF THE KLEEYA
SYSTEM
STRATEC will provide security patches of the Operating System addressing security
vulnerabilities once a year or in addition in particular critical cases, like worldwide
cyberattacks e.g. through ransomware worms.
If you like to exploit the possibility of getting periodical security patches of the
Operating System, please contact your distribution partner directly.
Security patches of the Operating System might negatively affect the performance
of the KleeYa System and therefore lead to malfunctioning. Therefore, the complete
KleeYa System would leave the controlled validated environment, if these updates
are installed in an uncontrolled manner without involvement of STRATEC.