Roche Diagnostics
User Manual · Version 2.1 15
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WARNING
Access to the application and user accounts
r Access to the application should only be granted to users who have been trained and
assigned a user name and password. The password must be confidential and must
comply with the usual security principles. It must be changed periodically to prevent
unauthorized parties from gaining access.
r It is recommended that you develop SOP to ensure that only qualified personnel access
the application.
r One account per user: do not create generic user accounts to be used by more than
one person. Create a different account for each user, even if they have the same
access rights.
WARNING
Passwords, access, and system shutdown
r Only authorized personnel should install this software. Personnel must ensure they do
not disclose internal Roche passwords to unauthorized parties.
r Access to application files and folders on any computer should also be restricted to
authorized personnel only.
r For security reasons and for patient confidentiality, all users must exit the application or
lock their computer before leaving their workplace.
NOTICE
System configurations
r The preconfigured settings in the system must only be used as a reference. It is
recommended that they are not used as default settings, since they should be modified
to suit the system and the health center requirements.
General
WARNING
System performance
r To ensure the operation of the system at full capacity, avoid connecting more users or
instruments than your infrastructure supports.
CAUTION
Servers and application performance
r Use servers that are correctly dimensioned to the needs of your installation in order to
guarantee the best performance of the application. It is recommended to configure the
servers using a high availability and data redundancy system. The existence of a
second server avoids data loss in case of severe or critical failures in the system.
CAUTION
Alarms in validation screens and reports
r To prevent users from validating results without noticing system or instrument alarms,
always configure alarms for validation screen and reports.
WARNING
Use of barcodes on the tubes
r In order to help locate the tubes, it is highly advisable to always use primary and
secondary tubes with barcodes whenever possible. If no barcode labels are used, take
special care not to misplace tubes when samples are put in the racks.
r It is strongly recommended to have appropriate Standard Operating Procedures (SOP)
to avoid an incorrect handling of tubes.
r It is recommended to use barcode labels to archive trays.
Q
All the changes made in the system are recorded using an audit trace.
