3.6
Process control software
Introduction
ÄKTA ready XL is controlled by process control software. This document does not de-
scribe the control software methods. For software methods/phases, instructions for
programming and for using the software for process control, refer to the software
user documentation provided separately.
Overview
ÄKTA ready XL is controlled by a process control software, such as UNICORN.
The control software can save established processes as methods/phases. The meth-
ods/phases include the instructions necessary for process operation and documen-
tation.
The control software may include a system of user access levels to be programmed
limiting the operations a given user may perform on ÄKTA ready XL. To secure safe
operation of the system, you should limit access to the system to those qualified and
trained in its operation.
System operators are responsible for designing methods which conform to standard
operating procedures and Good Manufacturing Practice procedures.
Prerequisite knowledge
A working knowledge of the control software is required to operate ÄKTA ready XL in
a safe manner.
Contact your local GE Healthcare or your control software representative for advice
if required.
System networks
ÄKTA ready XL can be controlled from a stand-alone computer or remotely from a
network. UNICORN can be installed on a stand-alone computer to control several lo-
cally attached systems. However, the computer can only show one system at a time.
Multiple computers can view the output data from one system. UNICORN can also be
installed on a network.
UNICORN software is compliant with FDA 21 CFR Part 11.
For information about other control software, refer to the product documentation
provided with the delivery.
Contact your GE Healthcare representative for more information.
3 System description
3.6 Process control software
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ÄKTA ready XL Operating Instructions 29281616 AE
*** TeDIS Valid on Date Printed Printed on: 15-09-2023 11:27:35 ***
