Unicorn Control System - GE AKTA ready Operating Instructions Manual

3 System description

3.5 UNICORN control system

3.5

UNICORN control system

Overview
ÄKTA ready is controlled by UNICORN process control software. ÄKTA ready can be
controlled by both UNICORN 5 and UNICORN 7.
UNICORN can save established processes as methods. The methods include the
instructions necessary for process operation and documentation.
UNICORN includes a comprehensive system of user access levels to be programmed
limiting the operations a given user may perform on ÄKTA ready. To secure safe operation
of the system, you should limit access to the system to those qualified and trained in its
operation.
The UNICORN software wizards and the UNICORN user documentation provide complete
instructions for programming and for using the software for process control.
System operators are responsible for designing methods which conform to standard
operating procedures and Good Manufacturing Practice procedures.
UNICORN is compliant with FDA 21 CFR Part 11.
Knowledge prerequisite
At least basic knowledge of UNICORN is expected to operate ÄKTA ready in a safe
manner.
Information on how to use UNICORN can be obtained from the UNICORN documentation
and available tutorials. This manual does not cover how to use UNICORN.
Contact your local GE Healthcare representative for advice if required.
System networks
UNICORN can be installed on a stand-alone computer to control one to four locally
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.
52 ÄKTA ready Operating Instructions 28960345 AD