 |
CLASS VP 7 is the Client / Server version
of the Chromatography software workstation package CLASS VP. The
software for controls beside Shimadzu LC and GC instrument also
other instruments in a network environment.
The software allow to store method and datafiles and additional
comments and parameters (User name, Sample ID, data and time of
acquisition) which can be later used to select one data file and
start search procedures. By using the right mouse button it is
now possible to get the user inter face more user friendly. In
each instrument window the operator will find the same functionality,
the most important functions can be accessed by toolbars such as
the integration events, the integration event table and the peak
table. For the integration the CLASS-VP and the Shimadzu Chromatopac
algorithm are selectable.
The software provides numerous new Good Laboratory Practice (GLP)
features, such as storage of results with data and method, file
overwrite protection. For handling a method, an Audit trail option
can be activated and will register all changes in the method with
or without additional comments to the changes. A multi level individual
user password security system takes care that different systems
can only be accessed by authorized staff. An alteration check program
verifies that all installed CLASS-VP program files have not been
corrupted or altered. Additionally to these features, the CLASS
VP 7 software supports features according to FDA 21 CFR Part 11
compliance such as audit trails for data, meta data file saving
concept and electronic signature option.
CLASS VP software is compatible to the CLASS Agent software, which
provides a laboratory wide solution concept for work under FDA
21 CFR part 11 compliance conditions.
The handling of sample sequences in done by a batch table, which
contains all information for acquiring of standard calibration curves,
running unknown samples as well as check the integrity of an calibration
and the full chromatography system by special QC check samples or
system suitability runs. The QC Check features verifies upper and
lower QC limits. The QC limits can be set different for each peak
in the method's ‘Peak table’ in the method. For the system
suitability test for example the column performance data, repeatability,
accuracy, noise or baseline drift can be used. Failure actions provides
automated control of real time sequences allowing criteria such as
re-injection of a sample if it is out of range to be set, or aborting
a sequence if it does not meet the validation criteria. Repetitions
from the same sample will be averaged by the software, for single
level re-calibrations it is possible to re-calibrate different levels
step by step or all together.
The configuration for each system is linked to the instrument
window, ‘auto config’ functions and a connection wizard
(CLASS VP 7) make it easier to add all necessary items for all
modules. Following the VP concept, the serial number and firmware
version is read out automatically, alert levels for the major spare
parts such as plunger seals or detector lamps can be set, typical
values therefore are recommended as default. For direct access
to the main functions a special toolbar can be arranged on the
screen. This allows to activate/inactivate of the system, to switch
detector lamps on and off, to set the incoming signal at zero,
to rinse or purge the autosampler; start or to stop pumps or column
oven. CLASS-VP offers digital data exchange between LC modules
and PC via the systemcontrollers SCL-10Avp, CBM-20A and CBM-20ALITE
and between the GC instruments GC-2010 and GC-2014.
The VP functions, log files for all HPLC instruments will be checked
by an ‘Validation run’, the system check report offers
all information about all connected hardware components and the
pass/fail judgement for the whole system.
An additional Status log provides continuous measurement of parameter
condition during an analysis. Key parameter such as pump pressure,
oven and ambient temperature create a permanent record of how a
sample run. All of these parameters, existing data files or (and)
the gradient profile can be overlaid over an running chromatogram
so that you are informed about the current status of your system.
Flexible report editor: Customized analytical result reports can
be prepared by the custom report functions; providing customisation
of report fonts and colours, insertion of any bitmap images (your
company logo, photos etc.) OLE compatibility to import graphs,
charts, text documents etc. Summary report function provides calculation
of % RSD of response factor, area and concentration as well a pass/fail
judgement according to the result of the calculation.
Class VP 7 Client/Server software is designed to provide a regulatory
compliant network solution to chromatography control, data analysis
and storage. Including Method, Data and Sequence audit trails,
status logs, QA/QC reports, electronic signatures, advanced system
administration and many other features, it is the ideal solution
to address 21 CFR part 11 issues. |
-
HPLC - Software and Control
