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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.
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