Software

SYKAM Data System: Clarity

Clarity is an advanced chromatography station designed to acquire and evaluate data from up to four chromatographs at a time. Clarity - a top product in its category - represents a universal solution for laboratories. It enables the user to acquire data from any commercially available chromatograph with standard analogue output.

Up to four chromatography systems, each of which can be equipped with up to four detectors, can be connected simultaneously. The chromatography station package includes an A/D converter (internal PCI card or external USB box) and the corresponding Clarity Software.

 

Support for GLP/ 21 CFR Part 11

In recent years, chromatography practice has brought about not only the necessity of efficiency in laboratory work, but also new demands relating to monitoring

and security mechanisms, particularly in the field of data management. The Clarity supporting tools help you to comply with the requirements of GLP (Good

Laboratory Practice) and FDA - 21 CFR Part 11.

Data Security

A system of access rights and passwords is set up within the station. This system allows to create a unique password protected profile for each user.The user profile then defines in detail the user’s rights within the station (e.g. authority to effect changes in the methods of measurement) and may limit ones access to only certain connected instruments. Electronic signatures are also incorporated into the

system so that a user may sign his or her data. This electronic signature is stored with the name and date and supplemented with a set phrase (e.g. measured

by, approved by, etc.).

Audit Trail

Detailed logs and histories of modifications enable users to maintain an audit trail. Clarity documents all parameters describing the conditions and methods of data processing for the user. This allows for easy access to a complete profile of information regarding any prior modification’s performance.

 

Qualification Tools

The Test IQ (Installation Qualification) is an integral component of the station. This test monitors that the software has been properly installed and the results can be accessed from a printed protocol. Clarity Validator for OQ (Operational Qualification) is an optional package available for testing and validating the Clarity chromatography station.This is accomplished simply with the use of our chromatogram generator and a software utility.

 

U-PAD - External USB A/D Converter

The U-PAD is an external measuring unit for acquisition of data from detectors with standard analog output. U-PAD uses a USB communication channel, which allows direct connection from the PC. U-PAD represents an ideal solution for connecting chromatographs to a laptop computer. The unit contains two independent channels equipped with the latest 24-bit A/D converters, which attain higher effective resolution, particularly at higher integration frequencies and lower voltage ranges. The channels are isolated with symmetrical inputs.

 

Software Features

 

Algorithm for Detection of Peaks

Highly responsive algorithms enable users to detect hundreds of peaks in each hromatogram. Data from the analysis can naturally be reprocessed without the necessity of repeating the analysis.

 

Integration

All integration parameters are saved in the integration table. Parameters such as Peak Width and Threshold are programmable in time. There are a total of 27 integration parameters incorporated to ensure the optimal integration of peaks.

Most of these parameters can be applied also with the mouse from icons on the toolbar. Every change of basic integration parameters in the chromatogram window will force immediate reintegration.

 

Method

All parameters for data acquisition and peak integration, including baseline operations and link to the calibration file are saved in the template method. After

creating of a chromatogram, a copy of the template method becomes a part of the chromatogram file.

 

Multi-Detector Measurement

Once a measurement has been completed within the framework of one instrument and more than one detector (up to four), signals are simultaneously displayed

and accompanied by a legend identifying each signal and detector. Users may select the number of signals displayed according to preference.

 

Calibration

The Clarity Station uses linked calibration. Calibration curves are saved in a separate file, to which the template and chromatogram methods are referring. After updating or modifying this calibration file, results in all chromatograms linked to this file will be

automatically recalculated upon opening. Although the calibration is linked, the current states of the calibration file and methods are stored in the chromatogram every time it is saved (using the commands Save, Print or Export).

The chromatogram with its former method settings and calibration curves may thus be opened from any prior saved state.

 

Calibration Calculations

Clarity offers the ability to calculate using external or internal standard methods.

There are six types of curves to fit calibration points with the option to include a zero point. The station allows you to select automatic or manual (interactive) method of data transmission from the calibration standard into the calibration file. Groups

of peaks may also be calibrated.

 

Method of Reference Peak

Use reference peaks and or customizable identifi-cation windows for individual peaks to enhance the accuracy of compound identification.

Editing and Calibration

Browsing and adjustment of calibration data is simple thanks to the consolidation of all compounds in a single global calibration table.

 

Print Protocols

The Clarity station supports printing of user defined protocols. Its configuration is saved in report style, which defines the content and form of the printout. Pick from the predefined report styles or adjust them and store for further use. Different report styles can be predefined according to the dialog in which you are working.

You can review the printout on the screen in the print preview. For printing protocols from multiple analyses users can either use batch processing of data or print a

summary table.

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