List of terms

To prevent any errors or misunderstandings, the following list of terms (often-used or differing) has been provided.

21 CFR Part 11

A directive which specifies the conditions under which a company may use electronic records and signatures. The directive is mandatory for companies that use computer system designed for the manufacturing or distribution of products which are subject to regulation by the FDA (known as, "regulated products").

Access rights

A system which governs the activities that specified users are allowed to perform. Among other things, a user may be restricted in their authorization to change fundamental station settings, access certain instruments, inspect or change the data of other users, etc.

Active calibration signal

When performing a multi-detector measurement, each calibration file may contain calibration curves for up to 32 signals, the same as with chromatograms. Only one of these signals may be active at a time and this signal is modified.

The active calibration signal (i.e. its table or curve) is recognizable by its name highlighted in the header of the Calibration Summary Table or its curve. At the same time, all values that are signal specific will be displayed in the same color as the active signal.

Active chromatogram

The chromatogram name which is displayed in the header of the Chromatogram window. All data being displayed and operations performed will only relate to this active chromatogram. The name of the active chromatogram is highlighted in the key by bold letters.

Active chromatogram signal

When performing a multi-detector measurement, each chromatogram file may contain a record from up to 32 detectors (this is what we call “signals”). The active signal in the chromatogram is the signal whose name is being displayed behind the name of the chromatogram in the window header and header of the tables (divided by a hyphen).

The name of the active signal together with the name of the chromatogram are highlighted in the graph key by bold letters.

Active detector

A detector whose measurement and calculation parameters are displayed in the Acquisition or Calculation tabs in the Method Setup dialog with the help of the Select Detector field. The field is visible only when performing a multi-detector measurement.

Analogous Select XXX fields may be present for other devices than detectors - for example valves on the Method Setup - Valve tab if more than one valve is present.

AIA format

Also named NetCDF format, export format serving as a common format for chromatographic data. The data are saved in the vector format with the header containing the information on the data type and chromatogram information. Clarity only exports and imports raw data, not the results.

Calibrated group

A group of peaks calibrated as a single component.

Calibration file (Calibration)

Contains calibration curves and further data for calibrated calculations. When performing a multi-detector measurement, each substance will have its own calibration curves for all detectors.

Calibration standard

A chromatogram containing known amounts of some compounds that is used to calibrate/recalibrate at a specified calibration level.

Channel

Part of the converter which enables the independent collection of data from one single detector. DataApex produces A/D converters that has 1, 2 or 4 channels.

Clarity Offline (used to be Clarity EVAL)

A version of the Clarity station that, although otherwise fully functional, does not allow the data acquisition.

Clipboard

A Windows tool that uses the Copy, Cut and Paste commands for the simple transfer of data between items, including those in other applications.

Closed window

A closed window is invisible and its activity has been terminated. A window is usually closed using the Close or Close Window command (see also the Hidden window term).

Configuration of the station

Sets the number of Instruments, the allocation of the A/D converters, directly controlled chromatographs, autosamplers, pumps and other devices.

Data processing string

A series of operations comprising the entire procedure used for everything from processing data from an analysis to printing the report. This procedure is shown graphically in the Instrument window using icons representing the main commands.

Desktop file - extension DSK

A file used to store the size, location and appearance of all windows and parameters of the Instruments.

Direct control of chromatograph (autosampler, pump)

An integrated additional module for selected chromatographs (pumps, autosamplers etc.) enabling the direct control and monitoring of selected parameters. For example, directly controlled detectors (GC or LC chromatographs with detectors) might not need A/D converter as they gather digital data directly from the controlled instrument.

Electronic signature

An electronic signature is an substitution of the handwritten signature for electronic documents. These electronic signatures thus must fulfil the same function and prerequisites. Meaning that it is a similar process of marking a document for protection and that it must be unique, clear and ensure the immutability of the document.

File sharing

Clarity enables file sharing between multiple stations. Any changes (saving) of such files are only enabled in the station that first opened it. Modifications performed with the shared file will take effect in the other stations only after the file has been reloaded. Clarity does not enable file sharing between Instruments of a single station. On the other hand, Clarity does enable projects to be shared between multiple Instrument of the same station.

Note:

It is still not possible to use the same file on multiple Instruments even if they share the same project. The same project on two Instruments of the same station are useful when one instrument is Offline and used to prepare methods for the other Instrument.

GLP

Good Laboratory Practice (GLP) is an internationally agreed upon system for ensuring and monitoring the quality of laboratory work. This is verified and its fulfillment confirmed by the issuance of a certificate.

Hidden window

A window which is not visible or has been “hidden”. Its activity has not been terminated but rather suspended or is proceeding in the background. Click the minimize button to hide a window (see also the Closed window term).

Information table

A table in the Instrument window displaying the Instrument name, the measurement methods and the identification of the measured chromatogram.

Instrument

(a) A part of the program designated to measure and evaluate analyses that share a common time base (from one chromatograph). The Instrument is indicated by the Instrument window, from which further windows and dialogs can be opened, e.g. Chromatogram, Calibration, etc. Detectors and control modules can be configured into individual Instruments. Clarity Lite has only one Instrument available. In this meaning, the word "Instrument" is written with the capital I.

(b) Sometimes also a chromatograph or generally any piece of equipment in the laboratory.

Instrument directory

The directory identified in the main Clarity window for each Instrument, where projects (i.e. project directories) are sought.

Integration Table

Constitutes a part of the method and contains a list of all modifications of the baseline or peaks that have been or will be effected in the chromatogram measured by that method.

Locked file (READ ONLY)

A file that can only be read and never modified. The file may be Read Only for several reasons, including (but not exclusive to) chromatogram measured in GLP mode and opened outside it, chromatogram opened with a version from the history, a user account not having user rights to modify method/chromatogram/sequence etc.

Locked instrument

An Instrument in the protected mode with locked control. Lock mode can be activated using a command from the Lock submenu in the main Clarity window. An Instrument is unlocked with the same password as was used to log on to the Instrument.

Main station directory

The directory where the executable file of the station clarity.exe is stored (C:\CLARITY\Bin by default). Supporting *.dll and other binary files are stored in the C:\CLARITY\Bin. Configuration and system files are stored in the C:\CLARITY\Cfg directory. User's data files are stored in the C:\CLARITY\DataFiles directory which holds individual projects, PROJECTS directory holding the project files, COMMON directory with print styles and other files.

Method file - extension MET

A template method file with a description of all parameters affecting the analysis.

Model Method

A chromatogram method marked as Model Method that can be easily used with other chromatograms by invoking the Copy from Model command.

Multi-detector configuration (measurement)

Setting of the station so that it measures, saves and evaluates one analysis by simultaneously using a signal from multiple detectors.

Password

A string of several characters which are necessary for working in the Protected Mode of the station. Each user has his own password. The minimal length of the password may be set centrally in the User Accounts dialog.

Printout

The layout of individual parts of analysis results and the setting of parameters controlling the resulting report. The layout is defined by the employed report style.

Project directory

Directory used to store all working files of an Instrument in which the homonymous project has been opened.

Project file - extension PRJ

The file that specifies the directories in which all user files will be stored.

Protected mode

A regime which enables only authorized users (users who have an account assigned in the User Accounts dialog) to work with the station and access data.

Raw data file - RAW

A file used in previous versions of the CSW10 - 17 and for the external PAD unit to save non-analyzed and non-adjusted data from the analysis. The CSW32 and Clarity stations save raw data directly into the chromatogram file, the *.RAW data file is used only for the gathering of the data during the acquisition (chromatogram file (*.prm) is created only after the acquisition ends).

Report style

An outline determining which analytical results will be incorporated into a report and subsequently printed. Each report style will be stored in a separate report style file.

Report style file - extension STY

A file storing information which determines what to print and how to print it.

Sequence file - extension SEQ

A file that defines an automatic sequence of analyses.

Splitter

A resettable bar dividing certain windows (e.g., the Chromatogram or Calibration windows) into several panes. The bar can be moved to change the size of individual panes - Adjusting the size of panes.

SST

The System Suitability Test is an Extension module designated to validate the chromatographic system on the basis of evaluation of chromatograms obtained from the Clarity station.

Station configuration

Determines the number and arrangement of Instruments and their interconnection to possible A/D converter board(s) and directly controlled chromatographic equipment. Also allows to name the connected detectors and set signal units for them.

Status table

A table displayed in the Instrument window containing the names of system files, the status of the analysis currently in progress, potentially the retention time and identification number of a sample.

System files

The decisive files for working with the station and individual data files: project, method, report style, sequence and calibration files.

Tabs

Tab is the term for a section of the window or dialog where several layers of control elements are "stacked" on itself. The system is frequently used in dialogs and also in the Chromatogram and Calibration windows. Click the only visible part of the tab - that with the tab name - to switch to the corresponding tab.

Template method

A method file that serves as a template for new analyses. Its name is displayed in the Information Table of the Instrument window and its contents are always copied to the newly created chromatogram.

Toolbar

A block of icons symbolizing a set of commands. Each toolbar can be situated anywhere on the screen and be configured by accessing the View - Customize… command in the window or by right clicking the mouse button on any toolbar to access the local menu.

Unprotected mode

A regime of the station that enables any user to work with the station and access its data. No passwords are necessary for opening the Instruments.

Window title bar

Title bar is the upper band of each window. It is comprised of the button which activates the control menu of the window, the window name, the minimize button and the maximize button.