List of terms
To prevent any errors or misunderstandings, the following list of terms (often-used or differing) has been provided.
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 determine what actions users can perform in the system. For example, some users may have restricted permissions to change fundamental station settings, access certain instruments, or modify certain documents (e.g., methods).
When performing a multi-detector measurement, each calibration file can contain calibration curves for up to 32 signals, just like chromatograms. However, only one signal can be active and its data modified at any given time.
The active calibration signal, whether its table or curve, is identified by its name (or number if no standard chromatogram is opened), which is highlighted in the header of the Calibration Summary Table or in the calibration curve itself. Additionally, all signal-specific values are displayed in the same color as the active signal.
The chromatogram name which is displayed in the header of the Chromatogram window. All displayed data and performed operations will only relate to this active chromatogram. The name of the active chromatogram is highlighted in the legend by bold letters.
When performing a multi-detector measurement, each chromatogram file may contain up to 32 detector 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 legend by bold letters.
A detector selected in the Select Detector field, whose measurement and calculation parameters are displayed in the Acquisition or Calculation tabs in the Method Setup dialog. 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.
Also named NetCDF format is an 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 imports raw data, not the results.
A group of peaks calibrated as a single component.
Contains calibration curves of all added compounds and further data, e.g., their amounts on different levels, for calibrated results.
A chromatogram containing known amounts of compounds you want to evaluate that is used to calibrate/recalibrate at a specified calibration level.
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.
A version of the Clarity station that, does not allow the data acquisition, it is intended for data evaluation from another PC.
Holds the information about the number of Instruments, and the allocation of connected devices to each active instrument.
A file used to store the user settings, such as User Options, size, location and appearance of all windows and panes, user columns.
Direct control of chromatograph (autosampler, pump)
An integrated additional module for selected devices (pumps, autosamplers etc.) enabling the direct control and monitoring of selected parameters. For example, directly controlled detectors (UV-VIS, PDA, etc.) gather digital data (or even the spectra) directly from the controlled instrument.
The electronic signatures must fulfill the same function and prerequisites as the handwritten ones. 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.
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.
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.
Good Laboratory Practice (GLP) is an internationally agreed upon system for ensuring and monitoring the quality of laboratory work.
A table in the
(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
(b) Sometimes also a chromatograph or generally any piece of equipment in the laboratory.
The directory set in the Clarity for each Instrument, where projects including all chromatographic data are located.
A part of the processing method that lists all operations affecting the chromatogram’s peak integration. Integration is the process of determining peak areas and heights, essential for quantitative analysis. The table displays all modifications to the baseline or peaks applied to the chromatogram.
A file that can only be read and not modified. The file may be Read Only for several reasons, including (but not exclusive to) chromatogram measured in GLP mode and opened outside of it, historic version of a chromatogram, or when a user account not having user rights to modify method/chromatogram/sequence etc.
An Instrument with locked control. Lock mode can be activated using a command from the Lock submenu in the main Clarity window. An Instrument is unlocked by logging in as the same user who locked it, or anyone who has the Access Right Take Control of Locked Instrument.
Defines the parameters of the acquisition and processing of the data. Its name is displayed in the Information Table of the
Multi-detector configuration (measurement)
Setting of the station so that it measures and evaluates chromatograms with more than one detector's signal.
The layout of individual segments that should be printed (e.g., results, measurement conditions). The layout is defined by the report style.
Directory used to store all files associated with the project (for example method, sequence, calibration files).
Identifies what project directory will be used, and holds the information about recently opened files.
A regime which enables only authorized users (users who have an account created in the User Accounts dialog) to work with the station and access data.
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).
Defines what information will be included in a report and how it will be printed.
Defines a set of analyses to be performed automatically, storing all necessary parameters for each run, such as the measurement method, sample injection volume, and other analysis settings.
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.
The Extension serves for statistic evaluation of the parameters from measured chromatograms. It can be used to validate the chromatographic system.
A table displayed in the
A tab is a section within a window or dialog that organizes different settings or options. Only one tab is visible at a time, and you can switch between them by clicking on their labels.
A toolbar is a set of icons that represent various commands. It’s typically located at the top or side of the screen and can be customized by going to View - Customize… or by right-clicking on the toolbar to open the context menu.
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.