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Clarity EA Chromatography Station
Clarity Elemental Analysis Software (Clarity EA) is designed for use
with elemental analyzers using the combustion/gas chromatography technique.
Clarity EA is a modification of Clarity Chromatography Software.
Its user interface is optimized for maximum efficiency in repetitive
tasks. Using features that are specific to EA Analysis, such as
Standard Table, automatic weight input from analytical balance and
other improvements, Clarity EA provides an interactive and automated
tool for determining the Carbon, Hydrogen, Nitrogen, Oxygen, and
Sulfur (CHNS-O) content of unknowns.
Contains tools supporting compliance with CFR21 Part 11. |
Features
Clarity Elemental Analysis Software can acquire data
from any elemental analyzer that is based on the combustion/gas chromatography
technique and is equipped with analog data output.
Multiple Instruments
Clarity Elemental Analysis Software acquires data using an A/D converter
(PCI, USB or TCP/IP). Clarity EA software can acquire and evaluate
data simultaneously from up to four instruments at a time (multi-detector
measurement support).
GxP Compliance
Clarity EA includes built-in tools for GLP and 21 CFR Part 11 compliance.
These tools include password protection with an expiration period,
electronic signature, detailed audit trail and configurable access
rights for each User Account.
Versatility
Clarity EA software can also be configured to standard chromatography
data processing mode, it means that users can have an elemental analyzer
and a chromatograph connected to one software.
Online signal monitoring
Sample peaks can easily be reintegrated and recalculated. A real time
chromatogram is especially valuable for monitoring baseline conditions
and viewing the chromatograms in real time.
Calibrations
Six types of calibration curves can be selected from the software
for fast, easy system calibration. For your convenience, the software
contains a Standard Table with a list of the most commonly used calibration
standards and their elemental composition.
Sequence Table
Measurement is managed using the Sequence Table. The Summary Table
displays results clearly. ASCII and AIA data formats can be exported
or imported directly. Results can also be exported in the .dbf format.
Analytical Balance Control
Clarity Elemental Analysis Software allows for direct interface with
analytical balance (Sartorius and Mettler). After weighing the sample,
the operator presses the print key on the analytical balance (or uses
software instruction) to directly transfer sample weight information
to the software sample information field, thereby eliminating any
possible transcription errors.
Reporting
Clarity EA supports the printing of user defined protocols. Its configuration
is saved in a report style, which defines the content and form of
the printout. Protocols can be printed to PDF file.
Clarity EA
An off-line version of Clarity EA called Clarity EA Offline is available
for setting up new methods and working with data outside of the laboratory.
Clarity EA Screenshots
Instrument Window
Instrument window is a control center for the whole process of data
acquisition and evaluation.
The Information Table displays the processed sample: Name, applied
template method, acquisition mode, etc.
The Status Line indicates the current state of the analysis: elapsed
time and state.
The Analysis-processing Diagram provides icons for fast access to
every process of the whole procedure. It starts with Sample Table
and through the measurement conditions.
EA Sequence
The EA Sequence enables to compose the sequence, control its processing
and atomatize the creation of printed outputs. With attached Analytical
balance (Mettler or Sartorius) the sample weght can be entered by
a mouseclick. Each sequence will automatically create its corresponding
calibration and method files.
Get Weight
The Clarity Elemental Analysis Software allows for direct interface
with the analytical balance (Sartorius and Mettler).
After weighing the sample, the operator presses the print key on the
balance (or uses software instruction) to directly transfer the sample
weight to the software sample information field thereby eliminating
any possible transcription errors.
Sample Table
The Standard Table stores predefined values for commonly used standards.
The table can be edited to add other standards or to delete the unused
ones.
Chromatogram - Summary Table
The Chromatogram window can overlay multiple chromatograms for visual
review of their graphs (marks "1" and "2").
The Summary Table (mark "3") displays results for all overlaid
chromatograms (e.g. all chromatograms from a sequence). The Summary
Table can be easily customized to display the desired information
in a suitable layout. This can be done by right clicking the table
and selecting the Summary Options (mark "4")„ or Setup
Columns (mark "5") commands.
Clarity software comparison table
The comparison table displays the feature matrix of four key Clarity
software products.
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FEATURE |
Clarity |
Clarity
Lite |
Clarity
EA |
Clarity
Offline |
| Multiple detector Instruments support |
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| Number of instruments connected simultaneously |
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| Supporting tools for 21CFR Part 11 (electronic
signature, audit trail, etc.) |
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| Clarity Control (AS, GC, HPLC pumps) |
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| System Suitability Extension - SST |
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| Column Performance Table |
|
| User columns in result table - calculations
defined by the user |
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| Archive/restore functions |
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| Batch processing |
|
| Single Analysis mode |
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| Sequence |
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| Special Elemental Calculation |
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| Table of Calibration Standards |
Compatibility
Clarity EA Windows OS and hardware compatibility is identical with
the compatibility of Clarity software. Clarity EA can be switched
to standard Clarity mode.
In consideration of the many and variant operating systems, chromatographic
stations and hardware available for data acquisition and in use
today we offer the following summary table of possible Clarity software
combinations:
PC Configurations
|
Minimal |
Recommended |
| Win XP/2000 |
| Monitor |
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|
 Clarity
21 CFR Part 11 compliance
Clarity, Clarity EA and Clarity Offline softwares provide variety
of tools supporting the GxP practices. These tools enable to configure
the chromatography station in a way to comply with the requirements
of the 21 CFR Part 11 directive of the FDA. This ensures its suitability
for use in regulated environments.
Clarity Lite does not contain some these tools and so it is not recommneded for use in regulated environments.
Supporting tools for 21 CFR Part 11 requirements
1. Software Validation
Certificate of Software Validation is available upon request.
2. Installation Qualification
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.
3. Operational Qualification
Validator for OQ (Operational Qualification) is an optional package available for testing and validating the station. This is accomplished simply with the use of our chromatogram generator and a software utility.
4. Logon with Password
5. User Accounts
Selectable rights, unique user profiles 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.
6. Password expiration and minimal length
7. Electronic Signatures
Electronic signature implemented. 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.). Two types of electronic signature have been implemented:
a) using user accounts
b) using a certificate
The signature information associated with the signing that indicates the printed name of the signer, the date/time, and the meaning, is included in any readable form of the records (see par 11).
8. Audit Trail
Audit Trail of whole system, chromatograms, calibrations and sequence. Audit Trails are part of corresponding files. Detailed logs and histories of modifications enable users to maintain an audit trail. The station 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.
9. Record of all changes
History of all methods and calibrations as part chromatogram files
10. System Suitability Test
- method performance and system consistency monitoring
11. Printed reports
- page numbering, labeled with date and time of analysis and print out, includes information about applied electronical signatures. Reports can be printed to electronically signed PDF files. |
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