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Clarity Offline
Clarity Offline Chromatography Software is offline software used for
evaluating and printing chromatograms and preparing methods. Clarity
Offline provides all the standard functions of Clarity Software except
that it does not allow for both data acquisition and the use of Clarity
Control Modules. The software works with the same files and provides
the same outputs (printing and exporting) as the Clarity station.
Clarity Offline Software is intended for use as additional offline
software that supplements online versions of Clarity software: Clarity,
and Clarity Lite and Clarity EA.
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Features
Measuring
Clarity Offline provides all the functions of Clarity Software except
for data acquisition and Clarity Control modules.
The software works with the same files and enables the same outputs
(printing and exporting) as the Clarity station.
21CFR Part 11 compliance
When used together with Clarity or Clarity EA software Clarity Offline
contains all functions Electronic Signatures, User Accounts, Audit
Trail, etc.) for compliancy with the 21 CFR Part 11 directive of the
FDA. Clarity Offline can be used for offline evaluation in regulated
environments.
Networked Solution
Clarity Offline can access files of Clarity software (Clarity, and
Clarity Lite and Clarity EA) installed on networked computers. This
enables offline evaluation of chromatograms, developing of new methods,
printing reports.
Fields of use
The Clarity Offline Software is intended as an additional offline
software to accompany the online versions of Clarity software: Clarity,
and Clarity Lite and Clarity EA.
It can be used for example:
Additional PCs in the laboratory
Clarity Offline can access the data of the online Clarity software
over a local network.
Multiple users will then be able to work with their projects from
distant computers and share access to the Clarity software, which
then serves as an acquisition server that is equipped with A/D converter
and instrument control.
Education
An additional field of use is in education, Clarity Offline enables
students to prepare projects offline and then easily access them from
the online version (Clarity) connected to a chromatograph.
Home computer
Clarity Offline can be installed on home computer or notebook giving
you anytime access to all your important data.
Clarity Screenshots
Instrument Window
In Clarity Offline the Data Acquisition is disabled. The icon for
monitoring signal from detector will be dimmed, the acquisition status
will display "disabled".
All other functions will be the same as in the Clarity software.
Clarity Offline Window
 The
Clarity Offline window is an entrance point to individual offline
Instruments.
The blue bar with the text "Offline" indicates that this
is the offline version that cannot be used for dataacquisition.
Up to four independent offline Instruments can be used. Each can be
predefined to specific type of analysis (e.g. GC or LC) or to access
specific projects.
Chromatograph Window
 The
Chromatogram window displays the chromatogram and results. Users can
easily edit acquired chromatograms visually in the graph or through
Integration table.
The Result tables (Results, Summary, Column Performance, etc.) can
be easily customized to display the data you want see exactly in the
way you want to see them.
The Summary tab displays data from overlaid chromatograms in one table
for easy comparison.
System Configuration dialog
It is not possible to add detector to the Clarity Offline Instrument
because the DataAcquisition is disabled in this offline version.
Clarity Control modules are also not able to control the device online.
However if you are preparing methods for chromatography system controlled
by Clarity Controls it is better to assign the corresponding control
module (e.g. the Agilent 68xx GC) to the Clarity Offline Instrument.
You will be then able to prepare the device specific methods.
Tutorials download
The tutorials present selected themes related with Clarity chromatography
Software. They will provide brief introduction into the topic. They
do not cover all the possibilities and functions of the presented
topic. Detailed and complete information can be found in the relevant
manuals.
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Clarity tutorials |
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Clarity Lite tutorials |
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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 |
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| User columns in result table - calculations
defined by the user |
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| Archive/restore functions |
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| Batch processing |
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| Single Analysis mode |
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| Sequence |
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| Special Elemental Calculation |
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| Table of Calibration Standards |
 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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