GC Sysadmin
GC Sysadmin
GC Sysadmin
Feb. 2009
Shimadzu GCsolution
Chromatography Data System
Administration Manual
Version 2.3
Read the instruction manual thoroughly before you use the product. Keep this
instruction manual for future reference.
Shimadzu Corporation
Analytical & Measuring Instruments Division
Kyoto, Japan
Copyright Shimadzu Corporation 2000-2009. All rights are reserved, including those to reproduce this publication or parts
there of in any form, without the express written permission of Shimadzu Corporation.
Information in this publication is subject to change without notice and does not represent a commitment on the part of the
vendor.
Any errors or omissions which may have occurred in this publication will be corrected as soon as possible, but not necessarily immediately upon detection.
Shimadzu Corporation makes no claims or warranty concerning the influence of the application of this publication on the
operation of the machine.
Note that Shimadzu does not have any obligation concerning the effects resulting from the application of the contents of this
manual.
Shimadzu Corporation will continue to supply original Shimadzu maintenance parts associated with a given product for a
period up to 7 years from the cessation of production of that product.
Please be informed that after this period of time, Shimadzu Corporation cannot guarantee supply of such original maintenance parts. However, following discontinuation of a product, the period of availability of maintenance parts which have
been produced on a subcontract basis is up to the discretion of the concerned sub-contracting company.
GCsolution is a trademark of Shimadzu Corporation.
DBWAX is a product name of S&W Corporation.
Microsoft Windows and MS-Excel are registered trademarks of Microsoft Corporation.
Microsoft Windows 2000, Windows XP, Windows Vista and MS-Word are products of Microsoft Corporation.
Adobe, Acrobat and Distiller are registerd trademarks of Adobe Systems Incorporated. Acrobat ReaderTM and Acrobat
PDFWriterTM are products of Adobe Systems Incorporated.
Introduction
Thank you very much for purchasing the GCsolution software for Shimadzu gas chromatography workstations (hereafter
called GCsolution).
GCsolution allows you to control the Gas Chromatograph (hereafter called GC) from your personal computer, acquire chromatograms and other different kinds of data, and reanalyze the acquired data under different parameters on your personal computer.
This manual explains the operational procedures and basic idea of system administration and data management using GCsolution. Its provided as a PDF file so that it can be referred to on-line whenever operations related to system administration are
needed.
As separate volume, the Operation manual is attached as printed manual, and the Reference manual is attached as PDF file on
GCsolution CD-ROM.
The Operation manual has been put together in order to familiarize you with the basic knowledge required to operate GCsolution. Be sure to read it throughly before using this software. After reading the manual, keep it in a safe place so that it can be
accessed whenever necessary.
The Reference manual covers the on-line help information in PDF format. For detailed information on the functions of GCsolution, refer to this.
This manual assumes that the reader is knowledgeable of basic operations of Windows. For the operation of Windows, refer
to the instruction manual that comes with that product.
Media
for
Description
Printed document
Explains the operational procedures for data acquisition and analysis using
GCsolution.
On-line help
GCsolution program
Provides the Quick manual as a PDF file so that it can be viewed on your
personal computer.
Provides the Reference manual as a PDF file so that the on-line help can be
printed out or referenced as appropriate via the hyperlink from the operations volume of the instruction manual (PDF version). The general table of
contents is available, including all the instruction manuals (PDF versions).
It allows you to use each instruction manual via the hyperlink.
Expands the operational procedures and basic idea of system administration and data management using GCsolution. This manual is provided as a
PDF file so that it can be refered whenever operations related to system
administration are needed. The general table of contents is available,
including all the instruction manuals (PDF versions). It allows you to use
each instruction manual via the hyperlink.
Meaning
Gives you tips.
L
<
>
Shows a window or view name; e.g., <Data Acquisition> window or <Method> view.
Shows a parameter, tab, column, cell, bar name, menu command , that can be selected from the menu bar.
[ ]-[ ] command
Shows a sequence of selecting the menu in the first [ ] and then selecting the command in the second [ ].
For example, [File]-[Print] command means that you should click on the File menu and then select the
Print command from the displayed list of commands.
Contents
1
1.1
1.2
2
2.1
System Administration
Reviewing System Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1
2.1.2
2.1.3
2.1.4
2.2
2.3
2.5
3.1
4.1
Using a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
3.3.1
3.3.2
3.3.3
3.3
3.2
2.4
What is GLP/GMP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
What is FDA 21 CFR Part 11? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Audit Trail
Important File Concepts for Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
LabSolutions/GCsolution Administration
4.2
4.3
4.4
Validation
5.1
5.2
5.3
Data Administration
6.1
6.2
6.3
Using CLASS-Agent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.4.1
6.4
Appendices
7.1
7.2
II
LabSolutions/GCsolution Administration
7.3
Index
LabSolutions/GCsolution Administration
III
11.1.
1.1.1
What is GLP/GMP?
GLP is an abbreviation for Good Laboratory Practices. GMP is an abbreviation for Good Manufacturing Practices.
Both terms are usually used by their abbreviations alone.
Note:
Many items and functions are common for GLP and GMP methodology, and this software also uses these functions as GxP support
functions.
This function ensures the reliability of inspection by keep openness of inspection to the public. For that purpose, all inspection operations are standardized through documents, and all inspection progress are recorded and kept. Also, the reliability
guarantee section and the actual inspection section are separated, and precision and machine condition are checked periodically.
In order to assure the quality of the finally obtained result (data), this method allows you to control the entire process (validation, workflow, and data) involved in acquiring that result, record it, and then trail it (audit trail)
GLP/GMP are guidelines/laws for performing correct analyses and inspections. Even if the use of GLP/GMP is not specifically
required for your laboratory, these functions are useful and effective for performing any operations correctly and smoothly.
1.1.2
It stands for the FDA (Food and Drug Administration) 21 Code of Federal Regulations Part 11, which states that the FDA
approves an electronic record with an electronic signature as equivalent to a document record with a handwritten signature so
far as that record conforms to this code.
The code is intended to speed up the FDAs process for approving new drugs. In the U.S., the electronic signature in the global/commercial trade is legislated and the legal status of the electronic signature is established. The above code may be
regarded as a common regulation for handling computer-based documents as they are in the electronic format.
Since this trend is worldwide, electronic data output from a computerized analysis system conforming to the FDA 21 CFR
Part 11 can be used throughout the world not only in the medical, pharmaceutical, and food categories, but also in other categories. The use of such electronic data provides effective means taking the place of long-term storage of paper-based data.
The FDA 21 CFR Part 11 mainly refers to the data security (function and access restrictions through security), data integrity
(all-in-one file structure and data that can be rolled back), audit trail, and login authentication, all of which are covered by the
GxP support functions.
LabSolutions/GCsolution Administration
11.2.
The LabSolutions/GCsolution supports the conformance to the GLP/GMP and the FDA 21 CFR Part 11 through the following functions:
System Administration
Audit Trail
Validation
Hardware validation
Software validation
Data rollback
Method validation
Data Administration
Data management and search based on sample information
Automatic generation of data file names
Creation and management of files in general-purpose formats such as AIA ANDi/PDF.
Functions associated with CLASS-Agent
The use of the GxP support functions available in the LabSolutions/GCsolution is optional, but will powerfully support and
save your GLP/GMP-related work that tends to become troublesome.
Note:
For electronic signatures for reviews and approvals of electronic records or for long-term storage of such records, the combination
with the optionally available CLASS-Agent conforms to the FDA 21 CFR Part 11.
LabSolutions/GCsolution Administration
22.1.
2 System Administration
2.1
This software includes a System Administration function. Users can use this function to limit the use of functions and programs to specific individuals to protect programs and data.
By utilizing this function, your laboratory can conform with GLP/GMP, such as for analysis environment and analysis data
reliability and management. This section explains the overall concept of the system administration function.
2.1.1
User
When this software is installed, an Admin who has a complete access right (i.e., system administration right) is registered.
When you use the system administration function for the first time, use the Admin setting to register one person who uses
this software as a User.
Admin registers users.
Admin
User A
User B
User C
Description
User ID
User Name
Description
Password
Group
Select groups where the user belongs. The user can use all functions that his/her group has the
rights to use.
Instrument
To use functions that require their usage rights, the user needs to enter his/her registered ID and password in the <Login>
window displayed when each program starts up.
If an ID or password entered in the <Login> window is different from the ones registered, the program will not start up.
LabSolutions/GCsolution Administration
2 System Administration
2.1 Reviewing System Administration
Rights (Group)
The [Rights] setting can limit the functions that can be used, using the system administration function.
The following groups with the rights shown have been registered. Registering a user to a group that has the necessary rights
enables the user to have the same usage rights.
User B
User C
Note:
A user can belong to more than one group. In this case, that user will have all the rights of whichever groups he/she belongs.
Note:
Note:
You can create a new group that has the desired rights.
For more information about creating new rights groups, refer to 2.3.2 Registering (Changing/Deleting) Rights Groups.
LabSolutions/GCsolution Administration
2 System Administration
2.1 Reviewing System Administration
2.1.2
When performing system administration, select the level of administration you require from the following:
Using the system administration function
User Registration
Password Administration
Uses passwords.
Program Administration
Set to single-user mode.
Set to multi-user mode.
In this case, user names can be recorded in the history information without setting passwords. Using this feature also improves system reliability compared with using the Admin-only setting.
Even when password entry is not used, if the [Normal Login] mode (explained later) has been set, User ID entry is required. Therefore, based on the User ID confidentiality management levels, a certain level of security can be obtained.
You must change the user ID of Admin (only possible at the initial time) because the user ID Admin is known. Even when a
password is registered, setting the [Normal Login] mode will provide a more secure environment.
LabSolutions/GCsolution Administration
2 System Administration
2.1 Reviewing System Administration
2.1.3
LabSolutions/GCsolution Administration
2 System Administration
2.1 Reviewing System Administration
2.1.4
The numeric settings are regarded appropriate if each parameter falls within the practical range* when a sufficiently short life
span of password (approximately one several thousandth or less) is set for the mean decryption time for a password, which is
obtained from the following equation:
* It is important to specify such Minimum Password Length and Maximum Password Age as you can remember without writing them down,
such a Lockout Duration value as would not cause great inconveniences on your tasks if you should become unable to log in the system, and
such a Login Attempt Limit value as provides allowance for you to correct it if necessary.
Minimum Password Length
Note:
If the user ID is properly managed, security level will be higher because decryption of user ID is also necessary. For the above calculation, however, no user ID is taken into consideration assuming that character strings such as employee numbers, which may be
found externally, are used.
The following example calculated by the above procedure shows one of the recommended set of values:
Number of Characters Used: 36*
Minimum Password Length: 6
In the case, the mean decryption time (converted into years) is 4,000 years or more providing an allowance of at least 8,000 times
the above life span value of password (0.5 year). If you need an allowance of 10,000 times or more, enter stricter values than those
specified in parentheses, which may be regarded as falling in the practical ranges.
If any of the above values is less strict, the other values will relatively become stricter for practical use. Therefore, Minimum Password Length = 6 and Maximum Password Age = 180 days are general settings for similar types of systems.
* Assuming that only alphanumeric characters are used. This case is not (Upper/Lower) case-sensitive for difficulty to force random mixedcase-strings.
Note:
The LabSolution/GCsolution has more powerful user administration functions than Windows in that:
Even if a user is deleted, it is only hidden, but its entry is retained. This prevents any other user with the same name from being
registered. Therefore, the traceability of data that was acquired by the deleted user can be kept intact.
The user ID is managed in combination with the corresponding user name and only used at login. For the subsequent display,
the user name is used.
LabSolutions/GCsolution Administration
22.2.
2 System Administration
Using the System Administration Tools
to Set Available Items
2.2
When using any functions related to system administration, call up the System Administration Tools.
Note:
Click on [Administration]
tab from the <GCsolution
Launcher>.
The settings entered <System Policy> and <User Administration> will become effective from the next time the program window is
started (logged in).
Yes
No
Remarks
<System Policy>
<User Administration>
Create a new rights group.
Cannot delete (= hidden) a user currently logged in nor the Admin user
registered at software installation.
Regular users can change only his/her
password.
<Log Browser>
LabSolutions/GCsolution Administration
22.3.
2.3.1
2 System Administration
2.3
To use the system administration function in this software, set the policies like login method and password limitations.
Level
Description
Level 1
If login failures exceed the specified number of times, all the users
on the PC or network will become
unable to log into the PC or network for the specified period of
time.
<System Policy>
(Reference Manual p504)
LabSolutions/GCsolution Administration
2 System Administration
2.3 Starting the System Operation
Note:
Note:
The settings on the <System Policy> window will become valid at the next login.
Note:
If User Authentication Mode is selected in SHIMADZU User Authentication Tool at GCsolution Installation, these policy setting parameters are restricted along setting range of SHIMADZU User Authentication Tool.
To set the system administration policies other than user administration, use the right half of the <System Policy> window.
Note:
<System Policy>
If this is checked, the title of
each print item always has
data file name as mark so
that reports created from
multiple data sets can be differentiated from each other.
Prints out the type of application window used to output a report in the header.
Prints out the status of special data that may be unsaved
or manipulated after data
analysis in the header.
If this is checked, the Audit
Trail Log of data/methods
is recorded in the System
Administration Log.
Allows you to disable EMail function.
The above setting to protect against overwriting files is not applicable when the contents of a file are modified and then saved.
If data acquisition is in progress or if the file is saved using [Save As] function, no existing file can be overwritten any longer. If file
editing itself is the problem, use User Rights Settings to specify whether or not to authorize each user with the right to perform edit
and postrun analysis, or enable the audit trail for method/data files and record the modification log when saving the file.
LabSolutions/GCsolution Administration
10
2 System Administration
2.3 Starting the System Operation
2.3.2
When this software is installed, a number of standard rights groups are set up such as H/W Administrator, Method Developer, Operator.
This section explains how to register (change/delete) a rights group.
d
Click
c
d
Note:
11
To specify a system administrator, use the <Add User> or <User Property> window.
LabSolutions/GCsolution Administration
22.4.
2 System Administration
2.4
Users can be registered not only to limit who can use this software, but also to understand each users program usage conditions.
Click
c
d
f
Select desired item from [Group List] and
move to [Selected Groups] using
[Add>>]. User will have groups rights.
Select desired item from [Selected Instrument items] and move to [Instrument
Item List] using [<<Remove]. User cant
use that Analytical Instrument.
Note:
If you try to register a user with the same user ID/user name as that of a previously deleted user through the <Add User> window, a
dialog box will be opened prompting you to confirm whether or not to restore the previous user.
LabSolutions/GCsolution Administration
12
22.5.
2 System Administration
Short Time after System Operation Has
Been Started
2.5
After the system has been used for a while, recheck to see whether the parameters set in 2.3 Starting the System Operation
(or the default settings used by registering a user) have met your purpose.
If the password validity is set, you will need to change the password after the expiry has come.
2.5.1
The system administration is traceable since changes in the system administration settings and operations performed on the
System Administration Tools, such as password changes and user registrations are recorded as event logs.
When
the
<GCsolution
Launcher> has not started yet,
double-click the desktops
[GCsolution] icon.
13
LabSolutions/GCsolution Administration
2 System Administration
2.5 Short Time after System Operation Has Been Started
2.5.2
Changing Passwords
You can change your own password at any time, whether you are a system administrator or a regular user. Also, if a password expiration date is set with the system administration settings, anytime to start a program after this date will bring up a
dialog box prompting to change the password after the <Login> window appears. At this time, use the procedure below and
change the password.
When
the
<GCsolution
Launcher> has not started yet,
double-click the desktops
[GCsolution] icon.
Note:
A user with the system administration right can perform initial settings/resettings of all users passwords in the [Users] tabs <User
Property> window.
For more information about of the initial settings/resettings of users passwords, refer to 2.4 Registering (Changing/Deleting) Users.
LabSolutions/GCsolution Administration
14
33.1.
The use of the security support functions facilitates controlling the workflow and improves the reliability of the obtained
data.
3.1.1
Login Authentication
To clarify a user when he/she uses a program, the system administration function uses user ID and password confirmation to
start a program. This is called the login procedure.
In particular, the FDA 21 CFR Part
11 clearly accepts login authentication as an electronic signature.
Unless the requirements are satisfied, no electronic data can replace
data on paper.
The concept of user ID and the
function of password are in a
mutually supplemental relation.
When both of them become valid,
the requirement as an electronic
signature is satisfied and the effect
of controlling the workflow of
each user is exerted.
Note:
The combination of two components (user ID and password) serves as an electronic signature.
Adoption of two distinct components in an electronic signature such as combination of a user ID and password is mandatory for
compliant systems; however, it is meaningful only when accompanied by proper user management.
Below are examples of some common practices that must be avoided.
Multiple individuals use the same user ID (i.e. Admin) for login.
This practice is dangerous as it inhibits the ability to identify who handled the data, and to prevent unauthorized access to the
system.
Registers multiple user IDs with no password. Users can use any user IDs easily and there is no record who actually performed
the operations.
See 2.3.1 Setting User Administration Policies, 2.4 Registering (Changing/Deleting) Users.
3.1.2
One of the GLP/GMP requirements is to display the current user name in each window.
When logging in using a correct user ID using the system
administration function, the user name will be displayed in
each windows title area.
15
LabSolutions/GCsolution Administration
3.1.3
In order to restrict a task so as to be performed in accordance with the standardized procedure or to certify that the task has been done under that
restriction, the system administration functions allow you to restrict the
operable functions.
Note:
The GLP/GMP assures the quality of the acquired data by showing the fact
that the section for securing the reliability has been separated from that for
actually carrying out the inspection and analysis and by certifying that the
tasks are performed in accordance with the standardized procedures.
This function is also effective for preventing wrong operations and decreasing the time required for mastering the operations by hiding the unnecessary
functions.
See 2.4 Registering (Changing/Deleting) Users, 2.3.2 Registering (Changing/
Deleting) Rights Groups.
3.1.4
The locking function is available to protect the data from any accident through operations by another operator or any malicious operation when you temporarily leave the workstation during the automatic analysis or for any other reason.
Click on [Window] [Lock].
LabSolutions/GCsolution Administration
16
33.2.
The standard procedure for a series of analytical tasks can be included in a batch table and used for the workflow management.
3.2.1
3.2.2
Also perform the QA/QC criteria checking condition settings for the
method file. (See Reference Manual page 527)
Note:
3.2.3
Outputting
Batch
Processing
Results in Common Format
The [AIA Convert] tab allows you to convert a data file into the AIA
ANDi format and then output it.
When saving a batch table using [File Type] - [txt], the batch table will
be saved in text format. Any file saved in text format can be loaded.
17
LabSolutions/GCsolution Administration
3.2.4
From the batch tables [Action] settings, batch progress control (stop/pause) and external program* startup performed based
on QA/QC or system check criteria checking results can be set.
* The [Action] settings can be performed independently from the user program settings (described later).
Note:
When checking criteria from the QA/QC results, click the [Execute QA/QC] check box on the [Batch] Assistant Bars [Settings]
icon - <Settings> window - [QAQC] tab. Also, when checking criteria from the system check results, select the system check function for batch rows. (System check can only be performed when real-time batch processing is performed.)
Note:
When checking criteria from the QA/QC results, the timing must be matched for the [Action] setting and QA/QC result output.
QA/QC result comes out only the end of series of the same sample type (or end of batch processing = meaningless for [Action])..
The technic to change sample type intentionally at the timing of [Action] by QA/QC criteria should be effective.
Note:
Be aware that, if QA/QC calculation or system check used to check criteria has not been set up on a batch row where action settings
have also been entered, the results of the criteria checking will be No Error (i.e., passed).
Note:
If starting an external program here, information such as a data file name cannot be sent to the program. To do so, preliminary settings are required such as specifying the file name to send.
See the appropriate section of Reference Manual 9.10.6 <Schedule Action> Window.
3.2.5
A program to be started before and after a batch row run can be entered into a batch rows [User Program] field.
The two kinds of user programs below can be started separately from an external program started based on the previously
described action functions. checking results.
Program activated before a batch row run (pre-data acquisition run program)
Program activated after a batch row run (post-data processing run program)
The following parameters can be set for programs run after data processing (Post-run):
Vial #
Line #
LabSolutions/GCsolution Administration
18
33.3.
3.3
Using a Template
When a new file is created, an available format can be loaded from a template.
3.3.1
Data
Batch
Report
Table
format
Method
Create new file in <Data
Acquisition> and <Calibration Curve> windows.
Acquiring
data
will create a data
file.
New files cannot be created using the <Data Analysis> and <Data Comparison> windows in the <GC Postrun> program.
When creating a new file in the <Data Explorer> window, the new file type will be determined based on the application window
that is active at the time.
Select whether or not to use a template to create new files by following the steps below.
Selecting [Prompt on File
New], the <File New> will
appear.
Click here.
Click [Select...]
to search for a
file.
<Setting Options>
(Reference Manual p564)
19
LabSolutions/GCsolution Administration
Click [Change...]
to change the
templates folder.
3.3.2
A template is a file that is the same as this softwares regular files (batch, report format and method files) and is saved in a special
template folder. This file can also be used as a copy source file when creating a new file. The procedure to save a file as a template
is the same as to change file data and to save it under another name. However, since saving a file as a template is effective in preventing overwriting file data by mistake, it is useful to create and use standard template files.
Right-click desired file name
to display [Delete] menu.
Click here.
<Save As Template>
(Reference Manual p570)
3.3.3
The default values may be changed when you create a new file. If the same settings are required whenever a new file is
required, the use of a template would ensure the constant setting quality by saving the settings and preventing any omission
in the settings.
In particular, this is effective for creating a blank batch file or a new report format file.
Items that are hidden in a standard table style, but always used must be displayed, For example, a sample name and
sample ID are not good enough as items and are supplemented with optional items.
In a standard table style, highly frequently used table items are not located on the left side and must be rearranged.
The default value for Autosampler Inj. Volume/Multi-Inj. Counts uses a setting in the method file, but is specified
every time since this parameter is set in a batch table.
A rule for naming a data file is established for the management purpose and the automatic data file naming function
for a batch table is used by setting it every time.
Report file template
A report format may include report items that are always laid out or non-report items for which you want to change the
default values.
In a given position on paper, the bit-mapped corporate logo must be printed out.
The printer restrictions require the paper margins to be changed from the default values.
The date and user name are always printed out in the header for the management purpose.
LabSolutions/GCsolution Administration
20
44.1.
4.1.1
4 Audit Trail
4.1
The System Configuration File stores the connection conditions between the personal computer and Analytical Instruments, as well as installation information for each modules that are connected to the Analytical Instrument. When multiple
Analytical Instruments are connected to the PC, this file will be created for each of them.
When clicking the [System Configuration] icon on the <GC Real Time Analysis> - [RealTime] Assistant Bar, the <System
Configuration> window will appear. Setting data entered in this window will be saved in the System Configuration File.
The structure of the System Configuration File will reflect the GCs instrument structure with 2-line analysis performance.
System Configuration File
Line 1
Detector ch. 1
Auto-sampler
Column
Injection unit
Detector ch. 2
Detector ch. 3
Column oven
Line 2
Detector ch. 4
Auto-sampler
Column
Injection unit
called
Note:
The history of system configuration changes may be saved as audit trail log in the system configuration file.
Opens the <Audit Trail Settings For Instrument Configuration File> window.
21
LabSolutions/GCsolution Administration
4 Audit Trail
4.1 Important File Concepts for Operation
4.1.2
Method File
The Method File has an extension of gcm and contains the following saved information:
System configuration:
Instrument parameters:
Stores each instrument settings data that has been entered using the <Instrument Parameters> view in the <GC Real Time Analysis> window.
Instrument Parameters
Line common settings
Line 1 connected instrument settings
Line 2 connected instrument settings
On the other hand, data processing parameters will be used to process chromatogram data obtained from the detectors, therefore,
these parameters will be set for each detector.
Note:
Only the QA/QC parameters, however, can be set for the first
channel (i.e., chs. 1 and 4) for each line.
The separate parameter and data ranges used for each GC, line,
and detector channel are important concepts to understand with
this program.
For more information about how to set the instrument parameters, refer to
3.1.3 Operation Example Analysis Conditions.
For more information about how to set the data processing parameters,
refer to 5 Next Step - Data Processing.
Note:
The history of method changes may be saved as audit trail log in the method file. The history of changes in some parameters
including the QA/QC parameter cannot be saved.
Once the audit trail log option is selected, it can no longer be deselected. To cancel the audit trail setting for the method file, create
a new method file on the <Data Acquisition> window, specify the method file for which you want to cancel the audit trail setting
after selecting [File] - [Load Method...], load that method file, and then save it as another file with the same content.
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4 Audit Trail
4.1 Important File Concepts for Operation
* The audit trail setting for a method recorded in the data file cannot be changed.
For example, if data is processed using another method file in post-run batch, the presence or absence of the audit trail setting for a method
in the data is not affected. If the audit trail setting exists, the log remains as though the data processing parameters were modified in accordance with the details of the method used in post-run batch.
4.1.3
The Report Format File has an extension of gcr and stores report format settings used to print analysis results.
For more information about report format file settings data, refer to Operation Manual 8 Report Functions.
Since reports are output for each line, designate a report format file for each line. Therefore, one report can include report
items for data up to three detectors.
Note:
When using the same report format for both Lines 1 and 2, the same report format file can be designated.
Note:
When there are multiple detector channels on Line 1, be sure to designate a report format file for multiple channels.
4.1.4
Batch File
In this software, conditions to be used for multiple data acquisition and data analysis have been set in the batch table in the
<Batch Table> window, allowing continuous data processing to be performed.
The Batch File has an extension of gcb and its parameters for the entire batch, which are set on the <Settings> and
<Table Style> windows, are saved in addition to the parameters that can be set in a batch table.
For more information about batch file settings data, refer to Operation Manual 7 Batch Processing.
Unlike the case with a report, the 2-line analysis requires that the parameters for 2 lines be set in a single batch table.
Note:
Only a single run of analysis batch processing is performed at a time on the <GC Real Time Analysis> window. Therefore, no
asynchronous analysis can be carried out creating a batch table for each line.
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4 Audit Trail
4.1 Important File Concepts for Operation
4.1.5
Data File
The Data File has an extension of gcd and contains data and its meta (= peripheral) data saved in the all-in-one structure.
When performing data acquisition, the System Configuration and Method Files used at that time, Chromatogram (peak
data) actually acquired, and Data Processing Results are all saved in one data file.
Note:
System
Configuration
Method File
Batch File
Format File
File
Report
Data Acquisition
Copy
Copy
Copy
Copy
Method File
Batch File
System
Configuration
Report
Format File
file
Acquire
Create
Data Pro-
Chromatogram
cessing
Results
Record
Status Information
System
Configuration
Method File
File
Data Acquisition
Copy
Copy
Acquire
Data Proc.
Method
System
Configuration
File
Instrument
Data Proc.
Parameters
Method
Data Proc.
Method
Chromatogram
Chromatogram
Chromatogram
Record
Create
Data Proc.
Results
Data Proc.
Results
Data Proc.
Results
Ch1
Status Infor-
Ch2
mation
Ch3
Method File
Data File Contents
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4 Audit Trail
4.1 Important File Concepts for Operation
Among the above, the following information is duplexed with information at data acquisition and at final post-run
analysis. For data analysis, the information for data processing (latest information) is used with the information at
data acquisition (original) remaining unchanged.
Data processing method in method file, and Batch file
If a data processing method is changed through <GC Postrun> - <Data Analysis>, then the latest data processing
method in the data is used and the method used for data acquisition remains unchanged.
To reflect any change in the method file, export the method file in the data (See 5.1.1 Import/Export Method File in the instruction manual for operations).
When a method is imported to the data, only different parameters in the latest data processing method are rewritten
without overwriting all the parameters.
This allows you to properly save the audit trail log as the parameter changes even if the audit trail function is selected.
Note:
If post-run analysis is performed with a method file specified on the post-run batch row, and if a method file is loaded through the
<Calibration Curve> window and a data file is registered in the <Data Tree> view, then the method will be imported.
Note:
A data processing method can be explicitly imported to a data file when [File] - [Load Method...] is selected on the <Data Analysis> window, or to a method file when [File] - [Load Data Processing Parameters...] are selected on the <Calibration Curve> window. In this case, a method file or data file (a method in which) may be specified as the import destination.
Since the latest data processing method is imported, other methods (instrument parameters and original method) are retained as
records without being modified. This explains why the original method file (at data acquisition) and the latest method file (at the
last post-run analysis) are recorded separately from each other as data file propertues.
If an existing file is specified in exporting data to a method file, only the parameters different from those in the
exporting source are rewritten without overwriting all the parameters.
This allows you to properly save the audit trail log as the parameter changes even if the audit trail function is selected.
Note:
Selecting [File] - [Save Method As...] on the <Data Analysis> window starts exporting data.
Note:
If a data file is loaded by selecting <GC Postrun> - <Data Analysis> and if a Data Report is printed out, then the same
output as the finally printed data can be obtained. Even if the report format in the data is changed, the original report
format file remains unchanged.
To reflect the changes in the report format file, export the report format in the data.
Note:
25
Selecting [File] - [Save Format File As...] on the <Data Report> window means exporting data.
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44.2.
4 Audit Trail
4.2
A data file contains various conditions such as the system configuration and instrument parameters used at data acquisition,
in addition to analysis data and data processing methods. The <Data Analysis> window allows you to reference them.
For the details of the file structure, refer to 4.1 Important File Concepts for Operation
4.2.1
Using [File] - [Data File Properties], sample information for the data acquisition and related files using during the data acquisition/processing can be referred* (viewed) at each tab page.
* Some of the sample information may be edited. In this case, the history of changes is recorded for a data file for which the audit trail setting
is valid.
Click here.
Note:
To edit [ISTD Amount], [Sample Amount], and [Dilution Factor], display <Properties> by selecting <Data Analysis> - <Method>
view - [Quantitative] tab and clicking on the [Sample Info] button.
Some of the information displayed here may be viewed on the <Data Analysis> or <Data Explorer> window, and may be printed
out as sample information items in a report.
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4 Audit Trail
4.2 Referencing a Record in a Data File
4.2.2
Select [Method] - [Instrument Parameters] or [Line Configuration] to display the instrument parameter settings or the system
configuration only with used instruments at the time of data acquisition recorded in the data file.
Click tab for desired
unit.
Click here.
Note:
The operations to refer to each units settings are identical to operations performed by <GC Real Time Analysis> - <Data Acquisition> - <Instrument Parameters>
view area and -<System Configuration>.
Note:
<Line Configuration>
4.2.3
Status information display if the analysis was performed correctly based on the instrument parameters.
<Status Information> (Reference Manual p188)
Click here.
27
Note:
Note:
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4 Audit Trail
4.2 Referencing a Record in a Data File
4.2.4
The change tracking of data processing method can be recorded as audit trail log to the method saved in the data file during
postrun analysis.
Using [File] - [Audit Trail] on the <Data Analysis> window allows to view audit trail log.
This is valid for data on which Apply to
the data file acquired with this method
file was selected on the [Audit Trail]
tabbed page of the Method Properties window when data was acquired.
4.2.5
Data Rollback
In the data file, the data processing method (i.e., the original method used
for recording during data acquisition) has been duplicated, as well as the
latest method to be edited (= the latest method for which the parameters
were modified when post-run analysis was performed) in the <Data
Analysis> window.
Using [File] - [Rollback to Original Data], the original data processing
method will overwrite the latest method and post-run analysis will be
performed. Because of this feature, the data processing results can be
Click [Rollback
to Original Data]
on [File] menu.
Roll Back
Data File
For reference only, close the data file without saving it.
Original
Latest
Data Process-
Data Process-
back, a method file with the same settings as the original method file can
ing Method
ing Method
be created.
4.2.6
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44.3.
4 Audit Trail
4.3
The LabSolutions/GCsolution provides the function for Checking Raw Data for any corruption.
In the LabSolutions/GCsolution, the raw data in an acquired data file cannot be modified. This function can be used to show
that the raw data is not affected by a computer virus or illegal file corruption.
<Check Raw Data> (Reference Manual p547)
Click on the
[Open] button.
The
Note:
The term Raw Data used in the range of this function refers to detector signal data such as a chromatogram. The term Raw
Data (unprocessed original data) as defined in the GLP/GMP differs from that used in the range of this function.
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44.4.
4 Audit Trail
4.4
This software includes an <Output Window> that records users who start and finish programs and their dates, as well as an
Audit Trail function that records system configuration file and method file change information.
4.4.1
4.4.2
Update information for the system configuration and the saved method file can be viewed in the <Audit Trail> window.
Click here after setting at [Audit
Trail] tab page in Method File
Properties window.
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55.1.
5 Validation
5.1
To support the system suitability test, the column performance calculation function and the QA/QC functions are available.
Note:
5.1.1
1.
These functions may also be used for the method validation and the evaluation of normal analysis results.
Set the column performance parameters on the [Performance] tabbed page of the <Method> view from the <Data Analysis> window.
Click
[Data Analysis].
Click [Performance]
tab.
Click
[Edit Mode].
Enter
necessary
parameter values.
For more information about column performance calculation setting parameters, refer to Reference Manual 16.7 Column Performance
Parameters.
2.
After editing the <Method> view areas parameters with the [Edit Mode]
button to enter [View] mode. Then, data that has been read into the <Data Analysis> window will automatically be re-analyzed using the <Method> view areas data processing parameters. The column performance marker value
can simultaneously be obtained.
Note:
If the settings are saved in a method file by clicking on the [Save Method] icon on the [Data Analysis] Assistant Bar, the column
performance calculation will be automatically carried out for any subsequent analysis using that method file.
3.
Note:
The data processing results can be checked on the <Results> view areas [Peak Table].
The processing result may be printed out as a report using the report item for [Peak Table] on the <Report> window.If the column performance marker value column is not displayed on the <Results> view areas [Peak Table], use a right-click
shortcut menu on the [Peak Table] to select and display <Table Style> (Reference Manual p553).
Note:
If no value from the column performance calculation is printed out using the peak table report item on the <Report> window, set
the parameters on the [Format] tabbed page to print the necessary calculation results for the peak table report item.
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5 Validation
5.1 Testing the System Suitability
5.1.2
1.
Note:
Edit a method file directly from the [Method] menu displayed by selecting <GC Real Time Analysis> - <Data Acquisition> or <GC
Postrun> - <Calibration Curve>. If a method in the data is edited by selecting <GC Postrun> - <Data Analysis>, click on the [Save
Method] icon on the [Data Analysis] Assistant Bar to export the method to a method file.
Displays
[Report
Type] settings for
each [Sample Type].
Click here.
For regular analysis, samples are classified into two kinds: standard samples
and others. But, all sample types are
available for QA/QC settings. Select
desired type in batch table.
Select QA/QC calculation timing
p`pbvZs^C
~OAATv
either
as time when a series of same
^CvI_Aob
sample
data processing is done, or time
`I...B
when
batch processing is done.
Click here.
The QA/QC calculation can be performed only using channel 1 and channel 4 (i.e., Line 2s channel 1) in a dual-line configuration.
This calculation cannot be performed using channels 2 and 3 when multiple detectors are connected to Line 1.
For more information about QA/QC calculation, refer to Reference Manual 16.8 <QA/QC> Calculation Methods.
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5 Validation
5.1 Testing the System Suitability
2.
3.
The QA/QC calculation result file is created using the file name and format specified in the reference project (folder) for the
batch table, which is displayed in the upper left corner of the batch table, (or those specified in the path that is used to designate the file name on the [QAQC] tabbed page of the <Settings> window).
Note:
If the evaluation in each QA/QC category is specified for the action parameter in the batch table, the batch processing can be
stopped/paused or the external program can be started in accordance with the evaluation value specified on the [Criteria] tabbed
page of the <QA/QC> window for the method. Unless the action parameter in the batch table is set to the timing at which the QA/
QC calculation result is output, no evaluation result is output.
For more information about <Action> setting, refer to Reference Manual 9.10.6 <Schedule Action> Window.
4.
Internet Explorer
<Data Explorer>
[All Files] tab
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55.2.
5 Validation
5.2
The LabSolutions/GCsolution provides the System Check function, which is used to check the status of the GC and the
time for replacing consumables. Prior to performing data acquisition on the GC, be sure to perform a system check and verify that the GC condition is appropriate.
5.2.1
button on the
Click on the
[Run] button.
Displays
previous
system check results
report.
File
name
format
=
#_YYMMDDHHMM.gcc
. (# = system number)
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5 Validation
5.2 Performing Hardware Validation
5.2.2
After the system check has completed, if there are any consumables whose check result is Not Passed, replace them with
new ones as soon as possible.
button on the
Click [Reset...].
Note:
Note:
For more about system check criteria setting, refer to Reference Manual 4.4.2.1 <Coolant consumption> Window, 4.5.2.1 <Injection
port Maintenance> Window.
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55.3.
5.3.1
5 Validation
5.3
The LabSolutions/GCsolution provides the Program Alteration Check function, which is used to see whether the programrelated files for this software remains unchanged.
This function allows you to find the identity of the software (eliminate any wrong program component and immediately find
infection with computer virus after installation).
Select [Check the Program Files...] from the
[Tools] menu.
Program
check
result details are
viewed via the
Result Viewer.
After program check
is complete, check
results appear.
Previous
program
check result details
are displayed.
Note:
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5 Validation
5.3 Performing Software Validation
5.3
5 Validation
5.3.2
Check to see that the installed program is operating normally, using the following procedure.
1.
Use the GCsolution function check data group. Please refer following file list.
Data name
Check.gcb
Check.gcm
Check01.gcd
Check02.gcd
Check03.gcd
CheckRep.gcr
Note:
The data used here is rewritten whenever the function check is performed. Each time, load the data to the Project folder* on the
hard disk from the CD-ROM.
2.
3) Select the
CheckData
Project folder.
Login
3.
37
Check to see whether the following report result agrees with the output report result.
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5 Validation
5.3 Performing Software Validation
Evaluation criteria
GCsolution is assumed to pass the function check when: the files are used in step
5.3.3
1.
Click on [Run...] on the [Startup] menu of Windows, and directly start the program for loading the function check data
group (setup.exe), which is located in the CheckData folder on the GCsolution CD-ROM.
Note:
After the GCsolution CD-ROM has been inserted into the CD-ROM drive, the <LabSolutions GCsolution Setup> screen will open
automatically. Since this screen is not used here, click on the [Exit] button to terminate it.
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5 Validation
5.3 Performing Software Validation
Enter E:\English\CheckData\Setup.exe
in the [Name] text box, and click on the
[OK] button.
(The E: part varies depending on the location of the CD-ROM drive.)
2.
3.
Note:
The install program will automatically detect the location where GCsolution is installed.
Check to see whether the destination of the file to be
installed matches with the location where GCsolution
is installed.
4.
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5 Validation
5.3 Performing Software Validation
Date:
Model No.:
Signature:
Serial No.:
Version:
Check item
Action
Result
Pass / Fail
F Septum
F Insert
F CRG Coolant
F CPU
F Detector ROM
F Detector ADC
F Detector High Voltage
F Detector Ignite
F Heat Sensor
F DC Voltage
F Environment
F Primary Pressure
Details (If the result is Fail.)
Check item
Action
Result
Program check
Pass / Fail
Check item
Action
Result
Function check
Pass / Fail
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66.1.
6 Data Administration
6.1
This section describes how to manage the files based on various kinds of information.
6.1.1
Right-click the <Data Explorer> to display a pop-up menu, where you can set/select display items.
In addition to the normal file names and time stamps, the sample information and others included in a data file may be displayed or rearranged. This allows you to easily search for a data file within the same project (folder).
In the preview section, not only the sample information, but also the profile of raw data is displayed. This profile serves as
reference in finding a desired data file from its rough data shape.
Same settings as in
Windows Explorer.
41
Note:
The setting data entered here will be saved for each user.
Note:
If the number of files in the project (folder) is too large when the file information is displayed, it may take longer time for display.
LabSolutions/GCsolution Administration
6 Data Administration
6.1 Facilitating File Management
If [File Information] is selected, the displayed information increases. In this case, expand the displayed width of the <Data
Explorer> window or dock the window into the top or bottom of the screen so that the window is extended horizontally (Data Preview is laid out to the right). This should make File Information easier to reference. This may cause the other displayed panes to
become narrower and more difficult to view. Therefore, change the display as appropriate by the following method:
Double-click
Docking View
6.1.2
Double-click
Floating View
Click here.
Note:
In each column for data file names in the batch table for which the automatic data file naming function is selected, the data file
name at the last batch analysis is retained. Therefore, the batch post-run analysis using the same batch file can be performed for
only the data that has been acquired by the directly previous batch analysis.
To perform the batch post-run analysis under the same conditions as those at batch analysis/post-run analysis for the subsequent
data, export the batch table saved in the data file (See 4.2.6 Export a Batch Table).
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6 Data Administration
6.1 Facilitating File Management
6.1.3
File searches can be performed from the program windows main window at anytime.
Click for <File Search>
window.
Click to cancel a
running search.
Click
to
exit file search.
For each search condition entry drop-down list box, you can select from among the previous five search conditions.
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6 Data Administration
6.1 Facilitating File Management
In the lower part of the <File Search> window, the following search results display view will appear.
Click [Preview].
Changes chromatograms
intensity
scale.
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6 Data Administration
6.1 Facilitating File Management
6.1.4
If the search based on the file name and sample information is unsuccessful by the above method, then open the data file
using the <Data Analysis> window or <Data Comparison> and check the data.
Clicking on a file name instantaneously displays data in the preview section of the <Data Explorer> window, or double-clicking
on a file name displays data on the <Data Analysis> window.
Double-click
<Data Analysis>
(Reference Manual p175)
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66.2.
6 Data Administration
6.2
The traceability and management of files other than data, method, batch, and report format files may be required.
For example, files that are output as validation results and print images that have been managed on a paper basis are now
managed as electronic records.
6.2.1
Click on the right mouse button with the cursor positioned on the <Data Explorer> window. Select [Data Explorer Properties] from the pup-up menu that will appear. The <Data Explorer Properties> window will be opened allowing you to select
additional tabs to be displayed.
Double-clicking on a file icon
starts the associated application.
Click on [Data
Explorer Properties].
This function allows you to carry out the following series of tasks more efficiently:
After analysis has been finished using a batch table for which the output of QA/QC calculation result in the HTML format is
specified, double-click on the *HTML file that has been created on the additional tabbed page. Start the associated WWW
browser and then check the QA/QC result.
After a report image in a data file has been converted into the PDF by the file conversion function of the <Data Explorer> window, start Adobe Acrobat by double-clicking on the PDF* file that has been created on the additional tabbed page, and then
check the contents of that file.
* If the files are sorted using their time stamps after the <Data Explorer> window has been set to the detailed mode, the last created file can be
displayed at the top. This allows you to relatively easily find a desired file.
Note:
The settings on the <Data Explorer Properties> window are saved for each user. Therefore, if you log in the system using another
user ID, the addition file tab created here will not be displayed.
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66.3.
6 Data Administration
Reviewing the Long-Term Storage of
Data
6.3
The previous sections describe the functions to support the management of working data. This section explains important
points in the long-term storage of data.
6.3.1
Among the existing techniques, printing out a report on paper and then storing it is the most excellent one for the long-term
storage of data. This is still true today, but the disadvantage of this method lies in a problem with storage space and costs.
As a solution, print images are photographed on microfilm in some cases. At present, however, an approach for recording
reports in an electronic document format that will be supported for a long period of time is adopted. Since some electronic
document formats are accepted for formal documents, the electronic recording of documents has become popular.
The GCsolution provides the capability of outputting reports in the PDF (Portable Document Format) among the above electronic document formats when it is used with Adobe Acrobat, a tool for the creation, management, and edit of PDF documents.
<Setting Options> - [PDF Export] tab (Reference Manual p 564)
Allows you to convert report images into a PDF
file when a report is printed out Analysis Result
Report (Single/Batch Analysis & Post-run) or
Report Generator*.
Only the Normal Speed Mode is supported, and
the mode cannot be selected since Acrobat 6.0.
* Since print images from <Report> are converted into the PDF, the reports from the following functions using those print images can be converted into PDF files:
Printing of reports within the data on <Data Analysis> window
[File] - [Print Method] from the <GC Real Time Analysis> window
[File] - [Print Graph Image] from the <Data Comparison> window
Note:
A PDF file has the original file name with its extension changed to PDF and is output to the folder including that original file.
When a PDF file is output at Single Run/Postrun (Data Report) or Batch Processing, it is a data file; or when a PDF file is output by
selecting [File] - [Print Method File] from the <Data Acquisition> window, it is a method file. Selecting [Print Image] from the
<Data Comparison> window, etc. will output the currently displayed data. Therefore, when a specific file name (Data Comparison
Report.pdf in this case) is used, the data will be output to the referenced project (folder).
Note:
The document information and security are added to the output PDF file. The settings are the same as those shown in the table for
conversion into the PDF.
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6 Data Administration
6.3 Reviewing the Long-Term Storage of Data
The use of the GCsolutions capability of converting a file into the PDF allows you to obtain a PDF report file created under
the following rules, at any time other than report printout, in the same project (folder) that contains the original file:
Source File
Data file
Method file
Output image
Remarks
If the normal mode (Acrobat Distiller) is selected on the [PDF Export] tabbed page of the <Setting
Options> window and if a password is specified in <Security Password for PDF Document> window, that password is used as the master password and Not Allowed in Changing the Document
setting is selected for the Acrobat standard security.
Note:
If a PDF file is output using a function shown in the table, the normal/high-speed mode setting on the
[PDF Export] tabbed page of the <Setting Options> window becomes active.
Note:
The other settings for document rights in the normal mode follow the settings in Acrobat Distiller.
Other information does not displayed, but some information such as sample information is embedded.
Note:
The use of these functions is subject to the prior setup of the PDF export by performing the steps described in 7.3 Setting the PDF
Output.
Note:
Each file that is not covered by this capability should be loaded using software that can handle it (text editor for a text file or a
WWW browser for an HTML file) and then printed out on the printer by specifying PDFWriter or Acrobat Distiller (PDF output). This is more advantageous in the security setting and others rather than storing such a file in the original format.
For any file that cannot be output as a file, but can only be printed out, specify Acrobat Distiller or PDFWriter for the printer
and then print out the file. This makes management easier without using paper reports. In this case, the document security and
brief document information are not added automatically, and should be specified on the Adobe product.
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6 Data Administration
6.3 Reviewing the Long-Term Storage of Data
6.3.2
In addition to print images, the GCsolutions data files* and those that can be analyzed (machine readable data), such as data
files of the AIA ANDi format, may be stored for a long period of time.
CLASS-Agent and some of other archiver products that have been described above support the capability of storing files on CD-R.
Note:
The data file existing in the subfolder* under \GCsolution\Data will be copied at the specified timing through
the designated path.
* No data files existing in any other folder will be copied.
If files are transferred to a storage destination where the appropriate security (e.g., the setting for the file operation right for Windows XP folders) is provided using this capability, the data can be managed more safely.
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6 Data Administration
6.3 Reviewing the Long-Term Storage of Data
6.3.3
To store both printed image data and machine readable data, the relation between print images and the data files used to
acquire them must be maintained.
It is one of the most recommendable methods that data be managed using the abovementioned CLASS-Agent. Agent Manager provides the capability of properly managing GCsolution data files and PDF files for print images.
Even if CLASS-Agent is not used, each data file has the all-in-one structure and self-contained information. Therefore, the
following method will make the management easier:
Note:
In this case, print images are regarded as equivalent to analysis results (electronic documents that are conventionally created by
merely printing out the saved analysis results on paper), and data files as meta data used to obtain analysis results. The meta data
must be all the data for obtaining the analysis results. The GCsolution meets the requirements for meta data by providing data files
of the all-in-one structure.
In a PDF file for a print image, save GCsolutions data file used to obtain that print image, as an attached file.
on the toolbar.
Adobe Acrobat
The Dialog to select file will appear. Select the data file for GCsolution to be attached and then click on the [OK] button.
Click on [File
Attachment
Tool].
Clicking on the
[OK]
button
attaches the file.
The advantage of this method lies in the point that managing the PDF files as analysis results (print images of reports) allows
you to manage all other information as well. Even in the environment without the GCsolution, the use of Adobe Acrobat
allows you to view analysis results as print images and check the details of data, as appropriate, on the PC having the GCsolution installed.
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6 Data Administration
6.3 Reviewing the Long-Term Storage of Data
In this method, data can no longer be searched for based on sample information via the <File Search> window of the GCsolution.
However, Acrobat provides a search plug-in, which allows you to search for all the PDF files based on document information and
a character string included in the documents.
The GCsolution itself does not provide the data acceptance function based on electronic signatures, but Acrobat has the electronic
signature function and protects a PDF document with a proper electronic signature including the data files included in that document. This is regarded as effective means conforming to the legal regulations such the FDA 21 CFR Part 11.
The use of the method for including a data file in a PDF document allows you to manage analysis data on an electronic document
management system that can manage PDF documents. Some of the electronic document management systems have the approval/
decision function and are regarded as effective means conforming to the legal regulations such as the FDA 21 CFR Part 11.
6.3.4
If a report image of an analysis result report is saved as a PDF file, the character information and image information on the
report can be utilized on other software.
Toolbar of
Adobe Acrobat
The [Table/Formatted Text Select Tool] allows you to pass character information of the tabular image, such as a peak report,
to MS-Excel or the like. This will be convenient for creating other reports using an analysis result or gathering multiple
analysis results on MS-Excel and then perform statistic calculations.
In addition, copying and pasting graphics to MS-Word or the like allows you to create a report.
Note:
In this case, the copied image is dependent upon the magnifying power for the PDF document. Using the [Graphic Select Tool],
define the extent of the image you want to copy, enlarge the displayed image as far as possible, and then copy it. This allows you
to obtain a high-quality chromatogram image to the printable resolution at maximum
However, if the image size at the pasted destination is small, it is further reduced there. As a result, lines become thinner and faint
or the image may be blurred depending upon the image reduction algorithm of the software at the pasted destination. Therefore,
check the actually pasted state and choose the optimal magnifying power for copy and paste.
51
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66.4.
6 Data Administration
6.4
Using CLASS-Agent
This software allows you to carry out optional data management when used in association with our data management product, CLASS-Agent.
6.4.1
This setting allows you to automatically register the specified file in the Agent database when a data file is created or
updated.
When
the
<GCsolution
Launcher> has not started yet,
double-click the desktops
[GCsolution] icon.
Note:
When the data acquisition and post-run to tick the [Register Acrobat file to Link File 10 field] check box displayed
when Configuration is selected by the [Select Items] list,
the report image in PDF format is automatically output.
It is registered in CLASS-Agent.
Note:
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52
77.1.
7 Appendices
Performing the Maintenance of System
Management Database
7.1
The <Database Maintenance> window allows you to perform maintenance of the database, such as compacting or repairing
the database and changing the database file.
7.1.1
1.
2.
program in C:\GCsolution\Program.
3.
When the user having the system administration right logs in the system, the <Database Maintenance> window will be
displayed.
Note:
If the network mode is selected, the system administration information (user registration, etc.) entered
from one point on the LAN can be shared by all the
LabSolutions software.
53
LabSolutions/GCsolution Administration
77.2.
7 Appendices
7.2
Using the <Maintenance of Instrument Information> window allows you to share the system administration information on
the network.
7.2.1
1.
2.
3.
4.
Unlike the standalone mode, multiple PCs are managed on the System Administration Database. Therefore, using the
following Instrument Maintenance tool, associate the current PCs with PC information on the System Administration
Database (or Add Computer information if not available). Double-click on GCMntPC.exe
in C:\GCsolution\Program. The <Add/Specify Computer> window will appear from the
<Instrument Maintenance> window.
<Login> window will appear. When the user with the system administration rights logs into the system.
Note:
If the Add/Specify Computer option is already selected and if the current PCs are associated with PC information, then this window
is skipped.
After finishing the
setting, click on
the [OK] button.
5.
6.
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54
77.3.
7 Appendices
7.3
The GCsolution provides the capability to output a report in the PDF (Portable Document Format) when it is used with
Adobe Acrobat (Ver. 5.0 or later), a tool for creation, management, and editing of PDF documents. When used with the
CLASS-Agent, the GCsolution also provides the capability of outputting such report to the printer and converting print
images into a PDF file, which is then sent to the CLASS-Agent.
7.3.1
The following products must be set up before the PDF output capability can be used.
This software package does not include Adobe Acrobat, which must be purchased separately. Adobe Reader, which is
included in the GCsolution installation disk, can only be used to read electronic documents of the PDF. It does not include the capability of creating a PDF file.
Note:
To use the PDF output capability of this software, Acrobat Distiller or Acrobat PDFWriter is required. The standard setup of
Adobe Acrobat 5.0 will install Acrobat Distiller only. In Adobe Acrobat 6.0, Acrobat PDFWriter is no longer supported
and only Acrobat Distiller is installed.
Note:
The standard setup of Adobe Acrobat 5.0 will not install Acrobat PDFWriter. To install Acrobat PDFWriter, specify this
installation using the custom setup. In this case, it is recommended that Acrobat Distiller be also installed.
To make archives in PDF format using CLASS-Agent, set it up in accordance with the installation manual for
CLASS-Agent.
55
LabSolutions/GCsolution Administration
7 Appendices
7.3 Setting the PDF Output
7.3.2
Before using this capability, set up the PDF output by the following steps:
1.
2.
3.
Click here.
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56
7 Appendices
7.3 Setting the PDF Output
4.
On the <Local Port Selection> window, select FILE: for the port.
Click on the [Next] button. The <Select Printer Model> window will appear.
Select FILE:.
5.
Click on the [Browse...] button on the <Select Printer Model> window to display the <Browse for Printer> window.
Change the drive/folder over to system32\spool\drivers\w32x86 under the Windows folder. Now Acrobat Distiller
is available for selection from the list of printers. Select it and then click on the [OK] button.
You will return to the <Select Printer Model> window. With Acrobat Distiller selected, click on the [Next] button and
subsequently go forward based on the default values until the <Printer Information> window appears.
Select Acrobat
Distiller.
Click
57
LabSolutions/GCsolution Administration
7 Appendices
7.3 Setting the PDF Output
6.
* Each one blank space must be given before and after PDF.
Correctly enter
LabSolutions PDF Printer.
Select No meaning
that no print test is performed.
7.
After the installation has been completed, display the <GC Postrun> window to see whether the PDF output settings are
valid.
* If a data file in which no report format is recorded is converted into the PDF and then saved, a blank PDF file will be created.
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58
7 Appendices
7.3 Setting the PDF Output
7.3.3
1.
2.
3.
59
LabSolutions/GCsolution Administration
7 Appendices
7.3 Setting the PDF Output
4.
5.
6.
7.
On the "Welcome to the Add Printer Wizard" window, click [Next]. For WIndows Vista is dialog box
will not appear, goto step 7.
The "Local or Network Printer" window will appear.
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60
7 Appendices
7.3 Setting the PDF Output
8.
9.
10. On
61
LabSolutions/GCsolution Administration
7 Appendices
7.3 Setting the PDF Output
LabSolutions/GCsolution Administration
62
7 Appendices
7.3 Setting the PDF Output
Now the PDF format is available for saving your data report
image.
63
LabSolutions/GCsolution Administration
2
2.1
What is GCsolution?
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Software Overview
GCsolution Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.1.1
2.1.2
3
3.1
Performing an Analysis
Preparing for Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
3.1.6
3.2
4.1
4.2
3.7
Quantitative Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.5.1
3.5.2
3.6
3.5
3.4
3.3
GCsolution Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
File Types and Data Explorer File Tabs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
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64
4.3
4.4
4.5
4.8
Vial number 0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.1
5.2
5.3
5.4
5.5
5.6
6.1
6.2
65
4.10
4.9
4.7
4.6
LabSolutions/GCsolution Administration
tion 60
6.2.1
6.2.2
6.2.3
6.3
6.4
7.1
8.1
Summary Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
7.4.1
7.4
7.3
Batch Processing
7.1.1
7.1.2
7.1.3
7.1.4
7.1.5
7.2
6.7
6.6
6.5
Report Functions
Creating Report Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
8.1.1
8.1.2
8.1.3
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66
8.2
8.3
Operation - Windows
9.1
9.2
10
Customizing Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
9.2.1
9.2.2
9.2.3
Operation - Tables
10.1
10.2
10.3
11
Operation - Files
11.1
11.2
67
LabSolutions/GCsolution Administration
11.3
12
12.1
Appendices
When Troubles Occur . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
12.1.1
12.1.2
12.2
12.3
12.4
12.5
LabSolutions/GCsolution Administration
68
69
LabSolutions/GCsolution Administration
Overview of GCsolution
Organization of GCsolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1.1
1.1.2
1.2
Starting up GCsolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.1
1.2.2
1.2.3
2.1
2.2
Assistant Bar
3.1
3.2
3.3
4
4.1
4.2
4.3
<GC> Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4.4.1
4.4.2
4.4.3
4.4.4
4.4.5
4.5
<Instrument> Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.3.1
4.4
4.5.2
4.5.3
4.5.4
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70
4.5.5
4.6
4.7
5.1
5.2
5.3
5.5
5.4
Assistant Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
5.2.1
5.2.2
5.5.4
5.5.5
5.5.6
5.5.7
5.5.8
5.5.9
5.5.10
71
4.5.4.1
<Detector Maintenance> Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
<Analytical Line>- [GC] or [GCMS] Tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
LabSolutions/GCsolution Administration
5.5.10.1
5.6
5.7
5.8
5.9
5.10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
5.11
5.12
5.13
6
6.1
6.2
6.3
6.4
6.4.4
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72
6.4.4.10
6.4.4.11
6.4.4.12
6.4.4.13
6.4.4.14
6.4.4.15
6.4.4.16
6.4.4.17
6.4.4.18
6.4.4.19
6.4.4.20
6.5
6.6
6.6.2
6.6.3
6.6.4
6.6.5
7.1
7.2
73
6.7
LabSolutions/GCsolution Administration
7.3
7.4
7.5
8.1
7.7
7.6
8.2
8.3
8.4
8.5
9
9.1
LabSolutions/GCsolution Administration
74
9.2
9.3
9.4
9.5
9.6
9.7
9.8
9.9
9.10
9.11
75
LabSolutions/GCsolution Administration
10
<Report> Window
10.1
10.2
10.3
10.4
10.5
<Header/Footer> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 386
10.6
10.7
10.8
10.9
10.10
10.10.5
10.12
10.11
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76
10.13
10.14
10.15
77
10.22
10.21
10.20
10.19
10.18
10.17
10.16
10.23
10.24
LabSolutions/GCsolution Administration
11
11.1
11.2
11.3
11.4
11.5
11.6
11.7
11.8
11.9
11.10
12
12.1
Administration Menu
Overview of Administration Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 503
12.1.1
12.2
12.3
12.4
[Configuration] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .516
[Assign Database per Instrument] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .517
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78
12.4.3
12.4.4
12.4.5
12.4.6
12.5
13
<QA/QC> Window
13.1
13.2
13.2.3
13.2.4
13.3
14
Common Windows
14.1
14.2
14.3
14.4
14.5
14.6
79
12.4.2.1
<A database setup classified by instrument> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .517
12.4.2.2
<A link setup of a database> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .518
[Select Database by Keyword] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .519
12.4.3.1
<Database distribution classified by keyword> . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .520
[Sample Information] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .521
[Select Compression Files] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .522
[Execute Application] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .523
14.7
14.8
LabSolutions/GCsolution Administration
14.9
14.10
15
15.1
Maintenance Tools
<Database Maintenance> Dialog . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 571
15.1.1
15.1.2
15.2
16.1
16.1.5
16.1.6
16.1.7
16.1.8
16.2.5
16.2.6
16.3
Reference Information
16.1.1
16.1.2
16.1.3
16.1.4
16.2
16
ID # . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .586
Window/Band Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .586
Identification Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .587
Identification by Adjacent Peaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .589
16.2.4.1
More than one peak within the time allowance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .589
16.2.4.2
One peak falls within two or more Peak # time allowances . . . . . . . . . . . . . . . . . . . . . . . . . .590
16.2.4.3
Identifying two adjacent peaks separately . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .590
Grouping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .591
16.2.5.1
Group Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .591
16.2.5.2
Conc. Summation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .591
Identifying Reference Peaks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .592
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80
16.4
16.5
16.6
16.7
16.8
16.9
Common . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .621
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .621
QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .623
Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .623
81
Linear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .607
Point to Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .607
Quadratic, Cubic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .608
Mean RF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .608
Exponential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .609
Manual RF(Linear, Exponential) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .609
LabSolutions/GCsolution Administration
Index
Numerics
21 CFR Part 11 C1, C49
A
Acquire B77
Acrobat C47, C55
Distiller C48, C55
PDFWriter C55
Action (<Batch Table>) A71, B335
[Add. Flow] Tab (<Instrument Parameter> View) B146
Add/Specify Computer C54
<Add Group> C11
Additional Analysis A77
<Additional Flow> (<System Configuration>) B59
Additional GC Units A118
[Additional Heater/Flow] Tab (<Instrument Monitor>) B158
<Additional Heater> (<System Configuration>) B57
[Additional Heater] Tab (<Instrument Parameter> View)
B144
[Add Rows With Data Files...] Menu A76
<Add User> C12
Admin C5
Adobe
Acrobat C55
Adobe Acrobat A108, C47
Acrobat Reader A108, C48
Agent C2, C49
AIA(ANDI) B629
AIA(ANDi) C49
All-in-One Structure C25, C49
[All users must use password] check box C9
<Analytical Line> B36
[Auto-Sampler] Tab B36
[Column] Tab B47
[Detector] Tab B49
[Base Period] List Box A34
[Injection Unit] Tab B41
Analytical Line Number A36, B23, B24, B25
AOC-20
AOC-20d(M) B17, B37, B99
AOC-20d(S) B17, B36, B99
AOC-20i B17, B36, B99
AOC-20i+s B17, B37, B99
Archiver C49
[ASCII Convert] Tab (<Settings>) B363
ASCII File B363
Assistant Bar A5, A89, A90, B11
[Batch]
[Settings] Icon C42
[Batch](Analysis) B319
[Batch](Postrun) B320
[Configuration]
[System Check] Icon C43, C34, C35
[Postrun] B14
[Report Generator] Icon B372
[RealTime] B12
Atmosphere Compensation B23, B24
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual
B
Background Chromatogram A74
Baking B77
Barcode (<Batch Table>) B335
Baseline Data File (<Batch Table>) A74, B333
Base Period B50, B51, B123, B127, B129, B133, B136,
B140, B142, B143
[Base Shift] Menu A56
[Batch](Analysis) Assistant Bar B319
[Batch] Assistant Bar
[Stop] Icon A31
Batch File A6, A100, A101, A103, C23
Prohibit overwriting C10
Batch File Template C20
[Batch](Postrun) Assistant Bar B320
Batch Processing A64
2Lines A73
Action C18
ASCII Output C17
External Program Run C18
Parameter A71
Progress Control C18
QA/QC Criteria C17, C32
User Program C18
[Batch Processing] Icon A25, A75
<Batch Queue> A77, B349
Batch Scheduler B313
<Batch Table> A89, A103, B313
Menu B321
Batch Table
Action A71
Injection Volume/Multi-Inj A71
Method File A71
Option # A71
Run Mode A71
Sample ID B332
<Settings> B356
Summary Type A71
System Check A71
User Program A71
<Batch Table Wizard> A26, B340, B342
Blank Analysis A40
<Browse Folder> B497
LabSolutions/GCsolution
Index
C
[Calib Level#] Edit Box A23
Calibration B540
<Calibration Curve> A89, A103, B267
<Calibration Curve> View B286
<Chromatogram> View B291
<Data File Tree> View B289
Menus B274
Opening B267
Calibration Curve A24, B258, B260, B532, B606
<Calibration Curve Properties> (Report Item)
[General ] Tab B432
[Table] Tab B439
[Calibration Curve] Tab (<Results> View) B229
<Calibration Information> B230
<Calibration Curve> View B286
Information B287
<Property> B294
Table B287
<Calibration Information> B230
[Cancel Edit] Menu A55
Carrier Gas B42, B43, B107, B110, B111
Cell A93
Multiple Selecting A97
Title Cell A93
Cell Data
Clearing A97
Copying A97
Cutting A97
Entering Value A97
Pasting A97
[Change Database] button C53
<Change Stop Time> A31, B164
<Channel Select> B301
<Check Raw Data> C29
<Check the Program Files> B546, B572
[Check the Program Files...] Menu C36
Chromatogram File
CLASS-GC10 A106
<Chromatogram Properties> B418
<Chromatogram View>
<Properties> B548
<Chromatogram> View
<Calibration Curve> B291
<Data Acquisition> B77
<Data Analysis> B195
<Data Comparison> B308
Magnify A56
Shift A56
Undo A56
CLASS-Agent C2, C55
CLASS-GC10
Chromatogram File A106
Data File A106
Method File A106
CLASS-VP4
Data File A106
Method File A106
ii
LabSolutions/GCsolution
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual
Clean Up A40
Column Performance C31, B261
Parameter B615
[Column] Tab (<Instrument Parameter> View) B120
[Column] Tab (<System Configuration>) B47
Communication B20
[Compound] Tab B257
Compound Table A61, A63, A65, A66, A67, A69
<Compound Table Format> B400
Conditioning A39
Configured Modules B18
Consumable C35
<Consumables Reset> B170
<Convert AIA ANDI file to Data file> B496
<Convert CLASS-GC10 file to GCsolution file> B494
<Convert Data file to AIA ANDI file> B493
<Convert Data file to ASCII file> A106, B491
<Coolant consumption> B32
Create from Template C19
<Create New Project (Folder)> A102, B500
[CRG/Relays] Tab B30
Cubic B258, B260
Current Folder B360
D
DAO A113
Install A109
<Data Acquisition> A89, A103, B61
<Chromatogram> View B77
Menu Tree B63
Opening B61
<Data Analysis> A17, A89, A103, C45, B175
<Chromatogram> View B195
<Display Settings> B197
Menu Bar B181
<Results> View B224
[Data Analysis] Assistant Bar B180
[Data Analysis] Icon A16, C31
<Database Maintenance> C53
[Change Database] button C53
[Network] check box C53, C54
<Data Comparison> A56, A89, A103, C45, B297
<Chromatogram> View B308
Menus B273, B300, B301
<Shift Data> B311
Data Description (<Batch Table>) B335, B354
<Data Explorer> A5, A89, A101, B471
Additional Tab C46
Display Setting C41
Display Mode C42
Double-Clicking on a File B475
Dragging a File B476
Maximizing A92
Menu Bar B478
<Data Explorer Properties> C46, B498
Index
Data File A6, A88, A100, A101, A103, C24
All-in-One Structure C25, C49
Automatic Filename Creation C42
CLASS-GC10 A106
CLASS-VP4 A106
Long-Term Storage C1, C47
Method in Data File C28
Prohibit overwriting C10
Rollback C28
<Data File> (<Batch Table>) B339
Data File (<Batch Table>) B333
[Data Filename] Tab (<Settings>) B362
[Data File Properties] Menu C26
<Data File Tree> View A20, B289
<Data Processing Parameters>
[Integration] Tab
[Width] Edit Box A34
Data Report C25, C58
Data Rollback C28
Detection Limit Detail B534
Detector
Maximum Temperature B50, B51
Temperature-Control Unit Port B50, B51
<Detector Maintenance> B55
[Detector] Tab (<Instrument Parameter> View) B122
[Detector] Tab (<System Configuration>) B49
Dilution Factor (<Batch Table>) B334
<Display Settings> (<Data Analysis>) B197
Distiller C48, C55
Double-Clicking on a File A90, A103, B475
[Download Instrument Parameters] Menu B73
[Download Parameters] Icon A12
Drift B237
E
Easy Login Mode C10
Electronic Record C1, C46
Electronic Signature C1
E-Mail function
Disable C10
Event Log C13
Exponential B258, B260
Export
Method File C25
Report Format A48
Extension A6, A101
F
FDA 21 CFR Part 11 C1, C49
File
Conversion B491
Copying A104
Deleting A104
Double-Clicking A90, A103, B475
Extension A6, A101
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual
G
<GC-2010> A33, B23
[CRG/Relays] Tab B30
[Device Information] Tab B33
[Units Position] Tab B34
<GC Real Time Analysis> B1
<GC Analysis (Editor)> A5, B1
gcb A6, A101
gcd A6, A101
gcm A6, A101
GCMntDB.exe C53
GCMntPC.exe C54
<GC Postrun> A89, B2
<Batch Table> B313
<Calibration Curve> B267
<Data Analysis> A16
<Data Comparison> B297
<Data Explorer> B471
Organization B9
<QA/QC> B527
<Report> B367
[GC Postrun] Icon A16
<GC Properties> A33
gcr A6, A101
<GC Analysis>
<QA/QC> B527
LabSolutions/GCsolution
iii
Index
<GC Real Time Analysis> A89
<Batch Table> B313
<Data Explorer> B471
Organization B7
<Report> B367
[GC Real Time Analysis] Icon A7
GCsolution
Install A112
Uninstall A116
<GCsolution Launcher> C8, C9, C11, C12, C13, C14, C37
[Log Browser] icon C13
[System Policy] icon C9
[User Administration] icon C11, C12, C14
<GCsolution Setup> A112
GC Status B77
Ghost Peak A40
Glass Insert B46
GLP/GMP C1
Good Laboratory Practice C1
Good Manufacturing Practice C1
Grid A84
Group Calibration A69
Calibration Curve A69
Group ID# B258, B259
Grouping B591
Concentration Summation A68
Group Calibration A68
Quantitative Results A70
<Group Properties> C11
<Group Results Properties> B428
[Group Results] Tab (<Results> View) B226, B227
[Group] Tab B259
Group Table A69
<Group Table Format> B404
GxP Support Function C2
H
Hardware Validation C34
<Header/Footer> B386, A85
Help A107
HTML Help A113
H/W Administrator Rights C4
Operation Manual
Reference Manual
Administration Manual
Injection Unit
Maximum Temperature B42, B43
Temperature-Control Unit Port B42, B43
[Injection Unit] Tab (<System Configuration>) B41
Injection Volume (<Batch Table>) A71, A72, B333
Insert Used Count B46
<Instrument Monitor> A29, A89, B153
[Line] Tab B155
Opening B154
[Instrument Monitor] Button A12
<Instrument Parameters> C27
<Instrument Parameter> View B83
[Auto-Sampler] Tab A10
[Column] Tab A11
[Detector] Tab A11
[Sampling Rate] List Box A34
[Injection Unit] Tab A10
<Instrument Property> B20
[Integration] Tab B233
<Integration Time Program> B235
Internal Standard Amount A63, B352
Internal Standard Amount (<Batch Table>) B334
Internet Explorer A113
<ISTD Amount> A63, B352
<Item List> B389
L
LabSolutions PDF Printer C58
[Layout] Menu B191
Level # (<Batch Table>) B334
Line B258, B260
<Line Configuration> C27
<Load Method> B162
[Lock] Menu C16, B75, B284, B330
<Log Browser> C13
[Log Browser] icon C13
<Login> A5, C10, C53, C54, B5
Login
Attempt Limit C7, C9
Lockout Duration C7, C9
Login Authentication C15
Login/Logout Condition Log C30
[Login with Windows Username] check box C7, C9
Import
Method File C25
Report Format A48
[Initialize Calibration Curve] Button A23
Inj. Port Dwell Time B102
Injection Mode (Injection Port) B106, B111, B115
<Injection Mode> (Auto-Sampler) B101
<Injection port Maintenance> B46
[Injection Port] Tab (<Instrument Parameter> View) B106
Injection Port Temperature B106, B110, B111, B115
iv
A:
B:
C:
LabSolutions/GCsolution
Index
Method File A6, A100, A101, A103, C22
CLASS-GC10 A106
CLASS-VP4 A106
Export C25
Import C25
Prohibit overwriting C10
Method File (<Batch Table>) A71, B333
<Method File Properties> B397
[Method File Properties...] Menu C23
Method in Data File C28
Method Validation C31
<Method> View
[Compound] Tab B257
Edit Mode A18
[Group] Tab B259
[Integration] Tab A18, B233
[Performance] Tab B261
[Quantitative] Tab B254
View Mode A18
[Move Left/Right] B310
Multi-Injection (<Batch Table>) A71, A72, B333
[Multi User] check box C7, C9
Multi-User Mode C6
N
[Network] check box C53, C54
<New Project (Folder)> B501
Normal Login Mode C10
Not Ready B77
O
OCI Fan B30, B31
Online Help A107
Online Manual A108
[Open Reference Data File] Menu A15, C45
Operator Rights C4
<Option> B388
[Option Items] Tab (<Settings>) B365
<Output Window> A5, A89, C30, B545, B571
[LogFile] Tab C30
[Message Log] Tab C30
P
<Page Setup> A85
Page Size A85
Part 11 C1, C49
Password C5, C12, C14, B508
Changing C14
Duplication C9
Force C9
Maximum Age C7, C9
Mean Decryption Time C7
Minimum Length C7, C9, C12, C14
Pause A77
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual
Q
<QA/QC> B527
[Criteria] Tab B537
QA/QC Function C32
[QAQC] Tab (<Settings>) B364
Quadratic B258, B260
Quality Control B535, B541
Quantitative Method B593
Area Normalization A59
Correct Area Normalization with Scale Factor A60
Corrected Area Normalization A60
Exponential A67
External Standard A60
Internal Standard A62, B352
Manual RF A66
Standard Addition A65
[Quantitative] Tab B254
LabSolutions/GCsolution
Index
vi
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual
LabSolutions/GCsolution
A:
B:
C:
Index
SLEEP TIME B24, B25
Slope B237
Slope Test B77
[Slope Test] Button A32, B79
[Snapshot] Button A32, B79
Software Validation C36
Solvent Selection B103
Spiked Amount B258
[Standard] Sample A23
Standby B77
[START] Button A15, A28, A44
Starting up GCsolution B3
[Start Row] Tab (<Settings>) B356
START TIME B24
<Status Information> C27
<Status Information Properties> B442
STOP TIME B24, B25
Stretch/Contraction
Left-Right A56
Upper-Lower A56
Subtract Detector B123, B127, B129, B133, B136, B142
Summary Type (<Batch Table>) A71
Syringe
Capacity B37
Injection Position B103
Insertion Speed B100
Suction Position B103
<System Administration>
[Event Log] Tab C13
[Policy 1] Tab C9
System Administration C3
Description C3
Group C3
History C13
Instrument C3
Network C54
Password C3
Policy C7
User ID C3
User Name C3
System Administration Right C11, C12
System Administration Tools C8
System Administrator C4
<System Check> C34, B167
System Check C35, B77
System Check (<Batch Table>) A71, B335
[System Check] button C34, C35
[System Check] Icon C43, C34, C35
<System Check Result> B169
<System Configuration> B17, B21
<Additional Flow> B59
<Additional Heater> B57
<Analytical Line> B36
[Auto-Sampler] Tab B36
[Column] Tab B47
[CRG/Relays] Tab B30
[Detector] Tab B49
<GC-2010> B23
[Injection Unit] Tab B41
<Instrument Property> B20
Setting A123
Operation Manual
Reference Manual
Administration Manual
System Configuration
Audit Trail C21
<Properties> (Report Item) B390
Referring C27
System Configuration File C21
[System Configuration] Icon A8
[System Off] Icon A29
[System On] Icon A12
<System Policy> C7, C10
[All users must use password] check box C9
[Login with Windows Username] check box C7, C9
[Multi User] check box C7, C9
[System Policy] icon C9
System Suitability Test C31
T
T.DBL B237
Table Column A93
Changing the Width A93
Display Condition Changing A94
Operation A93
Selecting A93
Table Row
Adding A95
Deleting A95
Display Quantity Changing A96
Selecting A95
<Table Style> A71, A94, A96, B553
[Table Style] Menu A55
Template
Batch File C20
Create from Template C19
Report Format File C20
Saving as a Template C20
<Text Properties> B462
Time Program B584
Title Bar A5
Title Cell A93
Toolbar A5, A89
[System Check] button C34, C35
[Type] Tab (<Settings>) A72, B359
U
Unit B258, B260
[Unknown] Sample A24
Upload GC Parameter B73
[Use Password] check box C12
User C3
Administration C9
Authentication C15
Changing C12
Deleting C12
Registering C12
Registration C5
LabSolutions/GCsolution
vii
Index
<User Administration>
[Groups] tab C7, C11
[Password] tab C14
[Users] tab C12
User Administration
User ID C12
User Name C12
[User Administration] icon C11, C12, C14
User ID C12
<User Information> A114
User Name C12
<User Program> B353
User Program (<Batch Table>) A71, B334
<User Property> C12, C14
[Use Password] check box C12
V
Validation
Hardware C34
Method C31
Software C36
Version Information B76, B194
viii
LabSolutions/GCsolution
W
Wait START TIME B77
Wait STOP TIME B77
Washing Volume B102
Weighting Method B258, B260
Width B237
Window Display Format A91
[Wizard] Icon A26
Z
[Zero Adjust] Button B79
[Zoom Up/Down] B309
A:
B:
C:
Operation Manual
Reference Manual
Administration Manual