C196-E055

Evolving together
with the times
CLASS-VP Ver. 6.1
& CLASS-Agent Ver. 2

The fact is, as users of chromatographic

equipment strive for greater efficiency and
reduced workload in analytical work, more
effort needs to be expended to ensure that
data reliability is improved as well.
Working with our customers, Shimadzu will continue to address
data reliability and other issues to provide new solutions through
technological innovations.

2
 Easy Operation
High levels of functionality and ease of use are provided by an improved
graphical user interface and expansion of Wizard functions.

Automation
From starting the system through the start and completion of an analysis,
automation has reduced the analyst's workload, with resultant labor savings in
the laboratory.

Flexibility
Flexible, automated analyses replaces the analyst through various automated pass/fail
judgment functions, such as online system suitability tests and action functions.

CLASS-VP & CLASS-VP AGENT

Network Solution
Network tools enable remote access from another location and efficiently manages vast
amounts of analytical data to support the creation of an effective, low-cost network.

Validation
Hardware validation is supported comprehensively, ranging from IQ/ OQ to daily PQ, as
greater reliability in analytical data is required.

FDA 21CFR Part11 Compliance

CLASS-VP ensures a high level of electronic records reliability through improved data integrity
and security with automatic database registration; CLASS-VP is also compliant with electronic
signature regulations.

The CLASS-VP Ver. 6.1 is the integrated workstation for

LC-2010, LC-VP Series, and LC-10A Series including
SPD-M10AVP Photodiode Array Detector. The LC-2010
with the SPD-M10AVP is also supported.

3
 Analytical Workload Reduction...

CLASS-VP Ver. 6.1's operation has been simplified by improving the

graphical user interface and Wizard functions. In addition, analysis
automation is provided through the auto-conditioning function.

Graphical User Interface (GUI)

The GUI has been enhanced in CLASS-VP Ver. 6.1 for visual and intuitive operation. Diagrams
of each module in a GUI are interactive icons that allow analytical conditions, etc. to be
visually set. Furthermore, the main parameters can be quickly set through the simple settings
function. Combined with the peak integration tool bar, etc. from previous versions, operation is
simplified for even first-time users, reducing the amount of time required to master operation.

Clicking each component's icon

will open the corresponding
LC Setup Assistant Window settings screen

Schedule Wizard
Schedule analysis with CLASS-VP incorporates a diverse range of functions such as online
insertion processing, automatic QC judgment and summary reports. The Schedule Wizard
supplements these CLASS-VP functions and makes its functionality more accessible.
Furthermore, the schedule created by the Wizard can be edited by running MS Excel and using
its Auto Increment and character string replacement functions.

Wizard Setup Screen Standard Location Settings Report Settings

Result of Automatic
Schedule Creation
4
 Easy Operation & Automation

Auto-conditioning Wizard
Settings are easily made with the Auto-conditioning Wizard that provides
automated operation from running the system to shutdown; freeing the analyst
from having to wait for baseline stabilization, etc.

Settings can be made easily by

following the Wizard

Automation of Analytical Work

By setting the mobile phase beforehand the analyst can exercise automated
control over system operation, from system startup to analysis and cool down.

To analyze... Analysis
Just set the mobile phase. Various automated decisions are
possible with the Action function.

Start at a specified
time

Purge the flow lines

Equilibration of system

After Completion of Analysis

Cool down in order to avoid column damage.

Automatic judgment of baseline stabilization

5
 Effective employment of networks...

Effective employment of the network will lead to greater efficiency

in laboratory operation. CLASS-VP provides tools to aid the
transition to a networked environment.

E-mail Function
When errors occur in the system, or at critical points during an analytical
process, such as the start and end of analysis, CLASS-VP will provide
notification via e-mail. Using e-mail allows an analyst to remotely monitor the
state of an analytical process without paying close attention to it and thus focus
on other tasks.
*) With the LC-2010, e-mail will also notify when the mobile phase is checked.

E-mail Settings Screen

Centralized Management of Analytical Data

Database management comes into its own when large amounts
of data from the analytical laboratory are to be employed
effectively. Optional data management software, CLASS-
Agent, automatically registers re-analyzed data and the data
collected by CLASS-VP together with the method file, etc. in
CLASS-Agent's database. Using “Filtering” and “Sorting” the
target data can be found within a short period of time.

Data can be checked instantaneously

Can be sorted and filtered down by analyst,

sample ID and date & time of analysis

Checking the Analytical Data

The comparison of chromatograms is an important step in
analyzing the acquired data. With CLASS-Agent, chromatograms
can be superimposed for comparison by just selecting the data
that you wish to compare.

Comparing the chromatograms of multiple data

6
 Network Solution

Exporting Data
At times, data obtained in analysis is further evaluated and
calculated through statistical analysis, etc. Manual input of
chromatograms from a report can consume a lot of time, in the
input and checking of entries. CLASS-Agent easily exports
peak integration processing results and quantitative calculation
results, etc. of data selected from the database to be
incorporated into spreadsheet software. MS Excel does not
require to be run and the reading of export files is unnecessary.
In addition, the chromatograms can be saved as Windows
Metafiles and used in reports, etc. Result of Exporting to MS Excel

Network Tools
The greater the amount of data, the more a network can reduce
workload and time consumed by creating an efficient
environment for running analyses and analyzing and managing
the data. CLASS-Agent provides the tools necessary to support
the creation of an effective, low-cost network.

Laboratory

Automatic Data Registration Remote Access

Ether Net
Browse/ Approval E-mail
Server

Office

7
 To support regulatory compliance...

A high level of validation is required in order to ensure the reliability of

analytical data, from the analytical instrument to daily analysis. Together
with various validation functions, this is backed up strongly through the
provision of documentation required for GLP/GMP etc.
System Suitability Test
Performance Qualification (PQ) is required to guarantee the reliability of daily
analytical results. In PQ the validity of the analytical system needs to be certified
through system suitability tests and the analysis of QC samples etc. By using the
online system suitability test function of CLASS-VP, suitability determination based
on a variety of parameters such as column performance parameters, peak area
values, retention times and range of QC samples or repeatability can be performed
online at the same time as the analysis. The analyst is freed from offline system
suitability analysis , thus reducing the time spent on PQ work.

The necessary test parameters can be set for each peak

Report on the results of the system suitability test

Action Function
The system suitability test needs to be performed before the analysis, and the system
needs to pass the test. The action function provides an automated analytical
environment by taking care of various processing routines such as re-testing and
shutdown, depending on the automated results of the system suitability test.

Example of setting the system suitability/action

The processing routine after suitability tests can be set beforehand

8
 Validation

System Check Function

Daily inspection of the system can be performed
automatically by executing the system check function.
The system's condition, such as frequency of
consumable parts usage and the results of self-
diagnostic tests can be easily determined.

System Check Report

Alteration Check Function

The program files used by the CLASS-VP may be
overwritten by the installation of other software or
corrupted in some manner, etc. The alteration check
function can check the state of the software to ensure it
has not been modified.

Alteration Check Report

Support for IQ/OQ 228-41026 228-41028

SHIMADZU SHIMADZU
Installation Qualification (IQ) requires that the CLASS-VP DATA PROCESSOR CLASS-VP DATA PROCESSOR

Installation Operational
installation environment, the device specification and Qualification Qualification

each accessory including the documentation be Certification of the Installation Qualification Protocol Certification of the Operational Qualification Protocol

checked. Operational Qualification (OQ) verifies that System Name

System ID No.
Installation Site
The undersigned performer certifies that the Installation Qualification Protocol has been successfully
System Name
System ID No.
Installation Site
The undersigned performer certifies that the Operational Qualification Protocol has been successfully

the instrument is functioning per specification. completed for the system stated above. completed for the system stated above.
• Performer · Performer
Signature Signature

Print Print
Date Date

Shimadzu provides, as standard, IQ/OQ documents

Title Title

Company Company

The undersigned reviewers certify that the performer has completed the Installation Qualification The undersigned reviewers certify that the performer has completed the Operational Qualification
Protocol successfully. Protocol successfully.

with the product to support the customer's validation

• Reviewer · Reviewer
Signature Signature

Print Print
Date Date

Title Title

process. • Manager
Company

Signature

Print
· Manager
Company

Signature

Print
Date Date

Title Title

Company Company

Cover sheets of the IQ &OQ documents

9
 For FDA 21 CFR Part11 compliance...

Under FDA regulations, the transition to 21CFR Part11 (electronic records/

electronic signatures) is being made for analytical data generated by computer
systems. Along with securing the integrity and security of electronic records,
CLASS-VP also offers compliance with electronic signatures.

CLASS-VP
Automatic Archiving
CLASS-VP ensures security by automatically storing analytical data
Chromatograms, quantitative
and re-analysis data in CLASS-Agent's database. Integrity is ensured calculation results, method,
during this process by storing the method files and the schedule files schedule files, AIA files etc.
together with the analytical data at the same time. Any data that is
required can be retrieved rapidly from the archived data by using Automatic Incorporation
CLASS-Agent's sort/ filter functions. The database is compatible with CLASS-Agent
Oracle and SQL Server.

Electronic Signature Comprising an ID and Database

(Oracle, SQL_DB)
a Password
CLASS-Agent supports electronic signatures comprised of user ID's
and passwords. Approved data is linked with the date and time of
approval and the name of the signatory. Furthermore, as an option, it
can also be configured for biometric user authentication based on
fingerprint verification.

Approval of
analytical data

Support for a backup function

As a security measure the system is protected from accidents such as
hard disk crashes through periodic backups. CLASS-Agent allows the
data and the log to be backed up as a set on formats such as CD-R.
The ID of the medium to which the data is backed up is managed with
the system log, so that they can be searched with ease.

Database backup settings

10
 FDA 21 CFR Part 11 Compliance

Setting Account Policy with the Authentication Server

The management of passwords is vital for electronic signatures comprised of user IDs
and passwords, and to protect against unauthorized access. In order to reduce the
system manager's workload, the Shimadzu user authentication server provides a
password management function that is compliant with Part 11, such as the minimum
number of letters for passwords and the expiration date, to be set in the system.
Furthermore, access to the system is denied for a certain amount of time when
unauthorized access is detected, with notification of the unauthorized access sent at
the same time via e-mail.

Notification
via e-mail

Setting the account policy

Audit Trail Function

For alterations of the record, Part11 requires that audit trail information be generated
automatically by the computer. Together with managing the record of data collection
and analysis as a log, CLASS-VP will not make changes to the analytical conditions
effective if the reason is not entered.

Menu Lock Function

A lock mechanism is essential in automated HPLC continuous analysis to ensure
security when the system is left unattended. The password-based menu lock function
of the CLASS-VP controls access to instruments, and even for multiple systems
access to a single instrument can be controlled selectively.

The menu lock is essential for continuous analysis

11
Specifications
Specifications
CLASS-VP Ver. 6.1 Multi
HPLC System control Up to four HPLC systems can be controlled (using a LC-2010A/C or a SCL-10AVP for each LC-10A/VP system)
Photodiode array detector Processed data from one SPD-M10AVP
Up to two digital detectors and two analog channels per HPLC system (for LC-10A/VP Series)
Other detectors
An integrated UV detector (for LC-2010A/C)

CLASS-VP Ver. 6.1 Single

HPLC System control One HPLC system can be controlled (using a LC-2010A/C or a SCL-10AVP for LC-10A/VP system)
Photodiode array detector None
Up to two digital detectors and two analog channels per HPLC system (for LC-10A/VP Series)
Other detectors
An integrated UV detector (for LC-2010A/C)
* The CLASS-VP Ver. 6.1 software operates on Windows NT 4.0 only.
* A minimum of 128 Mbytes of RAM is required on PC.

Controllable Units
Unit Model
System Controller SCL-10AVP
Pump LC-6AD, LC-8A, LC-10AD, LC-10AS, LC-10AT, LC-10Ai, LC-10ADVP, LC-10ATVP
Column Oven CTO-10A, CTO-10AC, CTO-10AVP, CTO-10AC VP, CTO-10ASVP
Autosampler SIL-10A, SIL-10Ai, SIL-10AF, SIL-10AP, SIL-10AXL, SIL-10ADVP
Fraction Collector FRC-10A
Option Box Option Box-L, Option Box-VP, Sub-controller-VP
SPD-10A, SPD-10AV, SPD-10Ai, SPD-10AVi, SPD-10AVP, SPD-10AVVP,
Detector
RF-10A, RF-10AXL, RID-10A, SPD-M10AVP
Integrated HPLC system LC-2010A, LC-2010C

Optional Software
CLASS-VP Agent Ver. 2.0
Database Management Software Microsoft Access 97 format, Microsoft SQL server 7.0, Oracle 8
Numerical information: Peak No., Retention Time, Peak Height, Peak Area, Peak Name, etc
Applicable Data
Files: data, method, sequence, cdf, sample information

Microsoft® is registered trademark, Microsoft Windows and MS Excel are trademarks of Microsoft Corporation.

Registered

SHIMADZU CORPORATION. International Marketing Division

3. Kanda-Nishikicho 1-chome, Chiyoda-ku, Tokyo 101-8448, Japan Phone: 81(3)3219-5641 Fax. 81(3)3219-5710
Cable Add.:SHIMADZU TOKYO
SHIMADZU SCIENTIFIC INSTRUMENTS, INC.
7102 Riverwood Drive, Columbia, Maryland 21046, U.S.A.
Phone: 1(410)381-1227 Fax. 1(410)381-1222 Toll Free: 1(800)477-1227
SHIMADZU DEUTSCHLAND GmbH
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SHIMADZU (ASIA PACIFIC) PTE LTD.
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Phone: 65-778 6280 Fax. 65-779 2935
SHIMADZU SCIENTIFIC INSTRUMENTS (OCEANIA) PTY. LTD.
Units F, 10-16 South Street Rydalmere N.S.W. 2116, Australia
Phone: 61(2)9684-4200 Fax. 61(2)9684-4055
SHIMADZU DO BRASIL COMERCIO LTDA.
Rua Cenno Sbrighi, 25, Agua Branca, Sao Paulo, CEP 05036-010, BRAZIL
Phone: (55)11-3611-1688 Fax. (55)11-3611-2209
SHIMADZU (HONG KONG) LIMITED
Suite 1028 Ocean Center, Harbour City, Tsim Sha Tsui, Kowloon HONG KONG
Phone: (852)2375-4979 Fax. (852)2199-7438
Overseas Offices
Istanbul, Beijing, Shanghai, Guangzhou, Shenyang, Chengdu, Moscow

URL http://www.shimadzu.com

Printed in Japan 3295-05109-50A-ADN