C191-E002A


    

 
     

CLASS-Agent Ver.2

CLASS-AGENT DATA MANAGEMENT SOFTWARE

 The CLASS-Agent Ver.2 is a network-compatible data
management tool, providing full support for FDA-required
CLASS-Agent
functions ver 2.0
such as data security, is new!!
integrity and audit-trail.
The CLASS-Agent comprises an array of unique tools to manage various types of data from HPLC, GC, LC/MS, GC/MS,
UV-VIS and FTIR spectrophotometers, electronic balances, and other analytical instruments. The CLASS-Agent supports
FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures) and data security management and electronic
signature functions are incorporated for data stored in the database. Data acquired by each analytical instrument are
automatically transferred and stored in the database, for quick and easy data retrieval thereafter. All pertinent information
associated with the data, such as the analytical method, original data acquisition date and time, operator's name,
chromatograms, analytical report in pdf format, are stored together. Both machine-readable data and human-readable
data are also stored for Part 11 compliance.
Optional "CLASS-Agent Report" software, enables report generation using spreadsheets by Microsoft Excel under Part 11
compliant environment.

■ Database management,
searching and browsing
■ Automatic data registration via CLASS-Agent ■ Electronic signatures and
electronic authentication
by ID code and password

Example of a client /server system using CLASS-Agent Ver. 2

supporting 21 CFR Part 11 (Electronic Records; Electronic Signatures)

Automatic data registration Database management ■ Electronic authorization of data

Manual data registration Chromatograms
Quantitation results
Methods
Schedules Chromatograms review
Other data files Statistical analysis
DB
Client PC Authorization by electronic signature
Report generation
Database server (public document)

Ethe
rNE Client PC
Printer
T LA
HPLC
N
Office
GCMS

HPLC
RS-232C cable Lab

Enhanced
GC
RS-232C cable

Balance

CLASS-Agent Balance

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New function to meet FDA 21 CFR
FDA21 CFR Part11
Part 11requirements
requirements
N Enhanced data security by electronic signatures with ID and password
ID and password are requested to log-in. The password is requested in subsequent
signing. As electronic signature routines, steps of signature approval can be
specified at different levels. Names of approval status (Rejection / Waiting for
Inspection / Inspection / Approval) can be changed. One person cannot sign more
than one time.
N Analysis report in Adobe Acrobat format (pdf file format)
Shimadzu electronic authentication server
Analysis reports can be handled in the format specified in the public document No. manager

92S-0251 to meet the requirement of the FDA. (Adobe Acrobat is required.)

Enhanced electronic signature function includes displaying the signature information
on PDF file. PDF files can be printed without opening the file.

N Automatic importing of analysis reports with inclusion of electronic

signatures
Human-readable analysis reports can be linked with machine-readable raw
data. In addition, electronic signatures can be executed to analysis reports
and audit trails of electronic signatures can be performed for electronic
record-keeping.

N Back-up function for enhanced reliability

It is possible to back up data and logs as sets along with comments onto User authentication server settings
public media or formats such as CD-Rs and DVDs. In addition, it is
possible to write directly to CD-Rs /DVDs when performing back-ups.

N Account policy settings with the Shimadzu authentication server

• Prevents unauthorized access by limiting the number of password input attempts. (The system administrator is immediately
notified by e-mail if an unauthorized access is detected.)
• The minimum password length and validity period can be specified.
• Screen locks up when there is no keyboard input or mouse operation within a specified period of time.

N Time Management by GMT (Greenwich Mean Time)

The recording/approval time and data are stored in GMT and displayed as local time on the screen and in reports.

When using CLASS-Agent in 21 CFR Part 11-compatible mode, the following software products are required.
• OS: Microsoft Windows NT/2000
• Database: “Oracle” by Oracle Corp., or “SQL Server” by Microsoft Corp.
• Others: “Acrobat” by Adobe Systems Inc.

What is FDA 21 CFR Part 11: Electronic records; Electronic Signatures?

This is a rule enforced by the FDA (Food and Drug Administration) of the United States in August 1997 to regulate the
use of electronic records and electronic signatures. The rule stipulates the criteria under which electronic records and
signatures will be considered equivalent to paper records and handwritten signatures in manufacturing processes
regulated by the FDA.
Over recent years, the expanding number of pharmaceutical products and the increasing strictness of regulations on
such products has given rise to a need for streamlining the process of obtaining approval for new products, and for
enabling more efficient management of analysis data and operational records. In view of this, FDA 21 CFR Part 11 was
developed with the aim of promoting the transition from the use of conventional paper records and signatures to
electronic records and electronic signatures, by clarifying definitions of the original raw data and setting strict
requirements for data recording and archiving.

* Windows NT and SQL Server are registered trademarks of Microsoft Corporation, Oracle is a registered trademark of Oracle Corporation, and Acrobat
is a registered trademark of Adobe Systems Incorporated.

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 Features

N Easy processing of large amounts of data over long periods of time

Because the analysis results reside in a database, file names need not be remembered. Linking data associated with different
instruments and different dates is easy. Because there is no limit to the number of database files that can be created, data can be
stored separately based on categories such as sample, instrument, supervisor, or other parameters.

N Easy management of various types of instruments and large amounts of instrument data
By networking the instruments, the analysis results can be centrally managed in the database files residing on the network server.

N Direct compatibility with Excel and Word

The analysis results are managed in either MS Access or MS SQL Server format, allowing direct use of them in such
applications as Excel and Word.

N Quick and easy data searching capability

The data browsing software provided with the database (Agent Manager) enables quick data searches based on the specified
sample name, registration date, instrument, or analyst.

N Enhanced security using GLP/GMP standards

Only registered users can review the analysis results, and approval or deletion can be performed only by specified individuals.
Data that has been approved can no longer be modified. Further, the operational history associated with the data is
automatically recorded for subsequent verification.

N Support of both Access, SQL Server, and Oracle formats

The easy-to-use Access database, SQL Server, and Oracle formats which allows easy management of large amounts of data,
are both supported.

Functions

N Data from analytical instruments are automatically registered to the database

Data acquired from Shimadzu's CLASS-VP for HPLC,

GCsolution, GCMSsolution, LCMSsolution, UVProbe,
IRsolution and electronic balances can be automatically
registered to the CLASS-Agent database for integrated data
management.

Header information stored along with the analytical data, such as

instrument name, sample name, analyst name, and other
parameters, can be automatically read and entered into separate
fields in the database, allowing this information to be easily
queried. Further, collected data can be e-mailed automatically to
the addresses of individuals specified beforehand.

The analysis date and time, chromatograms, analysis method and

AIA format data can also be managed along with the sample
data. These data parameters are all compressed into a single file
for convenient and organized storage.

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N Data Search
The database browse and search software (Agent
Manager) allows you to easily search for data by entering
keywords associated with the sample name, analysis date,
instrument name, or analyst name.
For example, the user could easily display all of the data
associated with sample name ABC stored from 3/1/1998
to 5/31/1998, in tabular format.

Import to and export from data link files and File

compression are possible. Reinforced sample search
functions allows data search on the condition of "The
Latest Data Only", whose search conditions can be stored
as a file for later retrieval

N Chromatogram Display and Report Preview

Data is converted to Analytical Instrument Association (AIA)
format. Converted data such as chromatogram can be pre-
viewed. Chromatogram and numeric data can be pasted to
report by Word or Excel.
Report files in PDF format can be browsed
easily.

N Graph Creation and Report Generation

After locating the desired data using Agent Manager, simply cutting and pasting the data to Excel via mouse operation allows
you to create graphs. Reports can be easily created combining a variety of elements, such as chromatograms and quantitation
results, data from various instruments, or associated analysis data. User list, user authorization list, history log, and data
contents for individual samples can be printed out individually.

Conc progress time change Control chart

N "CLASS-Agent Report" optional software

Microsoft Excel is widely used to create reports from data obtained by analysis. The CLASS-Agent Report is software that
creates reports based on Excel's report templates and analysis results registered in the CLASS-Agent database. The Excel,
though widely used for creating reports, lacks audit trail, security and electronic signature functions mandatory for the
compliance with FDA 21 CFR Part 11. CLASS-Agent Report allows the use of Excel in an environment satisfying the Part
11 requirements by providing the features of Audit Trail, Security and Electronic Signature.

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 N User Administration and Access Control
Users accessible to the program are managed by Shimadzu user
authentication tool, which are independent from used OS, for
access control complying with FDA 21 CFR Part 11.
Functional operations can be limited according to the user, only
designated, authorized users will be able to enter or modify
information, reducing the probability of errors.
Password Checks
1) Passwords shorter than the preset minimum password length
are rejected for registration.
2) A compulsory password change is required when logging in
after the preset password validity period has elapsed.
3) Password entry is required for data approval. Each data item
has to be approved separately, prohibiting validating multiple
data items as a whole. User verification can be specified as
verification on the first time only or verification every time.
4) The latest 10 passwords registered for a user can be recorded
and checked.
5) Password complexity (whether it includes both alphabetic and
numeral characters) is checked.
N Security and Audit Trail
When the number of failed attempts at login exceeds the preset number, login from that
PC and with that ID is rejected for a specified period. When an unauthorized access
occurs, an alert can be sent to specified terminals, as well as to specified e-mail addresses.
This function allows the notification of
unauthorized access even in LAN environments
where e-mail cannot be used.
Operational records such as operator name, date
and time, remarks, and reason of change are
automatically recorded and can be reviewed
afterwards. Also it is possible to list up a part of
those information as desired.

N Data Integrity and Electronic Signatures

CLASS-Agent records instrument configuration, method and
operational status along with data. All these parameters can be
retrieved afterwards for data integrity. For all electronic
records, electronic signature can be applied. Electronic
signature are linked with analysis data and signer's name, date
and reason are recorded.

N Data Backup
The time period between backups can be specified. This
function also allows a setting that automatically deletes the
backed up data from the original media when the backup is
complete. Data and related logs are backed up together and
simultaneously. The log records the ID of the media on which
the backup is made, facilitating subsequent retrieval. The
backup data can be retrieved to the original database. Backup
data can be directly written to CD-R/DVD-R or to DVD-RAM.

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 N Integrated Management of Analytical Data by CLASS-Agent

N Flow of Analysis Operations and Data Browsing and Approval (in case of HPLC)

Agent Software Packages

Description 1 License Version 5 License Version
CLASS-VP Agent Ver. 2.1*1 223-18234-92 223-18234-94
GCsolution Agent Ver. 2.1*1 223-18251-92 223-18251-94
GCMSsolution Agent Ver. 2.1 *1 223-18253-92
LCMSsolution Agent Ver. 2.1 *1 223-18254-92
UVProbe Agent Ver. 2.11 *1 223-21500-92
IRsolution Agent Ver. 2.11 *1 206-21600-92
CLASS-Agent Manager Ver. 2.1*2 223-18233-92 223-18233-94
CLASS-Balance Agent Ver. 2.1*1 223-18235-92 223-18235-94
CLASS-Public Agent Ver. 2.1*1 223-18236-92 223-18236-94
*1 CLASS-Agent Manager software is included.
*2 CLASS-Agent Manager is used for a PC, which does not have workstation software and CLASS-Agent software installed, for data browsing/approval
purpose only.

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 Specifications

PC Requirements
The PC must be compatible with Basic Workstation software:
(The specification of PC, operating system, and required memory depends on the workstation software installed.)
Suggested memory: Required by Basic Workstation software memory plus 64MB or more.

CPU: Pentium 266MHz or greater

Video: SVGA (800 x 600 pixels) or better
OS: Windows 98/NT4.0/2000 (English or Japanese version only)
Hard Disk Drive: Up to 150MB required for CLASS-Agent installation

Compatible Basic Workstation Software

The versions of workstation software products compatible with the CLASS-Agent Ver. 2.1 are as follows.
CLASS-VP Ver. 5.02 and later
GCsolution Ver. 2.10 and later
GCMSsolution Ver. 2.00 and later
LCMSsolution Ver. 2.02 and later
UVProbe Ver. 2.1 and later
IRsolution Ver. 2.11 and later
WizAArd Ver. 2.10 and later *1
*1. WizAArd quantitation date is automatically registered in text format only.

Balance
Shimadzu (AE/AW/AX/AY/BW/BX Series) and Mettler (AE/AG/AT/PM Series) supported

Options
CLASS-Agent Report: To generate reports using CLASS-Agent data and Microsoft Excel

Supported Database
Local or workgroups: Microsoft Access 97
Client/ Server: Microsoft SQL Server 7.0 2000/MSDE
Oracle8i/9 Workgroup Server for Windows NT
Note:To refer to report files in pdf format, Adobe Acrobat Reader is required.

SHIMADZU CORPORATION. International Marketing Division SHIMADZU SCIENTIFIC INSTRUMENTS (OCEANIA) PTY. LTD.
3. Kanda-Nishikicho 1-chome, Chiyoda-ku, Tokyo 101-8448, Japan Units F, 10-16 South Street Rydalmere N.S.W. 2116, Australia
Phone: 81(3)3219-5641 Fax. 81(3)3219-5710 Cable Add.:SHIMADZU TOKYO Phone: 61(2)9684-4200 Fax. 61(2)9684-4055
SHIMADZU SCIENTIFIC INSTRUMENTS, INC. SHIMADZU DO BRASIL COMERCIO LTDA.
7102 Riverwood Drive, Columbia, Maryland 21046, U.S.A. Rua Cenno Sbrighi, 25, Agua Branca, Sao Paulo, CEP 05036-010, BRAZIL
Phone: 1(410)381-1227 Fax. 1(410)381-1222 Toll Free: 1(800)477-1227 Phone: (55)11-3611-1688 Fax. (55)11-3611-2209
SHIMADZU DEUTSCHLAND GmbH SHIMADZU (HONG KONG) LIMITED
Albert-Hahn-Strasse 6-10, D-47269 Duisburg, F.R. Germany Phone: 49(203)7687-0 Fax. 49(203)766625 Suite 1028 Ocean Center, Harbour City, Tsim Sha Tsui, Kowloon HONG KONG
SHIMADZU (ASIA PACIFIC) PTE LTD. Phone: (852)2375-4979 Fax. (852)2199-7438
16 Science Park Drive #01-01 Singapore Science Park, Singapore 118227, Republic of Singapore Overseas Offices
Phone: 65-778 6280 Fax. 65-779 2935 Istanbul, Beijing, Shanghai, Guangzhou, Shenyang, Chengdu, Moscow

URL http://www.shimadzu.com

Printed in Japan 3295-12206-10ATD