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Agilent ChemStation Plus
Security Pack—designed to sup-
port the requirements of 21 CFR
Part 11. It uses a relational data-
base based on the ChemStore C/S
database for secure result data
storage, data review and electroni-
cally signing off runs (pages
20–31).
Agilent ChemStation Plus
Method Validation Pack
advanced statistics module to cal-
culate the quality of analytical
results including configuration,
design and execution of method
development and method valida-
tion experiments. It provides an
automated printout of a complete
method validation report as
requested by ICH and Pharma-
copoeia guidelines. All validation
data are stored with versions in a
built-in relational database for full
data security and data integrity
and to support FDAs 21 CFR Part
11 (pages 32–59).
General Description
This document provides specifica-
tions for Agilent ChemStore C/S,
Agilent ChemStation Plus Security
Pack, Agilent ChemAccess C/S
Agilent ChemStation Plus Method
Validation Pack, which are part of
the Agilent ChemStation Plus fam-
ily. With the Agilent ChemStation
Plus family you need only pur-
chase the features needed. This
can be the fully featured software
package for the most advanced
capabilities, or you can exclude
features that you may not want
now, and add them later as your
needs change.
The Agilent ChemStation Plus
software package currently con-
sists of the modules below.
Agilent ChemStation for
GC, LC, LC/MSD, CE, UV-visi-
ble and A/D systems—instru-
ment control, data evaluation sys-
tems. Detailed specifications are
available in the Agilent
ChemStation Specifications
(Agilent publication number 5988-
5314EN).
Agilent ChemStore C/S
data organizing and storage mod-
ule that provides a scalable in-
process chromatographic data
organization system for Agilent
ChemStations (pages 2–16).
Agilent ChemAccess C/S
remote access module that pro-
vides a laboratory-wide remote
status and control client/server
data system for networked Agilent
ChemStations (pages 17–19).
Specifications
Agilent ChemStation Plus
January 2003
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Summary of Contents

Page 1 - Agilent ChemStation Plus

Agilent ChemStation PlusSecurity Pack—designed to sup-port the requirements of 21 CFRPart 11. It uses a relational data-base based on the ChemStore C/

Page 2 - Agilent ChemStore C/S

10ChemStore spooler – Managingdata transfer from AgilentChemStation to AgilentChemStore C/STo ensure optimum performanceof the Agilent ChemStation, ab

Page 3

11Figure 6Setup of custom expressionsFigure 5Summary statisticsPerforming statistics calculationsThe user may optionally select tohave statistical cal

Page 4 - Hardware considerations

Agilent ChemStore C/S — ReportingAgilent ChemStore C/S offers apowerful report generator enablingusers to easily create and generatefinal summary repo

Page 5

Agilent ChemStore C/S — User InterfaceChromatogram/spectrum pre-sentationHere, the display area can containboth graphics and a table. Thedetails diffe

Page 6 - Database size

Agilent ChemStore C/S — Database Administration, Backup and Recoveryweb-based application that can berun from any PC on the network.The Admin Client p

Page 7 - Station software

15Agilent ChemStore C/S — Installation and Upgrading• ChemStation Plus CD-ROM, and• ChemStore C/S client software(on ChemStation Plus CD-ROM).Agilent

Page 8 - From Agilent ChemStation to

16Agilent ChemStore C/S — Product Options and ConfigurationsStandalone versionThe complete Agilent ChemStoreC/S standalone software is provid-ed on th

Page 9 - Figure 4

HP 1090 Series and 1050 Series,Agilent 1100 Series, Agilent CEsystem, Agilent 5890, 6850, 6890GC systems, Agilent 5972,5973A and 5973N GC/MSD system,

Page 10

Working with Agilent ChemAccess C/Sview of the Agilent ChemStation.If the same results are retrans-ferred to the server, AgilentChemAccess C/S employs

Page 11 - Custom expressions

19Server hardware requirementsAgilent ChemAccess C/S supportsup to 15 “concurrent” AgilentChemAccess clients, where con-current is defined as a clien

Page 12 - Figure 7

Agilent ChemStore C/S is availablein two different configurations:• Agilent ChemStore C/S standalone databaseThis provides a low cost, easy-to-use, en

Page 13

offering advanced data security,data integrity and full change documentation in audit-trails.Specifications of the ChemStoreC/S database module are av

Page 14 - Database administration

• A modified batch review interface providing an automat-ed user-independent data ver-sioning with detailed audit-trails for all modifications.• Compl

Page 15 - Agilent ChemStore C/S data

Working with ChemStation Plus Security Packaccess to the data dictionarydescribing the meaning of thetable columns. The dictionary isonly available fr

Page 16 - Standalone version

Local directories storing relevantchromatographic data are alsoprotected with Windows file anddirectory permissions. Table 11gives an overview of the

Page 17 - Agilent ChemAccess C/S

ChemStation Plus Security Pack — User Management and Application Securitywhich should be enabled manu-ally before leaving the PC unat-tended, e.g. dur

Page 18

ChemStation Plus Security Pack — Data Integrity, Automated Result Versioning and Data ReanalysisIn addition, ChemStation Plusmanagers can perform manu

Page 19 - Server software requirements

26User-independent, automatedresult version managementThe data storage includes anapplication controlled versionmanagement that is based on thecreatio

Page 20 - Product Description

ChemStation Plus Security Pack—Graphical Result Review and Result Calculationsection. The ChemStation PlusSecurity Pack allows a graphicalrework of th

Page 21 - Client software requirements

2821 CFR Part 11 permits the use ofelectronic signatures if the appli-cation ensures data integrity, datasecurity and full audit-trail docu-mentation.

Page 22 - Data protection

ChemStation Plus Security Pack — Audit-trails and change documentation• all user comments during reanalysis cycles, and• a detailed change documenta-t

Page 23

3Based on standard database features, Agilent ChemStore C/Soffers functionality which focuseson the user’s needs for fast, secureand traceable handlin

Page 24 - Application security

Database logbookThe database logbook (figure 21)stores all application related activ-ities such as:• log-on/log-off events and failed logon attempts,

Page 25 - Result revision management

ChemStation Plus Security Pack—Product Options and Configuration31Standalone versionThe standalone version providesthe ChemStation CD-ROM revisionA.09

Page 26 - User-independent, automated

Agilent ChemStation Plus Method Validation Pack analytical problem to address thequantitative question.Eventually it requires an answerto the question

Page 27 - Security Pack

repetitive injections in order touse statistics for a quantitativeresult evaluation. The statisticalresults display whether the resultsmeet their spec

Page 28

• Some checkpoints can use thesame result data. MethodValidation Pack provides a wiz-ard to define multiple usage ofanalytical results as shown infigu

Page 29 - Sample audit trail

Data management and audit-trailsAll configuration and result dataalong with the MVS files and vali-dation reports form the "validationdatabase&qu

Page 30 - Database logbook

ChemStation Plus Method Validation—System RequirementsHardware requirementsThe following list shows the mini-mum hardware requirements forthe client a

Page 31 - Client/server version

Database size for Client-Serverinstallation using Oracle data-baseMethod Validation Pack suppliesthree pre-defined schemes fordatabase installation: s

Page 32 - Introduction

Working with ChemStation Plus Method Validation Pack • import wizard for templates,• new validation wizard,• planning wizard,• report settings (output

Page 33 - Configuration

From planning to execution3)Experiment setup and data management configuration (Level 3)a) Creation or update ofChemStore study for all MethodValidati

Page 34 - Test execution

4Agilent ChemStore C/S—System Requirements1. Agilent ChemStore C/SstandaloneHardware requirementsThe following list shows the mini-mum hardware requir

Page 35 - Data management and audit

Output settings The method validation output set-tings define contents of thecheckpoint calculations and thereport content for each check-point. For d

Page 36 - ChemStation Plus modules

the preconfigured header data.Using default header data speedsup the checkpoint configurationas it allows skipping data entry forthe checkpoint header

Page 37

missing values either as Zero oras MV in case the configurationallows 0 as valid data input)• Multiple injection and multiple determination ofdata poi

Page 38

input grids. The following defini-tions can be made:• name and description of the import mask,• source type (file extension) andpath,• field separator

Page 39 - Prior to test execution

ChemStation Method Validation Pack — Checkpoint Planningwhich could influence the result.Ruggedness of an analyticalmethod is given if the deviation o

Page 40 - Validation setup and configu

45• variance homogenity according to Bartlett.Lab capabilityKnowledge of lab capability is neces-sary for accurate estimates ofprocess capability (see

Page 41 - Level 4: Component configura

46LinearityLinearity calculates a linear regres-sion using the least square error forthe model y = a + bx. Linearity canbe carried out by multiple inj

Page 42 - Level 3: Checkpoint planning

47Output settings for calculations• Vector y=ax+b - curve equation in the case of linearity• Square sum of the residuals (only calibration function)•

Page 43 - Level 2: Data input

• Nominal value comparison:• Result of Wilcoxon test (additional for nominal value comparison)• Extended spiking method:• Test quantity for a and b• T

Page 44 - Robustness/Ruggedness

49Planning data• Number of values• Y-units• Nominal value resolution R• Add chromatogram bitmap• Multiple injections possibleOutput settingsAll data a

Page 45 - Lab capability

Server hardware requirementsAgilent has optimized the perfor-mance of a ChemStation Plusclient/server system to an averageof 30 “concurrent” AgilentCh

Page 46 - Calibration function

ChemStation Plus Method Validation Pack — Interaction with other ChemStationPlus modules and ChemStore databaseing acquisition runs and deletesthe fil

Page 47 - Figure 32

Agilent ChemStation Plus Method Validation Pack — Interaction with ChemStoredatabase• Save raw data with results• Delete raw data on the local hard di

Page 48 - Accuracy

ChemStation Plus Method Validation Pack — User Management and Access RightsThe user levels are part ofChemStation Plus user administra-tion as shown i

Page 49 - Ring experiment

Agilent ChemStation Plus Method Validation Pack — Data Security• Report section—all reports are stored as doc files that have been printed for the val

Page 50 - Interaction with ChemStation

File security for the standalonedatabase The local validation database mustbe protected from unauthorizedaccess through Explorer or MS-DOS. Method Val

Page 51

Audit-trail details for valida-tion and default validationaudit-trailThe validation and default valida-tion audit-trails display all actionsthat are r

Page 52 - Figure 37

56Default validation audit-trailThe default validation audit-trailrefers to the general configurationof validations. It covers allchanges that are not

Page 53 - Document management system

57Validation locking and electronic signaturesAfter completion of a checkpoint,an entire component or a full vali-dation, the validation can belocked

Page 54 - User documentation with

Agilent ChemStation Plus Method Validation Pack — InstallationThe Microsoft Data AccessComponents install a layer toaccess local databases or centrald

Page 55 - Audit-trails

ChemStation Plus Method Validation Pack — Product Options and Configurations59Standalone versionThe standalone version of MethodValidation Pack requir

Page 56 - Program audit-trail

6Figure 1Study setup for full data integrity in the server databaseServer software requirements• Windows NT Server 4.0 with Service Pack 6a or• Window

Page 57 - Validation locking and

www.agilent.com/chem/ndsThe information in this publication is subject tochange without notice.Microsoft®, and Microsoft Windows®are U.S.registered tr

Page 58 - Software

7Store in Addition DescriptionChromatograms Stores all available chromatograms (from each detector and/or signal)Spectra for quantified Stores spectra

Page 59

Agilent ChemStore C/S — Working with Agilent ChemStore C/Smenu item in “Data AnalysisView” or use the batch reviewinterface of the AgilentChemStation.

Page 60 - Qualification services

Using Agilent ChemStore C/S datareview capabilities, the lab manag-er or a quality control person canreview data generated on multipleinstruments thro

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