HP LC2000r - NetServer - 128 MB RAM Especificações

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/

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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