General Description

This document provides specifications for Agilent ChemStore C/S andAgilent ChemStation Plus Security Pack, which are part of the AgilentChemStation Plus family. With the Agilent ChemStation Plus family youneed to purchase only the features you require. This can be the fully fea-tured software package for the most advanced capabilities, or you canexclude features that you may not want now, and add them later as yourneeds change. The Agilent ChemStation Plus software package currentlyconsists of the following modules:

Agilent ChemStation for GC, LC, LC/MSD, CE, and A/D systems

Instrument control, data evaluation systems. Detailed specifications areavailable in the Agilent ChemStation Specifications (Agilent publicationnumber 5989-9795EN).

Agilent ChemStore C/S

Data organizing and storage module that provides a scalable in-processchromatographic data organization system for Agilent ChemStations(pages 2–20).

Agilent ChemStation Plus Security Pack

Support the requirements of 21 CFR Part 11. It uses a relational databasebased on the ChemStore C/S database for secure result data storage,data review and electronically signing off runs (pages 21–36).

Specifications

Agilent ChemStation Plus

February 2009

• Optional peak performance cal-culation per-run or sequenceline (see ChemStore C/S –

Reporting on page 14)

Open system connectivity

• File-less LIMS interface(see ChemStore C/S – LIMS

Connectivity on page 18)

Administration

• Email notification enhancements(see Agilent ChemStation Plus

Security Pack — E-Mail

Notification on page 34)• Configurable command line

access (see ChemStation Plus

Security Pack — User

Management and Application

Security on page 25)• Support for Windows XP

Professional Workstation• Support for Microsoft Vista and

Microsoft Access 2007• Support for Oracle 10g

Product DescriptionAgilent ChemStore C/S is a scal-able in-process chromatographicdatabase for Agilent ChemStations.It provides a means to easily organize, review and approve analytical data based on studyand sample information. AgilentChemStore C/S supports the users'data review process offeringstatistically result summaries,flexible control charts, cross-sample reports and documenteddata archiving and restoring.These services also aid users indoing on-going system suitabilitytesting. The Agilent ChemStoreC/S server database can be usedas a single place for data storagefor all analytical data includingmethods, sequences and the

raw data. This data storage alsosatisfies the requirements for data handling in a regulated environment including the detailedrequirements of the U.S. food anddrug administration for electronicrecords and electronic signatures,known as 21 CFR Part 11.

Agilent ChemStore C/S is availablein two different configurations:

• Agilent ChemStore C/S

standalone database

This provides a low cost, easy-to-use, entry-level databasemodule which integrates with asingle Agilent ChemStationworkstation.Very limited main-tenance support is required andany user with advanced know-ledge of the Windows XP orWindows Vista operation sys-tem functionality for backupand administration can main-tain it. This entry-level databasemodule allows for storage of allraw and meta data in singledatabase file to ensure full dataintegrity. The file format adheresto a common standard, whichis used by many other applica-tions, for example, MS Access.

• Agilent ChemStore C/S

server Oracle® database

client/server system

This client/server system isbased on an Oracle databaserunning on a Windows 2000server together with multipleAgilent ChemStations and/orAgilent ChemStore C/S reviewclients. It provides enhanceddata security and data integrity,distributed processing, as wellas the ability to store raw data,methods and sequence files

What’s New?With revisions B.03.0x and B.04.0xusers can benefit of new function-ality in many areas as listed below.

Workflow

• Up to three configurable levelsof approval linked to separateuser privileges (see Agilent

ChemStation Plus Security

Pack – Electronic signatures

and password settings on page 30)

• Optional locking of runs afterapproval to prevent them fromfurther modification (see Agilent

ChemStation Plus Security Pack

– Electronic signatures and

password settings on page 30)• New chromatogram viewer

providing dynamic zooming and rescaling capabilities (seeAgilent ChemStore C/S – User

Interface on page 15)• Direct Read-access to

ChemStation Method (seeAgilent ChemStation Plus

Security Pack – Audit Trails

and Change Documentation

on page 32)• Variables in advanced queries

for operator names and dates(see Agilent ChemStore C/S –

Working with Agilent ChemStore

C/S on page 8)• New database field for area%

results from ChemStation

Reporting

• Powerful custom calculator foradvanced calculations, reportingand charting of calculationresults, based on fully versionedcalculation templates (seeChemStore C/S – Working with

Agilent ChemStore C/S, Custom

calculations on page 12)

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Agilent ChemStore C/S1.

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within the database. This configuration reflects best theregulatory needs for electronicrecords and ensures full dataintegrity and traceability.

Based on standard database features, Agilent ChemStore C/Soffers functionality which focuseson the user’s needs for fast, secureand traceable handling of chro-matographic data:

• User-defined or automatedtransfer of selected data fromthe Agilent ChemStation intothe Agilent ChemStore C/S data-base.

• Define, edit and manage“studies” as the underlying datastorage format.

• Manage or restrict data accessin studies by assigning studyaccess only to authorized users.

• Create database queries interactively or execute pre-defined standard queries.

• Review entire sets of dataacross instruments and studies,that several sequences in a fastand easy manner.

• Create additional filters andselection criteria to produceadequate subsets of the study inorder to best sort the data andoptimize the performance.

• Complete audit traceability by individual log-ins and complete documentation within the data-base including authorizationfailures.

• Security check of all files thathave been transferred over thenetwork from the ChemStationapplication to the ChemStoredatabase application and back.

Whenever a corruption of thedatafile is detected, the userreceives an error message andthe file is no longer availablefor modifications.

• Approve or reject runs afterreviewing, following the rulesfor electronic signature.

• Ability to flag an arbitaryset of samples for reprocessing,and to initiate batch reprocess-ing of those samples on anyAgilent ChemStation in a C/Snetwork.

• Custom fields—User specifiedadditional information fieldswith each set of results (“run”)to hold values not measured bythe Agilent ChemStation (forexample, weights, pH, etc.) thatcan be used for later queries,reports or charts.

• Flexibility in scaling and labeling control chart data.

• Simple user-defined calculations for control chartsand reports.

• User-controlled fast and easydata export to other applica-tions such as MS Excel®.

• Powerful and intuitive report generator based on MSAccess runtime including mostcommonly used report tem-plates.

• Architecture allows for off-linereview. Can be installed as adata review client running on aseparate PC without needingthe Agilent ChemStation soft-ware.

• Data from non-Agilent chroma-tography systems may be included via the Agilent Chem-Station AIA import capability.

• Agilent ChemStore C/S offers the possibility to start with anentry level solution, and to thenupgrade when the data process-ing needs increase.Laboratories can easily upgradefrom one or more entry-levelstandalone systems to anAgilent ChemStore C/S serverOracle database client/serversystem. Previously stored datain the entry-level databases canbe easily migrated to the newserver database. The user inter-face does not change, exceptthat some additional items areavailable for administrators.

• A built-in archive/delete toolallows for easy data transfer toother disks and or media to freeup database space while keep-ing a complete audit-trail of allarchiving and delete operations.

• Automatic archivingbased on a set of configurablearchive queries for easy data-base maintenance and adminis-tration.

• Open system connectivityusing XML (Extensible MarkupLanguage) for easy dataexchange with other applica-tions.

• Advanced email notificationfeature (C/S only). See page 34for details.

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Agilent ChemStore C/S—System Requirements

1. Agilent ChemStore C/Sstandalone

Hardware requirementsThe following list shows the mini-mum hardware requirements forthis application:• 1.5 GHz Pentium IV• 4 GByte of free hard disk space• 512 MB RAM for single Chem-

Station instrument.• 1 GB RAM for two or more

instruments• Display: 1280 × 1024, small

fonts, true color (32 bit)• For Windows Vista the mini-mum requirements for processorspeed and memory are:3.4 GHz Pentium IV, 1 GB RAM

Software requirementsThe following list shows the minimum software requirementsfor this application:• Windows Vista Business Ed.

with Service Pack 1 or Windows XP Professional Service Pack 3

• Agilent ChemStation revision B.04.01 or later

• Microsoft Internet Explorer 7.0 or later

• A local or network printer mustbe installed and configured.

Hardware considerationsDisk space requirements dependon several factors, such as:• number of runs and compounds,• technique (3D data requires

more disk space than 2D data)• Agilent ChemStation report

style• the “Store in Addition” settings

of the study to which the run isassigned, (see table 4 on page 7),and

• use of custom fields• database backup requirements

Typical runs use approximately 10 KB for a short report with fourpeaks, and use up to 300 KB perrun for an extended performancereport with 20 peaks. Table 1

helps calculate the amount ofhard disk space requirements.Additional information on thistopic may be found in the Agilent

ChemStore C/S Installation man-ual and the Concepts Guide.

Note:

The standalone database size islimited to 800 MB due to somestrict size limitations in the under-lying file format. To ensure opti-mum performance for later datareview Agilent strongly recom-mends not to exceed this data-base size limit. Additional stand-alone databases can be createdvia the Agilent ChemStoreC/S utility. If a larger single data-base is required, Agilent recommends that the client/serverversion of the product be pur-chased. The client/server databaseuses Oracle 10g as a managementsystem, which allows for a muchlarger database.

Table 1

Client storage requirements for result only data storage

Number of peaks Agilent ChemStation report style Run length Approximate size (minutes) per run (KB)

4 short 6 104 short 30 404 extended performance 6 8020 short 6 19020 extended performance 6 300

Server hardware requirementsAgilent has optimized the perfor-mance of a ChemStation Plusclient/server system to an averageof 30 “concurrent” AgilentChemStation/Agilent ChemStoreReview clients, where concurrentclients are defined as clients con-nected to the central ChemStoreC/S data organization system, thatactively either spool data to thedatabase or perform interactivequeries (review client). Due to thenature of the application theimpact of data retrieval is higher asthis requires direct access to thedatabase, while during acquisitionthe spooler is able to buffer data,thus ensuring a secure transfer incase of a network failure, for exam-ple. So the optimum number ofconcurrent clients might varydepending on the work practice inthe laboratory. Depending on thecombination of 2D/3D instruments,a typical high-end configurationcan thus grow to approximately 30acquisition clients with a maximumof 90 instruments. It is therefore

recommended to use a high speedmulti processor system with suffi-cient RAM.

The minimum requirements for theserver in a Client/Server installa-tion are the following:• 1.5 GHz Pentium IV processor• 1 GB RAM• RAID SCSI controller• 6 disk drives - 36 GB or larger–

2 drives configured as a mirrorset and 4 drives configured as aRAID-5 array

• Backup tape device• Uninterruptable power supply

(UPS)Note: The drive configuration yields onemirrored partition for the operat-ing system and application soft-ware, and one large array for thedatabase files.

Server hardware considerationsThe hardware requirements of theAgilent ChemStore C/S server will

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2. Agilent ChemStore serverOracle® database system

Client hardware requirementsThe following list shows the mini-mum requirements for the client

in a client/server installation.• 1.5-GHz Pentium IV

processor• 4 GByte of free hard disk space• 512 MB RAM for single Chem-

Station instrument.• 1 GB RAM for two or more

instruments• Display: 1280 × 1024, small

fonts, true color (32 bit)• For Windows Vista operating

systems the minimum requirements in respect to processor speed and memory are:3.4 GHz Pentium IV1 GB RAM

Software requirementsThe following list shows theminimum software requirementsfor this application:• Windows Vista Business Ed.

with Service Pack 1 or WindowsXP Profession Service Pack 3

• Microsoft TCP/IP protocol• Microsoft Internet Explorer

7.0 or later• Oracle 10g client version

10.2.0.4.0.(included with the ChemStoreC/S server software)

• Agilent ChemStation version. B.04.01 or higher.

• A local or network printer mustbe installed and configured.

Entry level Standard level Highend levelNo. of concurrent review clients 1-5 1-15 > 15Processor speed (GHz) 1 3 3Number of processors 1 2 2RAM (GB) 1 4 32Number of RAID controllers 1 2 2Disks for operating system 2 × 36 GB RAID 1 2 × 36 GB RAID 1 2 × 18 GB RAID 1

(Controller 1) (Controller 1)

Disks for Oracle database 5 × 36 GB RAID 5 5 × 146 GB RAID 5 5 × 36 GB RAID 5, (OracleRAID 5 (Controller 2) Data, Contoller 2)

2 × 18 GB RAID 1 (IndexLog Files, Rollback Seg-ments, Controller 1)

Hot swappable drives yes yes yesBackup device Ultrium tape drive Ultrium tape drive Ultrium tape driveUPS yes yes yes

Table 2

Recommended server configurations for Agilent ChemStore C/S

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Figure 1

Study setup for full data integrity in the server database

Server software requirements• Windows 2003 R2 server with

Service Pack 2 • Microsoft Internet Explorer 7.o

or later (for admin client only)• Internet Information Server

version 6 or greater (IIS is installed as part of the applica-tion server role.)

• Oracle 10g Standard or Enterprise Editionversion 10.2.0.4.0.

Database sizeThe database size is selected atinstallation time and should begiven careful consideration as this

will affect the total number ofruns which can be accessed onlineand the frequency ofarchive/dearchive operations.Archive with delete (to recoverrun space in the database) ordearchive operations (to accessrun data online). At installationtime you can either select fromthe preconfigured databases con-figurations listed in table 3, orhave a customized configuration.Note: The custom database config-uration must be planned as a pro-ject with Agilent database consult-ing specialists prior to system

Database Approx. Database configuration no. of runs size

small ≤ 7500 4 GBytemedium ≤ 25000 10 GBytelarge ≤ 80000 40 GByte

Table 3

Database configurations

vary based on the size of the data-base selected at installation timeand the number of concurrentconnections (the number of activeinstruments acquiring samples tothe database and Agilent Chem-Store C/S review clients) and thebackup requirements for the serv-er database. Table 2 shows threerecommended server configura-tions. In a very small networkedinstallation with less than threeclients and no need for advancedsecurity using RAID, the Chem-Store C/S Oracle database canalso run on a high-end PC usingMicrosoft Windows 2003 serversoftware as operating system.

Note:

Planning the server disk configu-ration is very important:36 GByte (for small database) to146 GByte (for large database) hard disk, RAID 5 configuration is recommended. Using a RAID 5hard disk configuration (redun-dancy and striping) yields less free hard disk space than RAID 0 (noredundancy). For example, 3 disksof 9 GByte each using RAID 5yields 18 GBytes while using RAID 0 yields 27 GByte. RAID 5 is recommended for maximum performance and protection ofyour data. For backup operationof the database, the required diskspace must be duplicated, that is a54 GByte RAID 5 configurationshould have an additional 54 GByteof disk space available for databasebackup. When calculating servermemory requirements, calculate 8 MB of additional memory foreach Agilent ChemStore C/S client.For more details on setup and

configuration of the server, pleaserefer to the Agilent ChemStore

C/S Installation manual.

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Store in Addition Description

Chromatograms Stores all available chromatograms (from each detector and/or signal)

Spectra for quantified Stores spectra from all peaks that have been identified and quantipeaks fied as compounds in the calibration table.

Raw data Stores the acquired data in addition to the calculated result.Note: This setting has a significant effect on the amount of storage space required for each run in the ChemStore C/S database. For example ChemStation data which is created from 3D techniques such as a liquid chromatography diode array detector will require more storage space than a 2D technique such as gas chromatography.

Sequence Stores the ChemStation sequence.

Method Stores the ChemStation method

Table 4

Store in Addition study settings

installation. The size of theAgilent ChemStore C/S databaseis based on an Agilent ChemStoreC/S system which has an averagedistribution of all AgilentChemStation 2D and 3D tech-niques. Also, all Store in Addition

checkboxes are enabled for all studies, as shownin figure 1. The space require-ments for runs stored in theAgilent ChemStore C/S databasewill vary depending on your envi-ronment. A run is defined as a sin-gle set of results produced from asingle sample acquisition orreprocessed by an AgilentChemStation which has beentransferred and stored in theAgilent ChemStore C/S database.

The actual amount of space con-sumed by each run in an AgilentChemStore C/S database will varydepending on:

• the Store in Addition

to Result settings of the studyto which the run is assigned(table 4), and

• the technique and complexity (numbers of peaks, AgilentChemStation reports, customfields, and so on) of your chro-matography for that run.

• For details on the size ofraw data files by technique,please refer to table 5.

Supported Agilent Chem-Station softwareAgilent ChemStore C/S can beused with the following AgilentChemStation software:

• Agilent ChemStation for gas chromatography, revisionB.04.01 or later,

• Retention time locking software, add-on module forAgilent ChemStation for gaschromatography,

• Agilent ChemStation for liquid chromatography, revisionB.04.01 or later or later,

• Agilent Method Scouting Wizardfor method development systems

• Agilent ChemStation forcapillary electrophoresis, revi-sion B.04.01 or later,

• Agilent ChemStation for liquid chromatography mass selectivedetection, revision B.04.01 orlater.

• Agilent ChemStation for analogsignal acquisition, revision B.04.01 or later,

• Agilent ChemStation for capillary electrophoresis massselective detection, revisionB.04.01 or later,

Technique Average file size (kB)

2D GC/LC 503D LC 603D LC/MS 7503D CE 600

Table 5

Average raw data file size by technique

Agilent ChemStore C/S — Working with Agilent ChemStore C/S

Interactive mode

Users perform the transfer manu-ally from the Agilent ChemStationmenu item in “Data Analysis View”or use the batch review interfaceof the Agilent ChemStation. Thismode of operation is useful foranalysts who wish to perform afirst pass data review from theAgilent ChemStation data analysisview before transferring theapproved results to the database.

Automated mode

Results are transferred automati-cally to the database at the end ofeach run. This mode ensures thatall analytical data are transferredinto the Agilent ChemStore C/Sserver database and are protectedfrom unauthorized modification. If the same sample injection isreanalyzed and then transferred, anew version of the result data is

created, together with an entry in the audit trail of the AgilentChemStore C/S database, thusensuring a full history of the injection.

File security during data

transfer

Each file that is transferred overthe network from the Chem-Station to the ChemStore data-base or back is protected with ahash value. The application soft-ware automatically calculates thehash value prior to any data trans-fer using a 24 character valuebased on the RSA Data Security,Inc, MD 5™ message digest algo-rithm. The hash value is storedwith the data file. Whenever thisdata file is transferred over thenetwork, e.g. for a reanalysiscycle, the same message algo-rithm calculates the hash value of

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1. Data transfer

The Agilent ChemStation Plusconcept consists of different soft-ware components designed for thevarious tasks in the chromato-graphic laboratory. The AgilentChemStation manages data acqui-sition and data analysis, and theAgilent ChemStore C/S databaseoffers advanced data and resultmanagement along with additionalsample information managementsuch as data organization, advancedresult calculations, result approval,and archiving. This concept allowsa clear separation of result reworkand advanced result review andoffers unmatched data integrityand traceability by tracking thedata history — Results inChemStore can only be underreview or after review completion,locked and pending for archival,while results in ChemStation areunder rework. It is therefore veryimportant to have a secure anddocumented data transferbetween the software application.The specifications will offer adetailed outline of the data transferincluding security measures forboth directions. To further manifestthis separation between reworkand review, results can be lockedfrom further modification whengiving an approval.

From Agilent ChemStation toChemStore databaseAgilent ChemStore C/S offers twomodes of data transfer from theAgilent ChemStation into the Agilent ChemStore C/S database –• interactive mode and • automated mode. Figure 2 shows the interactivemode.

Figure 2

Data transfer setup screen in the Agilent ChemStation

be executed. Custom fields canalso be used in later queries forreports, custom calculations orcharts.

Study and custom field

configuration

A custom field and its type aredefined globally per database asshown in figure 3. The availablefield types are:• True/False selection• Configurable selection list• Integer value• Real value• Text field• Date or Date/Time

Custom fields need to be assignedto a study to activate them for use.As part of the study setup the userdefines how the custom field ispopulated and whether it is amandatory field or not. A customfield can be filled by a ChemStationfunction or manually. Manualfields can be flagged as “required”

or a default value as well upperand lower limits can be specified.

Custom field values are enteredbefore the single sample orsequence acquisition:• Single sample/manual

operation: Study and customfield values are entered by a“single run” Agilent Chem-Station menu item (figure 4).

• Sequence operation: Studyand custom field values arespecified per sequence line andand stored with the sequence.

Using Agilent ChemStore C/S datareview capabilities, the lab manageror a quality control person canreview data generated on multipleinstruments throughout the lab.Samples can be approved, rejected,excluded or assigned for reworkby the Agilent Chem-Station (seebelow From database to the

Agilent ChemStation).

ChemStore spooler – Managing

data transfer from Agilent

ChemStation to Agilent

ChemStore C/S

To ensure optimum performanceof the Agilent ChemStation, abackground spooler takes care ofa secure result transfer from theAgilent ChemStation data into theAgilent ChemStore C/S database.

9

the current file and compares itwith the stored value. Any differ-ence is reported as an error andthe data transfer is interrupted.

Assignment of studies and

custom field information

Runs are stored in studies whichform the top level hierarchical ele-ment of the Agilent ChemStoreC/S database similar to a drawerin a cabinet. Study access isrestricted to users that wereexplicitly granted the permissionto access the data inside thisstudy. Users must be assigned to astudy in order to review studydata or spool data into the study.The amount of result and metadata that is stored in the AgilentChemStore C/S database is definedon a per study basis. For example,the transfer of a set of results mayalso include chromatograms andspectra, and the raw data, methodsand sequence file used to producethose results.

Custom fields allow additionalinformation or result fields to belinked to each set of results (“run”).They are used to store additionalinformation that is not accessiblefrom the Agilent ChemStationmethod or results, that is, informa-tion which may reflect other mea-surements (for example, LIMS ID, sample pH, patient weight,dosage, and so on) or may be usedto organize the data (for example,the identification code of the testpatient from whom a serum sam-ple was obtained). These customfields may be configured as“required” or “optional”. For theformer, a value must be specifiedbefore results can be transferredto the database or a sequence can

Figure 3

Creating a custom field

Figure 4

Data transfer setup screen in the Agilent ChemStation

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This approach has several advan-tages, including• releasing the Agilent Chem-

Station to go on with other tasks quickly while the transfer continues in the background and

• guarding against data loss incase the database insert opera-tion fails or the network isdown.

From database to the Agilent ChemStationRuns which require furtherrework, for example manual integration, can be transferredfrom the database to the AgilentChemStation. Agilent ChemStoreC/S creates an Agilent ChemStationbatch to ensure a consistent easeof operation. The setup for thisbatch submission is a two-stepapproach:

1. Create the batch request fromthe Agilent ChemStore C/Sreview client by marking theruns for transfer in the userinterface. An authorized userconfigures the transfer detailsin an interactive pop-up window (figure 5). These include

• assigning the run data to oneor, in case of several runs, tomore than one user for reanaly-sis on a per run basis,

• optionally transferring themethod with the data (includingthe choice between all versionsof the method), and

• entering a comment with eachrun transfer that will be dis-played to the AgilentChemStation operator.

2. Use the Agilent ChemStationLoad Batch from ChemStore

menu item to select the desiredbatch from the pool of pendingAgilent ChemStore C/S batchesto download the runs to theAgilent ChemStation. The operator then reviews the datain the ChemStation batchreview and makes the necessarychanges. After completion of thereview the modifications can betransferred to the database asnew result versions.

2. Task flow in the review client

Retrieve and review sampledataThe ChemStore C/S review clientprovides two user interfaces fordata review - the sample-centric

Sample view and the compound-centric Compound view. Bothviews are further subdivided intoa tabular display, with or withoutchromatograms and/or spectra,and a chart display for plottingsample- or compound-related data.

The task flow of AgilentChemStore C/S is designed to support the laboratory’s workflowand can be outlined as follows:

1. Select the database that contains the data you want towork with.

2. Extract the set of results youwill work with. This is done viaa database query and theresults become the “current setof data”.

Figure 5

Batch setup for data transfer from database to the Agilent ChemStation

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Figure 6

Summary statistics

3. Perform any of the followingtasks, in any order:

• Review the results “by sample”or “by compound”. Whilereviewing the results, you mayswitch between any of severaldifferent data presentations (for example, a table, a chart, orplots of the chromatograms andor spectra). In addition, youmay specify additional statisticalcomputations to be done on the results and included in thetabular or graphical presenta-tions.

• Generate a report on thedata in the set of data. Any of aset of report templates may beused, and you may customizethose templates according toyour needs or create new ones.

• Export selected data. Data maybe sent to an Excel 2007 “*.xls”file or to an application thatsupports cut-and-paste of theappropriate format.

• Execute custom calculationssuch as cross-run or cross-com-pound calculations or advancedstatistical calculations. Pre-defined templates can be modified or new ones can becreated. Modifications arestored as new template version.Calculation tables and charts of calculated values can be integrated into the report.

• Set up a “batch” by markingruns whose data and methodare to be transferred back tothe Agilent ChemStation for re-analysis.

• Filter or exclude any run in the current data set.

• Approve or reject runs based on your result review. Both steps follow the FDA require-ments for electronic signatures.

The standard query builder ofChemStore C/S provides fastaccess to the commonly useddatabase fields for fast and easydata retrieval. For more sophisti-cated queries the advanced querybuilder provides for access to all database fields, conditionalquery capabilities as well as theuse of variables for the operatorname (“currently logged on user”)and the date (for example “notolder than 2 days”).

Performing statistics calculationsThe user may optionally select tohave statistical calculations per-formed on the (numerical) datawhich is being reviewed, as shownin figure 6. This can be achievedusing summary statistics that cal-culates statistical values based ona single column of numerical val-ues. The calculated values are:• number• minimum• maximum• sum• mean• variance• standard deviation• relative standard deviation

In addition, Regression Statistics

can also be used to calculatecurves and statistics of twonumerical columns. Curve typesinclude:• linear• quadratic• cubic• logarithmic• exponential• power

The curve parameters for thecurves and the residuals will becalculated and displayed. Residualand curves can also be displayedin a chart.

Custom expressionsSimple Mathematical calculationsmay be performed on results usingthe built-in expression definitioninterface (figure 7).

This offers the basic expressionfunctions (addition, subtraction,division and multiplication) plusthe following functions:• exponential• natural logarithm• logarithm• square• square root

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Figure 7

Setup of custom expressions

Figure 8

The custom calculator user interface

Custom calculationsThe ChemStore C/S custom calcu-lator provides all means to developcustom calculations that cannotbe done with the simple expressionbuilder. The custom calculatoruser interface for development ofcalculation templates is shown infigure 8. Calculation templates arefully versioned. The modificationof an existing calculation templateis stored as a new template version.Only users with the appropriatepermission have access to the custom calculator.

For a fast and easy template development the custom calculatoris equipped with eight wizards:• Create Table defines the data

items for the calculation• Create Subtable defines a sub-set

of data• Insert Column allows to define

columns that are populatedwith calculation results and canbe used in further calculations

• Define Variable allows to specify variables (fixed valuesor calculation results) that canbe used in further calculations

• IF condition defines conditionalvalues, for example for limitchecking, resulting in a con -figurable result output, such as “pass” or “fail”.

• Format defines the number format and precision of dataitems for reporting

• Transpose allows to transpose atable or subtable

• Group allows to group by a specific data item and do statistical group calculations,such as – number of values (“count”), – maximum value, – mean value,

– minimum value, – relative standard deviation, – standard deviation, – sum, and – variance.

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Figure 9

The expression builder of the custom calculator

The expression wizard (figure 9)is used for defining a calculation,which can be either an expressionor condition. Calculations can bedefined for all available columnsor variables. It provides a set of arithmetical and statisticalfunctions that can be used in conditions or expressions, theseinclude:• addition• subtraction• multiplication• division• absolute value • count• exponential• logarithm• natural logarithm• mean value• minimum• maximum • relative standard deviation• square• square root• standard deviation• sum• variance

Multiple calculations can bedefined within a single templatebased on any table or subtable.

All calculations are strictly column-based operations and easily allowany kind of cross-compound calculation, for example for thedetermination of relative retentiontimes as required in some regula-tory methods for confirmation of a successful identification or forcalculating relative responses. Thetranspose wizard converts a tablefor doing cross-run calculationssuch as the comparison of resultsto a reference run. The group wiz-ard provides for the ability ofgrouping a set of results by criteria

stored in any other database fieldincluding custom fields. Groups ofdata can be used in statistical cal-culations, where the results mayserve as a data source for furthercalculations. The IF condition wiz-ard integrates with the expressionbuilder and can filter result databased on virtually any condition.The output can be reportedaccording to the specific laboratoryor regulatory requirements, forexample for limit checking – asample result lying outside of aspecified interval can be flagged as“out of spec.”.

During the development the customcalculation is documented in ascripting window as shown in figure 8. This protocol is stored inthe database as the calculationtemplate. Each new version of atemplate is stored with version

information. Optionally it can beincluded in the report to fully document the calculation.

Any part of the calculation or thecomplete template can be testedon sample data obtained by adatabase query. Any error orinconsistency is identified anddocumented in the error window.The related calculation piece ishighlighted in the protocol forconvenient and simple trou-bleshooting.

Calculation result tables as well ascharted calculation results can beintegrated into ChemStore reports.The user may choose whether tobase a report on the latest versionof a calculation or any earlier one.The reporting capabilities ofChemStore C/S are outlined in thefollowing section.

14

Agilent ChemStore C/S — Reporting

Agilent ChemStore C/S offers apowerful report generatorenabling users to easily create andgenerate final summary reports.The preview function helps tointeractively develop the desiredreport without requiring test print-outs. Agilent ChemStore C/Scomes with a set of built-in tem-plates to cover the most commonneeds for summary reporting.These templates can be used as astarting point to build your owncustomized reports.

Following is a list of built-inreports • Analysis Results reports.• Audit Trails reports• Compound Amounts reports

for individual results. • Instrument and Run reports • Peak Details reports• Kinetic Decay reports. • Sample Summary reports with

numeric tables of the resultinformation.

• Sequence summary report— a complete report for GMPrequirements including summa-ry statistics, graphics of chro-matograms and spectra andresult charts with control limitsfor each compound typegrouped by the sample type.

• System Suitability summaryreports including statistics overreplicate injections.

The following are key customizablefeatures of the reporting• display of the selection criteria

of the query,• display of all custom calculations

that have been used in the datasection of the report

• an overall report header displayed on each page thatallows to include graphic itemssuch as a company logo,

• table information,• configurable table contents and

table header.• fonts and font attributes,• individual sections with additi-

onal individual headers contain-ing data tables, chromatogramand spectra (if available from adiode array detector) or datacharts,

• individual page breaks,• additional sorting criteria within

one data section to group datalogically, for example, around avial number, a sample type orany other item that the userrequires,

• restriction capabilities to focuson an adequate subset of thedata, that is, one peak within achromatogram, and

• statistical calculations selectedinteractively at any time duringthe data review from theChemStore C/S user interface.

• inclusion of custom calculationresult tables, charts of calculatedvalues and full documentationof the custom calculations,including calculation formulaand calculation errors.

The ChemStore C/S applicationoffers an additional functionality toprint the current view. This func-tion gives access to an immediateprintout of the actual screenincluding all graphics without anyformatting or configuration tasks.

For system suitability reports thecalculation of system suitabilityparameters can be triggered independently of the ChemStationmethod during sample or sequencesetup by enabling the “CalculatePeak Performance” checkmarkper run or sequence line (see figure 2).

15

Agilent ChemStore C/S — Data Export into Other Applications

Agilent ChemStore C/S allows aneasy export of selected databaseinformation (selection by recordsand data fields) to third partyapplications (notably MS Excel).The user has control over whichfields are included and in whichorder. This can be done based onqueries or reports exporting datainto the native file format. AgilentChemStore C/S also offers clipboardcut-and-paste for both tabular andgraphical data (figure 10). Reportoutputs can be in a file formatallowing convenient publishing ofreports, for example, HTML forinternet and intranet publishing.

Figure 10

Interactive data export from Agilent ChemStore C/S into other applications

ChemStore C/S allows printing inthe following file formats:• HTML format for review with

an Internet browser (excluding graphics).

• CSV format for spreadsheet applications

• XML format as generic file-interface (excluding graphics)

Agilent ChemStore C/S — User Interface

detailed inspection of the baselineto judge whether any rework ofthe integration is required.

General chart presentation In the chart layout view the chartpresentation is available only if no

The Agilent ChemStore C/S reviewclient offers the user two main“toolkits”: data review and databaseadministration. The latter will bedescribed in the next section.

Sample and compound reviewWithin the data review toolkit, theuser has a choice of whether to seedata organized by analysis (alsoreferred to as “run” or “sample”)or by compound. In the table layout view data is displayed inconfigurable tables, either sample-or compound-centric.

Chromatogram/spectrum presentationIn the review layout view, the display area can contain bothgraphics and a table. The detailsdiffer for sample and compoundreview. The chromatogram viewerprovides for dynamic zooming andrescaling capabilities, allowing a

Figure 11

Chart for retention time reproducibility with warning and

critical limits

summary or regression statisticsare in use. If regression statisticsare being calculated, the regres-sion chart and residual chart pre-sentations replace it. Figure 11 isan example of a chart containedin the display area.

16

Agilent ChemStore C/S — Database Administration, Backup and Recovery

Agilent ChemStore C/S — Security

Data acquisition, data analysis anddata review are password-protected.Each user must have a valid user-idand a password to log on to theapplication, as shown in figure 12.To be able to transfer data to thedatabase the user must be loggedon to the database. User validationis done on a per database level andalways requires to enter a username and a password. Permissionsfor several tasks like approval orarchival of runs, creation of customfields, report templates, calculationtemplates or studies can be assignedto each individual user. Four usergroup templates for permissionrights are supplied with the reviewclient. They can be used as a starting point for the assignment of the permissions. Note that usersand their security permissions areconfigured separately for each

Agilent ChemStore C/S database.Users and their permissions canbe imported from an existing database during creation of a new standalone database. In aclient/server environment usersare centrally managed in theOracle database.

Electronic signatures andpassword securityAgilent ChemStore C/S uses elec-tronic signatures based on theapplication User-ID/passwordcombination to uniquely identifythe users and their signatures. Inorder to keep the passwordunique to the individual user anadditional security function isimplemented to periodically checkand revise passwords, and applythe company's password policy.

Minimum length is the minimumacceptable length (in characters)of a password. Password validity

is the length of time (in days) overwhich the password remains valid.Minimum password recycle is theminimum number of new, uniquepasswords that a user must usebefore a password can be usedagain.

Figure 12

Password protection of the application

software

Database administrationThe review client provides thegraphical user interface (GUI)through which the user can accom -plish the following administrativetasks. Although the capabilities ofthe entry-level and client/serverversions are to some extent differ-ent, the GUI is identical.• Create a new database–(entry

level database only),• Compact (defragment) a data

base–(entry level database only),• Create or modify a study or

custom fields,• Administer system settings,• Administer users and security, • Manual or automatic archive,

delete and de-archive data (server-only),

• Assign studies to users,• Email notification for example

on security violations (server-only).

The client/server version offerssupplementary tools for administra-tors in the Admin Client to per-form proper maintenance of theserver database, archive/dearchiveor archive/delete functions andother setup tasks. The AgilentChemStore C/S Admin Client is aweb-based application that can berun from any PC on the network.The Admin Client performs thefollowing main tasks on the serverdatabase using a service runningon the server.

• Schedule archive, dearchive and delete operations.

• Modify scheduled operations.• View reports detailing pending

operations. • Review archive and dearchive

history.• View information about

archives, runs and other objects, including a list of all runs in the archive unit.

• Execute archive, dearchive and delete operations immediately.

• Keep an audit trail of all archiveand archive delete operations.

• Add and modify database con-nections to offer connection toa second Oracle database.

17

ing and testing a ChemStore C/SServer Backup and Restore strategy.This strategy should ideally beplanned before the implementationbut Agilent offers both, a serviceprior to the installation as well asa post implementation service.

For this purpose a ChemStore C/SBackup & Recovery strategy paperhas been developed. With thisstrategy paper and by workingwith a customer’s ChemStore C/S

administrator Agilent provides aconsulting service to plan andimplement the right backup andrecovery strategy for your business.

With a working knowledge ofimplementing solutions Agilentuses software from Symanteccalled Veritas Backup Exec Agentfor Oracle™ and BrigthStor ®

Arcserve® with Agent for Oracle,or Recovery ManagerRMAN® from Oracle®.

Database backup and recoveryOne of the most important IT routines is the implementation ofa Backup and Restore concept.Backups and – equally as important– the ability to restore a backupare important tasks in order toprotect business data and labo -ratory investments.

Agilent Technologies can provideassistance in creating, implement-

Agilent ChemStore C/S — Archiving Data

The client-server version providesfor manual or automatic archivingof runs present in the database toa separate file on disk or tape.

Manual archivingManual archiving is done from the“Archive/Delete” view in theChemStore C/S review client andis based on the selected data set. Manual archiving requires the userto have the permission for archival.Individual runs or the whole set ofruns are marked interactively forarchival. These runs are thenscheduled for the next archivaloperation on the server.

Automatic archivalAn administrator with archivalpermission can set up a list ofindividual archive queries forautomatic archiving, which areexecuted at predefined time inter-vals. Each custom query is puttogether from a set of criteria,including for example, injectiontime, sample name, instrument

name, operator name, sequencename, method name, study name,custom field values, approval statusand so on (figure 13). The availableoperands depend on the data cate-gory (text, numeric values, date)

including wildcards and relativevalues (for example, runs “olderthan x days”). For performancereasons the number of clausesthat can be defined for automatedarchival is restricted to 10.

Figure 13

Setup of automatic archive queries

18

Agilent ChemStore C/S — LIMS Connectivity

The sample list must contain aLIMS ID for each sample. ThisLIMS ID is mandatory for sampletracking from and result transferto the LIMS. Optionally additionaltwo fields can be populated withLIMS-specific data.

Result update to LIMSChemStore C/S provides for file-less access to all result datastored in the database as LIMSdata (identified by the LIMS ID).This is achieved through a combination of read-access to allresult data in the database as wellas a controlled write-access forthe LIMS. Prerequisite for resultsto be accessible by LIMS is theexistence of a LIMS ID which isassigned per sequence line. Inaddition a LIMS notification maybe used, which is tied to the

ChemStation Plus can be easilyconnected to a LaboratoryInformation Management System(LIMS). For this purpose theAgilent ChemStation provides fora sample list import function toconveniently translate a work listfrom the LIMS into a ChemStationsequence. An instant, file-lessresult transfer back to the LIMSfrom the ChemStore C/S database(server only) is achieved throughthe integrated ChemStore C/SLIMS interface.

Sample list import from LIMSThe sample list generated by the LIMS can be imported to the Agilent ChemStation as aChemStation sequence in XML-fileformat. XML is a very portable and flexible protocol for inter -connectivity between systems.

approval of data as shown in figure 14. The administrator maydecide which approval level isappropriate to initiate the LIMStransfer. In addition the LIMS can acknowledge data that wassuccessfully transferred to LIMSto exclude it from future updates.

WorkflowThe workflow can be divided into five sequential activitiesshown below:1 The sample list is generated

by the LIMS system in an XMLformat

2 It is imported by the AgilentChemStation and translatedinto a ChemStation sequence

3 Samples are analyzed, resultsare calculated and stored inthe ChemStore C/S relationalOracle database

Each archive query is storedunder a unique user-defined nameand can be executed based on aconfigurable time interval (perquery), for example, daily, weekly,monthly or in conjunction with acounter such as every x days. Atest functions allows the user toobtain information on the numberof runs that the query returns atthe moment with the given querycondition. For each archive querythe name and path for the archiveunit have to be specified. The

filename for the automatic archivefile is appended with the archivaldate, resulting in a file name format“<filename>-yyyy-mm-dd”. Eacharchive query can be disabled whennot required permanently. Aftersuccessful completion of thearchive the data can be automati-cally deleted to create free spacein the database.

Both manual and automaticarchival require re-identificationwith user-ID and password.

A checksum-protected archivecatalog file in XML format is gen-erated with each archive unit,which contains detailed informa-tion about the content of the binary archive file. A genericarchive interface provides a clos-er linkage to other applicationsfor enhanced archive manage-ment (for example, archive man-agement or hierarchical storagemanagement systems).

19

4 Information typically requiredby LIMS systems are instantlymade accessible in theChemStore C/S database (tiedto the existence of the LIMS ID)

5 If enabled on the system or for a specific study, a LIMS notification is triggered upon the approval of data (asconfigured in the approval configuration console)

6 A program from the LIMS systems can scan a table in thedatabase for a specific updateflag to see if any new recordsare available for processing,and can amend the flag so that it is not scanned duringsubsequent scans.

Agilent ChemStore C/S — Installation and Upgrading

Agilent ChemStore C/S data-base migrationThe Agilent ChemStore C/S sys-tem includes a migration utilitywhich enables you to migrate yourAgilent ChemStore C/S data in thefollowing ways:• Migrate Agilent ChemStore

B.0x.0x data (standalone) toAgilent ChemStore C/S B.04.02(standalone).

• Migrate Agilent ChemStoreB.0x.0x data (stand-alone)to Agilent ChemStoreB.04.02 (standalone).

• Migrate Agilent ChemStore C/SB.04.02 data to AgilentChemStore C/S server data.

The standalone version of AgilentChemStore C/S is user-installablefrom the ChemStore C/S CD-ROMand can be added to an existingChemStation installation (AgilentChemStation software family CD-ROM version B.04.01 or higher).

The Agilent ChemStore C/S Oracleclient/server version includes :• ChemStore C/S server

software (included on the ChemStation Plus CD-ROM),

• Oracle 10g standard edition version 10.2.0.4.0 (included inChemStore C/S server softwareon a separate DVD),

• ChemStore C/S client software(on ChemStation Plus CD-ROM).

If you are currently runningAgilent ChemStore B.01.0x,B.02.0x, or B.03.0x on your sys-tem, and you wish to migrate yourdata to the Agilent ChemStore C/Sserver Oracle database, you willneed to migrate in two steps. First migrate to the B.04.02 AgilentChemStore C/S standalone data-base, then migrate from there tothe Oracle database.

Figure 14

Configuration of approval levels and LIMS transfer

20

Agilent ChemStore C/S — Product Options and Configurations

Standalone versionThe complete Agilent ChemStoreC/S standalone software is provid-ed on the Agilent ChemStationPlus CD-ROM as described intable 6a.

Agilent ChemStore C/S serverThe Agilent ChemStore C/S serverproduct includes the ChemStationPlus CD-ROM and Oracle10g revi-sion 10.2.0.4.0 software on a sepa-rate DVD offering one Oracle stan-dard edition license. In addition anapplication-specific full userlicense is required and sold fromAgilent for each additional userrunning a ChemStore reviewclient. Five application-specificnamed user licenses are alreadyincluded with the AgilentChemStore C/S server software.Refer to table 6b for details.

Description Product No.

Software module to add Agilent ChemStore C/S to an existing ChemStation for GC, LC, LC/MSD, CE, CE/MSD or A/D. G2181BA

License to use the ChemStore C/S database module on another computer. G2186BAMust either be on the same order as G2181BA or the customer must supply the license number for the original software. Does not require ChemStation.

ChemStation Plus client upgrade software, upgrades a single ChemStation G1657APlus client to the latest software revision. Requires valid software licenses and ChemStation upgrade software G1656A.

Description Product No.

ChemStore C/S client/server version. Includes ChemStore C/S server software G1410A Oracle standard editions, 5 Oracle application-specific named user licenses. Qty: 1 per server

Oracle named user license for Agilent NDS G1411ARequired for each additional named user Qty: (number of of the ChemStore C/S server database. named users) –5

Software module to add Agilent ChemStore C/S to an existing G2181BAChemStation for GC, LC, LC/MSD, CE, CE/MSD or A/D. Qty: 1 per server

Licence to use the ChemStore C/S review client on another computer. G2186BAIncludes one online ChemStore license for use with an online data acqui- Qty: (number ofsition ChemStation plus an additional offline ChemStore license for clients connectedoffline data review to the server) –1

ChemStation Plus client upgrade software, upgrades a single ChemStation G1657APlus client to the latest software revision. Requires valid software licenses and ChemStation upgrade software G1656A.

ChemStation Plus server upgrade software G1655BAUpgrades ChemStation Plus server software to the latest revision. Includes G1656A ChemStation software upgrade. Requires valid software licenseand can only be ordered along with a Software Maintenance Agreement.

Table 6a

Agilent ChemStore C/S standalone version

Table 6b

Agilent ChemStore C/S client/server version

support of 21 CFR Part 11 byoffering advanced data security,data integrity and full change documentation in audit-trails.Specifications of the ChemStoreC/S database module are availablein the ChemStore C/S section ofthis document.

To achieve data security, theChemStation Security Pack utilizesa combination of Windows useraccounts and file permissions andauditing. In addition, it utilizes anapplication-related second layer ofdata security based on standarddatabase security features. Theapplication-related securityrequires a valid ChemStation Plususer account allowing the log-onto the application. A user withadministrative priviledges canassign appropriate user permis-sions to other users within theChemStation Plus software.

The ChemStation Plus SecurityPack software allows to match usertasks in the laboratory with userroles in the software. It modifiesthe ChemStation operator rights,allowing to routinely operate theChemStation application in theoperator mode. For proper use andto achieve the best data securitycapabilities all users except thosewith administrative functionsshould utilize the ChemStationoperator mode.

To achieve data integrity, all usersare required to log on to a singledatabase. This database (determi-nation of the database connectionrequires the log-on to the Windowsoperating system with a Windowsadministrator account) will storeall raw, meta and result data. In

addition, any recalculation ofresults in the ChemStation willautomatically be recognized as anew result version and will betransferred to the database as anew version. This versioningassures that no data is ever lost oroverwritten and that a completechain of events is documented. Ifa new result version is generatedinteractively, the user is forced toenter a mandatory comment,which is written to the audit trail.

To achieve data traceability, theChemStation Plus Security Packutilizes logbooks and audit trailsthat document who did what, whenand why. These logbooks and audittrails are user-independent andcannot be modified or deleted.

All data is in electronic formatand capable of long-term storagethrough archive/restore as well asviewing and printing in humanreadable format.

Key product features of theChemStation Plus Security Packinclude storage of all chromato-graphic data in a relational data-base, secured through• password protection to access

the data,• full data protection using

Windows security and data-base security features,

• application protection with a mandatory log-in, consisting ofboth identification components- user-id and password,

• user management withindividual user profiles andprivileges for the application –independent of the user privi-leges assigned for the operatingsystem,

21

Product DescriptionThe ChemStation Plus SecurityPack is a module of the AgilentChemStation Plus Series designedto support the requirements of 21 CFR Part 11. In the AgilentChemStation the ChemStationPlus Security Pack modifies dataanalysis and provides advanceddata management with regard tosupporting the requirements forelectronic records. It also offers aprocedure to sign off runs with anelectronic signature. To supportthe typical approval workflow in aregulated laboratory the SecurityPack optionally provides for threelevels of approval which can becombined with run locking. Itoffers an easy upgrade for anexisting ChemStation installation.

The Agilent ChemStation PlusSecurity Pack is compatible with thefollowing ChemStation modules:• Agilent ChemStation for GC,

LC, A/D, CE, CE/MS and LC/MS for instrument control and data analysis

• Agilent ChemStore C/S data organization and data storage module

The UV-Vis as well as GC/MSChemStation offer separate solutionsfor 21 CFR Part 11. Please refer to the specifications of the UVChemStation Security Pack and theMSD Security ChemStation includedin publication number 5989-9914EN and 5989-3015EN, respectively.The ChemStation Plus SecurityPack is available as a standalonesolution or in a fully integratedclient server network connectedto the ChemStore C/S serverOracle database. It provides full

Agilent ChemStation Plus Security Pack2.

• A configurable access to theChemStation commandlineindependent of the ChemStationuser level, thus also preventingaccess for ChemStation managers.

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

• Complete change control documentation for methods andmanual integration changes.

• Four levels of audit-trails for data acquisition, data analysis application tasks and securityviolations.

22

• an application-specific session lock allowing to explicity lockone ChemStation session whileleaving a second instance running on the same PC, and

• a configurable time-based application lock to lock the current ChemStation orChemStore session after a specified time of inactivity andthus avoids any unauthorizedaccess to the application.

• A completely revised ChemStation operator access level which allows operatingthe entire application asChemStation operator.

• Electronic signatures for eachresult version following theguidelines of 21 CFR Part 11.

• Three configurable levels of approval.

• Optionally locking of runs uponthe approval to prevent themfrom further modification.

ChemStation Plus Security Pack — System Requirements

Client hardware requirementsThe following list shows the mini-mum hardware requirements forthis application:• 1.5 GHz Pentium IV processor• 4 GByte of free hard disk space• 512 MB RAM for single Chem-

Station instrument. • 1 GB RAM for two Chem-

Station instruments • Display: 1280 x 1024,

small fonts, true colors• For Windows Vista operating

systems the minimum require-ments in respect to processor speed and memory are:3.4 GHz Pentium IV1 GB RAM

Client software requirementsThe following list shows the mini-mum software requirements forthis application:• Windows Vista Business Ed.

with Service Pack 1 or WindowsXP Professional Service Pack 2

• Agilent ChemStation revisionB.04.01 or later

• Microsoft Internet Explorer7.0 or later

• A local or network printer must be installed and configured.

• The hard disk partition that isused for installation of SecurityPack must be formatted withNTFS.

The standalone database size islimited to 800 MB due to somestrict size limitations in the under-lying file format. To ensure opti-mum performance for later data

review Agilent strongly recom-mends not to exceed this databasesize limit. A configurable size-checking tool automaticallylaunches a warning message whenthe specified size limit is reached.

If a larger single database isrequired, Agilent recommends thatthe client/server version of theproduct be purchased. The client/server database uses Oracle,which allows for a much largerdatabase. Table 9 gives some dataon the time required for down-loading data from the standalonedatabase into the active memoryof the client. The time mainlydepends on the size of the stand-alone database, the number ofruns marked for download and

Data protectionUsing the Security Pack in thestandalone version, all data isstored in a single database file. Thesubdirectory storing the databasefiles is protected with Windowsfile security permissions and onlyallows write access for membersof the Windows user group.

The application denies access todata without a valid ChemStationPlus user-id and password. Anyattempt to access the data in thestandalone database directly withanother application such asMicrosoftAccess fails as itrequires a password/user-id com-bination that is strictly confiden-tial and only known by Agilent. Itis not known by or given to anyAgilent customer or user of thisproduct.

In client-server installations ofChemStation Plus Security Packdirect, uncontrolled access to datain the Oracle database withoutusing the ChemStore user interfaceis virtually impossible. This isbecause users must have a validOracle user account and theymust have access to the data dic-tionary describing the meaningand contents of the Oracle tablesand table columns. The dictionaryis only available from AgilentTechnologies against a writtenConfidentiality Agreement andshould not be available for appli-cation users. Overall the attemptto falsify or delete data requiresthe collaboration of the user andthe database administrator thatprovides the direct databaseaccess. Sufficient security constraints need to be imposedwithin the organisation to preventany uncontrolled modifications.

23

the performance charactistics ofthe computer. All runs were storedwith raw data, methods, sequences,and all result versions. Tests wereperformed on a PC with an IntelPentium IV Dual Core processor, 2 GHz, 2 GB RAM, and no dataacquisition running in the back-ground).

Database Size No. of peaks No. of runs No. of runs loaded from database Time [s]

670 MB 71,000 5,200 100 41900 16

350 MB 26,000 1,300 100 3500 6

120 GB 2,000,000 500,000 100 131700 36

Table 9

Run download time depending on the number of runs selected for download and

the database size.

Working with ChemStation Plus Security Pack

Result management The ChemStation Plus SecurityPack is designed to storeChemStation data in a relationaldatabase by transferring it as apost-data analysis spooling job tothe database. Depending on thelaboratory workflow the dataanalysis can also be separated from the acquisition. In this caseonly raw and meta data are automatically spooled to the database, without a first set of dataanalysis results (data is acquiredin acquisition-only mode). TheChemStore C/S ODBC spooler is a proprietary tool managing thetransfer and protecting dataagainst loss, modification or damage in case of transfer problems or network errors.

the database). From then on, thedata security mechanisms of thedatabase itself secure the data.The temporary directory wherethe database spooler stores inter-mediate data is protected usingWindows NTFS file and foldersecurity.

If a first pass review in theChemStore review client results in the need for some reanalysiswork, for example reintegration,the data is submitted as a batch to ChemStation. This requiresrestoring data files to a temporarysubdirectory. The Security Packprotects this subdirectorychem32/x/data/chemstor where xis the instrument session numberwith read-only access for membersof the Windows users group thusdenying unauthorized access foroperators.

Configuration and data protection using Windowssecurity featuresFor security reasons, a user mustbe a member of the Windows user

group Administrators or Power

Users to access the configurationof the ChemStation Plus SecurityPack. It restricts access to all datadirectories on the local PC withimportant information using theWindows users group privileges.The default configuration automat-ically sets all directory permis-sions and access limitations aspart of the installation using theWindows groups “Users”, “PowerUsers” (on Windows XP only) or“Administrators”. Each ChemStationuser has to be member of eitherone of the groups.

Note:

Normal users must not be members of the WindowsAdministrators nor Power Usersgroups. The membership to thesegroups should be dedicated forsystem administrators.

Table 10 gives an overview of thepermission rights that are limitedto members of the WindowsAdminstrators and Power Users(XP only) groups.

Data storageBy default the the database storesthe following data:• calculation results of the

ChemStation,• contents of the ChemStation data

directories; the *.d directoriesincluding the chromatographicraw data files,

• current method used for dataacquisition and data analysis,

• current sequence, if a sequencewas run to acquire or reprocessdata,

• sequence, run and method logbooks,

• detector channel chromato-grams as images according to the report configuration of the method, and

• apex spectra of all identifiedpeaks in a chromatogram, whenusing a 3D detector.

• Optionally all peak performanceparameters independent of theChemStation method.

Protection of temporary datafilesThe ChemStation uses a givendata directory structure to storeacquisition and result data. TheChemStation Plus Security Packalso protects this data. After com-pletion of data acquisition and afirst result calculation, by defaultthe data transfer is immediatelyinitialized through the ChemStorespooler and the *.d directory withall its contents is deleted from thelocal hard disk (these default settings can only be modified by auser with administrative rights in

User task Granted to members of Granted to member of Power Windows User group Users or Administrators group

Create a new MS Access database no yesConfigure database Alias no yesAccess the ChemStore ODBC spooler to resume interrupted data transfer yes yesAccess to the selection list of available databases no yes

Table 10

Tasks requiring membership in the Windows Administrators or Power Users group

24

privileges compared to the standardChemStation for data acquisition.The ChemStation Manager alwayshas access to all tasks within theChemStation with the exceptionof access to the ChemStation command line. Unlike the standardChemStation this privilege can be

assigned individually and is nottied to any ChemStation user level (see figure 15). A detaileddocumentation of the data reviewuser privileges in the ChemStoreC/S database is in the ChemStoreC/S concept guide.

User management andChemStation Plus SecurityPack user access rightsSecurity Pack provides a fullyintegrated user management thatis independent of the Windowsoperating system. The user management covers both theChemStation Plus data acquisitionand data analysis tasks and theChemStore C/S database datareview privileges. The entire useradministration itself is a user-privilege granted to administratorsin the ChemStore C/S database. TheChemStation Plus Security Packincludes a modified ChemStationoperator level allowing operators toperform all important acquisitionand data analysis tasks for dailyoperations. Table 12 shows themost important changes in user

25

Local directories storing relevantchromatographic data are alsoprotected with Windows file anddirectory permissions. Table 11gives an overview of the Windowspermission rights on the datadirectories and files on the localhard disk. The first item in brack-ets displays the permission rightson the folder; the second item displays the individual file permission rights.

Note:

Windows file security does notgive any access to a folder or directory for users that do nothave access rights to the folder,even if the user has control overthe files in the folder. Table 11

Directory and file permissions [(directory)(file)] set by the ChemStation Plus

Security Pack [W=write, R=read, X=execute, D=delete, full=all permissions]

File path Permission Permission Windows Directory/file Data directoryWindows Administrators owner contentsUsers or Power Users

\chem32\chemstor (W)(full) (full)(RWXD), All members of Contains \database local Admini- database *.mdb file

strators or Power storing all raw andUsers group meta data

\chem32\chemstor (WX)(full) (full)(RWXD) All members of Spooler jobs and \spool local Admini- data files

strators or PowerUsers group

\chem32\chemstor none (full) All members of Access to ChemStore \hputil00.exe local Admini- utility tool to create/

strators or Power copy and manageUsers group local database files

\chem32\X (instru- (WX)(Full) (full)(RWXD) All members of Stores data files re- ment session num- local Admini- loaded from Chem-ber)\data\chemstor strators or Power Store database to

Users group ChemStation batchreview

ChemStation Plus Security Pack — User Management and Application Security

User privilege Security pack operator ChemStation operator

Save acquisition method no noSave data analysis method yes noLoad/run/save sequence yes yesModify acquisition parameter yes yesRe-Integrate chromatograms manually only in batch review noChange integration events only in batch review noRecalibrate overview and peak summing only in batch review noRecalibrate other no noApply method to data and print report yes yesUser-independent automated result versioning yes noAccess to tasks with manual result versioning no no

Table 12

Comparison of user privileges in the ChemStation Plus Security Pack and the

standalone ChemStation

base to unlock the session, for example during shift changes (figure 16). If a dialog is still open the application will automatically lock privately.

26

Application securityThe Security Pack only allows userswith a given user-ID to log on tothe ChemStation Plus application,as shown in figure 12. Users needto be set up by the administratorto gain access. At initial login, usersmust specify their initial passwordin order to keep it unique to eachuser. Protecting the applicationsoftware from unauthorized accessduring operation is possible with aseparate session lock (figure 16).This lock function offers • an interactive session lock which

should be enabled manuallybefore leaving the computerunattended, e.g. during a breakor shift change, and

• for enhanced security a time-based automated lock of thesession for other periods ofshort-term absence from thecomputer.

The time-based session lock isconfigured centrally through userswith administrative rights in theChemStore C/S database, and is automatically applied on allconnected ChemStation Plusclients. The session lock allows to lock each instrument sessionindividually and independently, sousers sharing computers with twoor more instruments connected toone computer can operate with aclear user distinction and uniqueuser identification. The name ofthe current user and the instrumentsession are always shown in thetitle bar. The instrument sessionscan be locked either • privately, allowing only the user

who locked the session or anadministrator to unlock it, or

• non-privately allowing all users with a valid user-ID in the data-

Figure 16

Instrument session lock

Figure 15

User Management in ChemStation Plus Security Pack

ChemStation Plus Security Pack — Data Integrity, Automated Result Versioning and Data Reanalysis

In addition, ChemStation Plusmanagers can perform manualresult manipulation interactivelyin the Data Analysis view withou-tusing the batch review user inter-face. The user-independent revi-sion management does not coverthe manual reanalysis of results inthe standard ChemStation dataanalysis view. The user createsnew result versions in this reviewfunction by generating a reportpreview(figure 18).

The following manual tasks in the Data Analysis view, outside of batch review, require a userselected Transfer Data to Database

command to create a new resultversion:• drawing a manual baseline, • deleting a peak, • tangent skimming of one peak,• splitting a peak, and • integrating manually with a

negative baseline.Access to tasks with a user-dependent creation of new resultsis the only difference in the result management between the ChemStation Security Pack manager level and the ChemStationSecurity Pack operator level. The new result version in the database is the same for bothautomated and user-dependentdata transfer.

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Data integrityThe Security Pack maintains fulldata integrity by storing all resultsalong with the raw and meta datain a relational database as shownin figure 17.

Result revision managementDaily work in the analytical labo-ratory often requires samplereanalysis. The ChemStation PlusSecurity Pack includes a resultversioning that stores all recalcu-lation results from one originalinjection as result versions. Inaddition, the application softwareincludes a tool that automaticallydetects new results during thereanalysis process. This applica-tion-controlled automated processdoes not require any user interac-tion such as Save Results or a similar action. It is completelyuser-independent and covers thefollowing reanalysis steps:• All functions in the batch review

that calculate or change resultssuch as reintegration, recalibra-tion, method modifications (forexample changing compoundnames) execution of predefinedmethods including manual reintegration

• In the data analysis view: Integrating, printing reports andrecalibration excluding manual reintegration

Sequence reprocessing as well asall initial review tasks (loading abatch from disk, initial loading ofa run into the interactive dataanalysis view) always create newresult versions. These reanalysistasks cover all activities of theChemStation operator thus ensur-ing that all reanalysis steps at theChemStation operator level includea user-independent versioning. Figure 18

Manual revision management

Figure 17

Default configuration of data storage in

database

Application Note “Handling ofElectronic records withChemStation Plus” publicationnumber 5988-9643EN.

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User-independent, automatedresult version managementThe data storage includes an appli-cation controlled version manage-ment that is based on the creationof a result reference file. Prior toreprocessing, the application soft-ware creates a binary result registryfile called save_sec.reg for each file.This save_sec register is storedalong with the raw data. It includesall numeric results of the currentresult revision in a binary format,such as amount, compound reten-tion time and so on. Whenever anew result is calculated, the soft-ware automatically compares thenew run result with the originalresult in the register file. If theresults changed, the softwaredetects the difference between themost recent and the current resultand creates a new result version.

For proper documentation of thechanges, the application softwarecreates a second file in a humanreadable format that stores theresults of the comparison and documents the changes. The file isnamed sec_trac.txt and is storedalong with the raw data in the *.dsubdirectory, as shown in figure 19).Both the registry and the text fileare also stored in the databasealong with the raw data and theycan be restored to disk with thedata file, if necessary. Thesechanges including manual integration events are also docu-mented in the Manual IntegrationEvents section of the ChemStoreaudit-trail as shown in figure 20.The audit trail as well as thesec_trac.txt can be used in order toregenerate the result from raw andmeta data at any time, for examplein an audit situation (see also

Figure 19

Text file documenting result changes for the actual run revision

Figure 20

Manual integration events documented in ChemStore run audit-trail

the database. Each data transferof new results creates a new ver-sion entry in the database so thatno data is ever overwritten. Theversioning also assures that no“data” is lost and that a complete“chain of events” is documented.This ensures full data integrity andtraceability.

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Summary of version manage-ment in the ChemStation PlusSecurity PackEach time a new result is calculat-ed in the ChemStation, the appli-cation compares the values withthe result values of the lastreprocessed result copy. If itdetects a difference, it automati-cally initializes the data storage in

ChemStation Plus Security Pack—Graphical Result Review and Calculation

calculation section. The applica-tion allows a graphical rework ofthe chromatogram for each runthat was included in the batch.This is done by setting new integration events and applyingmanual events such as baselinedrawings and others without animmediate transfer to the data-base. The transfer is initiatedautomatically as soon as the userhas finished his work and decides

to calculate the results with thenew settings by moving to thenext run or starting an automatedresult recalculation (figure 21). Assoon as new results are created,the result transfer to the databaseis performed either for the singlerun, or if starting an automatedresult recalculation, for allreprocessed runs. During thetransfer of manually integrateddata the user is prompted for amandatory comment that is writtento the results audit trail. The comment can be either a selectionfrom a set of predefined commentsor a free text or a combination ofboth. After finishing the datareanalysis and closing the batchreview interface, the temporaryfiles will be deleted from the localhard disk.

The graphical result review forexample inspecting the baselineof the chromatogram or zoomingin to check the integration, isdone in the ChemStore reviewclient. If any further rework isrequired the data is submitted tothe ChemStation batch reviewuser interface for data reanalysis.In batch review the ChemStationPlus Security Pack allows splittingthe review into a working and a

Figure 22

Result calculation and automated versioning

Agilent ChemStation Plus Security Pack—Graphical Result Review and Calculation

ChemStation Plus Security Pack—Electronic Signatures and Password Security

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21 CFR Part 11 permits the use ofelectronic signatures if the appli-cation ensures data integrity, datasecurity and full audit-trail docu-mentation. If an electronic signa-ture is supposed to be equivalentto a handwritten signature it mustcontain at least two distinct identi-fication components such as an identification code and a password.

Approval of resultsThe ChemStation Plus SecurityPack protects all activities thatcreate, modify or delete electronicrecords with user privileges andelectronic signatures. Signing forapproval is a privilege that mustbe configured and granted by thesystem administrator and is there-fore limited to certain users.Signing runs for approval or rejection always prompts for a re-identification and passwordconfirmation of the signer for eachrun, plus a mandatory comment forthe sign off, as shown in figure 22.The signer has to be the currentlylogged-on user.

ChemStation Plus provides threelevels of approval tied to two separate user permissions to support the typical approval work-flow in an analytical laboratory. Itcan be configured on a study levelwhether multiple approval levelsshould be applied or not. Theapproval configuration is part of the study settings. For newstudies the settings from the globalapproval configuration template arecopied to the study. The approvalconfiguration is shown in figure 23.

Figure 22

Signing off results requires reentry of user-ID with password confirmation and a

mandatory comment

Figure 23

Global approval configuration template

or change the free-text comment.The approval comments aredefined by the administrator in theglobal approval configuration tem-plate.

All other sensitive actions (forexample, changing run-relatedcustom field values such as thebatch ID) and the archival or deletion of runs follow the sameprocess as described above andare tied to distinct user permissions.All electronic signatures are notedin the individual sample audit-trailand in the database logbook.

The ChemStation Security Packuses electronic signatures based onthe application User-ID/passwordcombination to uniquely identifythe user and his or her signature.In order to keep the passwordunique to the individual user anadditional security function isimplemented to periodically checkand revise passwords, and applythe company's password policy(figure 24). The administrator can specify the values for theseconditions.

• Minimum length is the minimumacceptable length (in characters)of a password. Passwordsshorter than the minimumlength are invalid and rejectedby ChemStore C/S. The defaultis eight characters with a validrange between 0 and 30.

• Password expiry date is thenumber of days over which thepassword remains valid. Thepassword expires after thespecified validity, and a new password must be provided.The default is 90 days with a

valid range between 1 and 32000.• Password uniqueness is the

minimum number of new,unique passwords that a usermust use before a password canbe re-used. The default is 12,which means that a user mustchange the password at least 12times before re-using the originalpassword. The range is between0 and 32000.

• Account lockout after ‘x’attempts (where ‘x’ is the number of failed log-on attempts)is the maximum number of consecutive unsuccessfulattempts that a user can enterbefore ChemStore rejects theuser. The default is three with a valid range between 0 and32000. If the maximum numberof re-entries is reached, the current user is invalidated andmust be reactivated by a userwith the required permission.

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The operator will typically givethe first level approval whenreviewing his results. To allow forpeer reviews the application sup-ports multiple first levelapprovals. The second levelapproval lies in the responsibilityof the laboratory manager whensigning off the results and pre-vents a signed run from furtherfirst level approvals, unless therun is rejected. The third levelapproval (equals a 2nd secondlevel approval) can serve as thefinal sign-off by the quality controldepartment. It requires the signinguser to have the second levelapproval permission. After thethird level approval no more sig-natures can be applied unless therun is rejected. Optionally runscan be locked from reanalysisafter the approval (see figure 23).Which level finally locks the run isconfigurable. The administratorassigns the permissions for thedifferent approval levels to theusers.

Preconfigured approval commentsThe ChemStation Plus SecurityPack provides the ability to globallydefine approval comments. These comments consist of twocomponents - a short fixed text thatcannot be modified nor deleted bythe signer and a pre-defineddefault text that can be changedduring the signing. These twocomponents appear during theapproval. The signer has to choose a fixed comment from thedropdown list box containing thepre-configured comments as shownin figure 22 and can optionally enter

Figure 24

Password policy

ChemStation Plus Security Pack — Audit-trails and change documentation

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The Agilent ChemStation PlusSecurity Pack includes four audit-trails:• run logbooks, • method revision history data,• sample audit-trail, and • database logbook.

Run and sequence logbookDuring data acquisition, all eventsare documented in the sequenceand run logbooks with date andtime stamp (figure 25). Thesequence and run logbook documents all data acquisitionevents such as• start and execution of methods• the actual sequence line in the

sequence table,• any failure during method

execution, and• any modification of method

parameters during the analysis,such as manually extending therun time

• initialization of data spooling tothe ChemStore C/S database.

Method changesThe method changes are storedwith each current method versionincluding a mandatory user comment for the change (figure 26).The method audit-trail stores• the time of change and the

operator who performed the change

• the current method revision in the database, and

• a mandatory comment of at least five characters each time the method was saved to disk.

Sample audit trailThe sample-related audit-trail,shown in figure 27 documents • all changes and modifications,

on one sample,

• all run versions,• all user comments during

reanalysis cycles, and• a detailed change documentation

of manual integration events.• all approval events including

the name of the approver, date& timestamp, approval com-ment and the level of approval.

All reanalysis events and resultversions are documented in thesample audit-trail. The sampleaudit-trail creates for each resultchange one new line in the audit-trail table. It displays both theinteractive manual changes andthe system generated entries each

Figure 25

Run and sequence logbook

Figure 26

Method change audit-trail

Figure 27

Audit-trail table with manual change documentation in the comment field

Review of method parametersEach result version is associatedwith its ChemStation method that isstored in the relational ChemStoredatabase. To inspect the differencesin method parameters betweenresult revisions or to review amethod that was used to generatea specific result the applicationprovides direct access to themethod information from theChemStore user interface. Allmethod parameters, includingacquisition parameters, data analysis parameters and calibrationinformation can be reviewed inread-only mode as well as printed.The method report header con-tains information on

• the associated result version, • method name, • method modification date, • study name, • database name, • sample name, • injection date and • acquisition instrument.

Changes to method parameters canonly be applied in the ChemStation.For this purpose the method hasto be restored from the database.New result versions generatedwith the modified method arespooled to the database alongwith the method.

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in a separate line. Examples formanual interactive changes are:• change of custom field values • manual reintegration during

reanalysis,• approval, rejection and retransfer

to batch,• reloading data to disk,• archiving and dearchiving, and• re-opening of read-only runs.

The automated entries in the sample audit-trail are created when• a run is transferred to the

database • a new result version is created• a run is reloaded in the

ChemStation batch review interface for reanalysis.

Database logbookThe database logbook (figure 28)stores all application related activ-ities such as:• log-on/log-off events and failed

logon attempts, • archive/delete/reopen activities,• session locks and unlocks,• approval and rejection of runs,• modification of custom fields

and custom field values,• changes in user administration,• modification of user

permissions,• password resets and password

clearance, and• database migration from

Access to Oracle.• Account lockout events.

Figure 28

Database logbook

Agilent ChemStation Plus Security Pack — E-Mail Notification

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The email notification feature(client-server only) allows to sendan email to a configurable list ofrecipients on the event of• account lockout• batch submission• user permission change• user creation

For each event the recipients canbe defined separately as well as auser-defined message text andsubject.

This function requires an e-Mailserver to be running in the network.The e-mail message can be trans-ferred to the e-mail server throughSimple Mail Transfer Protocol(SMTP). For example this canserve for the purpose of instantnotification on unauthorizedattempts to access the database.An e-mail message can be triggeredby account lockout events in theChemStore C/S database logbook.(figure 29).

Figure 29

Setup of e-mail notification

ChemStation Plus Security Pack—Product Options and Configuration

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Standalone versionThe standalone version providesthe ChemStation CD-ROM revisionB.04.01 or higher and the Chem-Station Plus CD-ROM revisionB.04.02 or higher as described inthe table next to this text.

Client/server versionThe client server/version of theproduct consists of a set of components that are required toimplement ChemStation PlusSecurity Pack in a client/serverversion. The product number arelisted in the table next to this textalong with the required quantities.

Description Product No.

ChemStation Plus Security Pack. G2183AAAdds the secure ChemStore C/S relational database add-on software 1 per PCmodule to the ChemStation Plus SW for A/D, GC, CE, LC and CE/LC-MSD. 1 per laboratorySupports 21 CFR Part 11. Includes user documentation, licenses and media.

License to use G2183AA on another PC. G2187AAIncludes license and user information only. Supports 21 CFR Part 11. Must 1 per PC be in thebe on same order as G2183AA or requires a valid license for G2183AA. same laboratory

ChemStation Plus client upgrade software. G1657AUpgrades a single ChemStation Plus client to the latest software revision. Requires valid software licenses and ChemStation upgrade software G1656A.

Description Product No.

ChemStore C/S server application software. G1410AIncludes:1 x ChemStore C/S and Oracle 9i standard edition software, Qty: 1 per server5 Oracle application-specific named user licenses are included.

Oracle named user license for Agilent NDS G1411ARequired for each named user of the ChemStore C/S server database. Qty: (number of

clients connectedto server) – 5

ChemStation Plus Security Pack. G2183AAAdds the secure ChemStore relational database add-on software Qty: 1 per servermodule to the ChemStation Plus client server SW for A/D, GC, CE, LC and CE/LC-MSD. Supports 21 CFR Part 11.

ChemStation Plus ChemStore client license. G2186BAIncludes one online ChemStation Plus license for online data acquisition Qty: (number ofand one ChemStore C/S offline data review license. clients connectedIncludes license and user information only. to server – 1Requires but does not include ChemStation Plus software media.

License to use G2183AA on another PC. G2187AACan be used as additonal copy for standalone installations or 1 per PC in the as additional Security Pack client in ChemStation Plus Security Pack C/S same laboratory.installations. Includes manual, 1 license for either online or offline useand media. Supports 21 CFR Part 11 Must be on the same order as G2183AA or requires a valid license for G2183AA.

ChemStation Plus client upgrade software. G1657AUpgrades a single ChemStation Plus client to the latest software revision. Requires valid software licenses and ChemStation upgrade software G1656A.

ChemStation Plus server upgrade software.upgrades ChemStation Plus server software to the latest revision. G1655BAIncludes G1656A ChemStation software upgrade. Requires valid software license,and can only be ordered together with a Software Maintenance Agreement (SMA).

Installation, Qualification Services and Training

www.agilent.com/chem/cds

The information in this publication is subject tochange without notice.

Microsoft® and Microsoft Windows® are U.S. registered trademarks of Microsoft Corp.MDS™ is a trademark of RSA Data Security, Inc.Oracle®, and RMAN® are U.S. registered trademarksof Oracle Corp. BrigthStor® and Arcserve ® areU.S. registered trademarks of Computer AssociatesInternational, Inc. (CA).

© Copyright 1999-2009 Agilent Technologies Inc.

Published in Germany, February 1, 2009Publication Number 5990-3718EN

TrainingAgilent’s ISO-registered trainingscan save you time, help keep yourlaboratory operating costs low,broaden your capabilities, andensure that your laboratory complies fully with regulatory and quality requirements.For your convenience, standardizedcourses are offered in selectedlocations worldwide. Onsitecourses can be tailored to yourspecific needs.

Installation and familiarizationAgilent Technologies’ installationand familiarization service ensuresthat the Agilent ChemStation Plusis installed correctly and in theright environment.

In addition, Agilent offers a rangeof on-going support services tohelp:• get your system up and running

fast,• resolve problems quickly,• keep productivity high,• extend instrument life, and• comply with regulatory quality

requirements.

Qualification services• Agilent Technologies offers a

full range of qualification services to provide the evidenceyou need to satisfy the requirements from agenciessuch as the U.S. Food and Drug Administration (FDA), theU.S Environmental ProtectionAgency (EPA), the InternationalStandardization Organization(ISO), and the Organization forEconomic Cooperation andDevelopment (OECD).

• Installation qualification (IQ)service

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