The EZChrom Elite Chromatography Data System is in widespread use in a number ofchemical analysis laboratories throughout the world. It has been used in many differentlaboratory markets including pharmaceutical, environmental and the petrochemical/chemical market. A number of built-in software capabilities position EZChrom Elite ideallyfor the Pharmaceutical and GLP/GMP industry.

Scalable CDS OperationScalable CDS OperationScalable CDS OperationScalable CDS OperationScalable CDS OperationEZChrom Elite is designed as a scalable CDS software application, that can be readilydeployed as a single user/single instrument system to a multi-user/multi instrument client/server application. In this way, EZChrom Elite is particularly well suited for the pharmaceuti-cal and GLP/GMP industry as it can be flexibly deployed for a particular laboratoryoperation and then easily scale as the laboratory environment grows and changes.

EZChrom Elite™ CDSFeatures for the Pharmaceutical andGLP/GMP Laboratory

Key BenefitsKey BenefitsKey BenefitsKey BenefitsKey Benefits

• Fully address 21 CFR Part 11 and GLP/GMP issues to facilitate compliance.

• Be efficient with a single cost effectivesolution with control of over 300 analyticalinstrument modules from 26 differentmanufacturers or analog acquisition fromany source.

• Protect your investment with a scalablesolution, from workstation to enterpriseclient/server deployments.

• Enhance productivity and tailor a solutionwith RapidControlTM and EZChrom EliteAutomation ToolBoxTM technologies.

• Respond automatically and intelligently toreal world conditions withSmartSequenceTM technology.

Regardless of whether EZChrom Elite is used for a single user ormulti-user environment, the same core software is used to ensurea uniform software interface for all environments.

Multi-Multi-Multi-Multi-Multi-VVVVVendor Instrument Control for HPLC and GCendor Instrument Control for HPLC and GCendor Instrument Control for HPLC and GCendor Instrument Control for HPLC and GCendor Instrument Control for HPLC and GCDesigned to provide integrated instrument control with CDS datahandling capabilities, EZChrom Elite can offer instrument control formore than 300 different GC and HPLC instrumentation. Moreover,as part of Agilent Technologies’ “open” system approach, theinstrument control capabilities in EZChrom extend to leadinginstrument vendors such as Agilent, Shimadzu, Thermo Electron,Varian, PerkinElmer, Waters and others. Laboratories in thepharmaceutical and GLP/GMP industry are often populated with anumber of manufacturer’s equipment, many of differing genera-tions, will appreciate the ability of EZChrom to effectively controland process data from these multi-vendor environments. End userscan work with one single software platform to make softwareoperation easier and more efficient in support of this wide variety ofdifferent instrumentation.

EZChrom’s integrated instrument control is extensive and deep,taking advantage of many of the specific features and capabilitiesin each HPLC or system. Many HPLC’s equipped with PDA or DiodeArray Detectors, for example, can be supported so that pharma-ceutical laboratories interested in processing PDA data with theirHPLC runs can take full advantage of this capability in EZChrom.Extended calculations for peak purity and component matching areavailable.

Software Features Specific for Pharmaceutical NeedsSoftware Features Specific for Pharmaceutical NeedsSoftware Features Specific for Pharmaceutical NeedsSoftware Features Specific for Pharmaceutical NeedsSoftware Features Specific for Pharmaceutical NeedsIn addition to addressing data reduction commonly used by theseoperations, EZChrom provides some key features that are ideallysuited for the pharmaceutical and GLP/GMP operation.

1. Data File Integrity:Data File Integrity:Data File Integrity:Data File Integrity:Data File Integrity: EZChrom Elite files are provided withstandard features ensuring ensuring file integrity – “tamper-ing” with files (access to files outside of the intended softwareapplication) is controlled through the use of embeddedchecksums to ensure file integrity at all times.

2. Data File ProtectionData File ProtectionData File ProtectionData File ProtectionData File Protection: : : : : EZChrom Elite will not allow a user to“overwrite” a file. Reprocessing files appends the new resultsto the end of the data file, preserving all previously accumu-lated information.

3. T T T T Traceability and Recovery of Changesraceability and Recovery of Changesraceability and Recovery of Changesraceability and Recovery of Changesraceability and Recovery of Changes: : : : : EZChrom Elite’sunique compound data file structure allows for total traceabil-ity of results. Each data file contains the raw data, acquisitionparameters, instrument configuration and audit trail. Each timethe file is analyzed, a copy of the analysis parameters andresults are appended to the original file. Even though a datafile may have undergone a series of re-analyses, it is alwayspossible to recover the original (or any intermediate) analysisand instrument parameters and results, as well as theinstrument parameters used to generate the original file.

4. User Security Features:User Security Features:User Security Features:User Security Features:User Security Features: EZChrom Elite has a built-in optionto setup user accounts with control of access and operationalprivileges on an instrument by instrument or project by projectbasis. By controlling who has access to a particularinstrument you can address concerns where you wish torestrict “unauthorized” operation of an instrument. Bycontrolling who has access to a project, you can addressconcerns where you wish to restrict who can “see” certaindata.

5. Audit TAudit TAudit TAudit TAudit Trails, System Logs, and Instrument Logs: rails, System Logs, and Instrument Logs: rails, System Logs, and Instrument Logs: rails, System Logs, and Instrument Logs: rails, System Logs, and Instrument Logs: EZChromElite provides features to track and record changes to files andto the system. Audit Trails are maintained for any changes to

For example, EZChrom Elite today offers instrument controlcapabilities for virtually all of the world’s leading commercial HPLCsincluding the Agilent 1100 HPLC, Waters Alliance HPLC, ShimadzuLC 14, 17, 20A, and 2010 HPLC, Hitachi La Chrom and La ChromElite HPLC, Jasco series 2000 and 1500 HPLC, Thermo ElectronSpectraSYSTEM and PerkinElmer Series 200 HPLC. No other CDSpackage offers this broad range of integrated instrument control.Moreover, many of the world’s leading instrument specializeddevices such as high throughput precision autosamplers from CTCAnalytics, or the charged aerosol detector from ESA can be readilyadded and controlled to EZChrom for a completely integratedsolution.

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methods, sequences and results. These audit trails recordwho made the change, what was changed, when the changewas made, and why (the reason) for a change. System andInstrument logs provide a systematic unambiguous record onall changes to the system and activities on the instruments.

6. Electronic Signatures and Signoff Capabilities for 21CFRElectronic Signatures and Signoff Capabilities for 21CFRElectronic Signatures and Signoff Capabilities for 21CFRElectronic Signatures and Signoff Capabilities for 21CFRElectronic Signatures and Signoff Capabilities for 21CFRPart 11: Part 11: Part 11: Part 11: Part 11: If desired, you can use Electronic Signatures inEZChrom Elite in accordance with 21CFR Part 11 rules.Flexible signoff procedure to allow multiple levels of signaturefor submission, review, approval, etc. if desired. One to 5levels can be used. Other GLP/GMP features including UserSecurity (passwords, controlled access), Audit Trails, Systemand Instrument Logs, etc. address all 21CFR Part 11 issues.

7. Agilent Instrument Controller Network Appliance forAgilent Instrument Controller Network Appliance forAgilent Instrument Controller Network Appliance forAgilent Instrument Controller Network Appliance forAgilent Instrument Controller Network Appliance forNetworked Data Acquisition Addresses GLP/GMP Issues:Networked Data Acquisition Addresses GLP/GMP Issues:Networked Data Acquisition Addresses GLP/GMP Issues:Networked Data Acquisition Addresses GLP/GMP Issues:Networked Data Acquisition Addresses GLP/GMP Issues:EZChrom’s unique system architecture through the AgilentInstrument Controller allows networked access to all instru-ments and can be especially important to the pharmaceuticaloperation. It provides a “closed” system design to controlunauthorized use and access. Its powerful data bufferingcapability maintains data acquisition even if network isinoperative.

8. Controlling Changes to the SystemControlling Changes to the SystemControlling Changes to the SystemControlling Changes to the SystemControlling Changes to the System: In a perfect world, userscould setup their CDS and then simply run the samples,without ever needing to make changes once acquisition hasbegun. But in the “real world”, this rarely happens. How wella system controls these changes is important to a GLP/GMPlaboratory. Whenever data is analyzed (or re-analyzed) inEZChrom, the results are appended to the data file and aretraceable. Original results or intermediate results can berecalled and viewed — they are never overwritten. UserSecurity lets you control access to your methods andsequences. In this way, you can restrict who can work withyour methods and sequences. You can permit other users touse your methods but not change them. Changing activelyacquiring sequences: Once a sequence has been started,users with the proper authority can modify the method andthe system will automatically ensure that the changed methodis used for the next injection. If a run has already started youcan shorten or EXTEND the run time. Depending on thehardware control, you might be able to change someconditions (change temp, flow rate via direct control toolbar).Any of those changes are put into the Audit Trail.

Wide Range of Flexible ReportingWide Range of Flexible ReportingWide Range of Flexible ReportingWide Range of Flexible ReportingWide Range of Flexible ReportingEZChrom Elite puts ultimate report customization and automationfor many pharmaceutical operations. In addition to a wide selectionof ready-made, desktop publishing-quality report templates tailored

to general methods, EZChrom Elite also allows custom-madereports to address specific needs. Reports can be appended withany data originating from EZChrom Elite, including run, calibration,system suitability, and even summary reports. Custom parametersspecific for the analysis can be easily added to reports for extendedcustom calculations.

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Practical Automation FeaturesPractical Automation FeaturesPractical Automation FeaturesPractical Automation FeaturesPractical Automation FeaturesUsing SmartSequence™ technology, EZChrom Elite enablesintelligent analysis and decision-making by providing “go/no-go”acceptance of results. This powerful capability allows thepharmaceutical lab to setup truly automated system suitabilitytesting. Conditional actions to re-calibrate, run shutdownmethods, even issue automated e-mail alerts in case of deviationof expected results can be established for each HPLC EZChromreports and data can be easily generated in appropriate format forthird party applications such as Excel though built-in format options.

21 CFR Part 11 Compliance21 CFR Part 11 Compliance21 CFR Part 11 Compliance21 CFR Part 11 Compliance21 CFR Part 11 ComplianceEZChrom Elite’s security and compliance tools enable adherence toregulations such as the FDA’s 21 CFR Part 11 for electronic recordsand signatures. Audit trails are comprehensive, recording everyevent starting from file creation. Once electronically signed, datafiles are tamperproof. All audit trails provide “who, what, when, andwhy” traceability and are CRC check-summed to prevent un-wanted manipulation.

Providing WProviding WProviding WProviding WProviding Well Established Vell Established Vell Established Vell Established Vell Established Validated Solutionsalidated Solutionsalidated Solutionsalidated Solutionsalidated SolutionsEZChrom Elite and the worldwide network of Agilent Technologiesservice and support are available for any laboratory involved invalidating the system. A wide range of built-in features, optionalproducts and services are available to assist in the task ofvalidating every EZChrom deployment. The unique ISO9001 andTickIT quality certifications in place for the Agilent development of

Visit wwwwwwwwwwwwwww.agilent.com/chem/scisw.agilent.com/chem/scisw.agilent.com/chem/scisw.agilent.com/chem/scisw.agilent.com/chem/sciswor call toll free 1-800-227-97701-800-227-97701-800-227-97701-800-227-97701-800-227-9770(U.S. and Canada).

In other countries, please call your localAgilent Technologies analytical sales office orAuthorized Agilent Technologies Distributor.

This information is subject to change without notice.© Agilent Technologies, Inc. 2006Printed in U.S.A. January 27, 20065989-3714EN

EZChrom mean that every system shipped is backed by acomprehensive quality management system based on wellestablished standards of software development quality.

Simplifying VSimplifying VSimplifying VSimplifying VSimplifying Validation with Client/Server Architecturealidation with Client/Server Architecturealidation with Client/Server Architecturealidation with Client/Server Architecturealidation with Client/Server ArchitectureEZChrom Elite fits nicely in the corporate network by adhering toMicrosoft® and industry standards and minimizing network traffic.With user management administered through a company’s currentNT domain security, there is no need to manage multiple systemsfor usernames and passwords. In a client/server deployment withthin client configuration, acquired data is processed centrally. Datais maintained and buffered even in the event of a network failure.Using Citrix Metaframe XP, EZChrom Elite clients require only theinstallation of the Citrix ICA client application. No further validationof the client computers is required. Moreover the unique design ofthe Agilent Instrument Controller permits a “validate once – deploymany” approach which can save time for the pharmaceuticallaboratory. Each Agilent Instrument Controller variant is identicalso that laboratories do not need to validate and re-validate eachAgilent Instrument Controller individually.

Agilent TAgilent TAgilent TAgilent TAgilent Technologies Compliance Servicesechnologies Compliance Servicesechnologies Compliance Servicesechnologies Compliance Servicesechnologies Compliance ServicesAgilent’s Compliance Portfolio can address all the qualificationneeds of your Agilent networked chromatographic systemsincluding the LAN and WAN infrastructure itself. The SoftwareSoftwareSoftwareSoftwareSoftwareEditionEditionEditionEditionEdition products provide efficient and accurate IQ and OQ for yourEZChrom Elite chromatography data system (CDS). For theequipment connected to the CDS, Agilent’s new EnterpriseEnterpriseEnterpriseEnterpriseEnterpriseEditionEditionEditionEditionEdition is the perfect solution for vendor-independent hardwarequalification of most LC’s and GC’s. In addition, the laboratorynetwork infrastructure can be validated with our metrology-basedqualification services called, Network Edition.Network Edition.Network Edition.Network Edition.Network Edition.