Cerity Networked Data System for Pharmaceutical QA/QC Revision A.02.03

Specifications

Introduction

Cerity NDS for Pharmaceutical QA/QC is a fail-safe networked data

system specifically designed for pharmaceutical QA/QC laboratories. It is

powerful, flexible and utilizes an integrated client-server architecture

enabling seamless industry standard distributed client-server scalability.

Its user interface is optimized to model the way analysts work in the

QA/QC environment, fully supporting their everyday tasks. Cerity NDS

for Pharmaceutical QA/QC is available in two configurations: A stand-

alone system as entry level and a distributed client/server system.

April 2006

Table of Contents

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Cerity NDS for Pharmaceutical QA/QC Professional . . . . . . . . . . . . . . . . . . .3Cerity NDS for Pharmaceutical QA/QC Client/Server . . . . . . . . . . . . . . . . . . .3

General Description – Cerity NDS for Pharmaceutical QA/QC Client/Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Data Acquisition and Instrument Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Acquisition Controllers and Reprocessing Servers . . . . . . . . . . . . . . . . . . . . .4Agilent Instrument Driver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Drivers for Non-Agilent Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Data Processing and Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Software Administration Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Network Infrastructure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Recommended Topology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Recommended Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5Network Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6Assignment of IP Addresses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Support for High Availability Configurations (Failure Resilience) . . . . . . . . . . . . . . . . . .7Support for Clustering (Server Failover) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Cerity Database Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Acquisition Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Supported Analytical Instrumentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Agilent 1100 Series Liquid Chromatograph . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Agilent 1090 Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Agilent 1090 Solvent Delivery Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Agilent 1090 Sampling Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Detector systems for the Agilent 1090 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Interfacing of the Agilent 1090 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8Number of Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Agilent 35900E Dual Channel Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Agilent 6850 and 6890 Gas Chromatographs . . . . . . . . . . . . . . . . . . . . . . . . . .9HP/Agilent 5890 GC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Supported Sampler Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Water Alliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Shimadzu LC 10A Series . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Cerity Generic Instrument Control (GIC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Hardware Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Cerity NDS for Pharmaceutical QA/QC Professional . . . . . . . . . . . . . . . . . .12Cerity NDS for Pharmaceutical QA/QC Client/Server . . . . . . . . . . . . . . . . . .13Database Server Configurations Overview . . . . . . . . . . . . . . . . . . . . . . . . . .13Terminal Server Configurations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Acquisition Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Review Client . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Print Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Operating System/Software Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Oracle Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Cerity NDS for Pharmaceutical QA/QC License . . . . . . . . . . . . . . . . . . . . . . .16GMP Module License . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Instrument Control and Spectral Evaluation Licenses . . . . . . . . . . . . . . . . .16Installation Qualification Tool (IQT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Operation Qualification Tool (OQT) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Functional Specifications – Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Functional Specifications – Electronic Records and Electronic Signatures Checklist (21 CFR Part 11) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

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Cerity NDS for PharmaceuticalQA/QC ProfessionalCerity NDS Professional is thesolution for laboratories thatrequire instrument control, dataacquisition, data analysis, flexiblereporting and support for up to 82D chromatographs (up to 4 3Dchromatographs) controlled by asingle computer with strict adher-ence 21 CFR Part 11 (electronicrecords and electronic signatures)and related predicate rules suchas to 21 CFR 210 (GMP) and 21CFR Part 211 (cGMP). This con-figuration provides system accessfor one user at a time. It isdesigned for small laboratoriesthat require secure data storage,data collection of electronic ana-lytical records and support forseveral instruments without theneed for multi-user operation andcentralized chromatography datamanagement.

The underlying technical infra-structure of Cerity Professional(e.g. processes, services and userinterface components) is identicalto the client/server configuration.A Cerity Professional system canbe reused as a client when scalingup to a Cerity client/server config-uration.

Cerity NDS for PharmaceuticalQA/QC Client/ServerThe Client/Server configurationextends the capabilities of CerityProfessional by distributing sys-tem tasks between the centraldatabase server, any number ofconnected instruments, acquisi-tion controllers and review clientworkstations. This allows for mul-tiple users to access and concur-rently work with the central data-

Overview

Figure 1Cerity NDS for Pharmaceutical QA/QC Professional allows a single user to control, acquire andprocess data from up to 8 dual channel instruments.

base and any connected instru-ment transparently from any con-nected client workstation.

You can configure as many clientsas necessary on the Cerity NDSsystem, considering any licensingand resource limitations.

Figure 2Example configuration of Cerity NDS for Pharmaceutical QA/QC Client/Server with one centralOracle database server and two groups of instruments controlled by dedicated acquisition controllers. Users access the system through the review client PCs.

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InstrumentsLAN

Cerity Prof.Workstations

Cerity ClientWorkstation

Server

AcquisitionsControllers

Data Acquisition and Instrument Control

Acquisition Controllers and Reprocessing ServersClient/Server configurations allowthe addition of optional acquisi-tion controllers to balance instru-ment data stream and buffer itbefore upload to the central data-base server. The Cerity NDS acqui-sition controller is a dedicatedMicrosoft Windows Workstationrunning the Cerity NDS acquisi-tion controller software. Theacquisition controller performsdata acquisition and instrumentcontrol. This component controlsinstruments that have been sched-uled at the review client to exe-cute an analysis using the speci-fied method. It collects andprocesses the raw data and trans-mits it to the central databaseserver. Acquisition controllers cantheoretically be used as reviewclients. However, the backgroundprocessing load on the acquisitioncontroller may decrease systemperformance for interactive useand is therefore not recommendedfor routine use.

Agilent Instrument DriverThe suite of drivers to control the

supported instruments is installedwith the Cerity NDS base software.The supported instruments arethe Agilent 1100, 1200 (in CerityA.02.03 SR1)*, 1090 HPLC, theAgilent 5890, 6850 and 6890 GasChromatographs, the Agilent7694E Headspace Sampler andAgilent G1888A Network Head-space Sampler, the Agilent 35900EA/D, the Shimadzu LC10vp LC andthe Waters Alliance 2690/2695 LC,Waters 2487 Dual WavelengthDetector and Waters Alliance 2996Photodiode Array Detector.Cerity NDS controls instrumentparameters and components andcollects digital signals from detec-tors. Data can be acquired at ratesup to 200Hz, the data rate requiredfor fast GC and supported on AgilentGCs. One Agilent instrument con-trol license is required for eachinstrument. *The 1200 HPLC control is only possible in1100 compatibility mode which realize the1200 HPLC control with the functionalityof the 1100 HPLC. For detailed informationplease contact Agilent support.

Drivers for Non-Agilent InstrumentsCerity NDS provides full instru-ment control of and data acquisi-

tion from the Waters Alliance 2690and 2695 LC system. Instrumentcontrol of and data acquisition fromthe Waters Alliance LC require adirect connection between the computer and instrument, using an Agilent 82350 PCI high-perfor-mance GPIB interface adapter and cable. The standard interfacecontrol library software (SICL)required for GPIB communicationis delivered with the Cerity NDSsoftware. It must be installed on theacquisition controllers where theGPIB support is required. A sepa-rate instrument control license(Agilent product number G4062AA)is required for each Waters AllianceHPLC system controlled by CerityNDS for Pharmaceutical QA/QC.

Cerity NDS provides full instrumentcontrol of and data acquisition fromthe Shimadzu LC10vp HPLC,through Cerity’s Generic InstrumentControl interface in conjunctionwith an Agilent 35900E dual chan-nel interface. Instrument control isperformed through the serial port,and data acquisition through theanalog/digital IO interface of the35900E.

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In a client/server environment, theCerity NDS database server is aMicrosoft Windows server hosting anOracle database. This is the centraldata repository of the Cerity NDSsystem. The system includes thefollowing networked components:database server, acquisition con-trollers, instruments, printers, clientworkstations and other devices. Allraw data (acquired signals), meta-

data (i.e. methods, calibrationinformation, calculation formular,logbook), and calculated results arestored centrally in the databasealong with the computer-generatedaudit trail and revision information.Standard queries allow searching,retrieving and displaying data forreview and other purposes, such asinstrument status checking, resultsreview, results approval and reporting.

The size of the database dependson the number of concurrent users,concurrent instruments and theamount of data available online inthe database.

General Description – Cerity NDS for Pharmaceutical QA/QC Client/Server

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The Cerity NDS review client isthe interface to the Cerity NDSsystem. Users perform their workwith the graphical user interface

(GUI) of the review client. Sampleand sequence scheduling, instru-ment status monitoring, methodsetup, results review and approval

and other tasks can be performedfrom the Cerity NDS review client.

The Cerity Software Administra-tion module provides a so-called“snap-in” for the Microsoft Manage-ment Console (MMC). MMC is aconsole designed to integrate man-agement tools and functions and topresent a common visual environ-ment for management applications.

Only authorized users can log on tothe console. The Cerity SoftwareAdministration module permitsadministrators to set up systemcomponents, administer and tracksoftware licenses and license con-sumption, application modules,instruments, logon permissions,

user capabilities and roles, auditingand system wide settings for elec-tronic sign-off and numeric format-ting and configure the Cerity sys-tem infrastructure e.g. load balanc-ing via print server and reprocess-ing server.

Network Infrastructure

OverviewThe Cerity NDS infrastructure isbased on operating system andcommon IT standards. For instance,Cerity NDS is standardized oncommunication through the TCP/IPprotocol for all Cerity networknodes, including analytical instru-ments, computers, and servers.

Recommended TopologyThe Cerity system relies on thecomputer network infrastructure.In order to provide optimum per-formance and uptime, the networkmust meet design criteria in termsof available bandwidth, IP addressassignment, name resolution andisolation of the lab subnet fromthe corporate network.Cerity acquisition controllers cap-ture the real-time data of net-worked instruments and transferit to the central database server,which is typically installed in adata center. Cerity acquisition con-trollers are designed to automati-cally reconnect to the requiredserver resources (i.e. Cerity sys-tem services and the database),but to protect instrument analysis

data from LAN/WAN failures thataffect the connection to the data-base server in the data center,Cerity acquisition controllersmust be installed on the samesubnet as the instruments. Formost environments, this actuallyrequires to place the acquisitioncontrollers at the departmentallevel (i.e. the lab) and not in thedata center.

Recommended Network SettingsAvailable bandwidth settings andcommunication modes can vary,depending on the networkinginfrastructure, switches, and thenetwork interface cards used incomputers and instruments. Dueto the lack of an establishedindustry standard, auto-negotia-tion (auto-synchronization) of net-work speed settings has beenreported to cause communicationfailures in some cases, especiallywhere both computers andswitches were configured to usethis mode. Agilent Technologiesrecommends a two-tieredapproach: For dedicated laborato-ry systems, fixed network speed

settings should be used at bothends. In this case, IT departmentsadjust the infrastructure settingsas needed, e.g. when equipment ismoved. If this level of control isnot available, then fixed networkspeed settings are recommendedfor instruments and clients withthe switches configured to auto-negotiate

1. Typically, the supported infra-structure for client/server con-figurations of Cerity requires aswitched environment. Switcheshave become an inexpensiveway to properly isolate theinfrastructure segments fromeach other. Hubs should remainan exception in a properlydesigned network, but can beaccommodated on a case-by-case basis. Servers are typicallyconnected to the backbonethrough a main switch. Theinterface should be set to usethe maximum speed (at least100MBit/s) full duplex.

2. Servers are typically connectedto the backbone through a mainswitch. The interface should be

Data Processing and Review

Software Administration Console

Network InterfacesTo connect Agilent Technologiesinstruments to the Cerity NDS forPharmaceutical QA/QC system, asuitable network interface card isrequired. The next table lists thenetwork interface cards supportedwith the Cerity NDS for Pharma-ceutical QA/QC software.

Assignment of IP Addresses • The system requires a static IP

address for the database servermodule, which is installed byselecting the Cerity Professionalor Cerity Database Serverinstallation.

• Proper name resolution must beenforced for all Cerity devicesto guarantee connectivitybetween all networked compo-nents of the system even if IPaddresses get reassigned. Thisallows referencing networknodes by hostname rather thanIP address.

• Agilent recommends that fixedIP addresses for clients, acquisi-tion controllers and instrumentsbe allocated

• If fixed IP address assignmentis not possible, Cerity clientsand instruments may receivetheir IP addresses by using theBOOTP, or dynamically usingthe Dynamic Host Configura-tion Protocol DHCP.

set to use the maximum speed(at least 100MBit/s) full duplex.It is strongly advised that acqui-sition controllers reside on thesame subnet as the instruments.Exceptions to this rule can bejustified on a case-by-case basisand may require additional mea-sures for the infrastructurebetween the laboratory and theserver The recommended inter-face setting is at least 100MBit/sfull duplex.

3. The recommended networkspeed setting for PC clients is atleast 100 Mbit/s full duplexfixed at both ends.

4. The network speed supportedby analytical instrumentationfrom Agilent depends on theexact model. The recommendedsetting for the Agilent 1100HPLC, 6850 GC and the 35900EDual Channel Interface, is100MBit/s half duplex. The Agi-lent 6890N Gas Chromatographis only supported at 10MBit/shalf duplex.

5. A simple recommendation is toset the network speed for allanalytical instruments to10MBit/s half duplex. Thisallows moving instruments inthe lab.

6. Network ports on the switchesneed to match the speed set-tings described above.

7. Agilent Technologies stronglydiscourages from using autone-gotiate at both ends due toimplementation incompatibili-ties observed with equipmentfrom some manufacturers.

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• The Cerity NDS system includesa dedicated BOOTP server(Bootstrap Protocol) that oper-ates as a service in Windows.The Agilent BOOTP service canbe used if no other BOOTPserver or DHCP server areavailable to assign IP addressesto networked instrumentationand clients.

• The instrument configurationrequires specific buffer settingson the Jetdirect interface card.The Cerity Software automati-cally configures these buffersettings.

• We recommend reserving IPaddresses for Cerity devicesand instruments when usingDHCP. This ensures that adevice will always have thesame IP address. IP addressreservation means that a staticIP address is assigned to a dedi-cated MAC address.

• The Agilent 1100 HPLC and theAgilent 6890/6850 GC allow set-ting instrument IP addressesfrom the handheld controller orlocal keyboard. BootP or DHCPservers are not required if fixedIP addresses are assigned to theinstrument via the local key-board or user interface.

Agilent P/N LC Agilent P/N GC Description Minimum FW

N/A N/A HP J2552B MIO card for 10Base-T, 10Base2 A.08.32

G1846A G1847A HP JetDirect 400N (MIO) card for 10Base-T, K.08.32 10Base2, 100Base-TX

G1369A N/A Agilent LAN Communication card for the All revisions.Agilent 1100 and 8453 Series. Adherence of G1369A to the requirements of IEEE 802.3, 2002 (Ethernet) has been verified by IOL, theInteroperability Laboratory of the University of New Hampshire's Research Computing Center.

Table 1 Supported instrument network interface cards

aware and interact with the operat-ing system to respond to failoversystem events. OFS ensures dataintegrity on the permanent datastore in a failover scenario. OFS isan optional utility available for Ora-cle 9i. Cerity A.02.01 SR1 and high-er support both MSCS and OFS.Cerity EMC Full Autostart S/E isalso supported.

Oracle Enterprise Edition-specificfunctionality such as the Transpar-ent Application Failover (TAF) andoptional packages such as RealApplication Clustering (RAC) pro-vide additional support to handlein-flight data or database replica-tion. These features are not sup-ported by the Cerity NDS software.

Cerity Database ServerCerity system services do not inter-act directly with the operating sys-tem to manage clustering relatedevents. Instead, Cerity respond tocluster failover scenarios throughMSCS. Cerity services running onacquisition controllers and clientsautomatically reconnect to thedatabase server cluster after thefailover is completed. Typicalfailover delays have been mea-sured at less than one minute. Ceri-ty acquisition buffering functionsmay be triggered during thefailover delay.

A working failover cluster configu-ration requires that all Oracle datafiles as well as the Cerity reportstorage be located on the sharedstorage of the cluster server.

Increased hardware resourcesshould be specified as perMicrosoft recommendations.Specifically, a separate mirroreddisk (a so-called quorum disk) ishighly recommended.

Acquisition ControllerCerity supports enhanced acquisitionbuffering for instrument measure-ment data. In the event of databaseconnectivity loss, acquired data isbuffered on the acquisition con-trollers, and automatically spooled tothe database once the database con-nectivity is re-established. To mini-mize buffering requirements, dataanalysis is suspended in acquisitionbuffering mode. Data analysis resultscan be generated by reprocessing thebuffered raw data. The Cerity system

continues and completes all sequences

running at the time of the network

failure.

Support for Clustering (Server Failover)Cerity for Pharmaceutical QA/QCsupports clustering in the so-called“Active-Passive Mode”, which isalso referred to as “Active-Stand-by”. All Cerity permanent data isheld on the shared storage in addi-tion to the so-called quorum infor-mation needed by Microsoft clus-tering.

Microsoft Windows 2000 AdvancedServer or Microsoft Windows 2003Enterprise Edition provides clus-tering at the operating systemlevel. Microsoft Cluster Server(MSCS) runs services required forcluster operation. In an active- pas-sive cluster, two servers (nodes)share access to an external stor-age. Both computers can see thedata in the shared storage, but onlyone of the nodes is active while theother is effectively on standby,waiting to take over if the primary(and active) computer fails torespond. Both servers have physi-cal IP addresses as well as host-names by which they can bereached through the computer net-work. In addition, a separate virtu-al IP address and machine nameare configured for the cluster. Thevirtual address is used to accessthe active physical node of thecluster. Required system servicesrun on the active node during nor-mal operation. In the case of afailover, those services are startedon the inactive node.

Oracle Fail Safe (OFS) servicesmake the Oracle RDBMS cluster-

Support for High Availability Configurations (Failure Resilience)

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8

• PV-5 pump system ternary and quaternary

Note: The isocratic system will

not be supported.

Agilent 1090 Sampling Systems• Standard autosampler with vial

positions 0 to 99 and special position 100

• 25-µL and 250-µL syringe optionsNote: The cooled autosampler

and manual injector will not be

supported.

Detector systems for the Agilent 1090• 1090 diode-array detector in

2D mode with up to 5 signals • Other detectors supported by

the Cerity software (e.g. 1100 Series detector)

• 35900ENote: The programmable filter-

photometric detector will not be

supported by Cerity if the 1090 is

equipped with an FPD instead of

a built-in DAD. This requires the

user to disconnect the FPD.

MiscellaneousIn comparison to the 1100 LC and1200 LC Cerity offer limited func-tionality for the 1090 LC.• Cerity controls the four

external contactsInterfacing of the Agilent 1090• The 1090 will be interfaced via

GP-IB to the acquisition controller. We support the82350A and 82350B cards with firmware revision L.02.01 or higher.

• Agilent does not support WatersAlliance and Agilent 1090 to beconfigured on the same acquisi-tion controller.

Agilent P/N Module/Device Firmware Revision

G1313A Autosampler A.05.06A.05.09A.05.11A.06.01

G1329A Thermostatted ALS See aboveG1330A/B Thermostat for ALSG1367A Wellplate ALS A.05.06

A.05.09A.05.11A.06.01.

G1368A Thermostatted Wellplate Autosampler See aboveG1310A Isocratic Pump A.05.06

A.05.09A.05.11A.06.01.

G1311A Quaternary pump See aboveG1312A Binary pump See aboveG1314A VWD A.05.06

A.05.09A.05.11A.06.01.

G1315A/B DAD See aboveG1315C DAD A.06.01G1321A FLD A.05.06

A.05.09A.05.11A.06.01

G1365A/B MWD See aboveG1365C MWD A.06.01G1362A RID A.05.06

A.05.09A.05.11A.06.01

G1316A Thermostatted Column Compartment A.05.06A.05.09A.05.11A.06.01

G1322A Vacuum Degasser N/AG1379A Micro Vacuum Degasser N/AG1323B Local User Interface B.03.01

B.04.01

Table 2 Supported Agilent 1100 Series LC modules

Agilent 1100 Series Liquid ChromatographFull (Level 4) instrument controlof the Agilent 1100 Liquid Chro-matograph via LAN interface.In revision A.02.02 and higher, thefollowing modules are supported:• Agilent 1100 Isocratic, Binary

and Quaternary pumps• Agilent 1100 VWD, MWD and

DAD (in 2D-chromatography and3D spectral acquisition mode)

• Agilent 1100 FLD (fluorescence detector)

• Agilent 1100 RID (refractive index detector)

• Agilent 1100 standard and Thermostated Autosampler

• Agilent 1100 Thermostated Column Compartment

• Support of 10-port switching valvein the Agilent 1100 series Ther-mostated Column Compartment

• Agilent 1100 Vacuum Degasser• Agilent 1100 Wellplate Sampler

and Thermostated Wellplate SamplerOne Agilent 1100 LC instrumentcontrol license is required per Agi-lent 1100 LC system connected tothe Cerity software. Note: A LAN interface is required

for the Agilent 1100 system. Cerity

does not support GPIB for this

instrument.

In revision A.02.03. SR1 Ceritysupports the Agilent 1200 HPLC in1100 compatibility mode.Note: 1200 HPLC in 1100

compatibility mode realizes the

1200 HPLC control with the func-

tionality of the 1100 HPLC.

Agilent 1090 Series • Agilent 1090 Series II/L • Agilent 1090 Series II/MNote: The 1090A series is not

supported.

Agilent 1090 Solvent Delivery Systems• DR-5 pump system binary and

ternary

Supported Analytical Instrumentation

Number of Instruments• Cerity supports up to four 1090

instruments in 2D mode or upto two instruments in 3D modeconnected to a single acquisitioncontroller.

Agilent 35900E Dual Channel InterfaceThis interface can be used to acquireup to two independent channels ofdata from instrumentation that isnot directly controlled by the soft-ware. The Dual Channel Interfacesupports data rates up to 100 Hz.The Agilent 35900E Dual ChannelInterface supports BCD-coded vialnumber and can be used to track thevial position of each injection fromthird party auto samplers in the soft-ware. One Agilent 35900E A/Dinstrument control license isrequired per Agilent 35900E dualchannel interface connected to theCerity software.

A LAN interface is required for thedual channel interface. The GPIBinterface is not supported in CerityNDS for Pharmaceutical QA/QCfor this device, refer to table 3 forfirmware requirements.

Agilent 6850 and 6890 Gas ChromatographsCerity NDS for PharmaceuticalQA/QC supports the Agilent6890A, and 6890N (table 4).

A LAN interface is required for theAgilent GC. The GPIB interface isnot supported in Cerity NDS forPharmaceutical QA/QC for thisinstrument (table 5).

Cerity NDS for PharmaceuticalQA/QC supports the 6850 GChardware listed table 6.

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P/N Description Firmware Comment

35900E A/D converter E.01.02 Data acquisition, remote start/stop, BCD, RS232

Table 3 Minimum firmware requirements

Agilent 6890A GC

Inlet: EPC-Split/Splitless, EPC-Purge/Pack, EPC-CoolOnColumn, PTV, VIColumn Inlet: Front, Back, UnspecifiedColumn Outlet: Front, Back, OtherOven: High Ramp Rate, RegularDetector: EPC-FID, EPC-TCD, EPC-NPD, EPC-ECD, EPC-µECD, EPC-FPD

Cryo: CO2, N2Valves GSV, Multiposition, Switching, OtherAux: EPC, Temperature

Data Channels: Revision A.02.0202 SR2 and higher supports two signals, dual simultaneous ("dual tower") injection is not supported

Table 4 Supported 6890 GC configurations

Agilent P/N Description Firmware Comment

Gas ChromatographsG1530A/G1540A 6890A/6890Plus A.03.08 With Jetdirect CardG1530N/G1540N 6890N N.05.04 Network ready 6890 GCG2630A 6850 A.03.03 With Jetdirect CardG2630A 6850 A.05.04 Network ready 6850 GC

Automatic Liquid SamplersG1512A 7673 Controller A.01.12G1513A 7673 Injector A.09.14G2612A 7683A Controller A.02.01G2613A 7683A Injector A.11.01G2614A 7683A Tray A.02.01G2912A 7683B Controller A.02.01 This controller is required to use 7683B

injector and tray with the for 6890A GCG2913A 7683B Injector A.11.01 6890N: firmware N.05.04 or greater required

6850N: firmware A.05.04 or greater requiredG2916A 7683B Tray A.02.01 6890N: firmware N.05.04 or greater required

6850N: firmware A.05.04 or greater required18593B 7673 Injector A.09.1418596C 7673 Tray N.A.

Headspace SamplersG1289B 7694B The Economy Headspace Sampler 7694E

Headspace Sampler 1.04 G1883A with manual pneumatics is G1290B 7694B not supported.

Stand-alone HS, on-board pneumatics 1.04

G1888A Network Headspace Sampler A.01.02

Table 5 Agilent GC firmware requirements

10

HP/Agilent 5890 GCRevision A.02.03 of Cerity forPharmaceutical QA/QC imple-ments a framework for GenericInstrument Control. This frame-work is used to provide instru-ment control and data acquisitionwith the Agilent 5890 GC.• HP 5890 Series II and HP 5890

Plus• The 19257–60020 card (revision

C or higher) is needed for con-trolling the instrument

• GC ROM firmware revision“HP5890 A.03.00” or higher

• Split/Splitless and Cooled OnColumn Inlets, Purge/Pack. The inlets are supported with orwithout EPC

• Electronic Pressure Control: 2-Channel or 6-Channel EPCThe 5890 VSIA supports EPCChannels A, B, C, D, E and F

• Detectors: TCD, FID, NPD andECD. Time-programmablepolarity switching for the TCDis not supported

• Oven Standard oven with orwithout cryogenic cooling

• In revision A.02.03, dual simul-taneous (“dual tower”) injectionis not supported.

In comparison to the 6890/6850GC Cerity offer limited functional-ity for the 5890 GC.Note: Please contact Agilent sup-

port for detailed information.

Supported Sampler Configurations• Injector 7673A • ALS Controller G1512A

Firmware revision A.01.05 orhigher

• ALS Injector 18593B andG1513A 8 Vial high-density turret is not supported

• Sample tray 100 vial tray(18596B/C) Barcode reader isnot supported

• The new 7683B injector(G2913A) does not provide aserial interface and is not supported with this driver

Waters AllianceFull control of the solvent deliverysystem, column heater andautosampler of the Waters 2690and 2695 Alliance Liquid Chro-

matograph via GPIB interface(optionally available with the soft-ware). Up to four Waters Alliancechromatographs can be controlledthrough a single GPIB interface.Full control of the Waters 2487Dual Wavelength Detector viaGPIB interface. Full control of theWaters 2996 Photodiode ArrayDetector via GPIB interface. One

Agilent 6850 GC

Injector: G2613A/G2880AInlet: Split/Splitless, Purge/Pack, PTV, COCColumn Inlet: Inlet, UnspecifiedColumn Outlet: Detector, OtherDetector: EPC-FID, EPC-TCD, EPC-FPD Cryo: CO2Valves: GSV, LSV, Multiposition, SwitchingAux: Temperature, PressureData Channels: 1Handheld controller G2629A

Table 6 6850 GC hardware supported by Cerity NDS for Pharmaceutical QA/QC

5890 Component Notes

Injector: 7673AController: G1512A Firmware rev: A.01.05 or higherTray: 18596B/CInlet: S/S EPC use require an Aux EPC chanel

P/P be used for each flow to be controlledEPC-COC

Column Inlet: FrontBack

Column Outlet: FrontBackOther

Detector: FID EPC use require an Aux EPC chanelTCD be used for each flow to be controlledNPDECD

Communications: RS 232 DICE card supported ( 19257A)Cryo: CO2

N2Valves: GSV

LSVMultipositionSwitching

Aux: EPCTemperature

BCD:Data Channels: 2 Dual simultaneous injection is not

supported. Data channels refer to the number of signals that can be collectedduring acquisition from a single injection

Table 7 Supported 5850 II GC configurations

Agilent's Generic Instrument Con-trol concept is a new approach tostandardize generic instrumentcontrol for non-Agilent instru-ments. With the Generic Instru-ment Control, short GIC you havethe advantage to integrate non-Agi-lent chromatographic instrumentsinto the Cerity architecture. GIC isintegrated into the core of the Ceri-ty software and is always installedalong with Cerity. Through the GICframework, Cerity sees and con-trols a third party instrument simi-lar to a specific known instrumenttype such as the LC 1100.The GIC concept allows the devel-opment of drivers for third partyinstruments without changing theCerity source code. Device drivers,called Vendor Specific InstrumentAdapters (VSIA), can be developedindependently of Cerity, becausethe interaction between the devicedriver and the rest of the system islimited to a well-defined interface.This is a clear advantage for com-panies such as independent hard-

ware vendors, who want to devel-op their own device drivers.

The Cerity generic instrument con-trol consists of two main compo-nents: the GIC framework and theVSIA. The GIC framework isinstalled as part of the Cerity Phar-ma Client/Server system software.GIC is responsible for handling allthe dynamic and configurable userinterfaces in the instrument andmethod context, which are dealingwith instrument control, status anderror handling and instrument set-points as part of the Cerity method. VSIA is the real "instrument driver".It is responsible for the communi-cation to the instrument download-ing method setpoints, reading actu-al values, error handling etc.) andthe translation of the set point val-ues into the control commands theinstrument understands. VSIA sup-ports “plug-and-play” installation.„Plug-and-play“ allows the installa-tion of VSIA files on a running Ceri-ty for Pharma Client/Server system

without interrupting the operation.Every third party instrument needsits own specific VSIA. Every VSIAmust be installed separately.The communication between theGIC framework and the VSIA isdone using the Common Instru-ment Control Language, shortCICL. CICL specifications combinea state model, a set of commandsand a COM interface. Device dri-vers that adhere to the CICL speci-fications can be plugged into theCerity software.

The GIC framework provides aready-made library for VSIA tointerpret GIC commands. All CICLcommands are in XML format.XML provides a great flexibility forcommunicating device specificparameters, and eases the writingof VSIA’s responses. VSIA under-stands the CICL commands andtranslates them to a instrumentspecific protocol and vice versa.

11

Cerity Generic Instrument Control (GIC)

Module Description Firmware

SIL-10ADvp Autosampler 5.32LC-10ADvp Pump 5.26FCV-10ALvp Switching Valve for quat. gradient n.a.DGU-14Avp Degasser n.a.SCL-10Avp System controller 5.33SPD-10AVvp UV/VIS Detector 5.24SPD-10Avp UV/VIS Detector (identical to SPD-10AV 5.23

vp but without a VIS lampCTO-10ACvp Column compartment 5.24CTO-10ASvp Column compartment 5.25

Table 9Shimadzu LC 10A series firmware requirements

Model Number Description Firmware

Waters 2690 Waters Alliance 2.02 or higherWaters 2695 Waters Alliance 2.0 or higherWaters 2487 Waters Dual Wavelength Detector 1.03Waters 2996 Photodiode Array Detector 3.5

Table 8 Waters instrument firmware requirements

instrument control license isrequired per Waters Alliance sys-tem (consisting of one Waters2690/2695 Alliance mainframe andone Waters 2487 detector) connect-ed to the Cerity software. A remotestart-stop cable is required to syn-chronize the Waters detector withthe LC. See table 8 for firmwarerequirements.

Shimadzu LC 10A SeriesCerity controls the Shimadzu LC10A series through the CerityGeneric Instrument Control frame-work (GIC).

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The data system consists of a per-sonal computer (PC) and Agilentsoftware. All hardware and periph-erals must appear in the appropri-ate Microsoft Windows Compatibil-ity Lists for the operating system.Cerity NDS for PharmaceuticalQA/QC is designed to run on com-puters that conform to the specifi-cations listed below.

Cerity NDS for Pharmaceutical QA/QCProfessionalIn a Cerity for PharmaceuticalQA/QC Professional system (single-user, standalone) all components –database server, acquisition con-troller and review client – reside ona single PC, no remote access ispossible. Table 10 lists the minimumcomputer configuration that is sup-ported for a Cerity NDS for Pharma-ceutical QA/QC professional sys-tem. This next table provides aguideline for computer hardwarespecifications, such as the amountof random access memory (RAM),

Entry Level Medium High End

Specification ″ 20 instrument channels ″ 70 instrument channels > 70 instrument channels″ 10 concurrent users ″ 20 concurrent users > 20 concurrent users″ 100.000 Tests ″ 330.000 Tests > 700.000 Tests

CPU Xeon, 2.4 GHz Xeon, 2.4 Xeon, 2x 2.4 GHzDual processor recom-mendedfor >50 instruments

Memory 1 GB 1.5 GB 3 GBDisk space 3 GB 3 GB 3 GB

Cerity server application and Oracle RDBMS installation4,5 GB 140 GB 290 GBData Tablespaces for data, index and BLOBs10 GB 32 GB 68 GBFile share for Archives and Reports50 GB 150 GB 300 GBTemporary Space and Archive Redo Log Files

Total (rounded) 110 GB 330 GB 670 GB

Table 11Recommended hardware configurations for Cerity NDS database server

Hardware Requirements

Specifications 8 single channel instruments, with a max. of 4 instruments that acquire on-line spectra, like DAD or FLD

Processor type or minimum speed, etc. Pentium 4, >=2 GHzMinimum memory 1.5 GB Minimum mass storage 120GBPeripherals required Keyboard, Mouse, CD-Rom driveInterfaces Network InterfaceDisplay 1024 x 768 pixels, 65536 Colors

Table 10Recommended hardware configuration Cerity NDS Professional

The definition of all setpoints is doneusing an industry standard XML fileformat, which makes it easy todescribe the instrument capabilitiesand setpoints using off-the-shelftools. The instrument specific para-meters are specified in a deviceconfiguration XML file called asVSIA XML. This is the startingpoint, where the GIC recognizes anew instrument type and its prop-erties. The XML configuration fileserves as a reference for the instal-lation of the new instrument driver.

Sample sources are provided in thedeveloper kit from Agilent to bring

additional clarity. The communica-tion between the VSIA and theinstrument is established using theAgilent analog/digital converterA/D 35900E interface as communi-cation interface. In addition theAgilent AD 35900E is responsiblefor acquiring the analog signal andconverting it into digital data. Thestandard 10/100 LAN interface con-nects the Agilent AD 35900E to thedata system. The implementationof VSIA into easy to understandgeneric standards allows advancedcustomers (future) or an experi-enced third party companies(today) to program the instrument

control portion outside of Agilent. The GIC framework covers the fol-lowing device categories andmakes them consistent with otherCerity drivers:

The GIC framework covers the following device categories andmakes them consistent with otherCerity drivers:• pump• injector• column• detector• integrated instrument • auxiliary devices

disk space measured in gigabytes(GB), central processing unit (CPU)speed measured in megahertz(MHz), etc.

Cerity NDS for Pharmaceutical QA/QCClient/Server

Database Server ConfigurationsOverviewTable 11 specifies the recommendedhardware configurations for a data-base server. Agilent Technologiesinstalls factory default configurationsthat have been optimized for a cer-tain system load in terms of numberof injections, number of concurrentusers and number of instruments.For example, the default system con-figuration of the large DB is opti-mized for 100 concurrent users and200 instruments. Larger configura-tions should be planned and opti-mized based on usage assessment byan Agilent Technologies NetworkedData Systems specialist.

NOTE:

• It is NOT recommended to use

the Cerity database server as a

print server for the Review

Client computers.

• It is not recommended to use

the Cerity Database server for

network administration ser-

vices such as domain control

or name services (DNS).

• For detailed disk configura-

tions and recommended RAID

settings based on your respec-

tive usage requirements, please

contact Agilent Technologies.

Terminal Server Configurations Table 12 specifies the minimumhardware requirements for distrib-uting the Cerity NDS user inter-face through a dedicated TerminalServer. One or more Windows

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server with Terminal Services andCitrix Presentation Server can beconfigured to run the Cerityreview client software. However,the terminal servers are notexpected to run other softwarebesides Cerity and cannot be con-figured in terminal server farm.

A Terminal Server configuration ofCerity for Pharmaceutical QA/QCwill require approximately 200 MBof memory per user (RAM and/orvirtual memory).

Acquisition ControllerIn client/server configurationswith multiple instruments, one ormultiple separate acquisition con-trollers are required for instru-ment data acquisition and instru-ment control.

There is no hard-coded limit onthe number of instrument chan-nels that can be collected by a sin-gle acquisition controller. In fact,feasibility tests have shown thatthe system can control as many as30 3D systems. However, the rec-ommended maximum number ofchromatography instruments foran acquisition controller is 15 2Dchromatography instruments (i.e.without spectral data acquisition)and 6 3D chromatography instru-ments with spectral data acquisi-tion.

Acquisition controllers can also beused to balance the reprocessingload within a distributed CerityNDS installation. It is possible todefine acquisition controllerserves as dedicated reprocessingservers and reprocessing is auto-matically scheduled on these

Low end High endProcessor type or minimum speed, etc. Pentium 4, 1.2 GHz Pentium 4, 2.4 GHzMinimum memory 1.5 GB 2.5GBMaximum number 8 instruments with no on-line 15 instruments with no on-line of instruments spectra capabilities or spectra capabilities or

3 instruments that acquire on-line 6 instruments that acquirespectra, like DAD or FLD on-line spectra, like DAD or FLD

Minimum mass storage 40 GBPeripherals required Keyboard, mouse, CD-ROMInterfaces Network InterfaceDisplay 1024 x 768 pixels, 65536 colors

Table 13Hardware prerequisites for Cerity NDS acquisition controller

<10 concurrent clients <25 concurrent clientsCPU Dual Pentium 4, 1.4 GHz Dual Xeon, 1.4 GHzComputer type Desktop PC or server ServerMemory (RAM) 768 MB 2 GBDisk size 18.2 GB 18.2 GB ; second disk may be added

for redundancy

Table 12Hardware prerequisites for Cerity NDS Terminal Server .

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Acquisition controllers with noreprocessing or the lowest num-ber of reprocessing tasks running.

For large systems with a heavyprocessing load, add an additionalacquisition controller for every 10review clients in your client/serversystem to perform off-line repro-cessing. Do not add any instru-ments to these systems. Bydefault, the Cerity server assignsthe reprocessing servers automati-cally. System administrators canexplicitly assign a dedicatedreprocessing server to specificreview clients. This configurationis useful if certain review clientscreate a much higher data loadthan others.

If server computers are availablefor acquisition controllers, RAIDcontrollers are recommended.Fast PCs with sufficient RAM andvirtual memory are also accept-able. For system redundancy,please consider standby comput-ers to be used in case of computerhardware failures.

To have Windows XP choose thebest paging file size, choose “Sys-tem managed size”. The recom-mended minimum size is equiva-lent to 1.5 times the amount ofRAM on your system, and 3 timesthat figure for the maximum size.Example, if you have 4 GB ofRAM, the minimum paging file sizeis 6 GB and the maximum pagingfile size is 18 GB.

Processor type or minimum speed, etc. Pentium III, 800 MHzMinimum memory Minimum 256 MB, 512 MB recommendedMinimum mass storage 20GBPeripherals required Keyboard, Mouse, CD-Rom driveInterfaces Network InterfaceDisplay 1024 x 768 pixels, 65536 Colors

Table 14Hardware prerequisites for Cerity NDS review clients

Processor type or minimum speed, etc. Pentium III, 2.4 GHzMinimum memory Minimum 512 MB Minimum mass storage 20GBPeripherals required Keyboard, Mouse, CD-Rom driveInterfaces Network InterfaceDisplay 1024 x 768 pixels, 65536 Colors

Table 15Hardware prerequisites for Cerity NDS print servers

If the paging file reaches its maxi-mum size in Windows 2000, awarning is displayed and the sys-tem may halt. To see whether yourpaging file is approaching itsupper limit before it reaches theupper limit, check the actual filesize and compare it to the maxi-mum paging file size setting in theSystem utility in Control Panel. Ifthese two numbers are close invalue, consider increasing initialpaging file size or running fewerprograms.

Review ClientReview clients are workstationsused for interactive entry of sam-ple and sequence data, methodentry and management, schedul-ing of analyses, data review,reporting and result approval.

The following table specifies theminimum hardware requirementsfor review a client. Keep in mind,as previously stated, the acquisi-

tion controller and review client mayoperate together on a computer. It isrecommended to deploy dedicatedacquisition controllers for optimumperformance and load balancing inthe Cerity NDS system.

Print Server Cerity A.02.03 supports special printserver PC’s. On this PC’s the Cerityprint service is running and are usedto create and print the report. Theprint requests are automatically dis-tributed between the print servers.This results in higher performancefor report generation and reducesload on the DB Server.

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installed and operate on any FIGSOS, especially decimal separator(dot, comma) and date/time formatare handled according the settingof the regional settings (locale).The database server must beinstalled on an English OS (Win-dows 2003 Server). However, allPCs of the cluster (Client, Acquisi-tion Controller, Print Server, andDB Server) must use the samelocale. For the VMWare environ-ments, the customer is responsibleto configure the virtual machinessuch that performance equivalentto the physical machine configura-tion is achieved. All releases ofCerity do not support the completeset of Active Directory features ofWindows 2000/2003. For example,Cerity cannot recognize UPN orfully qualified domain names,which are specific to active direc-tory. Therefore, for Cerity installedin Windows 2000/2003 active direc-tory setup, users will have to useNet bios name format to specifycomputer names and domain anduser name pair to specify users.

Operating System/Software Requirements

Manufacturer Product Revision Comment

Oracle Oracle 9i DBMS 9.2.0.7.0 Needs to be installed separately. Oracle Standard 9i is contained on Cerity product CD set.

Microsoft Data Access Components (MDAC) 2.7 Included with product

Microsoft Internet Explorer 6 SP1 Needs to be installed separately. Included on Cerity CD#1.

Agilent SICL library L.02.01 Required for the control of Waters Alliance and Agilent 1090 HPLC. Contained on product CD #1.

Microsoft Visual Basic 7.1 Runtime libraryMicrosoft Visual C++ 7.1 Runtime library

Table 16Other software requirements for Cerity for Pharmaceutical QA/QC

Table 16 defines the third partyrequired software revisions toproperly operate Cerity NDS forpharmaceutical QA/QC client/serv-er and professional systems. Any ofthese components is installed auto-matically during Cerity setup,except for the Oracle DatabaseManagement System (DBMS)which needs to be installed sepa-rately.

Oracle LicensingCerity NDS for PharmaceuticalQA/QC uses the Oracle RDBMS tomanage and store its records.• The Oracle RDBMS software

may only be installed and usedif the appropriate softwarelicenses have been purchased.You must possess an Oraclelicense for each user account("named user") established inyour Agilent Networked DataSystem valid for use with theAgilent NDS software.

• The base products of CerityNDS for Pharmaceutical QA/QC(Agilent G4000AA and

Cerity NDS for pharmaceuticalQA/QC supports Windows 2000Professional, Microsoft WindowsXP Professional. Microsoft Win-dows Server Operating Systems aresupported:• On Cerity Acquisition Con-

trollers configured as Reprocess-ing Server and for Cerity PrintServer

• On Cerity Acquisition Con-trollers running on Server Classcomputers

Terminal Services are supported inRemote Administration Mode only.

Note: Detailed information about

the supported configurations and

actual security hot fixes are avail-

able and updated on the Agilent

web site under

http://www.chem.agilent.com/cag/c

erityspecs.htm

Cerity NDS for PharmaceuticalQA/QC is fully supported on theUS-English, Japanese, French, Ger-man, Italian, and Spanish versionsof Windows. On non-US Englishversions of the operating system,language-specific hot fixes of theoperating system may be required.Any mandatory hot fixes are sup-plied on the Cerity NDS CD media.For correct interpretation ofnumeric floating point entries, spe-cific options need to be configuredin Windows’ regional settings.Please consult the software statusbulletin and release notes(readme.txt) for more informationon regional settings, number anddate formats required for correcthandling of floating point numberinput.

The Acquisition Controller, PrintServer and Review Client can be

Note: This table is subject to changes. Latest information is

available in the Agilent web site under

http://www.chem.agilent.com/cag/cerityspecs.htm

16

G4001AA) include 5 applicationspecific named user Oracleclient licenses. These licensesare subject to a restricted uselicense and can only be used inconjunction with the NDS appli-cation.

• Agilent provides support forincluded Oracle softwareaccording to the applicationrequirements of the respectiveAgilent networked data system.Further software maintenancefor Oracle software must bepurchased separately

• Alternatively, you may purchasefull use Oracle licenses fromOracle Co. or their authorizeddistribution partners.

• Each individual with a logon tothe Cerity software requires aseparate Oracle client license.

• Additional Oracle licenses, canbe purchased using Agilentproduct number G1411A. Note: Oracle licenses delivered

by Agilent Technologies are

application specific and may

only be used within the context

of the Agilent networked data

system.

Cerity NDS for PharmaceuticalQA/QC LicenseThe number of Cerity NDS con-current licenses in use must notexceed the number of licensesinstalled, otherwise the licenseagreement is violated. Additionallicenses are easy to order andeasy to install. The Cerity NDSlicenses float and are consumedby concurrent users. For theclient/server configuration, theremust be an equal number of CerityNDS licenses as there are CerityNDS concurrent users.• Cerity NDS for Pharmaceutical

QA/QC Professional (AgilentG4000AA) is a single-user sys-

tem and includes one concur-rent Cerity user license. The fol-lowing restrictions apply:

• Only one Cerity user can belogged on to the computer atany given time.

• G4002AA, the additional con-current Cerity NDS userlicense, is not applicable for theCerity Professional system. Ifthe professional system is usedby different operators at differ-ent times, each individual userrequires a separate named userlicense of Oracle Standard validfor the Agilent NDS family ofproducts.

GMP Module License• One GMP license is needed for

each concurrent user license(Agilent G4002AA)

• The GMP module enables strictauditing, audit comments and e-signature.

• The GMP module also enforcesa strict results review/approvalprocess. This will ensure thatanalysts review their ownresults before a peer reviewerand finally, a final approval isgiven.

• This is an enabling license; noadditional software is installed.The GMP module enables theaudit node in the Cerity SystemAdministration Console. Note: Only one GMP license is

needed in the professional system.

Instrument Control and Spectral Evaluation LicensesOne instrument control license isrequired per instrument controlledby the Cerity NDS software. Thelicenses are easy to install, andthey are monitored by the applica-tion. Cerity instrument controllicenses are available for the fol-lowing products:

• Cerity-P 1100/1200 HPLC con-trol license (G4061AA). Thislicense can be used to controlthe 1100 and 1200 HPLC instru-ment. Note: With Cerity A.02.03

SR1 the 1200 HPLC control is

only possible in 1100 compati-

bility mode, this means 1200

HPLC control with the func-

tionality of the 1100 HPLC.

Full control will be available in

later releases.

• Cerity-P Waters Alliance LCinstrument control license(G4062AA)

• Cerity-P 6890/6850 GC instru-ment control license (G4063AA)

• Cerity-P 35900E Dual ChannelInterface instrument controllicense (G4064AA)

• Cerity-P Spectral Acquisitionand Evaluation License(G4031AA). Enables data acqui-sition and data evaluation forspectral data obtained from anAgilent 1100 and WatersAlliance instrument with 3Dspectral capabilities (diodearray detector or fluorescencedetector). One spectral process-ing license is required per 3Dinstrument.

• Cerity-P Agilent 1090 HPLCinstrument control license(G4069AA). Note: Cerity realizes

limited functionality for 1090

HPLC.

• Cerity-P Generic InstrumentControl framework license(G4065AA) to enable instru-ment control and data acquisi-tion through the Agilent 35900Edual channel interface using theCerity Generic Instrument Con-trol framework. Requires onelicense and one 35900E channelper GIC instrument. G4064AAlicense is included, but 35900Ehardware is not. Requires oneadditional Vendor Specific

17

Instrument Adapter for eachinstrument.

• Cerity-P Shimadzu LC10AvpVSIA instrument control license(G4067AA)

• Cerity-P Agilent 5890 VSIAinstrument control license(G4068AA). Note: Cerity realizes

limited functionality for 5890

GC.

• Cerity-P Agilent Headspaceinstrument control license(G2926AA)

Installation Qualification Tool (IQT)The Installation Qualification Toolis a computer-based qualificationutility used to perform InstallationQualification (IQ) of the CerityNDS for Pharmaceutical QA/QCsystem. Computer-based installa-tion qualification protocols verifythe completeness and intactnessof the Agilent software installedon the PC. The computer-basedinstallation qualification utilityavailable for Cerity NDS for Phar-maceutical QA/QC reads requireddetails from the system directlyand inserts them into the docu-ment automatically. The utilityprovides input forms for detailsthat cannot be extracted automati-cally from the system (softwareand hardware). The entry formssupport further techniques forautomated data entry such as barcoding. Execution of the softwareIQ protocol requires a valid IQlicense. Without a valid licensenumber, the final acceptance pro-tocol cannot be generated.

Operation Qualification Tool (OQT)OQ allows qualification tests atdefined intervals on the data sys-tem and most of the connectedinstruments (except Waters PDA).Without a valid OQ/PV test result,the system must not be used in aregulated environment. OQ/PVtypically requires a series of differ-ent tests depending on the instru-ment, the lab’s specification andthe configured software capabili-ties. System IQ and OQ/PV areprovided both as a product and asa service from Agilent Technolo-gies. Computer based complianceprotocols are available for thesoftware and the instruments sup-ported by Cerity for Pharmaceuti-cal QA/QC. The Operational Quali-fication Tool is a computer-basedqualification utility used to per-form Operational Qualification(OQ/PV) of the Cerity NDS forPharmaceutical QA/QC system.The computer-based OQ protocolsavailable for Cerity NDS for Phar-maceutical QA/QC uses interfaces(so-called test harnesses) specifi-cally designed into the softwarefor the purpose of executing criti-cal system test cases automatical-ly. This comprises

• Automatic low and mid-levelfunctional tests that verify fun-damental system-level functionsthat are not even covered bythe traditional interactive proto-cols available for other datasystems

• Automatic high-level systemoperation tests that verify appli-cation functionality such assequencing, quantification orrecalibration. These tests exe-cute in unattended mode andthe evaluation is performedautomatically using known datasource, prerecorded acceptancelimits and self-evaluatingreports.

• A number of test cases requirescripted manual tests becauseof their interactive nature. Thetest scripts cover areas such aschallenging logon security,auditing of interactive changes,authority checks, andarchive/restore functions.

Execution of the OQ protocolsrequires a valid OQ license. With-out a valid license number, thefinal acceptance protocol cannotbe generated.

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Functional Specifications* – Application

Technology and Architecture

General description Cerity NDS for Pharmaceutical QA/QC is a high availability, fully scaleable networked data system for analytical QA/QC laboratories that requirechromatographic instrument control, data acquisition, data analysis, flexi-ble reporting and with strict adherence 21 CFR Part 11 (electronic recordsand electronic signatures) and related predicate rules such as to 21 CFR210 (GMP) and 21 CFR Part 211 (cGMP).

Description Central, secure data repository based on Oracle database of data repository management system.

Supported Database Oracle®9i Management System

Data model Object-relational data model.

Management of binary Binary data (e.g. raw instrument data) is stored in so-called BLOBs and large objects (BLOBs) managed within the Oracle 9i database.

Characteristics of the distributed • Full scalability (1 to n)Cerity configurations • High availability configurations (acquisition buffering, server clustering)

• Centralized system administration• Centralized backups• Import and export of data is possible between database servers • Multiple Cerity database servers may exist in a domain• Cerity review clients can connect to more than one Cerity servers• The number of review clients is limited by physical resources and

available licenses only• Multiple acquisition controller are supported per Cerity database server• Up to 15 2D instruments or up to 6 3D instruments are supported per

acquisition controller

Maximum size of data base No hard-coded limits. Three standard database configurations are offered supported (small, medium, large).Design language/tools UML, Visual C++, Visual Basic

Revision History

Cerity for Pharmaceutical QA/QC has been available in the following revisions:Revision A.01.01 (June 2002): Initial releaseRevision A.01.02 (August 2002): Support for Windows 2000, support of 6850 GCRevision A.01.03 (November 2002): Support under Citrix Terminal serverRevision A.02.01 (March 2003): Support for Oracle9i RDBMS and Windows XP for clients.

Data model change to manage binary large objects entirely inside the Oracle database. Support for clustering of database server

Revision A.02.01 SR1 (June 2003): Enable data buffering on acquisition controllers in case of network or server failure.

Revision A.02.02 (January 2004): Enable 3D spectral data acquisition and data evaluation for diode array and fluorescence detectors

Revision A.02.02 SR1 (October 2004): increase long-term stability in 24x7 operations

Revision A.02.02 SR2 (March 2005): New functionality to improve the ease-of-use and workflow of the system – Easier navigation and faster results review, Online sequence level calculation/ sequence line actions, Enhanced Manual Integration UI, Agilent Headspace control, new simple Query UI, automated workload management for reprocessing

Revision A.02.03 (December 2005): New functionality to adapt easily to laboratory structure and improve integration with other internal and external systems. Main features are: • project data organization with object level security and User Groups for

projects, methods and instruments• Better data import/export and programmatic connectivity to external

systems such as ERP, LIMS, ELN and analytics.• New and Enhanced Instrument Support: Waters PDA, Agilent 1100

Starlight detector and new instrument diagnostics• Support for MS Windows 2003 SP1 Server, Support of VMWare GSX

and ESX with optional Virtual SMP

Revision A.02.03 SR1 (February 2006): This service release introduce, French, German, Italian and Spanish versions of the manuals and on-line documentation and includes a numberof corrections requested by end-users and Agilent internal QA test staff.

*This information is subject to changes. Latestinformation is available on our website athttp://www.chem.agilent.com/cag/cerityspecs.htm

19

Operating System

• Microsoft Windows 2003 Standard Server Service Pack 1 (Cerity C/S Database server)

• Microsoft Windows 2003 Enterprise Edition Service Pack 1 (Cerity C/S Database server, Print Server)

• Microsoft Windows 2000 Advanced Server (Cerity C/S Database server,Print Server, acquisition controller)

• Windows 2000 Professional Service Pack 4 (Professional, acquisition controller, review clients)

• Windows XP Professional Service Pack 2 (Cerity C/S Database server, Print Server, Professional, acquisition controller, review clients)

All configuration require Microsoft Internet Explorer 6.0 Service Pack 1• For more details, refer to the respective chapter in this document.

Compatibility with Cerity for QA/QC supports thin client operation of Cerity review clients Terminal Server using Windows Terminal Services. Operation under Citrix Metaframe is

supported. Thin client specifications are dictated by the Terminal Server provider (Microsoft and/or Citrix Metaframe). Agilent does not add any requirements unless specified otherwise. For details on the requirements and configurations of Cerity for Pharmaceutical QA/QC, please refer to a separate technical note, available as Agilent publication G4000-90100.

Compatibility with VMWare GSX Cerity for QA/QC supports the VMWare environments for Cerity C/S Data-and VMWare ESX with base server, Print Server, Professional and review clients. Details seeoptional Virtual SMP separate chapter in this document. Other client/server capabilities • During running analyses, users can log out and log in without

interruption of the sequence • After log-out of the session, the user's license is released and

available for another concurrent user• Strict separation of user interface and background processing. E.g. power

failure on client does not affect data acquisition or data processingHardware requirements See separate chapter in this document.

High Availability

The Cerity system supports the following failure resilience mechanisms:• Server failover using Microsoft Cluster Server and Oracle Failsafe

configurations to ensure continued uptime even if the server fails• Acquisition buffering on the acquisition controllers ensuring that no

analysis data can be lost even if server/ network infrastructure fails.Microsoft Cluster Service Windows 2000 Advanced Server or Microsoft Windows 2003 Enterprise Edition SupportedEMC Full Autostart S/E Revision 5.1.2 SupportedOracle Failsafe (OFS) Supported Oracle Transparent Application Failover (TAF) Not supportedOracle Real Application Clustering (RAC) Not supported

Scalability

Cerity NDS for Pharmaceutical One user at any one time.QA/QC Professional Maximum number Note: By definition, Cerity NDS for Pharmaceutical QA/QC of concurrent users Professional is a single-user, multi-instrument configuration.Cerity NDS for Pharmaceutical No hard-coded limits (function of database server configuration andQA/QC client/server available network bandwidth).Maximum number Typical configurations have 30-50 users and 80-100 instruments.of concurrent users

User Interface

Characteristics Graphical user interface designed in adherence to Windows of the user interface standards and configurable to laboratory specific workflow (based on user

roles and analysis specific requirements).The user interface of Cerity NDS for Pharmaceutical QA/QC is streamlinedto adhere to the requirements of GMP regulated QA/QC labs.This includes, but is not limited to• Convenient arrangement of functions into four context areas: Sample

Entry, Instrument Status, Results Review and Method Management• Graphical instrument status display• “Explorer”-like Tree-View to conveniently display search results from

the database• Menus (pull-down as well as context menus)• Toolbars• Tables configurable to the method

User specific storage of Specific to job roles and analytical methods.user interface configuration If a user has no permission to use a certain system function, thedetails (profiles) function is not shown in the user interface or it is disabled (grayed out).

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Analytical instruments

Supported analytical techniques LC, GC, A/D converter (general purpose)

Number of instruments that No hard-coded limits (function of database server configuration andsystem can simultaneously available network bandwidth).control and acquire data from. Typical configurations have 30-50 users and 80-100 instruments.

Factory default configurations of Cerity C/S have been setup, optimized and tested for configurations with up to 100 concurent users and up to 200 instruments. Larger configurations should be planned and optimized based on usage assessment by an Agilent Technologies Laboratory Informatics specialist.

Data acquisition interfaces

LAN Level 4 instrument control of 1100 LC, 6890/6850 GC and 35900E ADC,using TCP/IP protocol as installed with Microsoft Windows.

IEEE-488 (HP-IB/GP-IB) Based on standard interface control library (SICL).

Level of bi-directional Level 4 instrument control (advanced full control) for instruments withinstrument control appropriate capabilities (e.g. Agilent 1100 HPLC, Agilent 1090 HPLC,

Agilent 5890 and Agilent 6850/6890 GC).Level 3 instrument control (full control) for Waters 2690/2695 Alliance LC,Waters 2487 Dual Wavelength Detector and the Waters 2996 PhotodiodeArray Detector.Level 3 (full control) for Shimadzu LC10Avp using the Cerity GenericInstrument Control (GIC) framework.

Instruments for which Agilent 1100 HPLC, Agilent 6850/6890 GC, Agilent 1090 HPLC Series II bi-directional control (all pump configurations and diode array detector), Agilent 5890 GC

(through Cerity Generic Instrument Control framework), Agilent 35900E ADC for general purpose / multi-vendor interfacing,.Shimadzu LC10Avp HPLCWaters Alliance 2690 and 2695, Waters 2497 Dual Wavelength Detector,Waters 2996 Photodiode Array DetectorAgilent Headspace G1289B, G1290B, G1888A

Proprietary control hardware No. Instruments interfaced via LAN require appropriate instrument LANrequired? interface and an Ethernet LAN card in the PC. Waters Alliance instru-

ments are interfaced via GPIB (IEEE-488) and require an Agilent 82350 GPIB board in the PC.

Network monitoring capabilities The networked design of all components ensures that all parts of the (computers and instruments) system can be monitored as nodes on the network.

Commercially available network monitoring tools allow to measure network bandwidth, network health, track errors and alerts and help in troubleshooting problems related to communication between computers and instruments on the network.

Network monitoring tools cannot be used to monitor non-networked instruments using legacy connections such as GPIB or RS232.

Data Transfer

Data import formats • Data files from Agilent ChemStation A.03.01 or greater• ANDI (Analytical Data Interchange) format• Import of work-lists in XML format, e.g. from a LIMS.

Data export formats • Microsoft Excel format (XLS) for tabular data• HTML for analytical reports• JPEG, GIF, TIFF, WMF for graphics • ANDI (Analytical Data Interchange) format• XML for export of results and archive catalog files (for use with

knowledge management or archive management system)

Standard interface protocols COM+/DCOMsupported between network components of the system

Results review By design, all result records are available for instantaneous online(o-line on-demand viewing) review in the results review context of the application.

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Direct FAX or PDF output Through standard operating system functions (print to fax, print to PDF device).

Other interfaces Examples for further customization based on the following techniques• Reports post-processing through DOM (Document Object Model)• Reports post-processing through embedded scripts (Javascript or

VBScript code)• Web-Access to queries through SSL (Secure Sockets Layer)• Programming interface (requires PSO consulting)

Documentation

Description of documentation • How-To Tasks (Online Help), delivered with the Cerity system • Cerity Quick Reference Card

• Cerity Concepts Guide • Cerity Installation Guide• Generic Instrument Control• Cluster Server Installation Guide• System Administration Guide (Online, PDF)• Quick Reference Guide • Cerity Technical Reference Guide

Description of formats PDF and HTML Helpused for online documentation.Number of printed manual One set per user licensesets provided with system (Note: Additionally, PDF-versions of all manuals are included on the

software media)

Link to standard operating The application user interface allows to configure a link directly toprocedures SOPs the intranet location where SOPs or monograph are stored.

Access Security and Control

Security concept Based on NT security system (user accounts management, password policy). Application does not have a proprietary account system but allowsreusing password and security policies directly from the operating system.

Access controls User with Cerity system administrator permissions. for security configuration Note: Cerity system administrators require system administration permis-

sions on the local computer.Granularity of security access Managed at the individual function level of the application.

Menus and toolbar functions can be selectively configured for each user role. Examples: Create method, reprocess chromatogram,approve result etc.

Description of • Cerity users must be authenticated through the operating system.application security controls • Mandatory login using user-ID and password.

• Cerity uses a role-based security concept based on job roles and job responsibilities of users.

• Prior to executing a function in the system, Cerity's security. service checks whether the user has the appropriate capabilities.

• Mandatory audit trail every time a record is created, modified or destroyed.

• Cerity allows to configure which system tasks require authorization by electronic signature (e.g. accept/reject an analysis result).

• System-wide inactivity time-out locks the session after a predefined idle period.

• Physical access security controls are not enforced by the application, but the system is compatible with physical access security controls such as bio-metric or smart-card identification as supported by the operating system.

Security mechanism Yes, using COM+ security.of network data packetsDefinition of User groups User with Cerity system administrator permissions is able to create any

number of user groups to easily manage access security. Users can be part of multiple groups. Summary reports are available to get an overviewof security settings for projects, instruments, users or groups.

Biometrics-based identification Planned for subsequent release: Support biometrics-based identification with standard interfaces for facerecognition, voice recognition, fingerprint scanning.

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Instrument Control, Instrument Status Monitoring and Analysis Scheduling

Instrument status monitoring • Graphical display of current online instrument status.

• Transparent real time access to any instrument connected to the network,independent of the instrument and the client computer.

• Transparent access to instrument control and equilibration functions such as reset injector, lamp on/off, set detector wavelength, balance

detector, wavelength calibration.

• Real Time Plot.

• Instrument actuals (run-time, instrument errors, warnings, instrument diagnostics data)

• EMF limit checking and reporting for the Agilent 1100.

Real-time display Configurable online plot for detector channels and diagnostic plots (e.g. thermostat temperature, pressure, flow).

Instrument actuals Configurable status information table (run-time, instrument errors, warnings, diagnosis buffers).

Real-time status – finding out Cerity offers three troubleshooting mechanisms for problems such as:why the instrument is in an • instrument status GUI and instrument actualserror state or not ready. • instrument logbook

• "Service Report" function that queries the diagnostic registers of theAgilent 1100 to generate a service report that helps to diagnose instru-ment problems down to the module level. The diagnostic reportincludes diagnostic information such as instrument error messages(e.g. “leak detected”), firmware revision, EMF limits and pump ripple.

Scheduling of analyses The system uses a scheduling process that allows submitting analysis jobs(“chaining of analyses”) (single sample analyses as well as sequences) to the so-called worklist.

The analysis priority is entered at sample entry and can be high, mediumor low.

Early Maintenance Feedback (EMF) EMF is an important measure for trustworthy and reliable instrument data in terms of level 4 instrument control. Cerity supports the EMF functions available in the Agilent 1100 HPLC. The EMF concept generatesEMF warnings when an user-defined wear and tear limit is reached forone or several parts in the chromatographic system. Cerity logs EMFwarnings in the sample logbook. This information can be used to provethat the instrument was in good working order when the original analysiswas performed.

Figure 3Project Based data Organization.

Project Based Data Organization/ Object Based Security and User Groups

All data are organized in projects • All user data are stored in projects: Methods/Samples/Sequences/Results

• Change projects within a Cerity session – no need to logoff and on again• Copy of methods from a different project• Overlay signals in results review from different projects• Lock/Unlock of projects• Archive/Restore projects• Archive & Delete data from one project can be restored in a different project

Administrator can define • If user has “No Access” project is not shown in the selection boxaccess rights to projects • Access Security can be defined using user groups or individual usersfor users and groups • Users system role defines the capabilities of the user within the project

• Individual user settings overwrite group based settings• Independent of access rights projects can be locked (Read-Only) by an

authorized userAdministrator can define • If user has “No Access” instrument is not shown in the instrument treeaccess rights to instruments • Access Security can be defined using user groups or individual usersfor users and groups • Users system role defines the capabilities of instrument control settings

within the project• Individual user settings overwrite group based settings

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Shutdown methods and Cerity supports so-called “error methods” on the Agilent 1100 HPLC. Thestandby conditions instrument will execute the error method after a defined time interval.

In addition, Cerity allows for a so-called “soft-timeout” after which themodule will be turned off. The time interval for initialization of the shut down commands is configurable from 0-999 min.This approach permits running the instrument in standby-conditions, such as a minimal flow rate with the lamp turned off, and avoid that the system will run out of solvent while being unattended.In case of a serious instrument error, such as a solvent leak, the systemwill shut down regardless of the timeout settings to prevent system damage or safety hazards.

Sample/Sequence EntryAutomatic data entry A “Sequence Template” can be configured as part of the Cerity method.

When creating a new sequence, the new sequence is pre-filled based onthe settings defined in the sequence template stored in the analysis method.

Mechanisms to minimize • Fill-down columntyping effort during data entry • Intelligent fill-down wizard

• Apply changes to a selection of sequence lines Multiple stop times in The sequence template allows setting analyis times ("stop times”)sequence methods for the different runs of a sequence. This is useful for cases where the

analysis time for samples is significantly longer than for calibration standards.Revision control of sample data Sample data is subject to strict revision control within the application.Entry of calibration standards Weights (concentrations) of calibration standards can be directly entered

during sample entry.Partial calibration and multi-vial standards are supported (standard com-pounds of a certain level can be provided in different vials).

Method specific sample Method specific sample variables (multipliers, divisors) are enteredvariables during sample entry and available for custom calculations.Custom naming of method Names for sample entry fields are configurable per method.specific sample variablesNaming conventions Names and description fields for samples, sequences, methods andallow for long descriptors instruments permit long descriptive names with at least 128 characters.Operator can selectively When scheduling an analysis, operators can selectively definerun data acquisition, which processing tasks will be performed. Options include dataprocessing, reporting acqusition, data analysis and reporting.Scheduling of analysis • The system uses a scheduling process that allows submitting multiple

analysis jobs (single sample analyses or sequences) to the instrument’sworklist.

• The analysis priority is entered at sample entry. The choices are high,medium or low.

• The system permits pausing and resuming of sequences and editing thecurrently running sequence.

Intelligent sequencing based on • The system allows to pause, stop or continue (with warnings) sequencesdynamic limit evaluation based on automatic evaluation of calculated results against user-defined

limits.Method ManagementChange control to methods Cerity subjects all methods to strict revision control and audit trailmaintained in the data system logging. No part of the method can be overwritten.Who needs to modify methods Method management is typically only required for a senior chemist or

chemist. Analysts (chemists, technicians) typically work with predefined methods.

Master methods Master methods are protected methods that serve as template for (template methods) instrument specific methods. By using a master method, analysts can be

sure that the analysis settings are coherent with the official analysis procedure.

Linking methods Cerity allows translating a chromatographic analysis procedure intoto analysis procedures a Cerity method. This includes the required sample entry variables, calcu-

lations, recalibration schemes, layout and reporting requirements and tem-plates for the sequence of injections.

Figure 4.1 and 4.2 Transparent access to connected instruments,including early maintenance feedback (EMF)information.

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System checks to ensure The software queries the current configuration details from theconsistency between method physical instrument prior to starting the analysis to ensure that theparameters and physical analysis parameters are compatible.instrument capabilities Cerity methods are specific to an instrument configuration

(e.g. Agilent 1100 Series LC with a DAD and a binary pump) and can beapplied for groups of instruments that have the same configuration.

Typical interaction of an • Login to systemanalyst with a method • Select sample entry context (view)

• Login the sample• Select the method (the system automatically suggests

the instrument suitable for this analysis)• Enter sample information (description, name, vial number, product code,

LIMS ID, concentration of standard etc.)• Schedule analysis

Settings controlled • Sample variables (numeric input values determined during sample preparation and required for calculations)

• Example chromatogram (i.e. a typical chromatogram as generated with this analysis) for display in online results review and on reports

• Instrument control/data acquisition• Integration• Peak identification (based on retention time)• Spectral compound confirmation (based on spectral comparison)• Spectral compound purity (based on similarity calculations of

compound spectra)• Calibration• Quantification• Custom calculations• Reporting• Data review layout• Reporting Limits

Reintegration • System allows reintegrating results in the controlled environment of Cerity results review context.

• Fine-tuning of integration settings on a specific chromatogram is performed under strict revision control of the result record.

• Fine-tuning of integration settings on a specific chromatogram remain private to the chromatogram and do not implicitly affect the master method.

Reprocessing • Reprocessing functions allow to reprocess data with modified sample parameters, or a different revision of the same method or a different method.

• Reprocessing calculations are subject to audit trail and revision control functions of the software.

Sequence template • The method allows storing the “Sequence Template”.• The sequence template defines the normal sequence of injections

required for analyses run with this method: blank injections, system suitability, standards, samples, QC samples etc.

• The sequence template of the method minimizes data entry effort during sequence setup.

Data Analysis

Integration algorithm Revised version of the Agilent Enhanced Integrator.

Integration events The system allows setting integration events to change integration para-meters appropriate for the signal measured during the analysis. Typicalintegration events include, but are not limited to:• Area reject• Height reject• Slope sensitivity• Peak width• Shoulder detection • Tangent skimming • Detection of negative peaks

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Manual Integration The system enables to manually construct the baseline under an area in the signal and add this as a peak to the signal. Typical functionalities are,but are not limited to:• Automatic snapping to the baseline to the signal• Use of SHIFT and CTRL- key to switch between integration modes• Changing start or end of the baseline for a single peak by dragging the

start or end markers to a different position• Multi-Level UNDO for manual integrations• Function to allow changing start, end and valley of integrated peaks

without changing the baseline• Merging multiple peaks to a single peak.• Switch a peak from rider to main peak and vice versa• Adjusting the baseline of an integrated peak or rider peak (including

shoulders and negative peaks) or integrating a new peak manually. These functions can be accessed using the mouse

• in the signal display of the results review (“click” or “click-and-drag functions” with the left mouse button).

• Changing a rider peak or adding peaks together (including shoulders and negative peaks).

• New “user defined baseline” integration events, which can be accessed via the “Timed Events” button or context menu.

Standard quantification modes Area%Norm% External Standard Quantification (ESTD)Internal Standard Quantification ( ISTD)

Support of manual background User can select any signal from any sample or sequence for overlay andsignal subtraction subtraction. The original and subtracted signals are stored. User can

revert back to original signal. Signals can be shifted (adjusted) on the x-Axis. Reports allow printing of original and subtracted signal.

Description of recalibration The system supports flexible calibration schemes: schemes for sequence analyses • Moving average calibration (single update calibration)

• Standard bracketing• Overall bracketing (also known as “grand average bracketing”)

Description of overall Two bracketing modes are available. Overall bracketing calculatesbracketing calibration scheme one calibration curve per calibrated compound for the sequence and

uses it for the quantification of all samples in the sequence. In terms of validation and traceability, this is a lot easier to handle than otherfloating average recalibration schemes.

Description how the system The Cerity report writer is a rendering device that only displays dataprevents discrepancies between already stored in the central data repository and does not performprinted reports and results any calculations of its own. This is to avoid discrepancies betweendisplayed on the screen. results shown on screen and paper.

Description of how system Every modification of a test result (e.g. in the course of reintegrationcontrols re-integration and or reprocessing using updated calibration information) results in areprocessing in a controlled new revision of the result record along with tight links to themanner according to GMP metadata and result.and 21 CFR Part 11. Manual intervention in the integration of a chromatogram

is notified in the report and in the system's online results view using the following measures:• Definition of user capabilities for authorized access• Strict auditing with mandatory audit comments• Authorization by electronic signature (configurable)• Data review layout and Report templates set up to include analysis

audit trail and method version

Support of method specific The system supports method specific calculations through a spreadcalculations sheet control integrated into the data analysis method. The control

enables for calculation formulae in Excel-compatible syntax.

Supported calculation functions Arithmetic, logical, statistical functions also available in off-the-shelfspreadsheet programs.

Storage of method specific Yes, including calculation formulae.calculation results

Triggering of warnings Yes, such as warnings if system suitability or other limits(pass/fail information) based are exceeded.on calculation results

Figure 5.1Manual Integration

Figure 5.2Background Subtraction

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Description of user-defined The built-in custom calculator is an Excel-compatible spreadsheetcontrol(custom) calculations embedded into the Cerity data analysis method. It allows setting up

method specific calculations. • Enables method specific calculations.• Calculations and calculation results are subject to strict revision control

within the Cerity method.• Eliminate manual transcription and manual recalculation of analysis

results.• Custom calculation formulae are entered in Excel syntaX.• Custom calculations result formatting conforms to pharmacopoeial

requirements when checking results against specifications.• Existing custom calculations can be edited, moved, extended if

calculation requirements change (e.g. due to an SOP change).• The Cerity custom calculator enables definition of custom calculations .

on custom calculated results (“caculations on calculations”).• Calculation formulae are printable for review and verification.• All custom calculated results are available for online results review

and reporting.Examples for method specific calculations enabled with the Cerity custom calculator:• Impurity calculations• Reproducibility calculations for replicates• Group statistics• Response factor statistics (calibration precision)• Content uniformity

Description of system • Cerity calculates peak performance parameters according to thesuitability criteria and limits. different pharmacopoeias (USP, EP, BP, JP and DAB). The user can

configure which of them are reported and shown.

• System suitability limits can be defined by component and sample type.

• Available noise calculations: peak to peak and ASTM.

Description of peak • The system supports identification by absolute and relative identification mechanisms. retention times (RRT).

• Peak windows for peak recognition are customizable per peak usingabsolute or relative peak retention time windows.

• Peak summing and peak grouping.• The system compensates for retention time variability during analyses

using reference peaks for the RT update.• Peak naming is flexible and allows for long names.• Peak confirmation based on spectral data comparison against a

prerecorded reference.

Calibration capabilities The system allows multilevel calibration with an unlimited number of levels, fixed amount, variable amount and manual response factors.

Reprocessing • All chromatographic runs in a sequence can be reprocessed automatically ("batch-wise").

• The system allows to reprocess analysis results after changes have been made to sample information, integration setpoints, calibration information or other setpoint changes.

• Existing data may be reprocessed with a newer revision of the original method or with a different method.

• Reprocessing efficiency is high because the system will only recalculatemodified results; Results not affected by a change are taken from their previous revision.

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Available calibration schemes Cerity supports the following calibration curves types: piecewise, linear, quadratic, cubic, exponential, logarithmic, power, average slope.

The following weightings are supported:• Equal• # of calibrations• Linear (x) – by the factor 1/Amount• Quadratic (x) – by the factor 1/Amount2

• Linear (y) – by the factor 1/Response• Quadratic (y) – by the factor 1/Response2

• Lg (x) – by the factor 1/lg(Amount) • Lg (y) – by the factor 1/lg(Response) • Ln(x) – by the factor 1/ln(Amount) • Ln (y) – by the factor 1/ln(Response)

Calibration curve • Includeorigin treatment • Force

• Ignore• Piecewise (connect)

Calibration review capabilities • An authorized user can reject individual calibration points manually from a calibration curve; This action is subject to audit trail and requires authorization by electronic signature if configured so.

• Calibration data display includes regression curve, correlation coefficients, confidence intervals (configurable) and relative residuals.

Quantification capabilities • Response factors are calculated from the calibration result and stored automatically.

• Response factors can also be entered manually per peak. • Response factors can be updated automatically after performing

a re-calibration.• Results can be calculated using a factor per peak in its calculations.• Results can be calculated using the same factor for all unknown

impurities in its calculations.• Specified impurities can be calculated using a specific factor.

Automated limit checking • During sequence execution, the system can be configured to react on limit checks: Pause, abort or continue the sequence with a warning.

• Limits can be defined for single injections and groups of injections, per sample type and per identified peak.

• Limits can be evaluated for all result data, including custom calculated results.

• Multiple limits can be defined for each item to allow for range checking.

Figure 5.3Setting up a method-specific statistical groupcalculation in the “Custom Calculator”.

Spectral processing

Interactive spectra handling • Configurable spectra display• Defining Wavelength range, background correction, number of spectra

and noise range for setup and display of spectral data in results display for UV Spectra handling

• Quick overview of purity and confirmation results with color coded results annotation for each compound and allows configuration of the spectra display in the results context.

• Interactive selection of spectra, reference spectra and spectra ranges• Display of selected spectra, spectra overlays, spectra differences

(residual spectra) and background spectra

Spectral compound purity UV Spectral Compound purity: UV purity results are presented similar to confirmation results window displaying both graphical and numerical results. Purity values display with color coding according to the pass/warning/rejection level of the calculation result. Purity results are available for interactive recalculation for users with access to interactive purity evaluation

Spectral compound confirmation UV Spectral Compound confirmation: In results context, compound confir-mation information is presented read-only. Users get a graphical result representation of spectra and similarity values plus all numerical results ina table. Confirmation values display with color coding according to the pass/warning/rejection level of the calculation result. Users can only modify the result display for original, background and overlaid spectra.

Figure 6.1Spectral compound purity results review. Purity results are calculated automatically andannotated with clear pass/fail results. If thepurity check fails the defined acceptance limits, the peak is not quantified.

Figure 6.2Spectral compound confirmation resultsreview. Confirmation results are calculatedautomatically and annotated with clearpass/fail results. If a confirmation result isbelow the defined acceptance limit, the compound is not identified and not quantified.

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Online Results Review and Approval

Display of analysis results • Online results review is a separate context (view) of the application..• Results can be queried from the Cerity database using standard or

customize queries (database searches).• Results are displayed according to the settings defined in the data

review layout of the method.

Results approval • The system supports a 3-step results approval process (analyst review, peer review, manager approval).

• Data can be approved, rejected, or marked for rework.• Operational system checks ensure the approval steps are

performed in permitted sequence of steps.• Approved data can be locked by the responsible analyst• Locked data can be unlocked by an authorized administrator

Description of retrieval • Database queries can be defined with a query wizardcapabilities to search for data.

• Queries can be defined based on Samples, Methods, Instruments and results.

• All results can be stored and retrieved.

Protection of electronic records All binary raw data is handled by the Oracle database and Ceritymanaged by the system information manager objects and is under strict revision control of the

Cerity security service.

The actual position of analyzed Yes, for Agilent 1100 Series LC and Waters Alliance LC.vials in auto-samplers is For 3rd party autosamplers, requires BCD vial number inputstored and reported (Part 11). to the 35900E.

All components of the system Automatic tracking and storage of instrument serial numbers andare identified in the system firmware revisions (depends on instrument capabilities).(Part 11).

Figure 7.1Result approval in the Accept/Reject screen for results sign-off

Figure 7.2Cerity results review displaying the results inan Explorer-like treeview. The most revision ofa record is always displayed first. Historicalrevisions of the record, including raw data,meta data and audit trail can be viewed byclicking on the “old revisions” mode in the treeview.

Reporting

Description of Cerity The reporting functions consist of a graphical report template editorreport generator and a reporting tool that extracts the data to be reported from the Cerity

database. Report design is done through drag & drop editing of thereport. Report templates are stored in HTML format. Reports can be pub-lished to a web browser and on paper.

Configurability • All Cerity reports can be customized using the report template editor.of the report generator • Report template editor allows to render (visualize) all data from the

application database. • Item selection is done using a tree view representation of the

system's “data dictionary”

Description of built in reports Single injection reports, group summary, composite (sequence summary) reports.Reports include headers, footers, pagination, logos, result tables, graph-ics and statistics.

Description • WYSIWYG (report preview in Internet Explorer). of reporting capabilities The report template editor is HTML based.

• Full control of format attributes (layout, fonts, colors).• Automatic pagination.• Headers and footers.• Reports can be printed in ‘Portrait’ and ‘Landscape’.• Chromatograms can be printed separately. (full page).• Result files can be printed separately from chromatograms..• Chromatograms and results can be combined on the same page.• The system can produce summary tables per analyte.• Result reports include integration codes per peak.• Peak markers are shown on the screen and in the report.• Peak names and retention times can be added to the chromatogram.• Date and time of printout is reported.• Date and time of processing or reprocessing is reported.• Date and time of acquisition is reported.• The scaling of a chromatogram in a report is user definable.• Reporting of custom calculator formulas • Automatically split long signals over multiple pages in vertical format• Printing the example chromatogram defined in the method• Select and print instrument curves

Conditional reporting (formatting The Cerity report template editor allows automatic formatting of report based on limit checks) sections such as tables, table columns or individual fields based on logical

conditions, e.g. to print a certain result in a specific color depending on its value. Multiple conditions on report tables and fields combined with Boolean operations are possible.

Report printing (after reprocessing) Reports are automatically generated when reprocessing an analysis e.g. after modifications of sample information, integration settings or other changes to the setpoints.

Figure 8.1Example report template

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Figure 8.3Reporting of formulars

Figure 8.2Example report published in a web browser.

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Report printing • For analysis results already stored in the Cerity database, reports can (without reprocessing) be regenerated at any time from the results review context without

requiring reprocessing.

Data Import/Export and Archiving

Description of Cerity ChemStation • IImport single ChemStation rawdata files (2D / 3D LC,GC,ADC) data Rawdata and Sequences Import files without conversion

• Import whole sequences with all sample information and all rawdata files• Batch.B file used to import sample name, sample type etc.• Allows to build a customized Cerity sequence based on any set of .D files• Special import options• Automatic split by ChemStation method• One sequence in Cerity for each method• Automatic multi-injection detection• Progress dialog gives detail status and error information• Sequence can be reprocessed with a native Cerity method

Description of Cerity data • The built-in archive/restore utility can be used to exchange archiving capabilities electronic records (accurate and complete copies) as well as to restore

and replay data throughout the record retention period. • Easy transfer of electronic records to other disks or media for

long-term storage and to free up database space.• Complete audit-trail of all archiving and delete operations.• Data selection is performed using an archive query wizard.• XML-based archive catalog allows for interface to archive

management tools.Description of measures • In order to maintain data integrity, Cerity archives related recordsto ensure data integrity in one consistent archive.of archived data • By design, the system prevents archiving incomplete information (e.g.

an individual injection from sequence, or injection results without audit trail or method information).

• If archived data was deleted from online storage, it needs to be reloaded to be accessed by the system.

Interface to Informtion Cerity follows an open system paradigm and can be interfaced to theManagement Systems following types of information management systems:

• Cerity can be interfaced to Agilent Cerity Enterprise Content Manage-ment Systems (ECMS) are ideal to manage results data and databasearchives generated with Cerity and can use Cerity’s XML-based archivecatalog for keyword indexing.Agilent Technologies is a technology partner of Nugenesis Technologies.Agilent Cerity can be interfaced to Nugenesis SDMS.

• Laboratory Information Management Systems (LIMS)Cerity provides a generic LIMS interface for the download of LIMSworklists into Cerity and upload of results data into LIMS.Agilent Technologies is a technology partner of Labtronics, Inc.Labtronics LimsLinkCDS provides configurable interfaces for integrationwith the major chromatography data systems, including Agilent Cerity.

Figure 9ChemStation Rowdata import

• Enterprise Resource Planning Systems (ERP)Cerity for Pharmaceutical QA/QC integrates with BayCovin Instruments.This software from Bayer Business Services bridges the gap betweenmySAP PLM QM and the laboratory instrumentation level. Using anSAP-certified interface to QM-IDI, BayCovin Instruments is designed toprovide a work list of inspections to a client depending on analyticalmethod and instrumentation requirements. Raw quality inspectiondata is collected from a wide range of instruments, managed, andarchived in compliance with FDA regulations (21 CFR Part 11) and ISOquality standards. After optional validation, measured and calculatedend results are sent back to mySAP PLM QM to trigger subsequentactions in the logistic chain.

Support of multi-tiered Requires 3rd party tool e.g., active data on hard drive, older data onarchiving technology slower optical magneto-optical disks, jukeboxes.Where are electronic signatures Configurable, depending on the organization's workflow. used in the system? What infor- Includes, but is not limited to, method changes, adding/changing ma-tion is stored by the system user permissions, result approval.for each use?Are experiments and/or reports Yes. The information can be retrieved and inspected in reviewed and approved electronic form as well as on paper for investigations or regulatory in the system? inspections.What features does the Cerity users must be authenticated Windows users. The Cerity systemsystem provide to administration console is based on the Microsoft Managementadminister user accounts? Console (MMC) and is used to set the Cerity specific permissions.Can the system support Yes (reuses password policies defined on the operating system level).password aging?Can the system support Yes, by directly reusing the account policy defined in the disabling / re-enabling Windows operating system.user accounts?Can the system support account Yes, see above.lockouts after a defined number of failed attempts to log-in?How are failed login attempts Standard Windows security, event log and password policies. recorded by the system? How does the system administrator gain access to information about failed login attempts? How are other security problems identified, recorded and accessed by the system administrator?

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Figure 10Audit trail and electronic signature for resultssign-off

33

Procedures and Controls for Closed Systems

Functional Specifications – Electronic Records and Electronic Signatures Checklist (21 CFR Part 11)

11.10(a)

11.10(a)

11.10(b)

11.10(b)

11.10(c)

11.10(d)

11.10(e)

QuestionIs the system validated?

Is it possible to discerninvalid or altered records?

Is the system capable ofproducing accurate andcomplete copies of elec-tronic records on paper?

Is the system capable ofproducing accurate andcomplete copies of recordsin electronic form forinspection, review, andcopying by the FDA?

Are the records readilyretrievable throughout theirretention period?

Is system access limited toauthorized individuals?

Is there a secure, computergenerated, time stampedaudit trail that records thedate and time of operatorentries and actions that cre-ate, modify, or delete elec-tronic records?

CommentsThe software development is following the software life-cycle and quality management system of Agilent Tech-nologies Lifescience and Chemical Analysis Group. Fullinstallation qualification (IQ) and operational qualification(OQ) services available for the software as well as theinstrumentation controlled by the system.

The product was designed to fulfill the validation require-ments of the users of this product according to currentregulations and quality standards including, but not limit-ed to, 21 CFR 210 (Good Manufacturing Practice forDrugs ), 21 CFR 211 (current Good Manufacturing Prac-tice for finished pharmaceuticals), 21 CFR 58 (Good Labo-ratory Practice), 21 CFR Part 11 (Electronic Records andSignatures).

The data managed by the system is under strict accesscontrol, revisioning and automatic audit trail. The imple-mentation ensures that alterations to records by autho-rized individuals result in a new revision of the respec-tive record along with a detailed audit trail. Softwareoperational qualification protocols and database integritycheck utilities allow detecting corrupted data (e.g. due toa technical failure of a computer hardware component). Cerity generates audit trail entries when a manual inte-gration result is created interactively and discarded later on.

Accurate and complete copies of electronic records arecreated and handled by the Cerity archive/restore utilityincluded in the standard productIn addition, the Cerity system provides an HTML basedreport editor that has the capability to render (visualize)the complete data records managed by the system.

Data can be reviewed online in the query-based "Sample","Instrument", "Method" and "Results Review" views.Navigation through hierarchical data is done using atreeview (similar to Windows Explorer). The Cerityarchive/restore utility is designed to create accurate andcomplete copies of electronic records by maintainingcomplete referential integrity within the archive.

The system manages all records under strict protectionand revision control. Data is accessible directly from theuser interface through predefined and customer defin-able selection criteria (queries). The system implementstechnical controls so data must be archived before anauthorized system administrator can remove it from theonline database.

The system requires mandatory login. The system admin-istrator grants user rights (capabilities) to individualusers and groups of users. The system checks the user'scapabilities prior to executing each task. The system'ssecurity implementation uses a combination of operatingsystem (Windows 2003/Windows XP) security/passwordpolicies and application specific access controls.

The system keeps a detailed, human-readable audit trail("logbook"), which is automatically maintained indepen-dently from operators. The audit trail documents everytime a record is created, modified or destroyed.Options for electronic sign-off on system tasks, config-urable and mandatory audit comments as well as systemchecks for electronic results review and approval can beenabled using the optional Cerity GMP module (AgilentP/N G4030AA).

Y / N / NA*Y

Y

Y

Y

Y

Y

Y

*Y=Yes, N=No, NA=Not Applicable

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11.10(e)

11.10(e)

11.10(e)

11.10(f)

11.10(g)

11.10(h)

11.10(i)

11.10(j)

QuestionUpon making a change toan electronic record, is pre-viously recorded informa-tion still available (i.e., notobscured by the change)?

Is an electronic record'saudit trail retrievablethroughout the record'sretention period?

Is the audit trail availablefor review and copying bythe FDA?

If the sequence of systemsteps or events is impor-tant, is this enforced by thesystem (e.g., as would bethe case in a process con-trol system)?

Does the system ensurethat only authorized individ-uals can use the system,electronically sign records,access the operation, orcomputer system input oroutput device, alter arecord, or perform otheroperations?

If it is a requirement of thesystem that input data orinstructions can only comefrom certain input devices(e.g., terminals) does thesystem check the validity ofthe source of any data orinstructions received?(Note: This applies wheredata or instruction cancome from more than onedevice, and therefore thesystem must verify theintegrity of its source, suchas a network of weighscales, or remote, radiocontrolled terminals).

Is there documented train-ing, including on the jobtraining for system users,developers, IT support staff?

Is there a written policy thatmakes individuals fullyaccountable and responsiblefor actions initiated undertheir electronic signatures?

CommentsThe system implements strict revision control of itsrecords. No previous entry is ever overwritten.

The audit trail cannot be separated from the originalrecord. The Cerity archive/restore utility maintains com-plete referential integrity of the record and archives therecord along with its associated metadata and audit trailinformation.

The Cerity audit trail can be reviewed online (e.g. Inresults review) and can also be included in printedreports.

Operational checks:The system implements technical controls that ensurethe permitted sequence of steps. Examples: The systemenforces the approval-rejection cycle of results data bythe person who generated the data (analyst review), by a2nd individual (peer review) and final sign-off (finalapproval). The system's archive-delete cycle requiresdata to be archived prior to deletion.

Authority checks:For every transaction, the security services determinewhether the currently logged on user has the appropriateauthorization based on the access permissions configuredfor this user or user group

Device checks:The system performs input verification for data entryfields. Invalid fields are marked red. Agilent instrumentsautomatically detect and record serial numbers andfirmware versions. The system stores the hostname ofthe originating client PC when an electronic record is cre-ated or modified.For the 1100 HPLC, the system supports the use of col-umn identifications tags that allow to trace and recordanalytical column information (e.g. batch number, numberof injections, dimensions etc.)

Appropriate user and administrator trainings are avail-able from Agilent Technologies. Customized trainings areavailable on request. Additional procedural controls are required.

This needs to be addressed by procedural controls in theuser's environment.

Y / N / NA*Y

Y

Y

Y

Y

Y

NA

NA

*Y=Yes, N=No, NA=Not Applicable

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11.10(k)

11.10(k)

QuestionIs the distribution of, accessto, and use of systemsoperation and maintenancedocumentation controlled?

Is there a formal changecontrol procedure for sys-tem documentation thatmaintains a time sequencedaudit trail for those changesmade by the pharmaceuticalorganization?

CommentsThis needs to be addressed by procedural controls in theuser's environment.

This needs to be addressed by procedural controls in theuser's environment.

Y / N / NA*NA

NA

11.30

11.30

QuestionIs data encrypted?

Are digital signatures used?

CommentsNot applicable.

Not applicable.

Y / N / NA*N

N

Additional Procedures and Controls for Open Systems

11.50 (a)

11.50 (b)

11.70

QuestionDoes signed electronicrecords contain the follow-ing related information?

• The printed name of the signer

• The date and time of signing

• The meaning of the signing (such as approval,review, responsibility)

Is the above informationshown on displayed andprinted copies of the elec-tronic record?

Are signatures linked to theirrespective electronic recordsto ensure that they cannotbe cut, copied, or otherwisetransferred by ordinarymeans for the purpose of falsification?

CommentsSee detailed comments below.

System shows the printed name of the signer, date/time(local time and timezone information)

See previous item.

The meaning of the signature is captured in the contextof the function currently executed (e.g. peerreview/approval) or through a mandatory comment.

Signatures become part of the original record. Changesresult in new revisions of records and previous entriesare never overwritten. The information is available onlineand on printed reports.

The signature information becomes part of the originalrecord according to the Cerity database schema.Changes result in new revisions of records and previousentries are never overwritten. In addition, audit trail ande-sig are part of the archived/restored records.

Y / N / NA*Y

Y

Y

Y

Y

Y

Signed Electronic Records

11.100(a)

11.100(a)

11.100(b)

QuestionAre electronic signaturesunique to an individual?

Are electronic signaturesever reused by, or reas-signed to, anyone else?

Is the identity of an individualverified before an electronicsignature is allocated?

CommentsThe Cerity security implementation is based on operatingsystem security. This allows to directly reuse the useraccount system defined by the user's IT operation alongwith the corresponding security and password policiesdeveloped and controlled by the user's organization.

The Cerity security implementation is based on operatingsystem security and supports appropriate behavioral con-trols of the user's organization. For instance, the operat-ing system user account must be disabled but not reas-signed to someone else when the respective individualleaves the organization.

This must be governed by appropriate company policies.

Y / N / NA*Y

Y

NA

Electronic Signatures (General)

*Y=Yes, N=No, NA=Not Applicable

36

11.200(a)(1)(i)

11.200(a)(1)(ii)

11.200(a)(1)(iii)

11.200(a)(2)

11.200(a)(3)

QuestionIs the signature made up of at least two components,such as an identificationcode and password, or an idcard and password?

When several signings aremade during a continuoussession, is the passwordexecuted at each signing?(Note: both componentsmust be executed at thefirst signing of a session).

If signings are not done ina continuous session, areboth components of theelectronic signature execut-ed with each signing?

Are non-biometric signaturesonly used by their genuineowners?

Would an attempt to falsifyan electronic signaturerequire the collaboration of atleast two individuals?

CommentsThe Cerity system uses operating system security. Loginto the Cerity system and electronic signatures requirethe user ID and password.

Signing a record always requires entering the user-id andpassword of that user.

A configurable inactivity timeout prevents impersonationafter a defined period without user activity. The currentlylogged on user must re-enter user ID and password tounblock the system.

Customer policy has to define, implement and maintain asuitable password policy. Cerity uses Windows securitysystem, allowing reuses of the password policies definedin Windows.

Yes, but requires appropriate account and password handling policies in the user's organization and IT environment.

Y / N / NA*Y

Y

Y

Y

Y

Electronic Signatures (Non-biometric)

11.300(c)

11.300(c)

11.300(c)

11.300(e)

11.300(e)

QuestionIs there a loss managementprocedure to be followed ifa device is lost or stolen?

Is there a procedure forelectronically disabling adevice if it is lost, stolen, orpotentially compromised?

Are there controls over theissuance of temporary andpermanent replacements?

Is there initial and periodictesting of tokens and cards?

Does this testing check thatthere have been no unautho-rized alterations?

CommentsThis needs to be addressed by procedural controls in theuser's environment.

This needs to be addressed by procedural controls in theuser's environment.

This needs to be addressed by procedural controls in theuser's environment.

This needs to be addressed by procedural controls in theuser's environment.

This needs to be addressed by procedural controls in theuser's environment.

Y / N / NA*NA

NA

NA

NA

NA

For Tokens, Cards, and other Devices Bearing or Generating Identification Code or Password Information:

11.200(b)QuestionHas it been shown that bio-metric electronic signaturescan be used only by theirgenuine owner?

CommentsNot applicable. Cerity for Pharmaceutical QA/QC revisionA.02.xx is not delivered with biometric ID devices.

Y / N / NA*NA

Electronic Signatures (Biometric)

*Y=Yes, N=No, NA=Not Applicable

37

11.300(a)

11.300(b)

11.300(b)

11.300(c)

11.300(d)

11.300(d)

QuestionAre controls in place tomaintain the uniqueness ofeach combined identificationcode and password, suchthat no individual can havethe same combination ofidentification code and pass-word?

Are procedures in place toensure that the validity ofidentification codes is peri-odically checked?

Do passwords periodicallyexpire and need to berevised?

Is there a procedure for elec-tronically disabling an identi-fication code or password ifit is potentially compromisedor lost?

Is there a procedure fordetecting attempts at unau-thorized use and for inform-ing security?

Is there a procedure forreporting repeated or seriousattempts at unauthorized useto management?

CommentsCerity uses the account system, security and passwordpolicies defined for the operating system. Therefore, thisrequires appropriate account and password handlingpolicies in the user's organization and IT environment.

Yes, see 11.300(a)

Yes, see 11.300(a)

Yes, see 11.300(a)

Yes, see 11.300(a). The Cerity security implementationuses the operating system event viewer to log securityevents. This requires appropriate configuration of theoperating system's event logging.

Yes, see 11.300(a)

Y / N / NA*Y

Y

Y

Y

Y

Y

Controls for Identification Codes and Passwords

Warranty and Please contact your local support sales representative.Support Contracts

Warranty Period Varies by country and can be from 1-3 years. Extended Warranty Available. Software telephone support Available. Software materials subscription Available. Software status bulletins Available from www.agilent.com/chem/nds (requires valid software

license number)

*Y=Yes, N=No, NA=Not Applicable

38

Services Please contact your local NDS sales representative.

Standard services Installation, Familiarization, Education

Available standard courses H2296A – Cerity Networked Data System Basic Operation (Full Access Users) 1 dayH2297A – Cerity Networked Data System Advanced Operation (Full Access Users) 2 daysH2298A – Cerity Networked Data System Application Administration 1 dayH2295A – Cerity Networked Data System Routine Operation 1 day

Personalized Customized education courses are available and can be delivered ateducation services a central Agilent location or on-site.

Qualification services Computer-based installation qualification (IQ)for NDS software Computer-based operation qualification (OQ/PV)

Delivered by Agilent customer engineers or a certified support provider.

Qualification services for Computer-based installation qualification (IQ)chromatography equipment Computer-based operation qualification (OQ/PV)

Delivered by Agilent customer engineers or certified support provider.

Customization services Available.Delivered through Agilent's Project Services Organization. Please contact your local NDS sales representative.

Qualification of somputer Regulatory agencies are endorsing a risk-based approach to compliance.network infrastructure Network infrastructure can be a high-risk, high-impact component for the

integrity and security of data it transports. Network infrastructure needs to be considered in a company’s overall master validation plan.

Agilent Technologies has taken a metrology-based approach to the qualification of computer network infrastructure and provides services the following services:• Design Qualification for networks

• Installation Qualification for networks

• Operational Qualification for networks

These services are delivered through Agilent's Project Services Organization.

Consulting services Available.Delivered through Agilent's Project Services Organization.

Project management services Available.Project management according to development lifecycle. Services comprise specification, design, implementation, deployment, validation and support.Delivered through Agilent's Project Services Organization.

Declaration of system validation Included with the shipment kit.

audit reports The quality management system of Agilent Technologies and the lifecycledocumentation for Cerity for Pharmaceutical QA/QC has been audited by independent inspectors according to PDA Technical Report #32. The audit report is available to subscribers from the audit repository center (ARC) www.auditcenter.com

Note: This table is subject to changes. Latest information isavailable in the Agilent web site underhttp://www.chem.agilent.com/cag/cerityspecs.htm

39

The information in this publication is subject tochange without notice.

Microsoft®and Microsoft Windows®are U.S.registered trademarks of Microsoft Corp.Oracle®is a U.S. registered trademark of Oracle Corporation, Redwood City, California.

Copyright © 2003-2006 Agilent Technologies, Inc.All Rights Reserved. Reproduction, adaptationor translation without prior written permissionis prohibited, except as allowed under thecopyright laws.

Published April 1, 2007Publication Number 5989-4926EN

www.agilent.com/chem/cds