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Agilent Cerity Networked Data System for Pharmaceutical QA/QC - Rev. A.02.02 - July 2004 Manual

1. rare Figure 6 sis ayer goa ges gee goe gor Beon Pio Mw tir T ECO za Example report template 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 e WYSIWYG report preview in Internet Explorer of reporting capabilities The report template editor is HTML based e Full control of format attributes layout fonts colors e Automatic pagination e Headers and footers e Reports can be printed in Portrait and Landscape e Chromatograms can be printed separately full page e Result files can be printed separately from chromatograms e Chromatograms and results can be combined on the same page e The system can produce summary tables per analyte e e e e e e e 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 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 b
2. The quality management system of Agilent Technologies and the lifecycle documentation 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 nt Cerity NDS for Pharmaceutical QA QC wadc Ele Edt View Go Tools Actions Help Instrument D HX Ram on gt x J O Agilent359004DC Et BD Agilent 100Lc Test Manager Execution Selection SelectAll UncelectAl Bun Thie RunNest Dpen3 VS Opend Register object Resuts aje sf Registered User with Security All Applications Run the test suite 1 mels FF Run in automated mode of Registered User with security GoodT oken Fun eachtest group time s sZ Registered User with security BadToken Cee il mas T Stop on fail of Registered User without security All Application Run each test case 1 timels F7 Start tests on load sf Registered User without security GoodT oken Ea Regiapa Upee vahou secuy HaT oken Security Testing The first area to be tested is the proper 3 P af Unvec tered User saah MAcko functionality of the security The test cases in this group are A5 Unregistered User with securiy Good oken Jexpected to run to completion successfully z of Unregistered User with security BadT oken Mf Unregistered User without security All Applications Test Cases Pass Fail a of Unvesistered User withou
3. Figure 7 Example report published in a web browser Data Archiving Description of Cerity data e The built in archive restore utility can be used to exchange archiving capabilities electronic record and replay data s accurate and complete copies as well as to restore hroughout the record retention period Easy transfer of electronic records to other disks or media for ong term storag Complete audit e and to free up database space rail of all archiving and delete operations e Data selection is performed using an archive query wizard e XML based archive catalog allows for interface to archive management tools Description of measures e In order to maintain data integrity Cerity archives related records to ensure data integrity in one consistent archive of archived data e By design the system prevents archiving incomplete information e g an individual injection from sequence or injection results without audit trail or method information e f archived data was deleted from online storage it needs to be reloaded to be accessed by the system Interface to Informtion Management Systems Cerity follows an open system paradigm and can be interfaced to the following types of information management systems e Cerity can be interfaced to Agilent Cerity Enterprise Content Manage ment Systems ECMS are ideal to manage results data and database archives generated with Cerity and can use Cerity s XML ba
4. The Cerity NDS review client is the interface to the Cerity NDS system Users perform their work with the graphical user interface Software Administration Console The Cerity Software Administra tion module provides a so called snap in for the Microsoft Manage ment Console MMC MMC is a console designed to integrate management tools and functions and to present a common visual Network Infrastructure Overview The Cerity NDS infrastructure is based on operating system and common IT standards For instance Cerity NDS is standard ized on communication through the TCP IP protocol for all Cerity network nodes including analyti cal instruments computers and servers Recommended Topology The Cerity system relies on the computer network infrastructure In order to provide optimum per formance and uptime the network must meet design criteria in terms of available bandwidth IP address assignment name resolution and isolation of the lab subnet from the corporate network Cerity acquisition controllers capture the real time data of net worked instruments and transfer it to the central database server which is typically installed in a data center Cerity acquisition controllers are designed to automatically recon GUD of the review client Sample and sequence scheduling instrument status monitoring method setup results review and environment for management applications Only operating sys tem a
5. Alliance mainframe and one Waters 2487 detector connected to the Cerity software Agilent 6850 GC Injector G2613A G2880A Inlet Split splitless purge pack Column Inlet Inlet unspecified Column Outlet Detector MSD Detector FID TCD Cryo co N Valves GSV LSV multiposition switching Aux Temperature Data Channels 1 Handheld controller G2629A Table 6 6850 GC hardware supported by Cerity NDS for Pharmaceutical QA QC Model Number Description Firmware Comment Waters 2690 Waters Alliance 2 02 or higher 2 02 is required to run Cerity compliance for the Waters Alliance Waters 2695 Waters Alliance 2 0 or higher 2 02 is required to run Cerity com pliance for the Waters Alliance Waters 2487 Waters Dual 1 03 Wavelength Detector Table 7a Waters instrument minimum firmware requirements Module Description Firmware SIL 10ADvp Autosampler 5 32 LC 10ADvp Pump 5 26 FCV 10ALvp Switching valve for quat gradient n a DGU 14Avp Degasser n a SCL 10Avp System controller 5 32 SPD 10AVvp UV VIS detector 5 24 SPD 10Avp UV VIS detector identical to SPD 10AVvp but without a VIS lamp 5 24 CTO 10ACvp Column compartment 5 24 CTO 10ASvp Column compartment 5 24 Table 7b Shimadzu LC 10A Series firmware requirements A remote start stop cable is required to synchronize the Waters detector with the LC See table 7a for firmware requirements Shimadzu LC 10A Series Cerity controls the Shimadzu LC 10A series throu
6. Instrument Control framework license G4065AA to enable instru ment control and data acquisi tion through the Agilent 35900E dual channel interface using the Cerity Generic Instrument Con trol framework Requires one license and one 35900E channel per GIC instrument G4064AA license is included but 35900E hardware is not Requires one additional vendor specific instrument adapter for each instrument Cerity P Shimadzu LC10Avp VSIA instrument control license G4067AA Cerity P Agilent 5890 VSIA instrument control license G4068AA Installation Qualification Tool IQT The Installation Qualification Tool is a computer based qualification utility used to perform Installation Qualification IQ of the Cerity NDS for Pharmaceutical QA QC system Computer based installation qualification protocols verify the completeness and intactness of the Agilent software installed on the PC The computer based installation qualification utility available for Cerity NDS for Pharmaceutical QA QC reads required details from the system directly and inserts them into the document automatically The utility provides input forms for details that cannot be extracted automatically from the system software and hardware The entry forms support further techniques for automated data entry such as bar coding Execution of the soft ware IQ protocol requires a valid IQ license Without a valid license number the final acceptance protocol cannot be g
7. Review views Navigation through hierarchical data is done using a treeview similar to Windows Explorer The Cerity archive restore utility is designed to create accurate and complete copies of electronic records by maintaining e complete referential integrity within the archive The system manages all records under strict protection and revision control Data is accessible directly from the ser interface through predefined and customer defin able selection criteria queries The system implements echnical controls so data must be archived before an authorized system administrator can remove it from the online database The system requires mandatory login The system admin istrator grants user rights capabilities to individual sers and groups of users The system checks the user s capabilities prior to executing each task The system s security implementation uses a combination of operating system Windows 2000 Windows XP security password policies 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 every ime a record is created modified or destroyed Options for electronic sign off on system tasks config urable and mandatory audit comments as well as system checks for electronic results review and approval can be enabled using the optional Cerity GMP
8. The GMP module enables strict auditing audit comments and e signature The GMP module also enforces a strict results review approval process This will ensure that analysts review their own results before a peer reviewer and a final approval is given This is an enabling license No additional software is installed The GMP module enables the audit node in the Cerity System Administration Console Note Only one GMP license is needed in the professional system Instrument Control and Spectral Evaluation Licenses One instrument control license is required per instrument controlled by the Cerity NDS software The licenses are easy to install and they are monitored by the applica tion Cerity instrument control licenses are available for the fol lowing products Cerity P 1100 Series LC instru ment control license G4061AA Cerity P Waters Alliance LC instrument control license G4062AA Cerity P 6890 6850 GC instru ment control license G4063AA Cerity P 35900E Dual Channel Interface instrument control license G4064AA Cerity P Spectral Acquisition and Evaluation License G4031AA Enables data acqui sition and data evaluation for spectral data obtained from an Agilent 1100 instrument with 3D spectral capabilities diode array detector or fluorescence detector One spectral process ing license is required per 3D instrument Cerity P Agilent 1090 HPLC instrument control license G4067AA Cerity P Generic
9. Y Yes see 11 300 a tronically disabling an identi fication code or password if it is potentially compromised or lost 11 300 d Is there a procedure for y Yes see 11 300 a The Cerity security implementation detecting attempts at unau uses the operating system event viewer to log security thorized use and for inform events This requires appropriate configuration of the ing security operating system s event logging 11 300 d Is there a procedure for Y Yes see 11 300 a reporting repeated or serious attempts at unauthorized use to management Y Yes N No NA Not Applicable 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 TY Agilent Cerity NDS for Pharmaceutical QA QC wadc1871 rhonsberg Administrator Cerity A 01 DB File Edt View Go Tools Actions Help rme D AIA MW Ou gt x E 11000qtcp xm AutoDoc P Allinstruments Fe Hep Pre Run FEFE Agienassooanc s gt Agilent 1100 Series HPLC al ee Instrument Operational Qualification Performance Verification OQ PV Test Creation Protocol Protocol Revision Number 01 00 PAGEBREAK In this Protocol This protocol is
10. automatically detect and record serial numbers and irmware versions The system stores the hostname of he originating client PC when an electronic record is cre ated or modified For the 1100 HPLC the system supports the use of col mn identifications tags that allow to trace and record analytical column information e g batch number number of injections dimensions etc Appropriate user and administrator trainings are avail able from Agilent Technologies Customized trainings are available on request Additional procedural controls are required This needs to be addressed by procedural controls in the user s environment Question Y N NA Comments 11 10 k Is the distribution of access NA This needs to be addressed by procedural controls in the to and use of systems user s environment operation and maintenance documentation controlled 11 10 k Is there a formal change NA _ This needs to be addressed by procedural controls in the control procedure for sys user s environment tem documentation that maintains a time sequenced audit trail for those changes made by the pharmaceutical organization Additional Procedures and Controls for Open Systems Question Y N NA Comments 11 30 Is data encrypted N Not applicable 11 30 Are digital signatures used N Not applicable Signed Electronic Records Question Y N NA Comments 11 50 a Does signed electronic y See detailed comments below records contain the follo
11. files as well as the Cerity report storage be located on the shared storage of the cluster server Increased hardware resources should be specified as per Microsoft recommendations Specifically a separate mirrored disk a so called quorum disk is highly recommended Acquisition Controller Cerity supports enhanced acquisition buffering for instrument measure ment data In the event of database connectivity loss acquired data is buffered on the acquisition con trollers and automatically spooled to the database once the database connectivity is re established To minimize buffering requirements data analysis is suspended in acqui sition buffering mode Data analysis results can be generated by repro cessing the buffered raw data The Cerity system continues and completes all sequences running at the time of the network failure Supported Analytical Instrumentation Agilent 1100 Series Liquid Chromatograph Full Level 4 instrument control of the Agilent 1100 liquid chromatograph via LAN interface In revision A 02 02 and higher the following modules are supported e Agilent 1100 isocratic binary and quaternary pumps e Agilent 1100 VWD MWD and DAD Gn 2D chromatography and 3D spectral acquisition mode mode e Agilent 1100 FLD fluorescence detector e Agilent 1100 RID refractive index detector e Agilent 1100 standard and thermostatted autosampler e Agilent 1100 thermostatted column compartment e Agi
12. if certain review clients create a much higher data load than others The following table specifies the minimum hardware requirements for an acquisition controller If server computers are available for acquisition controllers RAID controllers are recommended Fast PCs with sufficient RAM and virtual memory are also acceptable For system redundancy please consider standby computers to be used in case of computer hardware failures To have Windows XP choose the best paging file size choose System managed size The recommended minimum size is equivalent to 1 5 times the amount of RAM on your system and 3 times that figure for the maximum size Example if you have 4 GB of RAM the minimum paging file size is 6 GB and the maximum paging file size is 18 GB If the paging file reaches its maximum size in Windows 2000 a warning is displayed and the system may halt To see whether your paging file is approaching its upper limit before it reaches the upper limit check the actual file size and compare it to the maxi mum paging file size setting in the System utility in Control Panel If these two numbers are close in value consider increasing initial paging file size or running fewer programs Review Client Review clients are workstations used for interactive entry of sample and sequence data method entry and management scheduling of analyses data review reporting and result approval Table 12 specifies t
13. in an Explorer like treeview The most recent revision of a record is always displayed first Historical revisions of the record including raw data meta data and audit trail can be viewed by clicking on the old revisions mode in the treeview 29 Reporting Description of Cerity The reporting functions consist of a graphical report template editor report generator and a reporting tool that extracts the data to be reported from the Cerity database Report design is done through drag amp drop editing of the report Report templates are stored in HTML format Reports can be pub lished to a web browser and on paper Configurability e All Cerity reports can be customized using the report template editor of the report generator e Report template editor allows to render visualize all data from the application database e Item selection is done using a tree view representation of the system s data dictionary Ele Eat yew Insert Format Table tep olesia ala oleaas lt 2 roms alms smse Poz z afe zlujaj llre eleja Injection Sample method description OOOO Calibration C773 created Sample OOK OOOOOOOOOOX Calibration scheduler ORIN modified Method rev Instrument Instrument rev pie B BF YantiPep Acar Maples Compenrd S Lint Ren Compound 1510 RT Compound wanae aa oooooooooqN0OCoox x ODDO ez tz 0000 x DOOD sarts ane
14. limits the peak is not quantified Format e RAR ial firmatio Daneipion n Sin ay n Status Confemed OADIA 68296428 rece Soap1A szama Figure 4 2 Spectral compound confirmation results review Confirmation results are calculated automatically and annotated with clear pass fail results If a confirmation result is below the defined acceptance limit the Bama orev l Tapenceny Eara conesa tero resama E SE compound is not identified and not quantified Spectral processing Interactive spectra handling e Configurable spectra display e Defining Wavelength range background correction number of spectra and noise range for setup and display of spectral data in results display or UV Spectra handling e 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 e Interactive selection of spectra reference spectra and spectra ranges e 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 colour coding according to the pass warning rejection level of the calculation result Purity results are available for interacti
15. module Agilent P N G4030AA A FOCUS FOR IN EUROPE Eurachem D ANALYTICAL CHEMIS EP European Pharmacopeia r 21CFR Part11 33 11 10 e 11 10 e 11 10 e 11 10 f 11 10 g 11 10 h 11 10 i 11 10 j Question Upon making a change to an electronic record is pre viously recorded informa tion still available i e not obscured by the change Is an electronic record s audit trail retrievable throughout the record s retention period Is the audit trail available for review and copying by the FDA If the sequence of system steps or events is impor tant is this enforced by the system e g as would be the case in a process con trol system Does the system ensure that only authorized individ uals can use the system electronically sign records access the operation or computer system input or output device alter a record or perform other operations If it is a requirement of the system that input data or instructions can only come from certain input devices e g terminals does the system check the validity of the source of any data or instructions received Note This applies where data or instruction can come from more than one device and therefore the system must verify the integrity of its source such as a network of weigh scales or remote radio controlled terminals Is there documented train ing including on the job training for system
16. the evaluation is performed automatically using known data source prerecorded acceptance limits and self evaluating reports e A number of test cases require scripted manual tests because of their interactive nature The test scripts cover areas such as challenging logon security auditing of interactive changes authority checks and archive restore functions Execution of the OQ protocols requires a valid OQ license Without a valid license number the final acceptance protocol cannot be generated Functional Specifications Application Technology and Architecture General description Revision history Description of data repository Supported Database Management System Data model Management of binary large objects BLOBs Characteristics of the distributed Full scalability 1 to n Cerity configurations Maximum size of data base supported Design language tools Operating System Cerity NDS for Pharmaceutical QA OC is a high availability fully scaleable networked data system for analytical QA OC laboratories that require chromatographic instrument control data acquisition data analysis flexi ble reporting and with strict adherence 21 CFR Part 11 electronic records and electronic signatures and related predicate rules such as to 21 CFR 210 GMP and 21 CFR Part 211 cGMP Cerity for Pharmaceutical QA OC has been available in the following revisions Revision number Description Revision A
17. users developers IT support staff Is there a written policy that makes individuals fully accountable and responsible for actions initiated under their electronic signatures Y Yes N No NA Not Applicable 34 Y N NA Comments Y NA NA The system implements strict revision control of its records No previous entry is ever overwritten The audit trail cannot be separated from the original record The Cerity archive restore utility maintains com plete referential integrity of the record and archives the record along with its associated metadata and audit trail information The Cerity audit trail can be reviewed online e g In results review and can also be included in printed reports Operational checks The system implements technical controls that ensure the permitted sequence of steps Examples The system enforces the approval rejection cycle of results data by the person who generated the data analyst review by a 2nd individual peer review and final sign off final approval The system s archive delete cycle requires data to be archived prior to deletion Authority checks For every transaction the security services determine whether the currently logged on user has the appropriate authorization based on the access permissions configured for this user or user group Device checks The system performs input verification for data entry ields Invalid fields are marked red Agilent instruments
18. 01 01 Initial release June 2002 Revision A 01 02 Support for Windows 2000 support of 6850 GC August 2002 Revision A 01 03 Support under Citrix Terminal server November 2002 Revision A 02 01 Support for Oracle9i RDBMS March 2003 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 Enable data buffering on acquisition controllers June 2003 in case of network or server failure Revision A 02 02 Enable 3D spectral data acquisition and data January 2004 evaluation for diode array and fluorescence detectors Central secure data repository based on Oracle database management system Oracle 9i 9 2 0 3 0 Object relational data model Binary data e g raw instrument data is stored in so called BLOBs and managed within the Oracle 9i database High availability configurations acquisition buffering server clustering Centralized system administration Centralized backups mport and export of data is possible between database servers ultiple 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 ultiple acquisition controller are supported per Cerity database server e Up to 15 2D instruments or up to 6 3D instruments are supported per acquisition c
19. 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 nformatics specialist sing TCP IP protocol as installed with Microsoft Windows ibrary SICL Level 4 instrument control advanced full control for instruments with appropriate capabilities e g Agilent 1100 HPLC Agilent 1090 HPLC Agilent 5890 and Agilent 6850 6890 GC Based on standard interface contro and the Waters 2487 Dual Wavelength Detector Level 3 full control for Shimadzu LC10Avp using the Cerity Generic nstrument Control GIC framework all pump configurations and diode array detector Agilent 5890 GC is supported No Instruments interfaced via LAN require appropriate instrument LAN 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 The networked design of all components ensures that all parts of the 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 th
20. 22c a Gj Sample Variables Imp_Spec_RRF0 5 S Sequence Template Imp_cal1 4S Data Analysis p E Example Chromatog Imp_cal2 E Integration E Identification e Parent A Calibration _ Imp_Spec_RRF3 EF Quantitation Setup ISTD Custom Calculations i3 Fi 4 amp Limits 37 Not Identified Peaks Igure co a Data Review Layout zl i E Setting up a method specific statistical group noi calculation in the Custom Calculator Sample n who aia s w G Available calibration schemes Cerity supports the following calibration curves types piecewise linear quadratic cubic exponential logarithmic power average slope The following weightings are supported e Equal e of calibrations e Linear x by the factor 1 Amount e Quadratic x by the factor 1 Amount e Linear y by the factor 1 Response e Quadratic y by the factor 1 Response e Lg x by the factor 1 lg Amount e Lg y by the factor 1 lg Response e Ln x by the factor 1 In Amount e Ln y by the factor 1 In Response Calibration curve e Include origin treatment e Force e Ignore e 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 e Calibration data display includes regression curve correl
21. 44 2003 14472003 e Database queries can be defined with a query wizard to search for data e Queries can be defined based on Samples Methods Instruments and results e All results can be stored and retrieved All binary raw data is handled by the Oracle database and Cerity information manager objects and is under strict revision control of the Cerity security service UL Agilent Cerity SDS for Pharmaceutical QA QC Demo User Training Administrator Certy for Phartiis GA OC EI ralh roma He lof am Te SR R RR AK Signals of Acqared Saaks D 0 101 o Tarpheayt iE rs Amount Wapdam E Aroak toigh SS ae Cakadater seq dod 01 LC_1100 al _sameles Caladator_seq_dad_002 Reprocessed Calbr ation f sort 20 2613158 D Mcawaem Fy coomo a Contrat Panel 27 7 5 catbro Pycorfigaeti yi Agilent Ce The actual position of analyzed vials in auto samplers is stored and reported Part 11 All components of the system are identified in the system Part 11 Yes for Agilent 1100 Series LC and Waters Alliance LC For 3rd party autosamplers requires BCD vial number input to the 35900E Automatic tracking and storage of instrument serial numbers and firmware revisions depends on instrument capabilities Figure 5 1 Result approval in the Accept Reject screen for results sign off Figure 5 2 Cerity results review displaying the results
22. Cerity Networked Data System for Pharmaceutical QA QC Revision A 02 02 Specifications July 2004 Introduction Cerity NDS for Pharmaceutical QA QC is a high availability net worked 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 EE Agilent Technologies Table of Contents OV EIVI OW EETA E E tena Sothern A Sale Peto e ea ceeuhaeesane se 3 Cerity NDS for Pharmaceutical QA QC Professional 3 Cerity NDS for Pharmaceutical QA QC Client Server 3 General Description Cerity NDS for Pharmaceutical OA OC Client Server 4 Data Acquisition and Instrument Control 0 e cee ee eee ees 4 Acquisition Controllers and Reprocessing Servers 4 Agilent Instrument Driver cs ccs eision srar 00 eee eee eee 4 Drivers for Non Agilent Instruments 00 00005 4 Data Processing and Review 0cccceeeeeeeee eee ee eeeeeaee 5 Software Administration Console ccc cece eee eens 5 Network Infr
23. Each individual with a logon to the Cerity software requires a separate Oracle client license e Additional Oracle licenses can be purchased using Agilent product number G1411A Please note that Oracle licenses deliv ered by Agilent Technologies are application specific and may only be used within the context of the Agilent net worked data system Cerity NDS for Pharmaceutical QA OC License The number of Cerity NDS concurrent licenses in use must not exceed the number of licenses installed otherwise the license agreement is violated Additional licenses are easy to order and easy to install The Cerity NDS licenses float and are consumed by concurrent users For the client server configuration there must be an equal number of Cerity NDS licenses as there are Cerity NDS concurrent users Cerity NDS for Pharmaceutical QA QC Professional Agilent G4000AA is a single user system and includes one concurrent Ceri ty user license The following restrictions apply Only one Cerity user can be logged on to the computer at any given time G4002AA add concurrent Cerity NDS user is not applicable to the professional system If the professional system is used by different operators at different times each individual user requires a separate named user license of Oracle Standard valid for the Agilent NDS family of products GMP Module License One GMP license is needed for each concurrent user license Agilent G4002AA
24. a distributed Cerity NDS installation In this case the acquisition controller serves as a dedicated reprocessing server Low end Processor type or minimum speed etc Minimum memory Maximum number of instruments Pentium 4 1 2 GHz 1 5 GB spectra capabilities or 8 instruments with no on line High end Pentium 4 2 4 GHz 2 5GB 15 instruments with no on line spectra capabilities or 3 instruments that acquire on line 6 instruments that acquire spectra like DAD or FLD Minimum mass storage 40 GB Peripherals required on line spectra like DAD or FLD Keyboard mouse CD ROM drive Interfaces Network Interface Display 1024 x 768 pixels 65536 colors Table 11 Hardware prerequisites for Cerity NDS review client 1 Plan your client server systems to that you use no more than 15 data channels for each acqui sition controller For example a 35900E with 2 data channels configured and a DAD with all five chromatography signals configured leaves eight avail able channels 2 For large systems with a heavy processing load add an addi tional acquisition controller for every 10 review clients in your client server system to perform off line reprocessing Do not add any instruments to these systems By default the Cerity server assigns the reprocessing servers automatically System administrators can explicitly assign a dedicated reprocessing server to specific review clients This configuration is useful
25. ally only required for a senior chemist or chemist Analysts chemists technicians typically work with predefined methods Master methods are protected methods that serve as template for instrument specific methods By using a master method analysts can be sure that the analysis settings are coherent with the official analysis procedure Cerity allows translating a chromatographic analysis procedure into 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 continued 23 System checks to ensure consistency between method parameters and physical instrument capabilities Typical interaction of an analyst with a method Settings controlled Reintegration Reprocessing Sequence template 24 The so physica ware queries the current configuration details from the instrument prior to starting the analysis to ensure that the analysis parameters are compatible Cerity methods are specific to an instrument configuration e g Agilent 1100 Series LC with DAD and a binary pump and can be applied for groups of instruments that have the same configuration Login Selec Login Selec the instrument suitable for e Enter sample information d LIMS ID concentration of s e Schedule analysis o system sample entry contex he sample view the method the system automatically su
26. 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 medium or 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 generates EMF warnings when an user defined wear and tear limit is reached for one or several parts in the chromatographic system Cerity logs EMF warnings in the sample logbook This information can be used to prove that the instrument was in good working order when the original analysis was performed Shutdown methods and Cerity supports so called error methods on the Agilent 1100 HPLC The standby conditions instrument will execute the error method after a defined time interval Flow set to zemo Temperature at start of eure 26 23 In addition Cerity allows for a so called soft timeout after which the module 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 sy
27. are turned off To use them they have to be con figured on the GC keyboard before connecting the GC to Cerity for Pharmaceutical QA QC 6890N firmware N 05 02 or greater required 6850N firmware A 05 02 or greater required e Inlets Split Splitless and Cooled On Column The inlets are supported with or without EPC e Electronic Pressure Control 2 Channel or 6 Channel EPC The 5890 VSIA supports EPC Channels A B C D E and F e Detectors TCD FID NPD ECD and FPD Time programmable polarity switching for the TCD is not supported e Oven Standard oven with or without cryogenic cooling Supported Sampler Configurations e ALS controller G1512A firm ware revision A 01 05 or higher e ALS injector 18593B and G1513A 8 Vial high density turret is not supported e Sample tray 100 vial tray 18596B C barcode reader is not supported e The new 7683B injector G2913A does not provide a serial interface and is not sup ported with this driver Waters Alliance Full control of the solvent delivery system column heater and autosampler of the Waters 2690 and 2695 Alliance Liquid Chromatograph via GPIB interface optionally available with the software Up to four Waters Alliance chromatographs can be controlled through a single GPIB interface Full control of the Waters 2487 Dual Wavelength Detector via GPIB interface One instrument control license is required per Waters Alliance system consisting of one Waters 2690 2695
28. ased on logical conditions e g to print a certain result in a specific color depending on its value 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 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 30 AA sample sanle Injection Condensed Report Microsoft Internet Explorer provided by Agilent Technologies Be Es vew Favertes Iocs teb His OA Al Ah Grates Breda hy Adress B c aglone Certy Reperts pharmaQciReperts adminir ator cerkydade 11042003 11 25 151002 Haat injection Samele Surmery O Sample singe njectcnidefaut nem Go urs meee E 11704 2003 17 34 27 C meon ror Sample method description third dad method 23 Calibration created 1104 2003 16 2954 wadndsiidemo Calibration modified 11 04 2003 16 29 54 ceritydadic Instrument rev 2 Method rev Sample scheduler Instrument Talling f 1 058 1 042 0 994 0 350 Percent of biphenyl O METH PTHALATE D ETH PTHALATE BI PHENYL O TER PHENYL 385 8491 348 8729 402 2334 62 2460 9 9309 Nl 19 9360 nja 29 8992 _ NJA 398191 na 38 8534 17 5005 13 4530 14 1200
29. astructure 0 cece eee 5 OVETVIEW moorde yb ne eae ih tea ors oliee yaks banshee TA 5 Recommended Topology 0 cee ee ee eee eee ences 5 Recommended Network Settings 200 e eee eee 5 Network Interfaces coc vcccckccu kas ta ti de ee eee G eae Re ee OES 6 Assignment of IP Addresses 0 0 00 eee eee eee eee 6 Support for High Availability Configurations Failure Resilience 7 Support for Clustering Server Failover 0 05 7 Cerity Database Server 00 00s sce cee eee eet ae eens 7 Acquisition Controller seese sepesi tekei rere ee eee etek ee een 7 Supported Analytical Instrumentation 00 cece e eee eee 8 Agilent 1100 Series Liquid Chromatograph 8 Agilent 1090 Series oc cceeiaad veces ae cv oe eee soa ee aw eben 8 Agilent 1090 Solvent Delivery Systems 00 8 Agilent 1090 Sampling Systems 0 00 20 8 Detector systems for the Agilent 1090 4 8 Interfacing of the Agilent 1090 0 2 eee eee eee 8 Number of Instruments 0 0 00000 cece eee eee eee eee 8 Agilent 35900E Dual Channel Interface 8 Agilent 6850 and 6890 Gas Chromatographs 9 HP Agilent 6890 GC oeer ese wane 4 Os oe eae Gad ae oes 9 Supported Sampler Configurations 20 000 10 Water Aliance encare ron ieot Gree beaten s dale di One A 10 Sh
30. ation coefficients confidence intervals configurable and relative residuals Quantification capabilities Response factors are calculated from the calibration result and stored automatically e Response factors can also be entered manually per peak e Response factors can be updated automatically after performing a re calibration e Results can be calculated using a factor per peak in its calculations e Results can be calculated using the same factor for all unknown impurities in its calculations e Specified impurities can be calculated using a specific factor Automated limit checking e During sequence execution the system can be configured to react on limit checks Pause abort or continue the sequence with a warning e Limits can be defined for single injections and groups of injections per sample type and per identified peak e Limits can be evaluated for all result data including custom calculated results e Multiple limits can be defined for each item to allow for range checking 27 L Agilent Cerity NDS for Pharmaceutical QA QC Demo User Training Administrator Cerity fer PASS OAC 4011008 Coy oi DK 1e Can ar Siue pesaga velo Nanak Saan 7 on N F Figure 4 1 Spectral compound purity results review Purity results are calculated automatically and annotated with clear pass fail results If the te eae ee purity check fails the defined acceptance sve ca Romer ipana arene rime ima MO sm
31. current online instrument status e Transparent real time access to any instrument connected to the network independent of the instrument and the client computer e Transparent access to instrument control and equilibration functions such as reset injector lamp on off set detector wavelength balance detector wavelength calibration e Real Time Plot e Instrument actuals run time instrument errors warnings instrument diagnostics data e 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 TAD Signal A why the instrument is in an e instrument status GUI and instrument actuals error state or not ready e instrument logbook x e Service Report function that queries the diagnostic registers of the Agilent 1100 to generate a service report that helps to diagnose instru uve i MIM ad KS Nn ment problems down to the module level The diagnostic report ncludes diagnostic information such as instrument error messages e g leak detected firmware revision EMF limits pump ripple Scheduling of analyses The system uses a scheduling process that allows submitting
32. dards Sample data is subject to strict revision control within the application 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 ethod specific sample variables multipliers divisors are entered during sample entry and available for custom calculations ames for sample entry fields are configurable per method ames and description fields for samples sequences methods and instruments permit long descriptive names with at least 128 characters When scheduling an analysis operators can selectively define which processing tasks will be performed Options include data acqusition data analysis and reporting e The system uses a scheduling process that allows submitting multiple analysis jobs single sample analyses or sequences to the instrument s worklist e The analysis priority is entered at sample entry The choices are high medium or low e The system permits pausing and resuming of sequences and editing the currently running sequence e The system allows to pause stop or continue with warnings sequences based on automatic evaluation of calculated results against user defined limits Cerity subjects all methods to strict revision control and audit trail logging No part of the method can be overwritten Method management is typic
33. dministrators can log on to the console The Cerity Software Administration module permits administrators to set up system components administer and track nect to the required server resources i e Cerity system services and the database but to protect instrument analysis data from LAN WAN failures that affect the connection to the database server in the data center Cerity acquisition controllers must be installed on the same subnet as the instruments For most envi ronments this actually requires to place the acquisition controllers at the departmental level i e the lab and not in the data center Recommended Network Settings Available bandwidth settings and communication modes can vary depending on the networking infrastructure switches and the network interface cards used in computers and instruments Due to the lack of an established industry standard auto negotiation auto synchronization of network speed settings has been reported to cause communication failures in some cases especially where both computers and switches were configured to use this mode approval and other tasks can be performed from the Cerity NDS review client software licenses and license con sumption application modules instruments logon permissions user capabilities and roles audit ing and system wide settings for electronic sign off and numeric formatting Agilent Technologies recommends a two tiered approach For dedica
34. e Agilent instrument control license is required for each instru ment Drivers for Non Agilent Instruments Cerity NDS provides full instru ment control of and data acquisi tion from the Waters Alliance 2690 and 2695 LC system Instrument control of and data acquisition instrument status checking results review results approval and reporting The size of the database depends on the number of concurrent users concurrent instruments and the amount of data available online in the database from the Waters Alliance LC require a direct connection between the computer and instru ment using an Agilent 82350 PCI high performance GPIB interface adapter and cable The standard interface control library software SICL required for GPIB commu nication is delivered with the Ceri ty NDS software It must be installed on the acquisition controllers where the GPIB support is required A separate instrument control license Agilent product number G4062AA is required for each Waters Alliance HPLC system controlled by Cerity NDS for Pharmaceutical QA QC Cerity NDS provides full instrument control of and data acquisition from the Shimadzu LC10vp HPLC through Cerity s Generic Instrument Control interface in conjunction with an Agilent 35900E dual channel interface Instrument control is performed through the serial port and data acquisition through the analog digital IO interface of the 35900E Data Processing and Review
35. e network Network monitoring tools cannot be used to monitor non networked instruments using legacy connections such as GPIB or RS232 e Data files from Agilent ChemStation A 03 01 or greater e ANDI Analytical Data Interchange format e Import of work lists in XML format e g from a LIMS icrosoft 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 archive catalog files for use with knowledge management or archive management system COM DCOM By design all result records are available for instantaneous online review in the results review context of the application Level 4 instrument control of 1100 LC 6890 6850 GC and 35900E ADC Level 3 instrument control full control for Waters 2690 2695 Alliance LC Agilent 1100 HPLC Agilent 6850 6890 GC Agilent 1090 HPLC Series II through Cerity Generic Instrument Control framework Agilent 35900E ADC for general purpose multi vendor interfacing Shimadzu LC10Avp HPLC Waters Alliance 2690 and 2695 Waters 2497 Dual Wavelength Detector continued Direct FAX or PDF output Other interfaces Documentation Description of documentation delivered with the Cerity system Description of formats used for online documentation Number of printed manual sets provided with system Link to standard operating procedures SOPs Access Security and Control Security co
36. een shown that bio metric electronic signatures can be used only by their genuine owner Y Yes N No NA Not Applicable 36 NA NA NA NA NA This needs to be addressed by procedural controls in the user s environment This needs to be addressed by procedural controls in the user s environment This needs to be addressed by procedural controls in the user s environment This needs to be addressed by procedural controls in the user s environment This needs to be addressed by procedural controls in the user s environment Y N NA Comments NA Not applicable Cerity for Pharmaceutical QA QC revision A 02 xx is not delivered with biometric ID devices Controls for Identification Codes and Passwords Question Y N NA Comments 11 300 a Are controls in place to Y Cerity uses the account system security and password maintain the uniqueness of policies defined for the operating system Therefore this each combined identification requires appropriate account and password handling code and password such policies in the user s organization and IT environment that no individual can have the same combination of identification code and pass word 11 300 b Are procedures in place to Y Yes see 11 300 a ensure that the validity of identification codes is peri odically checked 11 300 b Do passwords periodically Y Yes see 11 300 a expire and need to be revised 11 300 c Is there a procedure for elec
37. enerated Operation Qualification Tool OOT OQ allows qualification tests at defined intervals on the data system and the connected instruments Without a valid OQ PV test result the system must not be used OQ PV typically requires a series of different tests depending on the instrument the lab s specification and the configured software capa bilities System IQ and OQ PV are provided both as a product and as a service from Agilent Technologies The scope of the validation services and products for Cerity NDS includes the Agilent 1100 HPLC Agilent 6890 6850 GC Agilent 35900E A D and software system qualification The Operational Qualification Tool is a computer based qualification utility used to perform Operational Qualification OQ PV of the Cerity NDS for Pharmaceutical QA QC system The computer based OQ protocols available for Cerity NDS for Pharmaceutical QA QC uses well defined interfaces so called test harnesses specifically designed into the software for the purpose of executing critical system test cases automatically This comprises e Automatic low and mid level functional tests that verify fundamental system level functions that are not even covered by the traditional interactive protocols available for other data systems e Automatic high level system operation tests that verify application functionality such as sequencing quantification or recalibration These tests execute in unattended mode and
38. ent 1100 Series LC modules Agilent 1090 Sampling Systems e Standard autosampler with vial positions 0 to 99 and special position 100 e 25 pL and 250 pL syringe options Note The cooled autosampler and manual injector will not be supported Detector systems for the Agilent 1090 e 1090 diode array detector in 2D mode with up to 5 signals e Other detectors supported by the Cerity software e g 1100 Series detector e 35900E Note 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 Miscellaneous e Cerity controls the four external contacts Interfacing of the Agilent 1090 e The 1090 will be interfaced via GP IB to the acquisition controller We support the 82350A and 82350B cards with firmware revision L 02 01 or higher e Agilent does not support Waters Alliance and Agilent 1090 to be configured on the same acquisi tion controller Number of Instruments e Cerity supports up to four 1090 instruments in 2D mode or up to two instruments in 3D mode connected to a single acquisition controller Agilent 35900E Dual Channel Interface This interface can be used to acquire up to two independent channels of data from instrumenta tion that is not directly controlled by the software It supports data rates up to 100 Hz The Agilent 35900E Dual Channel Interface supports BCD c
39. ge calibration single update calibration Standard bracketing e Overall bracketing also known as grand average bracketing Two bracketing modes are available Overall bracketing calculates one calibration curve per calibrated compound for the sequence and ses it for the quantification of all samples in the sequence In terms of validation and traceability this is a lot easier to handle than other loating average recalibration schemes The Cerity report writer is a rendering device that only displays data already stored in the central data repository and does not perform any calculations of its own This is to avoid discrepancies between results shown on screen and paper Every modification of a test result e g in the course of reintegration or reprocessing using updated calibration information results in a new revision of the result record along with tight links to the metadata and result 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 e Definition of user capabilities for authorized access e Strict auditing with mandatory audit comments e Authorization by electronic signature configurable e Data review layout and Report templates set up to include analysis audit trail and method version The system supports method specific calculations through a spread sheet control integrated into the data analysis method The c
40. ggests his analysis escription name vial number product code andard etc e Sample variables numeric i nput values determined during sample preparation and required for calculations e Example chromatogram i e a typical chromatogram as generated with this analysis for display in online results review and on reports Instrument control data acq Integration Peak identification based o Spectra Spectra compound spectra Calibration Quantification Custom calculations Reporting Data review layout Reporting Limits uisition n retention time compound confirmation based on spectral comparison compound purity based on similarity calculations of e System allows reintegrating results in the controlled environment of Cerity res Its review context e Fine tuning of integration settings on a specific chromatogram is per formed under strict revision control of the result record e Fine tuning of integration settings on a specific chromatogram remain private to method he chromatogram and do not implicitly affect the master Reprocessing functions allow to reprocess data with modified sample parameters or a different revision of the same method or a different method functions of the software Reprocessing calculations are subject to audi trail and revision control e The method allows storing the Sequence Template required for analyses run w The sequence
41. gh the Cerity Generic Instrument Control frame work GIC Cerity Generic Instrument Control GIC Agilent s Generic Instrument Control GIC concept is a new approach to standardize generic instrument control for non Agilent instruments GIC allows to integrate non Agilent chromatographic instruments into the Cerity archi tecture GIC is integrated into the core of the Cerity software and is always installed along with Cerity Through the GIC framework Cerity sees and controls a third party instrument similar to a specific known instrument type such as the 1100 Series LC The GIC concept allows to develop drivers for third party instruments without chang ing the Cerity source code Device drivers called Vendor Specific Instrument Adapters VSIA can be developed independently of Cerity because the interaction between the device driver and the rest of the system is limited to a well defined interface This is a clear advantage for companies such as independent hardware vendors who want to develop their own device drivers Cerity GIC consists of two main components the GIC framework and the VSIA The GIC framework is installed as part of Cerity for the Pharma Client Server system software GIC is responsible for handling all the dynamic and configurable user interfaces in the instrument and method context which are dealing with instrument control status and error handling and instrument setpoints as part of the Ceri
42. gly discourages from using auto negotiate at both ends due to implementation incompatibilities observed with equipment from some manufacturers required Table 1 lists the network interface cards supported with the Cerity NDS for Pharmaceutical QA QC software Assignment of IP Addresses The system requires a static IP address for the database server module which is installed by selecting the Cerity Profession al or Cerity Database Server installation Proper name resolution must be enforced for all Cerity devices to guarantee connectivity between all networked com ponents of the system even if IP addresses get reassigned This allows referencing network nodes by hostname rather than IP address Agilent recommends that fixed IP addresses for clients acquisition controllers and instruments be allocated If fixed IP address assignment is not possible Cerity clients and instruments may receive their IP addresses by using the BOOTP or dynamically using the Dynamic Host Configuration Protocol DHCP other BOOTP server or DHCP server are available to assign IP addresses to networked instrumentation and clients The instrument configuration requires specific buffer settings on the Jetdirect interface card Software The Cerity Software automatically configures these buffer settings We recommend reserving IP addresses for Cerity devices and instruments when using DHCP This ensures that a device will always have t
43. harmaceutical QA QC is streamlined to adhere to the requirements of GMP regulated QA QC labs This includes but is not limited to e Convenient arrangement of functions into four context areas Sample Entry Instrument Status Results Review and Method Management e Graphical instrument status display e Explorer like Tree View to conveniently display search results from the database e Menus pull down as well as context menus e Toolbars e Tables configurable to the method Specific to job roles and analytical methods If a user has no permission to use a certain system function the function is not shown in the user interface or it is disabled grayed out Analytical instruments Supported analytical techniques Number of instruments that system can simultaneously control and acquire data from Data acquisition interfaces LAN IEEE 488 HP IB GP IB Level of bi directional instrument control Instruments for which bi directional control Proprietary control hardware required Network monitoring capabilities computers and instruments Data Transfer Data import formats Data export formats Standard interface protocols supported between network components of the system Results review o line on demand viewing 20 LC GC A D converter general purpose No hard coded limits function of database server configuration and available network bandwidth Typical configurations have 30 50 users and 80
44. he same IP address IP address reservation means that a static IP address is assigned to a dedicated MAC address The Agilent 1100 HPLC and the Agilent 6890 6850 GC allow set ting instrument IP addresses from the handheld controller or local keyboard BootP or DHCP servers are not required if fixed IP addresses are assigned to the instrument via the local key board or user interface Support for High Availability Configurations Failure Resilience Support for Clustering Server Failover Cerity for Pharmaceutical QA QC supports clustering in the so called Active Passive Mode which is also referred to as Active Standby All Cerity permanent data is held on the shared storage in addition to the so called quorum information needed by Microsoft clustering Microsoft Windows 2000 Advanced Server provides clustering at the operating system level Microsoft Cluster Server MSCS runs services required for cluster operation In an active passive cluster two servers nodes share access to an external storage Both computers can see the data in the shared storage but only one of the nodes is active while the other is effectively on standby waiting to take over if the primary and active computer fails to respond Both servers have physical IP addresses as well as hostnames by which they can be reached through the computer network In addition a separate virtual IP address and machine name are configured for the cl
45. he minimum hardware requirements for review clients Keep in mind as previously stated the acquisition controller and review client may operate together on a computer It is recommended to deploy dedicated acquisition con trollers for optimum performance and load balancing in the Cerity NDS system Operating System type s Operating System version s Service pack version s Web Browser RDMBS Processor type or minimum speed etc Minimum memory Minimum mass storage Peripherals required Interfaces Display Table 12 Microsoft Windows Windows 2000 Professional Service Pack 4 Service Pack 1a MS Hotfix KB824146 MS HotFix KB824146 amp KB823980 Microsoft Internet Explorer 6 0 Service Pack 1 Oracle 9i Client Release 2 Oracle 9i Patch Set 2 Oracle OLE DB 9 2 0 2 Patch Windows XP Professional Pentium III 800 MHz Minimum 256 MB 512 MB recommended 20GB Keyboard mouse CD ROM drive Network interface 1024 x 768 pixels 65536 colors Hardware prerequisites for Cerity NDS review clients Operating System Software Requirements Table 13 defines the operating system requirements for each of the Cerity NDS for pharmaceutical QA QC components Table 14 defines the third party required software revisions to properly operate Cerity NDS for pharma ceutical QA QC client server and professional systems Any of these components are installed auto matically during Cerity setup except for the Oracle Database Managemen
46. ical magneto optical disks jukeboxes 31 Where are electronic signatures used in the system What infor ma tion is stored by the system for each use Are experiments and or reports reviewed and approved in the system What features does the system provide to administer user accounts Can the system support password aging Can the system support disabling re enabling user accounts Can the system support account lockouts after a defined number of failed attempts to log in How are failed login attempts 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 Configurable depending on the organization s workflow Includes but is not limited to method changes adding changing user permissions result approval Yes The information can be retrieved and inspected in electronic form as well as on paper for investigations or regulatory inspections Cerity users must be authenticated Windows users The Cerity system administration console is based on the Microsoft Management Console MMC and is used to set the Cerity specific permissions Yes reuses password policies defined on the operating system level Yes by directly reusing the account policy defined in the Windows operating system Yes see above Standard Windows security event log a
47. ific parameters are specified in a device configuration XML file called as VSIA XML This is the starting point where the GIC recognizes a new instrument type and it s properties The XML con figuration file serves as a reference for the installation of the new instrument driver Sample sources are provided in the developer kit from Agilent to bring additional clarity The communica tion between the VSIA and the instrument is established using the Agilent analog digital converter AD 35900E interface as communication interface In addition the Agilent AD 35900E is responsible for acquiring the analog signal and converting it into digital data The standard 10 100 LAN interface connects the Agilent AD 35900E to the data system The implementa tion of VSIA into easy to understand generic standards allows advanced customers future or an experienced third party companies today to program the instrument control portion outside of Agilent The GIC framework covers the following device categories and makes them consistent with other Cerity drivers e pump injector column detector integrated instrument auxiliary devices Hardware Requirements The data system consists of a personal computer PC and Agilent software All hardware and peripherals must appear in the appropriate Microsoft Windows Compatibility Lists for the operating system Cerity NDS for Pharmaceu tical QA QC is designed to run on computers that conf
48. ilable for online results review and reporting Examples for method specific calculations enabled with the Cerity custom calculator e Impurity calculations e Reproducibility calculations for replicates Group statistics Response factor statistics calibration precision Content uniformity e Cerity calculates peak performance parameters according to the different pharmacopoeias USP EP BP JP and DAB The user can configure which of them are reported and shown e System suitability limits can be defined by component and sample type e Available noise calculations peak to peak and ASTM e The system supports identification by absolute and relative retention times RRT e Peak windows for peak recognition are customizable per peak using absolute or relative peak retention time windows e Peak summing and peak grouping e The system compensates for retention time variability during analyses using reference peaks for the RT update e Peak naming is flexible and allows for long names e Peak confirmation based on spectral data comparison against a prerecorded reference The system allows multilevel calibration with an unlimited number of levels fixed amount variable amount and manual response factors e All chromatographic runs in a sequence can be reprocessed automatically batch wise e The system allows to reprocess analysis results after changes have been made to sample information integration setpoints calibra
49. imadzu LC 10A Series 0 00 00 10 Cerity Generic Instrument Control GIC 00 cece eee 11 Hardware Requirements 0 00 cece eect eens 12 Cerity NDS for Pharmaceutical QA QC Professional 12 Cerity NDS for Pharmaceutical QA QC Client Server 12 Database Server Configurations Overview 12 Terminal Server Configurations 0 0 eee eee eee 12 Acquisition Controller 0 00 e cence eee eee 13 Review Cliente 2 o dat 07nedes dees EE EEE E E 14 Operating System Software Requirements a a aaea 15 Oracle EICensSing sesrrsa yee fb Ste wa E pare AE E E TE a 15 Cerity NDS for Pharmaceutical QA QC License 15 GMP Module License 6 6 cee eee eh eed eee es 16 Instrument Control and Spectral Evaluation Licenses 16 Installation Qualification Tool AQT 005 16 Operation Qualification Tool OQT 00 eee 16 Functional Specifications Application 2cce eee cues 18 Functional Specifications Electronic Records and Electronic Signatures Checklist 21 CFR Part 11 33 Overview Cerity NDS for Pharmaceutical QA OC Professional Cerity NDS Professional is the solution for laboratories that require instrument control data acquisition data analysis flexible reporting and support for up to eight 2D chromatographs up to four 3D chromatographs con
50. intended for technical readers in regulated environments who are performing operational qualification OQ PV on Agilent 1100 Series HPLC Instruments Note No approval or verification signatures are required in this protocol The approval section and verifications in the OQ PV Protocol for the Agilent 1100 Series HPLC encompass this test creation protocol il For Help press F1 Now 150 min a T a Allnstruments Agient1100LC width 250 N Figure 9 Computer based protocol for 0Q PV on an Agilent 1100 Series HPLC system 37 Services Standard services Available standard courses Personalized education services Qualification services for NDS software i alification services for omatography equipment a Customization services io alification of somputer network infrastructure Consulting services Project management services Declaration of system validation audit reports 38 Please contact your local NDS sales representative nstallation Familiarization Education H2296A Cerity Networked Data System Basic Operation Full Access Users 1 day H2297A Cerity Networked Data System Advanced Operation Full Access Users 2 days H2298A Cerity Networked Data System Application Administration 1 day H2295A Cerity Networked Data System Routine Operation 1 day Customized education courses are available and can be delivered at a central Agilent l
51. lent 1100 vacuum degasser e Agilent 1100 well plate sampler and thermostatted well plate sampler One Agilent 1100 LC instrument control license is required per Agilent 1100 LC system connected to the Cerity software Note A LAN interface is required Sor the Agilent 1100 system Cerity does not support GPIB for this instrument Agilent 1090 Series e Agilent 1090 Series II L e Agilent 1090 Series I M Note The 1090A series is not supported Agilent 1090 Solvent Delivery Systems e DR 5 pump system binary and ternary e PV 5 pump system ternary and quaternary Note The isocratic system will not be supported Agilent P N Agilent 1100 Module Description Minimum Firmware G1310A Isocratic pump A 05 06 G1311A Quaternary pump A 05 06 G1312A Binary pump A 05 06 G1313A Autosampler A 05 06 G1329A Thermostatted autosampler A 05 06 G1330B Autosampler cooling module N A G1367A Agilent 1100 well plate sampler A 05 07 G1368A Agilent 1100 thermostatted well plate sampler A 05 07 G1314A Variable wavelength detector VWD A 05 06 G1315A Diode array detector DAD A 05 06 G1315B Diode array detector DAD A 05 06 G1365A Multiple wavelength detector MWD A 05 06 G1365B Multiple wavelength detector MWD A 05 06 G1321A Fluorescence detector FLD A 05 06 G1362A B Refractive index detector RID A 05 06 G1316A Thermostatted column compartment TCC A 05 09 G1322A Online degasser N A G1323B Control module B 03 01 Table 2 Supported Agil
52. lient Workstation Server Figure 2 Example configuration of Cerity NDS for Pharmaceutical OA OC Client Server with one central Oracle database server and two groups of instruments controlled by dedicated acquisition controllers Users access the system through the review client PCs instrument transparently from any connected client workstation You can configure as many clients as necessary on the Cerity NDS system considering any licensing and resource limitations General Description Cerity NDS for Pharmaceutical QA OC Client Server In a client server environment the Cerity NDS database server is a Microsoft Windows server hosting an Oracle database This is the cen tral data repository of the Cerity NDS system The system includes the following networked compo nents database server acquisition controllers instruments printers client workstations and other devices All raw data acquired sig nals meta data i e methods cali bration information calculation for mulae logbook and calculated results are stored centrally in the database along with the computer generated audit trail and revision information Standard queries allow searching retrieving and displaying data for review and other purposes such as Data Acquisition and Instrument Control Acquisition Controllers and Reprocessing Servers Client Server configurations allow the addition of optional acquisition controllers to balance in
53. ncept Access controls for security configuration Granularity of security access Description of application security controls Security mechanism of network data packets Biometrics based identification recognition voice recognition fingerprint scanning Through standard operating system functions print to fax print to PDF device Examples for further customization based on the following techniques e Reports post processing through DOM Document Object Model e Reports post processing through embedded scripts Javascript or VBScript code e Web Access to queries through SSL Secure Sockets Layer e Programming interface requires PSO consulting How To Tasks Online Help Cerity Quick Reference Card Cerity Concepts Guide Getting Started Cards Cerity Installation Guide Generic Instrument Control System Administration Guide Online PDF Cerity Technical Reference Guide PDF and HTML Help One set per user license Note Additionally PDF versions of all manuals are included on the software media The application user interface allows to configure a link directly to the intranet location where SOPs or monograph are stored Based on NT security system user accounts management password policy Application does not have a proprietary account system but allows reusing password and security policies directly from the operating system User with Cerity system administrator permissions ote Ceri
54. nd password policies AlResutsRestered 1 lt L Caleation wdi 011003 120_25 Bakk E Caldeaton 30FrsMethod Caib E tuin A 4 at nit Figure 8 Audit trail and electronic signature for results sign off 32 Functional Specifications Electronic Records and Electronic Signatures Checklist 21 CFR Part 11 Procedures and Controls for Closed Systems 11 10 a 11 10 a 11 10 b 11 10 b 11 10 c 11 10 d 11 10 e Question Is the system validated Is it possible to discern invalid or altered records Is the system capable of producing accurate and complete copies of elec tronic records on paper Is the system capable of producing accurate and complete copies of records in electronic form for inspection review and copying by the FDA Are the records readily retrievable throughout their retention period Is system access limited to authorized individuals Is there a secure computer generated time stamped audit trail that records the date and time of operator entries and actions that cre ate modify or delete elec tronic records Y Yes N No NA Not Applicable Y N NA Comments Y The software development is following the software life cycle and quality management system of Agilent Tech nologies Lifescience and Chemical Analysis Group Full installation qualification IQ and operational qualification OQ services available for the s
55. nt Data acquisition remote start stop BCD uECD Inlet EPC S S EPC P P EPC COC Column inlet Front back unspecified Column outlet Front back other MSD AED Oven High ramp rate Detector Cryo C02 N2 Valves GSV LSV Multiposition Switching Aux EPC Temperature Data channels Table 4 Supported 6890 GC configurations Agilent P N Description Firmware Gas Chromatographs G1530A 6890A A 03 05 G1530N 6890N N 04 05 G2630A 6850 A 03 01 G2630A 6850 A 05 01 Automatic Liquid Samplers G1512A 7673 Controller A 01 09 G1513A 7673 Injector A 10 04 G1514A 7673 Tray N A G2612A 7683A Controller A 01 07 G2613A 7683A Injector A 10 04 G2614A 7683A Tray A 01 01 G2912A 7683B Controller A 02 00 G2913A 7683B Injector A 11 00 G2916A 7683B Tray A 02 00 18593B 7673 Injector A 08 00 18596C 7673 Tray n a Headspace Samplers G1289B 7694B 1 04 G1290B 7694B 1 04 G1888A G1888A A 01 02 Headspace sampler Table 5 Agilent GC minimum firmware requirements In revision A 02 02 dual simultaneous dual tower injection is not supported Comment With Jetdirect card Network ready 6890 GC With Jetdirect card Network ready 6850 GC This controller is required to use 7683B injec tor and tray with the for 6890A GC 6890N firmware N 05 02 or greater required 6850N firmware A 05 02 or greater required The 7683B autoinjector has two additional parameters Wash mode and solvent saver mode By default these parameters
56. ocation or on site Computer based installation qualification IQ Computer based operation qualification 00 PV Delivered by Agilent customer engineers or a certified support provider Computer based installation qualification IQ Computer based operation qualification 00 PV Delivered by Agilent customer engineers or certified support provider Available Delivered through Agilent s Project Services Organization Please contact your local NDS sales representative Regulatory agencies are endorsing a risk based approach to compliance 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 e Design Qualification for networks e Installation Qualification for networks e Operational Qualification for networks These services are delivered through Agilent s Project Services Organization Available Delivered through Agilent s Project Services Organization Available Project management according to development lifecycle Services comprise specification design implementation deployment validation and support Delivered through Agilent s Project Services Organization Included with the shipment kit
57. oded vial number and can be used to track the vial position of each injection from third party auto samplers in the software One Agilent 35900E A D instrument control license is required per Agilent 35900E dual channel interface connected to the Cerity software A LAN interface is required for the dual channel interface The GPIB interface is not supported in Cerity NDS for Pharmaceutical QA QC for this device refer to table 3 for firmware requirements Agilent 6850 and 6890 Gas Chromatographs Cerity NDS for Pharmaceutical QA QC supports the Agilent 6890A and 6890N table 4 A LAN interface is required for the Agilent GC The GPIB interface is not supported in Cerity NDS for Pharmaceutical QA QC for this instrument table 5 Cerity NDS for Pharmaceutical QA QC supports the 6850 GC hardware listed in table 6 HP Agilent 5890 GC Revision A 02 02 of Cerity for Pharmaceutical QA QC implements a framework for generic instrument control This framework is used to provide instrument control and data acquisition with the Agilent 5890 GC e HP 5890 Series II and HP 5890 Plus e The 19257 60020 card revision C or higher is needed for controlling the instrument e GC ROM firmware revision HP5890A 03 00 or higher Firmware E 01 02 P N Description 35900E A D converter Table 3 Minimum firmware requirements Agilent 6890A GC AIB EPC FID EPC FPD EPC NPD EPC TCD EPC ECD EPC Comme
58. oftware as well as the instrumentation controlled by the system The product was designed to fulfill the validation require ments of the users of this product according to current regulations and quality standards including but not limit ed to 21 CFR 210 Good Manufacturing Practice for Drugs 21 CFR 211 current Good Manufacturing Prac ice for finished pharmaceuticals 21 CFR 58 Good Labo ratory Practice 21 CFR Part 11 Electronic Records and Signatures The data managed by the system is under strict access control 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 ive record along with a detailed audit trail Software operational qualification protocols and database integrity check utilities allow detecting corrupted data e g due to a 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 are created and handled by the Cerity archive restore utility included in the standard product In addition the Cerity system provides an HTML based report 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
59. ontrol enables for calculation formulae in Excel compatible syntax Arithmetic logical statistical functions also available in off the shelf spreadsheet programs Yes including calculation formulae Yes such as warnings if system suitability or other limits are exceeded 25 Description of user defined custom calculations Description of system suitability criteria and limits Description of peak identification mechanisms Calibration capabilities Reprocessing 26 The built in custom calculator is an Excel compatible spreadsheet control 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 recalculati results on of analysis Custom calculation formulae are entered in Excel syntax Custom calculations result formatting conforms to pharmacopoeial requirements when checking results against specifica ions 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 cus on custom calculated results caculations on calculati Calculation formulae are printable for review and veri om calculations ions ication e All custom calculated results are ava
60. ontroller No hard coded limits Three standard database configurations are offered small medium large UML Visual C Visual Basic e Microsoft Windows 2000 Advanced Server Cerity C S Database server e Windows 2000 Professional Service Pack 4 Professional acquisition controller review clients e Windows XP Professional Service Pack 1a Professional acquisition controller review clients All configuration require Microsoft Internet Explorer 6 0 Service Pack 1 e For more details refer to the respective chapter in this document continued Compatibility with Windows Terminal Server Other client server capabilities Hardware requirements High Availability Microsoft Windows 2000 Advanced Server Clustering Oracle Failsafe OFS Oracle Transparent Application Failover TAF Oracle Real Application Clustering RAC Scalability Cerity NDS for Pharmaceutical QA OC Professional Maximum number of concurrent users Cerity NDS for Pharmaceutical QA OC client server Maximum number of concurrent users User Interface Characteristics of the user interface User specific storage of user interface configuration details profiles Client workstations of Cerity for Pharmaceutical QA QC rev A 01 03 and higher are supported for operation in a Windows 2000 Terminal Server environment Thin client configurations are dictated by the Terminal Server provider Citrix Metaframe or Micr
61. orm to the specifications listed below Cerity NDS for Pharmaceutical OA OC Professional Table 8 lists the minimum computer configuration that is supported for a Cerity NDS for Pharmaceutical QA QC professional system This table provides a guideline for computer hardware specifications such as the amount of random access memory RAM disk space measured in gigabytes GB central processing unit CPU speed measured in megahertz MHz etc Cerity NDS for Pharmaceutical OA OC Client Server Database Server Configurations Overview Table 9 specifies the minimum and recommended hardware configura tions for a database server NOTE e It is NOT recommended to use the Cerity database server as a print server for the Review Client computers e It is not recommended to use the Cerity database server for network administration services such as control Terminal Server Configurations Table 10 specifies the minimum hardware requirements for distributing the Cerity NDS user Operating system type s Operating system version s Service pack version s Web browser RDBMS Configuration specifications Processor type or minimum speed etc Minimum memory Minimum mass storage Peripherals required Interfaces Display Table 8 Microsoft Windows Windows 2000 Professional Service Pack 4 Service Pack 1a MS Hotfix KB824146 MS HotFix KB824146 amp KB823980 Microsoft Internet Explorer 6 0 Service Pack 1 Oracle 9i Clien
62. osoft Agilent does not add any requirements unless specified otherwise For details on the requirements and configurations of Cerity for Pharmaceutical OA QC please refer to a separate Technical Note available as Agilent publication G4000 90100 e During running analyses users can log out and log in without interruption of the sequence e After log out of the session the user s license is released and available for another concurrent user See separate chapter in this document The Cerity system supports the following failure resilience mechanisms e Server failover using Microsoft Cluster Server and Oracle Failsafe configurations to ensure continued uptime even if the server fails e Acquisition buffering on the acquisition controllers ensuring that no analysis data can be lost even if server network infrastructure fails Supported in Active Standby mode Supported Not supported Not supported One user at any one time Note By definition Cerity NDS for Pharmaceutical QA QC Professional is a single user multi instrument configuration No hard coded limits function of database server configuration and available network bandwidth Typical configurations have 30 50 users and 80 100 instruments oO Graphical user interface designed in adherence to Windows standards and configurable to laboratory specific workflow based on user roles and analysis specific requirements The user interface of Cerity NDS for P
63. r Memory RAM 768 MB 2GB Disk size 18 2 GB 18 2 GB second disk may be added for redundancy Table 10 Hardware prerequisites for Cerity NDS acquisition controller interface through a dedicated Terminal Server One or more Windows 2000 servers with Terminal Services and Citrix Metaframe XP can be configured to run the Cerity review client software However the terminal servers are not expected to run other software besides Ceri ty and cannot be configured in server farm A Terminal Server configuration of Cerity for Phar maceutical QA QC will require approximately 200 MB of memory per user RAM and or virtual memory and 6 3D chromatogra phy instruments with spectral data acquisition Acquisition Controller In client server configurations with multiple instruments one or multiple separate acquisition controllers are required for instrument data acquisition and instrument control There is no hard coded limit on the number of instrument channels that can be collected by a single acquisition controller In fact feasibility tests have shown that the system can control as many as 30 3D systems However the recommended maximum number of chromatography instruments for an acquisition controller is 15 2D chromatography instruments i e without spectral data acquisition and 6 3D chromatography instru ments with spectral data acquisition Acquisition controllers can also be used to balance the reprocessing load within
64. responding secur developed and controlled by 11 100 a Are electronic signatures Y The Cerity security implemen ever reused by or reas system security and supports signed to anyone else trols of the user s organizatio ing system user account mus e user s IT operation along ity and password policies he user s organization ation is based on operating appropriate behavioral con n For instance the operat be disabled but not reas signed to someone else when the respective individual leaves the organization 11 100 b Is the identity of an individual NA This must be governed by appropriate company policies verified before an electronic signature is allocated Y Yes N No NA Not Applicable 35 Electronic Signatures Non biometric Y N NA Comments 11 200 a 1 i 11 200 a 1 ii 11 200 a 1 ii 11 200 a 2 11 200 a 3 Question Is the signature made up of at least two components such as an identification code and password or an id card and password When several signings are made during a continuous session is the password executed at each signing Note both components must be executed at the first signing of a session If signings are not done in a continuous session are both components of the electronic signature execut ed with each signing Are non biometric signatures only used by their genuine owners Would an attempt to falsify an electronic signat
65. s No Yes No Cerity for Pharmaceutical QA OC operating system requirements 1 Cerity NDS for Pharmaceutical QA QC is fully tested and supported on the US English Japanese French German Italian Japanese and Spanish versions of Windows On non US English versions of the operating system language specific hotfixes of the operating system may be required Any mandatory hotfixes are supplied on the Cerity NDS CD media For correct interpretation of numeric floating point entries specific options need to be configured in Windows regional settings Please consult the software status bulletin and release notes readme txt for more information on regional settings number and date formats required for correct handling of floating point number input Manufacturer Product Revision Oracle Oracle 9i DBMS 9 2 0 3 0 Microsoft Data Access 2 7 Components MDAC Microsoft Internet Explorer 6 SP1 Agilent SICL library L 02 01 Microsoft Visual Basic 6 0 SP4 Microsoft Visual C 6 0 SP4 Table 14 Comment Shipped on product CD ROM Needs to be installed separately Oracle Standard 9i is contained on Cerity product CD 2 through 6 Included with product Needs to be installed separately Included on Cerity CD 1 Required for the control of Waters Alliance Contained on product CD 1 Runtime library Runtime library Other software requirements for Cerity for Pharmaceutical OA OC Oracle Co or their authorized distribution partners e
66. sed archive catalog for keyword indexing ilent Technologies is a technology partner of Nugenesis Technologies Agilent Cerity can be interfaced to Nugenesis SDMS e Laboratory Information Management Systems LIMS ity provides a generic LIMS interface for the download of worklists into Cerity and upload of results data into LIMS ilent Technologies is a technology partner of Labtronics Inc Labtronics LimsLink provides configurable interfaces for integration ith the major chromatography data systems including Agilent Cerity erprise Resource Planning Systems ERP ity for Pharmaceutical QA QC integrates with BayCovin Instruments This software from Bayer Business Services bridges the gap between mySAP PLM OM and the laboratory instrumentation level Using an SAP certified interface to QM IDI BayCovin Instruments is designed to provide a work list of inspections to a client depending on analytical method and instrumentation requirements Raw quality inspection data is collected from a wide range of instruments managed and archived in compliance with FDA regulations 21 CFR Part 11 and ISO quality standards After optional validation measured and calculated end results are sent back to mySAP PLM QM to trigger subsequent actions in the logistic chain LIMS Support of multi tiered continued archiving technology Requires 3rd party tool e g active data on hard drive older data on slower opt
67. stem will shut down regardless of the timeout settings to prevent system damage or safety hazards Figure 3 Transparent access to connected instruments including early maintenance feedback EMF information 22 Sample Sequence Entry Automatic data entry A Sequence Template can be configured as part of the Cerity method Mechanisms to minimize typing effort during data entry Multiple stop times in sequence methods Revision control of sample data Entry of calibration standards Method specific sample variables Custom naming of method specific sample variables Naming conventions allow for long descriptors Operator can selectively run data acquisition processing reporting Scheduling of analysis Intelligent sequencing based on dynamic limit evaluation Method Management Change control to methods maintained in the data system Who needs to modify methods Master methods template methods Linking methods to analysis procedures When creating a new sequence the new sequence is pre filled based on the settings defined in the sequence template stored in the analysis method e Fill down column e Intelligent fill down wizard e Apply changes to a selection of sequence lines The sequence template allows setting analyis times stop times for the different runs of a sequence This is useful for cases where the analysis time for samples is significantly longer than for calibration stan
68. strument data stream and buffer it before upload to the central database server The Cerity NDS acquisition controller is a dedicated Microsoft Windows Workstation running the Cerity NDS acquisition controller software The acquisition controller performs data acquisition and instrument control This component controls instruments that have been scheduled at the review client to execute an analysis using the specified method It collects and processes the raw data and transmits it to the central database server Acquisition controllers can theoretically be used as review clients However the background processing load on the acquisition controller may decrease system performance for interactive use and is therefore not recommended for routine use Agilent Instrument Drivers The suite of drivers to control the supported instruments is installed with the Cerity NDS base soft ware The supported instruments are the Agilent 1100 HPLC the Agilent 5890 6850 and 6890 Gas Chromatographs the Agilent 35900E A D the Shimadzu LC10vp LC and the Waters Alliance 2690 2695 LC with a Waters 2487 Dual Wavelength Detector Agilent instruments implement Level 4 instrument control using standard LAN communications TCP IP Cerity NDS controls instrument parameters and com ponents and collects digital sig nals from detectors Data can be acquired at rates up to 200Hz the data rate required for fast GC and supported on Agilent GCs On
69. t Release 2 Oracle 9i Patch Set 2 Oracle OLE DB 9 2 0 2 Patch Low End 4 single channel instruments with a max of 2 instruments that acquire on line spectra e g DAD or FLD Windows XP Professional High End 8 single channel instruments with a max of 4 instruments that acquire on line spectra e g DAD or FLD Pentium 4 1 2 GHz 768 MB 80 GB Keyboard mouse CD ROM drive Network interface 1024 x 768 pixels 65536 colors Pentium 4 2 GHz 1 5 GB 120GB Recommended hardware configuration for Cerity NDS Professional Entry Level Specification lt 20 instrument channels Medium High End lt 70 instrument channels gt 70 instrument channels lt 20 concurrent users lt lt 10 concurrent users gt 20 concurrent users lt 100 000 Tests 330 000 Tests gt 700 000 Tests CPU Xeon 2 4 GHz Xeon 2 4 Xeon 2x 2 4 GHz Dual processor recom mendedfor gt 50 instruments Memory 1GB 1 5 GB 3 GB Disk space 3GB 3 GB 3 GB Cerity server application and Oracle RDBMS installation 4 5 GB 140 GB 290 GB Data Table spaces for data index and BLOBs 10 GB 32 GB 68 GB File share for archives and reports 50 GB 150 GB 300 GB Temporary space and archive redo log files Total rounded 110 GB 330 GB 670 GB Table 9 Recommended hardware configurations for Cerity NDS database server CPU lt 10 concurrent clients lt 25 concurrent clients Computer type Dual Pentium 4 1 4 GHz Dual Xeon 1 4 GHz Desktop PC or server Serve
70. t System DBMS which needs to be installed separately Oracle Licensing Cerity NDS for Pharmaceutical QA QC uses the Oracle RDBMS to manage and store its records e The Oracle RDBMS software may only be installed and used if the appropriate software licenses have been purchased You must possess an Oracle license for each user account named user established in your Agilent networked data system valid for use with the Agilent NDS software e The base products of Cerity NDS for Pharmaceutical QA QC Agilent G4000AA and G4001AA include five application specific named user Oracle client licenses These licenses are subject to a restricted use license and can only be used in conjunction with the NDS application e Agilent provides support for included Oracle software according to the application requirements of the respective Agilent networked data system Further software maintenance for Oracle software must be purchased separately e Alternatively you may purchase full use Oracle licenses from Windows 2000 SP3 Professional Cerity NDS for Pharmaceutical QA OC Database Server No Cerity NDS for Pharmaceutical Yes Cerity NDS for Pharmaceutical QA OC Review Client Cerity NDS for Pharmaceutical QA OC Acquisition Controllers Yes Yes Cerity NDS for Pharmaceutical QA OC Professional Table 13 Yes Windows 2000 SP3 Microsoft Windows XP Advanced Server SP1 1a Professional Yes No Yes Yes Yes Yes Ye
71. t security GoodT oken Af Unregistered User without security BadToken Registered User with Security All Applications O Data Management MutiTrans Registered User with security GoodToken Le RegisterNew using MuliTrans Commit Registered User with security BadToken are ehh Registered User without security All Application Registered User without security GoodToken n a pi a b 2 12 selected Test Cases Passed Unregistered User without security BadT oken Figure 10 The software qualification protocols are based on the Cerity TestManager an automated regression test utility Figure 11 The audit report is available to subscribers from the audit repository center ARC www auditcenter com www agilent com chem cds The information in this publication is subject to change 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 2004 Agilent Technologies Inc All Rights Reserved Reproduction adaptation or translation without prior written permission is prohibited except as allowed under the copyright laws Published July 1 2004 Publication Number 5989 1425EN Agilent Technologies
72. ted laboratory systems fixed network speed settings should be used at both ends In this case IT depart ments adjust the infrastructure settings as needed e g when equipment is moved If this level of control is not available then fixed network speed settings are recommended for instruments and clients with the switches configured to auto negotiate 1 Typically the supported infrastructure for client server configurations of Cerity requires a switched environment Switches have become an inexpensive way to properly isolate the infrastructure segments from each other Hubs should remain an exception in a properly designed network but can be accommodated on a case by case basis Servers are typically connected to the backbone through a main switch The interface should be set to use the maximum speed at least 100 MBit s full duplex 2 It is strongly advised that acquisition controllers should Agilent P NLC AgilentP NGC Description Minimum FW id th bnet N A N A HP J2552B MIO card for 10Base T 10Base2 A 08 32 resiae on same subdn i S C Same pU S as G1846A G1847A HP JetDirect 400N MIO card for 10Base T K 08 32 the instruments Exceptions to 10Base2 100Base TX this rule can be justified on a G1369A N A Agilent LAN Communication card for the All revisions case by case basis and may Agilent 1100 and 8453 Series Adherence of require additional measures for the infrastructure between the G1369A to the requiremen
73. template defines the normal sequence of injections ith this method blank injections system suitability standards samples OC samples etc The sequence template of t during sequence setup he method minimizes data entry effort Data Analysis Integration algorithm Integration events Standard quantification modes Description of recalibration schemes for sequence analyses Description of overall bracketing calibration scheme Description how the system prevents discrepancies between printed reports and results displayed on the screen Description of how system controls re integration and reprocessing in a controlled manner according to GMP and 21 CFR Part 11 Support of method specific calculations Supported calculation functions Storage of method specific calculation results Triggering of warnings pass fail information based on calculation results Revised version of the Agilent Enhanced Integrator The system allows setting integration events to change integration para meters appropriate for the signal measured during the analysis Typical integration events include but are not limited to e Area reject e Height reject Slope sensitivity e Peak width Shoulder detection e Tangent skimming e Detection of negative peaks Area Norm External Standard Quantification ESTD Internal Standard Quantification ISTD The system supports flexible calibration schemes e Moving avera
74. tion information or other setpoint changes e Existing data may be reprocessed with a newer revision of the original method or with a different method e Reprocessing efficiency is high because the system will only recalculate modified results Results not affected by a change are taken from their previous revision T Agilent Cerity NDS for Pharmaceutical GA QC System Admin Administrator Cerity for Pharma QA QC File Edt View Tools Actions Help Method yO RS aA ASAYBOASR Yt Ov at yy A MasteMethods F gt Singe Irjection Muti Injection Calibration Standard Group Sample Group QC Sample Group Custom Sample Group E AlMasterMethods P E amp P Assay incl PPQ_020321b E 6 Instrument Setup Quaternary Pump 4 DAD 3 Fie E5 PSTDEV 06 D8 AVERAGE 06 08 100 EE Sample Variables AB c D E Sequence Template Data Analysis New E Example Chromatog PPQ_Area_ Parent Coeff_Var_Area Parent E Integration E Identification sf Calibration Ef Quantitation Setup JE Custom Calculations EE Limits 5 8 Data Review Layout 2 Singe Injection Column selected Coeff_Var_Area Parent Information Coefficient of variance on Area Parent Calibration Samples Sample Group Variable STDEV OS D8VAVERAG i SR OUEBBGNUHEBEEBEBE E D6 D8y 1001 Multiple Injection T Calibration po ac DD Samples FD Calibration Group ED Custom Sample Gror 15 Reporting l C Old Revisions rt amp Assay_incl PPQ_0203
75. trolled by a single computer with strict adherence 21 CFR Part 11 elec tronic records and electronic signatures and related predicate rules such as to 21 CFR 210 GMP and 21 CFR Part 211 cGMP This configuration provides system access for one user at a time It is designed for small laboratories that require secure data storage data collection of electronic analytical records and support for several instruments without the need for multi user operation and centralized chromatography data management The underlying technical infra structure of Cerity Professional e g processes services and user interface components is identical to the client server configuration A Cerity Professional system can be reused as a client when scaling up to a Cerity client server configu ration Cerity NDS for Pharmaceutical QA OC Client Server The Client Server configuration extends the capabilities of Cerity Professional by distributing system tasks between the central database server any number of connected instruments acquisition controllers and review client workstations This allows for multiple users to access and con currently work with the central database and any connected Instruments SF ariy Prof Workstations Figure 1 Cerity NDS for Pharmaceutical 0A QC Professional allows a single user to control acquire and process data from up to 8 dual channel instruments Acquisitions Controllers gt Cerity C
76. ts of IEEE 802 3 2002 Ethernet has been verified by IOL the Interoperability Laboratory of the University laboratory and the server The of New Hampshire s Research Computing Center recommended interface setting is at least 100 MBit s full duplex 3 The recommended network speed setting for PC clients is at least 100 MBit s full duplex fixed at both ends 4 The network speed supported by analytical instrumentation Table 1 Supported instrument network interface cards Network Interfaces To connect Agilent Technologies instruments to the Cerity NDS for Pharmaceutical QA QC system a suitable network interface card is e The Cerity NDS system includes a dedicated BOOTP server Boot strap Protocol that operates as a service in Windows The Agilent BOOTP service can be used if no from Agilent depends on the exact model The recommended setting for the Agilent 1100 HPLC 6850 GC and the 35900E Dual Channel Interface is 100 MBit s half duplex The Agilent 6890N Gas Chromato graph is only supported at 10 MBit s half duplex A simple recommendation is to set the network speed for all ana lytical instruments to 10 MBit s half duplex This allows moving instruments in the lab Network ports on the switches need to match the speed settings described above If fixed speed settings are not in line with existing IT procedures and practices switches may use autonegotiate 8 Agilent Technologies stron
77. ty 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 and the translation of the set point val ues into the control commands the instrument 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 needs its own specific VSIA Every VSIA must be installed separately The communication between the GIC framework and the VSIA is done using the Common Instru ment Control Language CICL CICL specifications combine a state model a set of commands and a COM interface Device drivers that adhere to the CICL specifications can be plugged into the Cerity software The GIC framework provides a ready made library for VSIA to interpret GIC commands All CICL commands are in XML format XML provides great flexibility for communicating device specific parameters and eases the writing of VSIA s responses VSIA under stands the CICL commands and translates them to a instrument specific protocol and vice versa The definition of all setpoints is done using an industry standard XML file format which makes it easy to describe the instrument capabilities and setpoints using off the shelf tools The instrument spe c
78. ty system administrators require system administration permis sions on the local computer anaged at the individual function level of the application enus and toolbar functions can be selectively configured for each user role Examples Create method reprocess chromatogram approve result etc e Cerity users must be authenticated through the operating system e Mandatory login using user ID and password e Cerity uses a role based security concept based on job roles and job responsibilities of users e Prior to executing a function in the system Cerity s security service checks whether the user has the appropriate capabilities e Mandatory audit trail every time a record is created modified or destroyed e Cerity allows to configure which system tasks require authorization by electronic signature e g accept reject an analysis result e System wide inactivity time out locks the session after a predefined idle period e 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 Yes using COM security Planned for subsequent release Support biometrics based identification with standard interfaces for face 21 Instrument Control Instrument Status Monitoring and Analysis Scheduling Instrument status monitoring e Graphical display of
79. ure require the collaboration of at least two individuals Y The Cerity system uses operating system security Login to the Cerity system and electronic signatures require the user ID and password Signing a record always requires entering the user id and password of that user A configurable inactivity timeout prevents impersonation after a defined period without user activity The currently logged on user must re enter user ID and password to unblock the system Customer policy has to define implement and maintain a suitable password policy Cerity uses Windows security system allowing reuses of the password policies defined in Windows Yes but requires appropriate account and password handling policies in the user s organization and IT environment For Tokens Cards and other Devices Bearing or Generating Identification Code or Password Information Y N NA Comments 11 300 c 11 300 c 11 300 c 11 300 e 11 300 e Question Is there a loss management procedure to be followed if a device is lost or stolen Is there a procedure for electronically disabling a device if it is lost stolen or potentially compromised Are there controls over the issuance of temporary and permanent replacements Is there initial and periodic testing of tokens and cards Does this testing check that there have been no unautho rized alterations Electronic Signatures Biometric 11 200 b Question Has it b
80. uster The virtual address is used to access the active physical node of the cluster Required system services run on the active node during normal operation In the case of a failover those services are started on the inactive node Oracle Fail Safe OFS services make the Oracle RDBMS cluster aware and interact with the operating system to respond to failover system events OFS ensures data integrity on the permanent data store in a failover scenario OFS is an optional utility available for Oracle 9i Cerity A 02 01 SR1 and higher support both MSCS and OFS Oracle Enterprise Edition specific functionality such as the Transparent Application Failover TAF and optional packages such as Real Application Clustering RAC provide additional support to handle in flight data or database replication These features are not supported by the Cerity NDS software Cerity Database Server Cerity system services do not interact directly with the operating system to manage clustering related events Instead Cerity respond to cluster failover scenarios through MSCS Cerity services running on acquisition controllers and clients automatically reconnect to the database server cluster after the failover is completed Typical failover delays have been measured at less than one minute Cerity acquisition buffering functions may be triggered during the failover delay A working failover cluster configuration requires that all Oracle data
81. ve 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 in a table Confirmation values display with colour 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 28 Online Results Review and Approval Display of analysis results Results approval Description of retrieval capabilities Protection of electronic records managed by the system e Online results review is a separate context view of the application e Results can be queried from the Cerity database using standard or customize queries database searches e Results are displayed according to the settings defined in the data review layout of the method e The system supports a 3 step results approval process analyst review peer review manager approval e Data can be approved rejected or marked for rework Operational system checks ensure the approval steps are performed in permitted sequence of steps e Approved data can be locked by the responsible analyst e Locked data can be unlocked by an authorized administrator Injection Date 1142003 11472003 11472003 11
82. w ing related information e The printed name of Y System shows the printed name of the signer date time the signer local time and timezone information e The date and time of Y See previous item signing e The meaning of the Y The meaning of the signature is captured in the context signing such as approval of the function currently executed e g peer review responsibility review approval or through a mandatory comment 11 50 b Is the above information Y Signatures become part of the original record Changes shown on displayed and result in new revisions of records and previous entries printed copies of the elec are never overwritten The information is available online ronic record and on printed reports 11 70 Are signatures linked to their Y The signature information becomes part of the original respective electronic records record according to the Cerity database schema o ensure that they cannot Changes result in new revisions of records and previous be cut copied or otherwise entries are never overwritten In addition audit trail and ransferred by ordinary e sig are part of the archived restored records means for the purpose of alsification Electronic Signatures General Question Y N NA Comments 11 100 a Are electronic signatures Y The Cerity security implementation is based on operating unique to an individual system security This allows to directly reuse the user account system defined by th with the cor

Agilent Cerity Networked Data System for Pharmaceutical QA/QC - Rev. A.02.02 - July 2004 Manual

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