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Installation Qualification and Operation Qualification (IQ/OQ)

Be confident your resultswill be accurate andcompliant is not enough that your lab sinstruments perform to manufac-turer s standards. More importantly,they need to meet the regulatoryrequirements of your lab s team of serviceexperts understand the increasingneed for validation and regulatorycompliance and has designed acomplete Installation and OperationalQualification (IQ/OQ) programincluding an extensive Log Bookfor complete instrument complete program provides a permanent record identifyingselected key activities performedand verified during Installation ,before the instrument is put intoservice for actual analysis. TheIQ/OQ documentation is specificallydesigned to your instrumentincluding your company name,address, instrument serial number,purchase order number and anindividualized protocol is more than a simple instru-ment performance verification our IQ/OQ program produces thethorough audit trail of system performance you need to meet validation requirements imposedby internal and external regulatorygroups giving you the confidencein your instrument IQ/OQ program produces the thorough audit trail needed to meet internal and external validation requirementsDocumented tests confirm properinstallation and operationLog book for recording instrumenthistory ensures your instrument follows good GLP and GMP guidelinesMore factory-trained service peoplethan anyone else in the industry,available globallyKey Capabil

Be confident your results will be accurate and compliant everyday. It is not enough that your lab’s instruments perform to manufac-turer’s standards.

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Transcription of Installation Qualification and Operation Qualification (IQ/OQ)

1 Be confident your resultswill be accurate andcompliant is not enough that your lab sinstruments perform to manufac-turer s standards. More importantly,they need to meet the regulatoryrequirements of your lab s team of serviceexperts understand the increasingneed for validation and regulatorycompliance and has designed acomplete Installation and OperationalQualification (IQ/OQ) programincluding an extensive Log Bookfor complete instrument complete program provides a permanent record identifyingselected key activities performedand verified during Installation ,before the instrument is put intoservice for actual analysis. TheIQ/OQ documentation is specificallydesigned to your instrumentincluding your company name,address, instrument serial number,purchase order number and anindividualized protocol is more than a simple instru-ment performance verification our IQ/OQ program produces thethorough audit trail of system performance you need to meet validation requirements imposedby internal and external regulatorygroups giving you the confidencein your instrument IQ/OQ program produces the thorough audit trail needed to meet internal and external validation requirementsDocumented tests confirm properinstallation and operationLog book for recording instrumenthistory ensures your instrument follows good GLP and GMP guidelinesMore factory-trained service peoplethan anyone else in the industry,available globallyKey CapabilitiesInstallation Qualification andOperation Qualification (IQ/OQ)

2 AnalysisChromatographyMolecular SpectroscopyThermal AnalysisInformaticsPRODUCT NOTEE nsure you re ready to goright from the start Installation Qualification (IQ)providesformal checks and documentation to confirm that the instrument and itscomponents have been supplied asordered and properly installed inyour lab environment (Figure 1).Upon delivery, the shipment will bevisually inspected and reviewed forcompleteness followed by Installation ofall hardware, software and completely installed, the systemwill be turned on to confirm all modules and systems work , all information determined isthen documented within the the Installation QualificationPerkinElmer s Customer SupportEngineers will: Compare equipment as receivedwith purchase order including soft-ware, accessories, spare parts, anddocumentation such as tutorials,manuals and operating procedures Check equipment for any damageduring shipping Check that the documentation supplied is of the correct issue Establish that the laboratory environmental requirements areappropriate for the instrument (power,bench, lighting, accessibility etc.)

3 Review all hazards and safety precautions, including materialsthat may come in contact with the instrument Install hardware including all tubing, columns, cables for power,data flow and instrument control Install or confirm factory Installation ofsoftware on the computer followingthe Installation instructions Configure peripherals, , printersand equipment modules Document equipment tutorials,manuals and operating procedures Perform Installation functionalitycheck and prepare Installation report Activate utilities and pre-conditioninstrument ( warm-up, leak-test,flow controls etc.) Check that the response to theinitial application of power is asexpected and record deviations Record all relevant activities and actions and sign all requireddocumentsLocate the certificates of conformityand place them in the appropriateprotocol appendicesFigure 1. IQ/OQ Certification confirms all formal checks and documentation have been completed. Confidence your instrumentis ready to runOnce the instrument has been installed, Operation Qualification (OQ)willdemonstrate that the instrument willfunction according to its operationalspecifications.

4 The Service Engineerwill ensure the system is functioningto acceptable limits by testing relevantinstrument specifications, parametersand ranges as determined byPerkinElmer s Instruments PerformanceVerification (IPV). At the completionof the OQ all of the Operation testsare documented, the results arenoted, and all relevant certificatesare completed and signed. Once theinstrument is validated, the ServiceEngineer will provide instrumentfamiliarization training to confirm that you are ready to run your instrument that very day. TheService Engineer will also reviewand explain the contents of theInstallation Qualification and Operational Qualificationof the PerkinElmer Series 200 LC AutosamplerCertificationThe Installation Qualification and Operational Qualification final report for thePerkinElmerSeries 200 LC AutosamplerSerial number 123N4567890has been reviewed and was found to meet the requirements necessary for theinstrument to be used in the customer s REPORTR eviewed by (Name and Title)SignatureDateAuthorized PerkinElmer RepresentativeAuthorized Customer RepresentativeCustomer QA Representative (if applicable)Instrument Log Book so you are familiarwith the information provided.

5 For Operation QualificationPerkinElmer Service Engineers will: Perform basic instrument controlfunctions from both the instrument skeyboard and from the computer(if applicable) Perform basic functions of theapplication software Test the equipment hardware forproper functionality Perform Instrument calibration as documented in the suppliedconfiguration and Test Certificate Document all the Operation test results Perform familiarization training Explain the purpose and contentsof the Instrument Log Book andassociated documentationEnsure you re in complianceTo help ensure your instrument stays in compliance, the PerkinElmerService Engineer will affix an IQ/OQsticker to the validated instrument(Figure 2). This sticker will help youkeep your instrument testing up-to-date by noting the compliance dateof the instrument and the date thenext IPV should be Support Services for your lab Not only are we prepared to assistwith IQ/OQ, PerkinElmer s uptimeexperts are ready to assist you tomaximize your productivity andoptimize your lab s by 60 years of leading edgeinstrumentation experience,PerkinElmer s uptime experts are passionate about exceeding customerexpectations, every time.

6 We offermore factory-trained service peoplethan anyone else in the industry,available globally. Our team hasexpertise across a broad range oftechnologies so we can support yourentire lab. Through our extensiveinternal global programs such as SixSigma and ISO certification, we canensure consistent and reliable supporton a global basis. So no matter whatyour laboratory size or budget, we canassist you in improving every aspectof your lab s performance, frominstrument care and repair, training,validation, consulting and more. Figure IQ/OQ sticker affixed to theinstrument helps you keep your instrument testing System Log book ensures a complete record of activities is Instrument HistoryThe Instrument System Log Book is an integral part of the IQ/OQ program as it ensures a completerecord of activities and is maintainedfor the entire working life of yourinstrument (Figure 3). With this LogBook, users are able to keep recordsof all changes, modifications, service,maintenance, parts, etc.

7 All actionswith regard to the PerkinElmer systemare traceable, a requirement for GLPand GLAP. The instrument Log Bookhas more than a dozen sections rangingfrom who-to-reach at PerkinElmer to what reference material was usedthe last time the unit was serviced .Maintaining an up-to-date Log Bookof the overall history of the instrumentor system will satisfy GLP and ISO-9000 requirements. If for anyreason you need a copy of thePerkinElmer factory generated protocol,these documents are archived electronically to ensure easy systemlog bookLife Sciences Optoelectronics InstrumentsFluid SciencesModelSerial QualificationProtocol SignatureCustomer SignatureInstrument Performance VerificationNext IPV Due Date 2002 PerkinElmer, Inc. All rights reserved. PerkinElmer is a trademark of PerkinElmer, trademarks depicted are the property of their respective holders or reserves the right to change this brochure at any time and disclaims liability for editorial, pictorial, or typographical KG040205 Printed in USAP erkinElmer Instruments710 Bridgeport Avenue Shelton, CT 06484-4794 USAP hone: 800-762-4000 or(+1)


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