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SOLVING THECOMPLEXITYOF COMPLIANCECompliance Solutions withMultimode Plate Readers, Enhanced SecuritySoftware, and Commissioning Services

GUIDING YOUTHROUGHTHE PROCESSIntroductionReaching compliance according to the laws and regulations of each country can bea tedious, complicated process, and being GxP* compliant is necessary for deliveringtherapeutic treatments to market. Pharmaceutical and biotechnology companies,including clinical research organizations, need to have well-defined standardoperating procedures (SOPs), reliable instruments, compliant software, validatedassays and systems, and testing procedures to ensure everything performs at anoptimal level.Simplify compliance for your VICTOR Nivo , EnSight , or EnVision multimodeplate reader with the help of our Enhanced Security software. In addition, ourSoftwarewide range of assays can help you achieve your research goals, and our qualificationVICTOR NivoMultimode Plate ReaderEnSightMultimode Plate ReaderEnVisionMultimode Plate ReaderEnhancedSecurity Softwareservices will make sure your multimode plate reader and software are operating atthe recommended technical specifications.Installation and IQ/OQReady to get started? We can help guide you through the complexity ofthe compliance process with our proven solutions, customer training, andtechnical support so you can focus on your science and research.InstrumentsCompliance†Validations andQualificationsAssay PerformanceValidationServicesContact UsStandardOperatingProceduresAssays*Refers to “good practice” guidelines established in a regulated market such as goodmanufacturing practice (GMP) or good laboratory practice (GLP) when dealing with electronicrecords detailed by the FDA, EU, or WHO. Exact designations and terms may vary.Can include GLP, GMP, 21 CFR p11, EU Annex 11, etc.†

VICTOR NIVOMULTIMODE PLATE READERIntroductionThe VICTOR Nivo multimode plate reader is a fully equipped, high-performance,filter-based system with all the major detection modes you need for everydaybiochemical and cell-based assays. It’s a compact, lightweight unit so you can freeup valuable lab space for other activities.In addition, the VICTOR Nivo system features optional Enhanced Security softwarethat contains easy-to-use tools to help you reach compliance for 21 CFR Part 11and EU Annex 11.Learn more.VICTOR NivoMultimode Plate ReaderEnSightMultimode Plate ReaderEnVisionMultimode Plate ReaderEnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsAssay PerformanceValidationReference our detailed guideto learn how EnhancedSecurity software facilitatescompliance with specificreference to 21 CFR Part 11.Learn more about validationof Alpha technology detectionon the VICTOR Nivo systemwith no compromise onsensitivity or data quality.See the benefits of theVICTOR Nivo system – allmajor detection technologiesin the industry’s smallestmultimode plate reader.Download Our White PaperDownload Our Technical NoteDownload Our BrochureContact Us

ENSIGHTMULTIMODE PLATE READERIntroductionThe EnSight multimode plate reader offers fast well-imaging and multimode detectioncapabilities for target-based and phenotypic screening, all in a single benchtopinstrument. The system allows you to gain deeper insights that are impossible toachieve with detection measurements alone. When combined with our Kaleido workflow software, the EnSight instrument is perfect for multiuser environments,increasing productivity and elevating the confidence in your scientific results.In addition, the EnSight system features optional Enhanced Security softwarethat contains easy-to-use tools that help you reach 21 CFR Part 11 and EUAnnex 11 compliance.VICTOR NivoMultimode Plate ReaderEnSightMultimode Plate ReaderEnVisionMultimode Plate ReaderEnhancedSecurity SoftwareLearn more.Installation and IQ/OQValidations andQualificationsAssay PerformanceValidationLearn how the EnhancedSecurity software optionprovides the tools andguidance for 21 CFR Part 11compliance.Download Our White PaperRead about how the EnSightsystem can help you achievemore predictive results with atruly orthogonal approach.See the high-performancedetection and well-imagingtechnology benefits of theEnSight system.Download OurSpecifications SheetDownload Our BrochureContact Us

ENVISIONMULTIMODE PLATE READERIntroductionThe EnVision multimode plate reader provides exceptional speed, ultrahighthroughput, and maximum sensitivity across all detection technologies. It’s our goldstandard for high-throughput screening and gives you robust performance andreliable data, time after time, with exceptional sensitivity and minimal downtime.In addition, the EnVision system features optional Enhanced Security softwarethat contains easy-to-use tools to help you reach compliance for 21 CFR Part 11and EU Annex 11.Learn more.VICTOR NivoMultimode Plate ReaderEnSightMultimode Plate ReaderEnVisionMultimode Plate ReaderEnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsAssay PerformanceValidationLearn more about how therequirements of 21 CFR Part11 are met by a combinationof software and SOPs.Download Our White PaperRead about how the EnVisionmultimode plate readerprovides high speed, ultrahighthroughput, and maximumsensitivity across all detectiontechnologies.Download OurSpecifications SheetSee the benefits of EnVision –tried, tested, and proven toinspire science.Download Our BrochureContact Us

SOFTWAREYOU CAN TRUSTIntroductionOur multimode plate readers feature an optional EnhancedSecurity software that contains easy-to-use tools to help youreach compliance for 21 CFR Part 11 and EU Annex 11.Software is not compliant without the development andimplementation of other elements. To better support your standardoperating procedures, we included useful features for our EnhancedSecurity software, plus additional services and support.Key features include: User management Audit trail Electronic signatures Reasons for change Additional audit trail viewer for remote accessVICTOR Nivo settings screen for Security AdministratorTo learn more, watch our video.Our services include: Commissioning Services Installation Qualification (IQ) Software Qualification Operation Qualification (OQ) Performance Qualification (PQ) Full Computer System Validation (CSV) Performance validation for assay Declaration on certification for R&D and manufacturing Consultation to align multimode plate reader to yourcompany’s SOPsVICTOR NivoMultimode Plate ReaderEnSightMultimode Plate ReaderEnVisionMultimode Plate ReaderEnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsAssay PerformanceValidationContact Us

QUALITY ASSURANCE BRINGS PEACE OF MINDOnce you receive your multimode microplate reader, one of our local, highlytrained service technicians will install it for you. At that time, the EnhancedSecurity software license will be activated and you will have access to yourIntroductionVICTOR NivoMultimode Plate ReaderEnSightMultimode Plate Readercontrol software. The system will then be ready for integration into yourregulated environment and your company’s network. In addition, ourqualified experts will provide multimode plate reader training to your staff.Over the lifecycle of a multimode plate reader, several qualification testsare performed. These tests ensure the instrument is performing optimally.PerkinElmer performs these qualification tests and provides you withcertificates as proof of GxP compliance.Click on each qualification test below to learn more.INSTALLATION QUALIFICATION (IQ)*Software QualificationThis test is done during the instrument installation phase. The goalPerformance Qualification (PQ)Full System Validation*PerkinElmer will provide you with certificates as proof of compliance.EnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsInstallation Qualification (IQ)Operation Qualification (OQ)EnVisionMultimode Plate Readeris to verify the multimode plate reader was delivered as ordered,functional, and properly set up. Also, we’ll ensure all necessarydocumentation is available as well.Assay PerformanceValidationContact Us

QUALITY ASSURANCE BRINGS PEACE OF MINDOnce you receive your multimode microplate reader, one of our local, highlytrained service technicians will install it for you. At that time, the EnhancedSecurity software license will be activated and you will have access to yourIntroductionVICTOR NivoMultimode Plate ReaderEnSightMultimode Plate Readercontrol software. The system will then be ready for integration into yourregulated environment and your company’s network. In addition, ourqualified experts will provide multimode plate reader training to your staff.Over the lifecycle of a multimode plate reader, several qualification testsare performed. These tests ensure the instrument is performing optimally.PerkinElmer performs these qualification tests and provides you withcertificates as proof of GxP compliance.Click on each qualification test below to learn more.SOFTWARE QUALIFICATION*Software QualificationThis test is performed during the instrument installation phase. ThePerformance Qualification (PQ)Full System Validation*PerkinElmer will provide you with certificates as proof of GxP compliance.EnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsInstallation Qualification (IQ)Operation Qualification (OQ)EnVisionMultimode Plate Readergoal is to verify the multimode plate reader software was deliveredand installed as ordered, functional, and set up accurately.Assay PerformanceValidationContact Us

QUALITY ASSURANCE BRINGS PEACE OF MINDOnce you receive your multimode microplate reader, one of our local, highlytrained service technicians will install it for you. At that time, the EnhancedSecurity software license will be activated and you will have access to yourIntroductionVICTOR NivoMultimode Plate ReaderEnSightMultimode Plate Readercontrol software. The system will then be ready for integration into yourregulated environment and your company’s network. In addition, ourqualified experts will provide multimode plate reader training to your staff.Over the lifecycle of a multimode plate reader, several qualification testsare performed. These tests ensure the instrument is performing optimally.PerkinElmer performs these qualification tests and provides you withcertificates as proof of GxP compliance.Click on each qualification test below to learn more.OPERATION QUALIFICATION (OQ)*Software QualificationThis test verifies the multimode plate readers are performingPerformance Qualification (PQ)Full System Validation*PerkinElmer will provide you with certificates as proof of GxP compliance.EnhancedSecurity SoftwareInstallation and IQ/OQValidations andQualificationsInstallation Qualification (IQ)Operation Qualification (OQ)EnVisionMultimode Plate Readerto the standards as described in the specification sheet or userrequirements. The OQ is a reoccurring process, recommended tobe performed on a yearly basis.Assay PerformanceValidationContact Us