Life Sciences Building Management Solutions - Schneider Electric

Pipeline, timeline,deadlineImprove your bottom lineLife SciencesBuilding Management Solutions

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Keep your productpipeline flowingWe’ll show you howYou’re up against not only the competition, but regulatory demands for airtight proofof compliance. There are no excuses. There is no room for error.In an environment like this one, you needflawless performance from every facet of yourorganization—including your facilities. If yourbuilding management system isn’t doing its job,your product pipeline is at risk. And so is yourbottom line.At Schneider Electric, we specialize in creatingbuilding management solutions that control andmonitor critical systems, capture key facility data,and provide the proof of compliance you needto keep everything moving at optimum speed.The result is minimized risk, faster ROI, and acompetitive advantage in one of the mostunforgiving industries in the business world.Think about it. Are your buildings doingtheir share?The Genzyme Centerearned a Platinumcertification, the highestrating issued by the U.S.Green Building Council,under its LEED ® (Leadershipin Energy and EnvironmentalDesign) GreenBuilding Rating System.Benefit from our experience in ways you can measureSchneider Electric is an industry leader in helping life sciences companies get the most from their facilities. From initialdesign through installation and qualification, to ongoing operations and maintenance, Schneider Electric is a long-term partner youcan trust. Our global life sciences experience delivers measurable results that maximize capital procurement and operating efficiencieswhile running your facility with minimal regulatory and business risks. Why not put our experience to work for you?

A BMS you can depend onIt’s critical to your successA BMS directly impacts the timely delivery and compliant operations of a life sciences facility.Since product quality and the safekeeping ofresearch data are the lifeblood of a life sciencescompany, the last critical link in the facility deliverychain is the turnover of a properly qualified BMS.The need for more powerful, integrated andsecure building management solutions is tied toevolving regulatory compliance and increasingbusiness challenges.The World Health Organization (WHO) emphasizesthe factors that contribute to product quality in alife sciences manufacturing operation. A BMShas critical control and monitoring responsibilitiesin the areas of Environmental and Personnelmanagement. It also affects and is impactedby Procedures, Premises, Equipment, andValidated Processes.Schneider Electric helps life sciences companiesworldwide comply with regulations that apply tothe types of products they manufacture orprocess. Hundreds of facilities managed bySchneider Electric systems have passed thescrutiny of the US Food & Drug Administration(FDA), European Medicines Agency, HealthCanada, and more. Schneider Electric’s lifesciences customers—who include pharmaceutical,biotechnology and medical devices companiesalong with blood, organ, and tissue-handlinginstitutions—use Schneider Electric systems toprovide paperless proof-of-compliance with allpredicate rules.How a Schneider Electric BMS contributesto life sciences product qualityEscalating consequences of non-compliance: 483s (Notices of Inspectional Findings), Warning Letters, SubstantialFines, New Product Introduction Delays, Product Seizures, Plant Shutdowns, Operating License Revocations. SchneiderElectric helps you comply with the requirements of regulatory agencies such as: FDA (USA), EMEA (Europe), MHRA (UK), HealthCanada, TGA (Australia), PMSB (Japan), CDSCO (India), SFDA (China).

Accelerate your return on investmentThe process from discovery to approval of a new drug or device often takesmore than 10 years at a cost that can exceed $1 billion US. Further, betweenclinical trials and promotion lies a critical phase in the life cycle of a new drugor device—the phase in which a building management system’s value can helpaccelerate revenue realization or bring less than optimal return on investment.Schneider Electric focuses on delivering properly qualified life sciencesfacilities built to specification, within budget and on schedule. This results inan on-time facility turnover capable of capturing billions of dollars in additionalmarket opportunity.The gap between the lines of a problem facility scenario and a SchneiderElectric facility scenario in the diagram below shows the dramatic differencein return on investment if a facility experiences a delay in turnover. SchneiderElectric’s involvement early on—from the pilot plant stage through thecomplete life cycle—will accelerate your product’s time to market and assureconsistent, high levels of environmental quality that secure long-term returnson your facility investment.Schneider Electric has passed stringent audits by customers and prospectsworldwide as part of their due diligence processes for vendor selection andretention. Our history and success with key life sciences customers globallyhas given us the expertise to evolve with you. Trust in your BMS supplier is vitalto your operation and your company’s ability to reduce risk and optimize facilityvalue. Schneider Electric brings engineering experience, as well as flexible,scalable architectures that grow and adapt over the lifetime of your facility.Revenue$0.00Accelerationof ROISchneider Electric ScenarioProblem ScenarioR&DPilotPlantApprovalClinicalTrialsTime to MarketPromotionCompetitionTypical drug life cycle/return on investment

Take the most direct route fromdesign to qualificationWe’ll lead you down the right pathEven in an environment as complex as yours, a sophisticated BMS solutioncan find efficiencies in controlling and monitoring critical systems, capturingkey data, and providing the proof of compliance your facility demands.Applying Good PracticesSchneider Electric has experience supporting regulations and applyingGood Practices (GxPs) in the many areas under BMS control. For example,applying intelligent risk assessment techniques limits qualification effortsto areas of specific regulatory interest. This ensures on-time delivery ofvalue-optimized and properly validated facilities.Applicable regulations and guidance documents:• Title 21 Code of Federal Regulations (CFR)Parts 11, 58, 210, 211, 600, 610, 820• GxPs, GAMP5, Q7ACorporate OfficesManufacturingOperationsCentral UtilitiesClinical SupplyAnimal FacilitiesWarehousing& DistributionResearch& DiscoveryBuilding Management SystemGxP Non GxP MixedOur clients include: Amgen Inc.; AstraZeneca; B. Braun Medical Inc.; Bayer AG; Biogen Idec; Boston Scientific Corporation;Bristol-Myers Squibb; Canadian Blood Services; Cipla Ltd.; Eli Lilly and Company; F. Hoffmann-La Roche Ltd.; GenzymeCorporation; GlaxoSmithKline plc.; Héma-Québec; Johnson & Johnson Services, Inc.; Merck & Co., Inc.; Novartis AG; Novo NordiskA/S; Pfizer Inc.; Sanofi-aventis; STERIS Corporation; The American National Red Cross.

Critical facility issues have noplace to hideManage your total environmentTotal Environment ManagementTotal Environment Management (TEM) isSchneider Electric’s process to monitor andcontrol all the critical events and parametersthat can change the desired environmental state.This approach helps life sciences companiesreduce regulatory and business risks whileoptimizing facility value.Maximize control, minimize riskA TEM solution from Schneider Electric allowsyou to know and record all critical facility issues.All important events and parameters can becaptured along with authenticated operator IDsand explanations for actions taken. Together,this information provides complete eventtraceability and user accountability, along withoffering a panoramic view of what’s happeningin your facility. TEM delivers precise environmentaland security controls with the ability to answerthe questions of what happened when, why,where, and who was involved.Who is in thelaboratory right now?What is the MeanKinetic Temperature(MKT) of the warehouse?Where was the securityguard at 3:00 am?Why was the pressuresetpoint changed?When was the humiditysensor last calibrated?

You have to monitor what you controlWhy not use the same system for both functions?We have worked extensively with life sciencesindustry organizations like the BMS specialinterest group of the Good AutomatedManufacturing Practice (GAMP) Forum to determinebest industry practices. The GAMP Forum is partof the International Society for PharmaceuticalEngineering (ISPE). The diagram below depicts thefunctional requirements of a BMS in a regulatedfacility. One way to reduce BMS validation effortsis to partition the fulfillment of system requirementswith the use of a fully qualified, independent systemto monitor, log, and report.Schneider Electric systems can support thisapproach, but a single BMS, designed so that thedirect impact subsystems are identified, partitioned,and validated, fulfills the same requirements. Theresult is tighter control with the same degree ofmonitoring integrity. This approach yields costefficienciesfrom initial capital procurement throughthe operational life of the system.ReportingControl ParameterManagementCalibrationManagementData LoggingAlarm & EventLoggingControl & ProcessingMonitoringMeasurement/Outputs

Hit your product impact targetWe’ll improve your aimYour BMS plays an important role across the product impact spectrumand Schneider Electric systems are designed to monitor, log, archive, andreport information on a highly granular basis.Exacting criteria are applied to filter, group, andcorrelate information. This ensures that evidencerequired for proof of regulatory compliance is notlost within all the data a BMS system collects.Other data are of great business and operationalinterest to managers; to regulators, they aresuperfluous and distract from their targetof interest.Schneider Electric’s ProjectDelivery ApproachConsistent use of field- and time-provenmethodologies, along with rigorous ISO 9001quality controls, combined with skilled project andaccount management, contribute to the superiorresults you can expect from SchneiderElectric. Our extensive country, branch, and partnerorganizations draw on an international pool ofhighly trained and experienced project managers,engineers, and technicians to deploy our globalexpertise. Well established relationships witharchitecture, engineering, and constructionmanagement firms prevalent in life sciencesstrengthen our delivery capability.Schneider Electric Validation ToolkitSchneider Electric Validation Toolkit TM is a fullset of guidelines and customizable documenttemplates designed to support validation ofSchneider Electric systems in regulated industryapplications. It is based on industry standardmethodologies set forth in GAMP5—Guide forValidation of Automated Systems. The ValidationToolkit is the product of decades of BMSvalidation experience. Hundreds of facilities havebeen validated and passed regulatory inspectionsbased upon the practices it supports and classesof products it is used to deliver.All Facility Events & ParametersSystem DesignSpecificationsUserRequirementsRegulatoryRequirementsBusiness CriticalBusiness ValuableFunctionalDesignDetailedDesignPQ Test PlanOQ Test PlanIQ TestPlanImplementationExamples:Regulated spacetemperatures,pressures, airflows,setpoint changes,access recordsAir handleralarms, serverroom environmentEquipment runtimes,filterdifferential pressuresOffice spacetemperatures, parkinglot barrier positionInstallationQualificationFrom initial system specifications through qualification of the installed system, the SchneiderElectric Validation Toolkit provides comprehensive support to the entire BMS validation process.ImportanceSystem TestSpecificationsOperationalQualificationPerformanceQualificationThe Schneider Electric Validation Toolkit Contains: Sample Applications, Project Planning Guide, Project Quality Assurance Manual,User Requirements Specification (URS), Functional Specification (FS), Detailed Design Specification (DDS), Factory Acceptance Test(FAT), Site Acceptance Test (SAT), Project Turnover Package, Project Validation Plan, Installation Qualification (IQ), Operational Qualification (OQ),Performance Qualification (PQ), Summary Qualification Report, Traceability Matrix, 21 CFR Part 11 Assessment.

They’re called critical subsystemsfor a reasonBased on a detailed product impact assessment,Schneider Electric systems can be partitioned to isolatecritical control, monitoring, alarming, and reportingsubsystems from the overall BMS architecture.Extensive security features in Schneider Electricsystems can be configured to allow or restrictindividual or group access to system functions,equipment, and facility areas on a selective basis.This approach allows a validated subsystem to beeffectively “locked-down” and does not subjectother subsystems to the same strict qualityassurance requirements. Operations, maintenance,calibration, and documentation efforts for nonregulatedareas can be dramatically reduced. This“risk-based” approach yields major cost savingsand assures that secure logging, alarm monitoringand control of critical parameters is achieved.SQL Server“ The Schneider Electricsystem plays a critical rolein ensuring regulatorycompliance for ourfacilities.”— Luc Pelletier,Facility Director,Héma-QuébecGxP AreasSecureServerRoomNon-GxP AreasFacilityManagementWorkstationFacilityManagementWorkstationFacilityManagementWorkstationDoorModuleSupervisoryControllerDigital VideoRecordingDoorModuleSupervisoryControllerAccessControl &MonitoringBiometricSensorsAccessControl &MonitoringLightingAirHandlingUnitFieldControllerFumeHoodsCentralPlantFieldControllerFireSystemsIntrusionMonitoringIntrusionMonitoringTerminalUnitVAVControllerParticulateMonitoringTerminalUnitVAVControllerPowerMonitoringSecured ResourcesTouch ScreenDisplay

Lower cost. Lower risk.Guaranteed performance.Now that’s cleanClean Room ExpertiseManagement of a clean room serves as a primeexample of the advantages of an integratedcontrol system because clean rooms require tightintegration between air-handling and accessmanagement systems. An integrated systemfacilitates straightforward and cost-effectiveengineering and reduces validation costs and risks.Due to the extensive range of open standardssupported by Schneider Electric systems,integration of complementary specialist devicesand subsystems like particulate monitors andfume hood controls is easily realized.Precision EnvironmentsSchneider Electric has broad experience and awell established track record of building cleanroom projects with our Precision Environments (PE)group. This team of specialists from SchneiderElectric offers full clean room turn-key servicesincluding design, installation, commissioning, andvalidation. All system components such as floors,walls, and ceilings together with security, electrical,lighting, and control systems are integrated todeliver a “performance guaranteed” environment.• ISO 14644 Standards• ISO CleanlinessClasses 1 through 8• Biosafety Levels1 through 4“Schneider Electric lets me know there’s a problem immediately so I can take the appropriate action quickly.In a nutshell, I can run my facility from anywhere!”— Tom Martin, Facility Manager, Amgen

What’s at risk if your data isn’t secure?EverythingTAC Vista for Regulated IndustriesSchneider Electric answered the call from our life sciences customers forsupport of 21 CFR Part 11. We introduced enhancements like the use of aMicrosoft ® SQL database to securely store all long-term trend logs and events.Each record in the database is individually protected from alteration by a SHA1digital signature encryption algorithm that TAC Vista uses to automaticallygenerate an alarm if a record is modified. For any or all events, TAC Vista canbe configured so that operators must confirm their unique user name andpassword combination that serves as an authenticating electronic signaturesign-off for the action. Further, information about the cause of an event,any action taken as a result, and an explanatory comment can be entered.This data is stored in the SQL database and can be accessed to generatecomprehensive audit trails and reports.Andover Continuum CFR Compliance PackCFR Compliance Pack enhances Schneider Electric’s Andover Continuumsystem to provide technical controls and features that support the electronicrecords and signature requirements of the FDA’s 21 CFR Part 11 regulation.The rich standard feature-set of Continuum provides functions to supportregulatory compliance including:• Comprehensive password management• Enforced operator explanation for all alarm acknowledgements• Alarm generation for invalid and disabled user login attempts• Secure data point and event logging• Powerful report generation• Detailed audit trailsThe CFR Compliance Pack adds to these capabilities with powerful archivingand reporting tools allowing you to create PDF files protected with digitalsignatures. For all system changes, operators can be forced to provideelectronic signatures and an explanation of their actions.Typical operator dialog screensfor a critical alarm condition.

An integrated BMS is the centralnervous system of your facilityA smart facility is a smooth running and profitable facilityCapital Procurement and Operating EfficiencyIntegrated BMS solutions yield cost savings and operational benefits. A recentcase study identified cost savings of over 24% for an integrated BMS solutioncompared to a more traditional “separate systems” approach. Due to itshighly distributed nature, the BMS is pervasive throughout a facility andoffers a natural integration platform for all building systems. In effect, theBMS acts as the central nervous system of a facility.Schneider Electric’s leadership in open systems technologies supports theintegration of a diverse range of disparate devices and subsystems intounified, highly functional solutions. Included among the open technologieswe champion and support are BACnet ® , LonWorks ® , Modbus ® TCP, OPCand XML. Progressive life sciences companies use their BMS infrastructureto integrate electrical, utilities, process, access control, and fire and life safetysystems together. The BMS has the communications bandwidth, computingpower and database capacity to provide a common interface from thesesubsystems for centralized engineering and enterprise level functions such asmaintenance management, Manufacturing Execution Systems (MES) and HumanResources databases.The U.S. pharmaceuticalindustry consumesalmost $1 billion (USD)in energy annually. Howis that affecting yourbottom line? SchneiderElectric can help youposition yourself in theDow Jones SustainabilityIndex— significantlyimproving your imageand your financialperformance by focusingon energy efficiency. So,what is the first step?Set energy savings goalsand measure and trackenergy performance forall operations acrossyour business.How? Take that firststep with a partner—Schneider Electric, theglobal specialist in energymanagement. As anindustry leader, SchneiderElectric is helping top tierlife sciences corporationsprioritize and realizesustainability goals.Energy and Building Management Solutions for Life SciencesSimple software integrationInteroperable and open to third-party systems EcotruxureRenewable energiesHVAC controlLighting controlEnergy monitoring & controlMotor controlAccess controlGreen: Make renewable energy sourcesreliable and cost effectiveMake Energy Efficient & Productive:• Measure, control, automate, anddiagnose processes and systems• Make all utilities more efficientSecurityCritical power & coolingElectrical distributionReliable: Prevent power outages & quality variancesSafe: Transform and distribute power safely

Put our experience to workfor youYou’ll be glad you didThe Strength of Schneider Electric forLife SciencesSchneider Electric offers compatibility andsynergy through fully integrated building managementsystems. We combine industry-leadingelectrical and power products with buildingmanagement and security solutions. The result is aone-stop resource for controlling multiple buildingsystems, helping to manage regulatory andbusiness risks while optimizing life sciences facilityvalue.About Schneider ElectricAs a global specialist in energy management withoperations in more than 100 countries, SchneiderElectric offers integrated solutions across multiplemarket segments, including leadership positionsin energy and infrastructure, industrial processes,building automation, and data centers/networks,as well as a broad presence in residentialapplications. Focused on making energy safe,reliable, and efficient, the company’s 114,000employees achieved sales of more than 18.3 billioneuros in 2008 (27 billion USD), through an activecommitment to help individuals and organizations“Make the most of their energy.”www.schneider-electric.com/buildings“Schneider Electric’s hightechnology approachprovides us with thebest of what’s out there.And the companycontinues to respondto our needs.”— Sabi Bivas ,Senior SystemsAssociate, Merck & Co.114,000SchneiderElectricemployees availableto help you100countrieswith SchneiderElectric locations readyto serve you

Schneider ElectricOne High StreetNorth Andover, MA 01845 USAPhone: +1 978 975 9600Fax: +1 978 975 9698www.schneider-electric.com/buildingsThis document has beenprinted on recycled paper© 2007-2010 Schneider Electric. All rights reserved.BR-LS-BLDGMGTSYS-A4.BU.N.EN.2.2010.0.00.CCFebruary 2010 as