Life Sciences Building Management Solutions - Schneider Electric

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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?
Page 1 and 2: Pipeline, timeline,deadlineImprove
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Life Sciences Building Management Solutions - Schneider Electric

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