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Life Sciences Building Management Solutions - Schneider Electric

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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.<strong>Schneider</strong> <strong>Electric</strong> helps life sciences companiesworldwide comply with regulations that apply tothe types of products they manufacture orprocess. Hundreds of facilities managed by<strong>Schneider</strong> <strong>Electric</strong> systems have passed thescrutiny of the US Food & Drug Administration(FDA), European Medicines Agency, HealthCanada, and more. <strong>Schneider</strong> <strong>Electric</strong>’s lifesciences customers—who include pharmaceutical,biotechnology and medical devices companiesalong with blood, organ, and tissue-handlinginstitutions—use <strong>Schneider</strong> <strong>Electric</strong> systems toprovide paperless proof-of-compliance with allpredicate rules.How a <strong>Schneider</strong> <strong>Electric</strong> 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. <strong>Schneider</strong><strong>Electric</strong> 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).

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