Sphera Case Studies Life Sciences Industry Excellence Award Winner - Siemens
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Life Sciences Industry Excellence Award Winner - Siemens

Sphera
Analytics & Modeling - Data-as-a-Service
Application Infrastructure & Middleware - Data Exchange & Integration
Healthcare & Hospitals
Life Sciences
Product Research & Development
Quality Assurance
Regulatory Compliance Monitoring
Data Science Services
Software Design & Engineering Services
Siemens, a global Fortune 500 company, faced a major business challenge due to the confluence of two major regulatory changes becoming effective on the same date. The U.S. OSHA adoption of the United Nations Globally Harmonized System of Classification and Labeling of Chemicals (GHS) framework as its standard for hazard communication combined with the enforcement of the EU GHS regulation on mixtures meant Siemens had to reassess and reclassify over thirty-five hundred products by the June 1, 2015 regulatory deadline. Non-compliance would have created an extreme business disruption since Siemens would have been unable to sell its products in several markets. The GHS implementation project formally began in 2014 and leveraged software, content and expertise from Sphera to help them facilitate the transition.
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Siemens is one of the world’s top suppliers of systems for power generation and transmission as well as medical diagnosis technologies. As a Global Fortune 500 company, Siemens and its subsidiaries employ nearly 345,000 people and sell products in more than 200 countries. The company works to meet all regulations and standards required for Siemens products to access target markets worldwide. Consistent also with the company’s vision, Siemens works to extend its position as an industry leader in environmental and social sustainability by producing products and designing processes that are safe and eco-friendly. Every day, the Laboratory and Point of Care Diagnostics business areas of Siemens Healthcare strive to achieve important goals.
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Siemens leveraged software, content and expertise from Sphera to help them facilitate the transition. Sphera had been a trusted partner to Siemens for nearly a decade. In 2008, while merging three acquired companies into one, executives benchmarked best practices in terms of EHS systems. As it related to authoring and automation of safety data sheets, Sphera Intelligent Authoring™ was chosen to support Siemens’ global operations. A major business-wide team effort was established for the GHS Project, and the project was managed by Frank (Chuck) Fives, Vice President, Manufacturing, and Maria (Elisa) Bowling, Project Management Specialist. It took the partnership of over 17 cross-functional teams to execute the GHS implementations from end-to-end. Important operational partners included: Commodity Management, Communications, Demand Planning, Document Control, Engineering, Environmental Health & Safety, Information Technology, Labeling, Logistics, Manufacturing, Procurement, Project Management, Quality, Regulatory Affairs, and Technical Operations.
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Transitioning labels and Safety Data Sheets (SDSs) to the GHS standard was challenging from the start and without the Sphera delivered software; this would have been even more difficult.
The Sphera updates were delivered early in the process so Siemens had sufficient time to perform the required analysis, preview the results and make further modifications as necessary for each SDS.
As a result, Siemens was able to deliver GHS-compliant labeling and SDSs in 20 language formats to meet its customer requirements.
Reassessed 3,500 reagents according to new GHS classifications and updated 70,000 Safety Data Sheets prior to 2015 GHS deadline
Created GHS-compliant SDSs in 20 unique language formats
Avoided product interruption to customers in key GHS-affected markets
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