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Financial Regulatory Compliance Affecting the Life Sciences Industry

SAP solutions provide a complete financial management solution for companies in the life sciences industry. SAP is the leading enterprise software solution for accounting, financial reporting, performance management, and corporate governance. SAP for Life Sciences addresses a broad range of compliance and governance issues, including Sarbanes-Oxley, IFRS, Basel II, global trade compliance and environmental health and safety.


The Sarbanes-Oxley Act is among the most visible and far-reaching regulations that organizations face today. Failure to comply with the Sarbanes-Oxley Act can result in significant loss of market capitalization and shareholder trust, as well as criminal liability for corporate executives. SAP provides a uniquely integrated Sarbanes-Oxley governance process for SAP software. To effectively address control challenges of supply chain compliance regulated by Sarbanes-Oxley, SAP Global Trade Services leverages automated controls to avoid potential financial impacts of trade violations and inefficient global trade processes.

IFRS Compliance  

The International Financial Reporting Standards (IFRS) and International Accounting Standards (IAS)  were created by the International Accounting Standards Board to promote internationally comparable financial statements. Regulation 2002/3626 requires that some 7,000 listed companies in the European Union prepare their consolidated financial statements in accordance with IFRS/IAS.

Basel II Compliance            

The New Basel Capital Accord, or Basel II, defines requirements for banks to manage the risks of issuing loans. Basel II affects not just banks, but all organizations. In particular, it effectively requires organizations to demonstrate their ability to meet their payment obligations a process called rating. Rating typically involves a comparison of planned versus actual financial values covering a multiyear period. SAP ERP Financials provides a comprehensive set of capabilities to meet the requirements of the rating process.

Global Trade Compliance            

Companies must comply with local laws, satisfy trade security measures, meet documentation requirements, understand complicated tariffs, and coordinate various regulatory parties in order to conduct business internationally. The SAP Global Trade Services (SAP GTS) enables enterprises to automate and streamline complex import and export processes, to ensure full regulatory compliance, expedite customs clearance, mitigate the financial risk of global transactions, and take full advantage of international trade agreements.

Environmental Health and Safety Compliance  

Products and processes are constantly changing in manufacturing environments today and so are the laws regulating the related environment, health, and safety (EH&S) concerns. The EH&S and audit management functions within the SAP Product Lifecycle Management (PLM) solution monitor complex regulations, manage data and documents, track dangerous materials and products, manage waste disposal, enhance employee and public safety, and support preventive healthcare.
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