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Cost-Effective Compliance with FDA Regulations for Your SAP Applications

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Pharmaceutical companies and other companies from life sciences industry operate in one of the most highly-regulated industries in the world. They have to manage compliance with an increasing set of regulations - most importantly the FDA regulations. The need for proper traceability of business transactions is one of the key requirements of the FDA regulations. SAP business solutions for the life sciences industry include capabilities to minimally comply with these FDA regulations.

SECUDE delivers solutions that help these companies to go beyond the minimum requirement of FDA compliance in order to reduce business risk. This white paper explains how.

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White Paper: Cost-Effective Compliance with FDA Regulations for Your SAP Applications (PDF, 467 kb)

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SARBANES-Oxley and Basel II - Impacts on Corporate IT Security Strategies

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Corporations of the 21st century must face up to the growing challenge of compliance. Governments
worldwide are regulating information management and security with increasing amounts of legislation. At the core of all these laws are authorization, identity management, data integrity and security. As companies strive to reduce costs, improve customer service, increase sales and deal with environmental issues, they must now adapt to the constantly changing legal environment of information management regulations. Increased outsourcing necessitates the exchange of data with external partners, which raises the risk of data theft and errors significantly. The threats are compounded.

This white paper discusses corporate IT security strategies, SARBANES-Oxley (SOX), Basel II, the Health Insurance Portability and Accountability Act (HIPPA), Japanese Data Protection Directive, and US Code of Federal Regulation Part 11.

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White Paper: SOX and Basel II - Impacts on IT Security strategy (PDF, 88 kb)

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