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Governance, Risk and Compliance for Life Sciences Companies

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See how SAP solutions for governance, risk, and compliance for life sciences companies can help you automate compliance for financial and other critical regulations to let you focus on core business, …

See how SAP solutions for governance, risk, and compliance for life sciences companies can help you automate compliance for financial and other critical regulations to let you focus on core business, while introducing controlled, role-based access to enterprise data helps boost efficiency.

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  • 1. Solution Brief SAP Solutions for Governance, GOVERNANCE, RISK, AND Risk, and Compliance COMPLIANCE FOR LIFE SCIENCES COMPANIES INSTITUTIONALIZE COMPLIANCE TO REDUCE COSTS AND INCREASE PRODUCTIVITY SAP® solutions for gover- nance, risk, and compli- ance help you institutional- ize compliance throughout the enterprise. Across op- e erational, financial, global a As a life sciences company, issues of SAP solutions for GRC rest on a solid trade, and environmental n governance, risk, and compliance foundation of enterprise technologies (GRC) touch on nearly everything you and applications that include the compliance activities, you m do. But many organizations approach SAP ERP application and the SAP can reduce costs and risks GRC in an ad hoc manner – implement- NetWeaver® technology platform. These ing point solutions, one after another, in applications support industry-specific while boosting productivity response to regulatory demands as they best practices that help you streamline and increasing your com- r arise. This approach is inefficient and compliance processes. SAP NetWeaver costly. It also leads to the proliferation provides a foundation for enterprise petitive advantage. of silos and a lack of transparency service-oriented architecture (enterprise concerning compliance issues. SOA). This enables you to rapidly devel- op highly flexible enterprise services A more effective approach is to institu- that leverage your information and tionalize GRC throughout the global en- process foundation to meet specific terprise. This is where SAP® solutions requirements as they emerge. for governance, risk, and compliance can help. Equally important is the SAP GRC Re- pository application, which documents Turning GRC into a Competitive and stores all governance, risk, and Differentiator compliance information centrally. Its lo- cation-specific output (required lan- SAP solutions for GRC support a holis- guage and data, for example) gives you tic, enterprise-wide approach to compli- a pool of information from which to ana- ance and risk management. While point lyze risk and make informed decisions. solutions focus on document manage- The software also promotes reuse by ment and retrieval, SAP solutions for enabling enterprise-wide access to ex- GRC break down silos to establish a isting controls to meet the demands of 360-degree view of compliance and new regulations. audit trail transparency. No matter what new regulations tomorrow brings, you’ll What you get is a single platform that start from a position of enterprise-wide helps you manage financial, operational, data visibility, process flexibility, and environmental, and global trade compli- role-based access to enterprise re- ance and risk more effectively than pre- sources. Powerful decision support viously possible. By institutionalizing based on real-time key performance compliance throughout the enterprise, indicators empowers personnel to man- SAP solutions for GRC allow you to age compliance and risk efficiently and minimize your risk while enabling innova- securely at the lowest cost. The solu- tion. This turns compliance from an obli- tions also automate many compliance gation into a competitive advantage. and risk management processes, allowing you to manage by exception.
  • 2. Financial Compliance exception, immediately alerting control To comply with the Sarbanes-Oxley Act owners and managers to take action. In of 2002, Basel II, and other regulations, the end, you’re able to establish con- life science companies need appropri- trols that promote desired employee ate segregation of duties (SOD) and behavior, optimize business processes, strict access controls to safeguard and ensure cost-effective compliance. against fraud and enable sound corpo- rate oversight. The SAP GRC Access Operational Compliance Control application helps by constantly Numerous regulations in the life scienc- monitoring, testing, and enforcing ac- es industry require meticulous manage- cess and authorization controls. Not ment of business processes. Among only does this assist corporate compli- them are current Good Clinical, Labora- advantage of preferential trade agree- ance stakeholders in collaboratively en- tory and Manufacturing Practices ments, such as the North American forcing SOD policies, it helps you iden- (cGxP) and the FDA’s 21 CFR Part 11, Free Trade Agreement (NAFTA) and tify and remove access and authoriza- which sets down requirements for es- those of the European Union. Ultimate- tion risk from IT systems, which tablishing audit trails for electronic doc- ly, SAP GRC Global Trade Services en- heightens your compliance with finan- uments. To combat counterfeiting, sures easy, cost-effective compliance cial reporting, data privacy, and current companies must introduce electronic with all trade regulations, while reduc- Good Manufacturing Practice (cGMP) pedigree controls. The SAP GRC Ac- ing cycle times, expediting customs mandates. With the software, you can cess Control application ensures SOD clearance, and mitigating financial risks identify and remediate potential risks, compliance for cGMP between differ- for global transactions. such as conflicting authorizations within ent areas of operation, for example, a single user’s access profile; pinpoint production and quality management. actual risks, such as business functions Powered by SAP NetWeaver, SAP so- that violate SOD mandates; and embed lutions for GRC ease compliance with preventive controls in business pro- Part 11 requirements for documenta- cesses to help you reduce the time, tion and auditability, while providing a risk, and cost associated with common technical foundation that inte- compliance. grates with SAP Business Suite appli- cations and related Part 11 The SAP GRC Process Control appli- functionality. cation centralizes control management by integrating directly with control doc- Global Trade Compliance umentation in SAP GRC Repository. By embedding automated import and The application monitors financial-relat- export compliance into your core logis- ed controls and performs autovalidation tics processes, the SAP GRC Global at predefined periods. An easy-to-use Trade Services application helps you dashboard employs a global heat map meet the challenges posed by interna- interface that helps you pinpoint control tional, national, and regional trade regu- violation risks. Detailed root cause lations. The software automatically analysis helps you rectify problems and screens trading partners against offi- continuously improve processes for cially sanctioned party lists, checks for more effective corrective and preven- embargo restrictions, and manages ex- tive actions. The software creates re- port and import licenses. It also pro- mediation cases for each control vides information that lets you take
  • 3. Environmental Compliance • TechniData CfP – which collects, or- Comply and Thrive SAP and its partners provide a range of ganizes, and analyzes data about applications to help you proactively products, factories, suppliers, coun- By providing a foundation that pro- manage compliance related to environ- tries, and customers. The application, motes data transparency, process flexi- mental, occupational safety, and prod- developed by TechniData based on bility, and controls to enforce role- uct safety regulations. Some of these SAP NetWeaver, supports product based access, SAP solutions for GRC include: content and substance list documen- help you institutionalize compliance • The SAP Environment, Health & tation, compliance checking, and au- throughout the enterprise. You’ll be Safety (SAP EH&S) application – tomated communication with custom- able to: which helps manage product and ers and suppliers. • Reduce overall compliance costs – chemical safety specifications, haz- with a holistic, enterprise-wide ap- ardous substance inventories, and Together, these EH&S applications form proach and industry-specific applica- dangerous goods, with functionality a solid foundation for ensuring a tions that help you comply with for safer handling, better tracking, healthy work force, a clean environ- specific regulations at a lower cost and improved document manage- ment, and ongoing product safety – • Minimize risk – with processes that ment. The software helps you per- while driving down the cost of integrate compliance into the way you form risk assessment, exposure log- compliance. do business ging, incident management, exposure • Boost productivity – with automated profiling, and safety management for compliance that enables you to focus specific work areas and supports on core competencies location-specific labeling. • Increase competitive advantage – • The SAP Environmental Compliance with the ability to fulfill specific regu- application – which helps you track, lations faster and more effectively analyze, and record emission data than your competition and report to regulatory authorities. The application, which was devel- oped jointly by SAP and TechniData AG, includes functionality for auto- matic emissions calculation, automat- ic notification of high emissions lev- els, and emissions credit determina- tion and documentation for emissions trading markets.
  • 4. QUICK FACTS www.sap.com /contactsap Summary SAP® solutions for governance, risk, and compliance (GRC) help you institutionalize compli- ance throughout the enterprise. With a holistic approach to GRC, you’ll be able drive down costs and reduce the occurrence of errors. This turns compliance from a regulatory obliga- tion into a competitive advantage. Challenges • Highly regulated industry constantly subjected to new requirements • Compliance landscape made up of disconnected point solutions that are difficult and expensive to maintain • Low data visibility and limited audit transparency that make compliance costly and time-consuming Supported Business Processes and Software Functions • Financial and operational compliance – To establish segregation of duties and access and process controls • Global trade compliance – To perform sanctioned party list screening and manage im- port and export licenses • Environmental compliance – To support emissions management, product compliance, and environment, health, and safety management Business Benefits • Reduce overall compliance costs – Comply with individual regulations at a lower cost • Minimize risk – Integrate compliance into the way you do business • Boost productivity – Focus on core competencies by automating your compliance processes • Increase competitive advantage – Fulfill specific regulations faster and more effectively than your competition For More Information Call your SAP representative today or visit us at www.sap.com/lifesciences. 50 086 844 (08/03) Printed in USA. ©2008 by SAP AG. All rights reserved. SAP, R/3, mySAP, mySAP.com, xApps, xApp, SAP NetWeaver, Duet, Business ByDesign, ByDesign, PartnerEdge, and other SAP products and services mentioned herein as well as their respective logos are trademarks or registered trademarks of SAP AG in Germany and in several other countries all over the world. All other product and service names mentioned are the trademarks of their respective companies. Data contained in this document serves informational purposes only. National product specifications may vary. These materials are subject to change without notice. These materials are provided by SAP AG and its affiliated companies (“SAP Group”) for informational purposes only, without representation or warranty of any kind, and SAP Group shall not be liable for errors or omissions with respect to the materials. The only warranties for SAP Group products and services are those that are set forth in the express warranty statements accompanying such products and services, if any. Nothing herein should be construed as constituting an additional warranty.