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Partner Functions in Detail

SAP BEST PRACTICES FOR PHARMACEUTICALS PREPACKAGED BUSINESS EXPERTISE FOR SMALL AND MIDSIZE BUSINESSES

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CONTENTS Prepackaged Business Expertise for Small and Midsize Businesses . . . . . . . . . . . . . . . . . . . . 4 Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Product Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Technology and Automated Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical Building Blocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Roles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business Configuration Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CATTs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Preconfigured Business Scenarios Delivered by SAP Best Practices for Pharmaceuticals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Industry-Specific Business Content. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enterprise Resource Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supply Chain Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Customer Relationship Management. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Business Information Warehouse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Supplier Relationship Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preconfigured Smart Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Future Directions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary: Benefits of SAP Best Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . More Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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PREPACKAGED BUSINESS EXPERTISE FOR SMALL AND MIDSIZE BUSINESSES EXECUTIVE SUMMARY

Large or small, every company can profit from efficient streamlined processes, insightful business intelligence, and systems that are flexible enough to grow with changing business needs. But the solutions that deliver these benefits can strain the budgets of even large companies. For small and midsize businesses limited by finite time, IT personnel, and finances, the power of comprehensive enterprise solutions has seemed out of reach. SAP puts the power of integrated business solutions within the reach of smaller companies with mySAP All-inOne, a prepackaged, industry-specific version of mySAP Business Suite with built-in content, tools, and methodologies for a cost-effective, turnkey deployment. Partners can utilize SAP® Best Practices as the foundation for prepackaged, readyto-use, mySAP All-in-One solutions. Flexible technology enables midsize businesses to implement and adapt their mySAP All-in-One solutions so that it can even the largest organizations. Preconfigured business scenarios help you rapidly realize business benefits without extensive configuration.

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mySAP All-in-One solutions based on SAP Best Practices ensure maximum benefits for SMB customers because SAP Best Practices not only cover well-proven industry-specific business processes, but also includes everything that is needed to integrate and exploit the potential of mySAP Customer Relationship Management (mySAP CRM), mySAP Supply Chain Management (mySAP SCM), mySAP Business Intelligence (mySAP BI), and mySAP Supplier Relationship Management (mySAP SRM). Thus, customers who choose a mySAP All-in-One solution that is based on SAP Best Practices can be sure that they receive proven expertise and concrete values. All the comprehensive functions covered by SAP Best Practices can be fine-tuned to meet a company’s specific needs.

PRODUCT OVERVIEW

Product Components SAP Best Practices are built to meet SMB requirements. Three different components are included: • A detailed step-by-step implementation procedure including automated activities • Extensive reusable documentation that you can use for selfstudy and evaluation, as well as for project team and end training • Complete preconfiguration settings that give you everything you need to run SMB-specific key processes “out of the box” with minimal installation effort. The configuration is fully documented including preconfigured business processes, training material, roles, data conversion tools, and test catalogs. It is built using the latest technology, so you can adapt it quickly and easily. Flexible Technology SAP Best Practices provide the building blocks that can be utilized for a fast and smooth implementation of mySAP All-inOne to next line solutions. These building blocks contain the preconfiguration, the tools, and the documentation you need for this purpose. The size and content of building blocks can vary from simple technical building blocks to complex building blocks that can be used as stand-alone solution elements. You can thus assemble several basic, technical building blocks to form a higher-level building block, such as a scenario. Or you can use individual building blocks to modify an existing scenario or solution.

Areas of Use SAP Best Practices can be used in different phases of a project: In the evaluation phase, SAP Best Practices help to quickly set up a prototype that can be used to get a “look and feel” impression of a mySAP All-in-One solution. During the implementation phase, SAP Best Practices contain all the steps necessary for the implementation of selected business scenarios. The mySAP All-in-One solution based on SAP Best Practices can be used at an early stage during the implementation project for demo and training purposes for both the project team and future end s. In addition, SAP Best Practices deliver numerous end- procedures that can be used as training material for end- training and as a basis for end documentation. The following sections introduce the technology that SAP Best Practices are based on (see the section titled Technology and Automated Tools) and present the preconfigured business content for pharmaceuticals companies delivered by SAP Best Practices (see the section titled Preconfigured Business Scenarios Delivered by SAP Best Practices for Pharmaceuticals). Finally, the main benefits are outlined and it is pointed out where to find more information (see the section titled Conclusion).

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TECHNOLOGY AND AUTOMATED TOOLS TECHNICAL BUILDING BLOCKS

Definition Building blocks are reusable preconfiguration units that you can combine to install an SAP Best Practices business scenario or solution. Similar to a construction kit, you can assemble building blocks flexibly to set up business scenarios. Using building blocks for installing business content means reducing redundancies, because you can use a generic building block in different solutions. You can use the building-block installations as the basis for your own solutions. Compared to preconfiguration packages developed in the past, the building-block concept offers some major advantages. In the past, the configuration content was component focused. You had to import the configuration of an entire system, whereas you can now select blocks of scenario-oriented configuration. The reusability of building blocks accelerates and facilitates the installation because you no longer need to import the settings of an entire system but can build upon separate configuration blocks. As a consequence, development and maintenance costs are minimized because redundant development is reduced.

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Installation of Business Scenarios To set up an SAP Best Practices scenario, you have to install a number of building blocks in a predefined sequence. The role (see the section titled Roles) and the installation documentation guide you through this process. The information on which building block you have to install first is provided in the Scenario Installation Guide. The Scenario Installation Guide is the central installation document and provides all the information that is necessary to install the building blocks in the correct order. SAP Best Practices provide specific installation guides for all SAP Best Practices scenarios. When you have successfully installed your SAP Best Practices scenario, you can use the Business Process Procedure to go through the entire business process and test the functionality of the scenario. Business Process Procedures contain detailed application-focused descriptions of individual business processes and business processes of a business scenario. Business Process Procedures are provided for all business scenarios that are in the scope of SAP Best Practices.

ROLES

CATTS

roles are specific menus delivered with SAP Best Practices. There are different role types that serve different purposes. The activities of each role are ed by detailed documentation: • Installation roles are for installing SAP Best Practices. The installation roles are used in conjunction with the SAP Best Practices Installation Guides. • End- roles are for testing and using the business processes of the application that has been installed. The end role is used in conjunction with the Business Process Procedures.

Computer Aided Test Tools (CATTs) are used within the context of SAP Best Practices to create master data and to automate technically oriented activities such as connectivity. Executing the master data CATTs is useful in all components in the system landscape in which example data is needed. Automated CATTs can be used in all components in which initial technical settings, such as Remote Function Call (RFC) connections, to be carried out.

The installation role enables you to quickly access and conduct all required installation transactions and configuration activities in the correct order. The end- role is the menu for anyone who uses the installed business application. BUSINESS CONFIGURATION SETS

SAP Best Practices deliver the preconfiguration in the form of Business Configuration Sets (BC Sets) that can either be used to set up a prototype or a development system. By using the installation roles, you can choose which preconfiguration to use for the implementation of a business scenario. When activating the BC Sets, configuration settings are automatically carried out and saved in transport requests. If necessary, delta configuration follows in order to implement further customer-specific requests that are not covered by the SAP Best Practices scenarios. The transport requests resulting from the BC Set activation and delta configuration are then imported into the quality assurance or production system.

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PRECONFIGURED BUSINESS SCENARIOS DELIVERED BY SAP BEST PRACTICES FOR PHARMACEUTICALS INDUSTRY-SPECIFIC BUSINESS CONTENT

ENTERPRISE RESOURCE PLANNING

Apart from a progressive technology that enables you to rapidly implement software solutions, the SMB market needs solutions that specifically focus on the mid-market-specific requirements from a business point of view. To acknowledge this fact, the strategy of SAP Best Practices is to deliver the crucial business content that you need for a mid-marketspecific industry solution. This business documentation on the industry-specific scenarios is complemented with all the technical information that is needed to implement the respective processes in the system.

Solid Dosage Forms The solid dosage forms scenario describes all logistical processes necessary within a complete product life cycle for “SAPyrin” tablets. The following processes are provided to the solid dosage forms scenario: • Market-oriented planning and material requirements planning • Procurement of batch materials and procurement of non-batch materials • Four-step production covering: – Active ingredient production – Tablet production – Pharmaceutical packaging – Final packaging • Sales of drugs and sales of over-the-counter (OTC) products • Foreign trade • Vendor handling and customer handling

SAP Best Practices for Pharmaceuticals comprise preconfigured business scenarios that cover the most important requirements of midmarket companies in the pharmaceuticals industry. These requirements include: • Enterprise resource planning (ERP) – Various SAP R/3® scenarios aim at this traditional area. • Supply chain management (SCM) – These preconfigured scenarios adaptive supply chain networks in which suppliers, manufacturers, distributors, and customers work together. • Customer relationship management (CRM) – All scenarios in this area help to set up a customer-centric e-business solution that leads to satisfied and loyal customers. • Business information warehouse (BW) – These scenarios provide flexible reporting and analysis tools for analyses and decision-making . • Supplier relationship management (SRM) – These scenarios focus on automation of sourcing processes across the entire supply base.

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The following functions and processes were also implemented with regards to the specialized Good Manufacturing Practice (GMP) requirements: • Integrated sales and production rough planning • Cost center planning and product costing • Batch number generation with exits • Batch determination according to expiration date • Process order execution • Use of approved master recipes (engineering change management) • eXtensible Markup Language (XML) – based process instruction (PI) sheet covering manufacturing execution system (MES) functions • Digital signature functionality in the PI sheet for process steps and deviations • Material identification including completeness check and sequence check • Integration of an external weighing system (data exchange via standard PI-PCS interface) and bar code reader • Creation of handling units

• Material reconciliation for raw materials and packaging materials • In-process and post-process control with sample management and inspection plan • Digital signature during results recording in quality management (QM) • Creation of a complaint QM notification • Usage decision • Expiry date calculation (using pharmaceutical-specific functionality of batch derivation) • Batch where-used list • Batch Information Cockpit • Batch recall In addition, the browser-based PI sheet not only contains useful order-dependent information (such as dangerous goods symbols, notes on occupational health and safety, and material data), but also has a process manufacturing cockpit (PMC; see Figure 1). The PMC shows how to implement company logos, order-independent general documentation, intranet and Internet links, video clips that show complex processes, and access to standard transactions in SAP R/3.

According to U.S. Food and Drug istration (FDA) regulations, process data must be archived. SAP Best Practices show how to configure SAP R/3 in order to make use of an optical archive and generate an electronic batch record (EBR; see Figure 2).

Figure 2: Electronic Batch Record

The scenario of solid dosage forms also contains SAP OPC for Data Access (SAP ODA) and SAP Alert Management. SAP ODA is a component for reading and writing values of and into an OPC data access server. SAP Best Practices show how an OPC demo server can be connected to SAP R/3. This OPC demo server provides process data (for example, critical values) that are called up in the appropriate phase of the PI sheet. Depending on the severity of these values, alert messages can be sent. The OPC demo server can also provide data for alarms and events, in order to subscribe process data.

Figure 1: Browser-Based PI Sheet – Process Manufacturing Cockpit

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Liquid Dosage Forms In principal, the scenario for liquid dosage forms (cough-free syrup “TuSAPin”) comprises the same processes as the scenario for solid dosage forms. The main changes are that the active ingredient is purchased externally and the last two steps of the production process (filling and packaging) are performed by an external subcontractor. Internal Subcontracting In sales orders that appear in the internal subcontracting business scenario, the typical case of customer-provided packaging materials (tablets) has been implemented. The scenario covers sales order processing, receipt of provided materials, and packaging. Figure 3: Integrated Mettler-Toledo Weighing System

SAP Best Practices also contain preconfiguration data that makes it possible to connect a Mettler-Toledo weighing system over the SAP-certified mySAP Business Suite interface within the shortest time frame imaginable (see Figure 3). This reduces work on integration to an absolute minimum, so you can quickly and comprehensively exploit all the advantages of having a weighing system integrated into the production process. You can thus reap the benefits of such an end-to-end solution at the earliest stage possible.

Stability Study Stability studies are conducted to track and examine how different environmental conditions affect a compound, a material, or a batch over a specified period of time. The subject of the stability study scenario in SAP Best Practices is coughfree syrup, “TuSAPin.” It covers the following process stages: initiating stability study, initial testing, stability planning, stability testing, and completing the stability study. Third-Party Processing This scenario describes the sales of a third-party product (“VitaSAP”). The customer’s order, therefore, is ed on to an external vendor (of VitaSAP) who delivers the goods directly to the customer, making the delivery a third-party business transaction. Plant Maintenance The plant maintenance scenario describes the use of SAP Plant Maintenance (SAP PM) management, an SAP R/3 component used at a pharmaceutical company. (Additional components within this scenario are SAP Technical System Management,

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SAP Asset Management, SAP Breakdown Maintenance, and SAP Planned Maintenance). This scenario also contains a calibration process (test equipment management). Project Management in R&D The scenario, project management in R&D, describes how to use SAP Project System (SAP PS) for the planning and execution of strategic research and development (R&D) projects in the pharmaceutical industry. Business : FDA 21 CFR Part 11 Changes to business data and objects must be logged in the regulated manufacturing of pharmaceutical products. In order to meet requirements of the U.S. FDA Title 21 Code of Federal Regulations (21 CFR) Part 11 Electronic Records Electronic Signatures Final Rule, SAP has developed an add-on software tool (called FDA 21 CFR Part 11 Enhancement on Electronic Records), which provides an improved audit trail function. SAP Best Practices not only deliver the latest documentation on this particular tool, they also deliver a technical building block containing a configuration with a selection of transactions relevant for GxP-critical topics, change document objects, and associated tables. In addition, SAP Best Practices compare how changes to critical objects (such as master recipes) were recorded and displayed using standard SAP tools and the enhancement tool.

SUPPLY CHAIN MANAGEMENT

mySAP SCM helps companies create adaptive supply chain networks. It is the only supply chain solution that provides a complete suite of applications for networking, planning, execution, and coordination of the entire supply chain network. The supply chain planning capabilities of mySAP SCM are mainly provided by SAP Advanced Planning & Optimization (SAP APO), the key component within mySAP SCM. SAP APO functions include demand and supply planning as well as distribution and production planning and scheduling. The SCM business scenarios that come with SAP Best Practices focus on the preconfiguration of SAP APO. SAP Best Practices for Pharmaceuticals comprise the following preconfigured SCM scenarios: • The demand planning scenario allows you to create highquality forecasts and integrate employees from different departments in the forecasting process. • If you want to collaborate with your partners in the forecasting process, refer to the scenario on collaborative demand planning. • Supply network planning s your mid- to shortterm production and procurement planning across the locations in your entire supply chain. • The scenario on vendor-managed inventory enables you to perform replenishment planning for your business partners while taking into actual consumer demands as well as your partner’s inventory levels. • Using the production planning and detailed scheduling scenario, you can perform constraint-based production planning and finite scheduling. • If you need the finite scheduling functionality available with SAP APO, refer to the scenario on capacity planning in detailed scheduling. • With the campaign planning scenario, you can optimize your setup and storage costs on a production line.

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• The capable-to-match scenario describes a solution for

CUSTOMER RELATIONSHIP MANAGEMENT

demand fulfillment, which is achieved by conducting crossplant checks of production capacities and transportation capabilities based on predefined supply categories and demand priorities. For • real-time, global order promising that includes availability checks of finished products, components, and resources in a matter of seconds, refer to the scenario global available-to-promise (ATP). • Along with the “first come/first serve” principle of the ATP check, you can use the backorder processing scenario to redistribute confirmed quantities according to priorities and to adjust the results of the ATP check. • Finally, for the optimization of inbound or outbound transportation demands and vehicle scheduling, refer to the transportation management scenario.

With mySAP CRM, integration is native, not added. As a result, the solution blends seamlessly with your company’s overall e-business platform, right from the start. That means it allows your staff to work with real-time customer information, greatly enhancing the quality of service. And it establishes a seamless flow of customer information to and from your company’s e-business platform. SAP Best Practices comprise the following preconfigured CRM scenarios: • The scenario Internet sales – business-to-business comprises the functions of a business-to-business Internet selling process in which companies offer and sell goods and services over the Internet. • The scenario field sales – customer visit and order entry describes a business process that is typical for companies with a field sales organization. The scenario covers the basic tasks in the daily work of a sales representative. • The purpose of the scenario field sales – opportunities is to describe the opportunity management that is typical for companies with a field sales organization. The scenario covers the basic tasks a sales representative must perform in order to manage sales opportunities. BUSINESS INFORMATION WAREHOUSE

Business information warehouse (BW) allows you to analyze data from operative SAP applications as well as all other business applications and external data sources, such as databases, online services, and the Internet. The functions within BW control, monitor, and maintain all data retrieval processes.

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BW makes online analytical processing (OLAP) possible, which processes information from large amounts of operative and historical data. OLAP technology enables multidimensional analyses from various business perspectives. The BW server for core areas and processes is preconfigured with business content that lets you look at information within the entire enterprise. In selected roles in a company, business content offers the information that employees need to carry out their tasks. Also, business content contains other preconfigured objects, such as InfoCubes, queries, key figures, and characteristics that make a BW implementation easier. SAP Best Practices comprise various preconfigured BW scenarios including: s receivable analysis, s payable analysis, general ledger analysis, asset ing analysis, purchasing analysis, production plan/actual analysis, production period/specific analysis, capacity load utilization, status of manufacturing orders, cost center ing analysis, product cost controlling analysis, profit center analysis, sales analysis, CRM lead analysis, CRM activities analysis, CRM Customer Interaction Center (CIC) analysis, SRM analysis, demand planning analysis, and APO resource and operation data analysis.

SUPPLIER RELATIONSHIP MANAGEMENT

SAP Best Practices also comprise preconfigured SRM scenarios that allow you to rapidly set up procurement processes that are Internet based for requisitioning and purchasing of indirect and direct materials. You can choose between several indirect procurement scenarios: • The indirect procurement classic scenario is the procurement of indirect material over the Internet. • The indirect procurement classic extended scenario is indirect procurement using standard XML files. • The local procurement scenario is indirect procurement with limited access to an SAP R/3 back-end system. • The stand-alone procurement scenario is indirect procurement without access to an SAP R/3 back-end system. SAP Best Practices also end-to-end direct procurement. The component-planning scenario describes how planners can easily add new components to a plant maintenance order by using a Web browser. The catalog content management scenario helps you to manage product information in a catalog provided by multiple suppliers. Rather than creating product data manually, you can use XML to import catalog data from multiple external sources, such as marketplaces, content providers, and vendors. PRECONFIGURED SMART FORMS

SAP Best Practices also include preconfigured Smart Forms. A Smart Form is an easy-to-use, robust print form tool that allows you to create and modify forms easily using a graphical design tool. All preconfigured Smart Forms help you make immediate use of this new official print form tool.

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CONCLUSION FUTURE DIRECTIONS

SUMMARY: BENEFITS OF SAP BEST PRACTICES

The further development of SAP Best Practices will take place according to demand. The focus of the future will again primarily be on the small and midsize business market. Here, generic as well as industry-specific-oriented SMB scenarios are of importance.

Solutions Tailored to Meet SMB Needs With SAP Best Practices, you can quickly turn your SAP software into a live system that handles SMB-specific business requirements. SAP Best Practices provide the tools, content, and methodology you need to implement and optimize your mySAP All-in-One solution – from both a functional and a technical perspective.

Despite this, SAP Best Practices can of course still be used in other market segments that are not directly being focused on. For example, large enterprises can use SAP Best Practices as a basis for creating global templates for a worldwide roll out of a mySAP Business Suite solution. In order to ensure the marketability of SAP Best Practices, proven collaboration with select SAP partners will continue to play a central role. Due to great demand, the creation of partner solutions based on SAP Best Practices will be ed. More information can be found on the SAP Service Marketplace small and midsize business Web page at http://service.sap.com/smb

Rapid Implementation and Manageable Costs Rapid implementation techniques make it possible to reduce costs by more than 50% over traditional approaches. And the solution’s scalability means that a company invests only once – even when the organization changes or grows. Prepackaged Business Expertise SAP Best Practices largely anticipate common business requirements of small and midsize companies and deliver exactly the documentation and configuration that is needed for a smooth evaluation and implementation. All SAP Best Practices deliverables are fully reusable, and you can easily adapt them to meet your specific needs. Avoid E-Beginners’ Mistakes As a proven solution, SAP Best Practices help you avoid the system, business process, and configuration mistakes of those who start from scratch. SAP has already identified potential pitfalls up front, and delivers the solutions in SAP Best Practices.

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Extend Your Business Solution SAP Best Practices contain a fully documented implementation procedures that include automated steps and are based on a typical customer system. They run with one or more mySAP Business Suite components, delivering up-and-running e-business processes that use your own systems and data. Build a Working Prototype With SAP Best Practices, it only takes a few days to build a working, fully documented prototype that you can use as a starting point for your implementation. Improve Project Performance and Communication SAP Best Practices represent integrated tools that can be used to evaluate and demo mySAP All-in-One solutions, train your project team, and implement solutions based on mySAP Allin-One. All project use the same tools, which leads to effective communication.

MORE INFORMATION

How to Order SAP Best Practices SAP Best Practices are available free of charge. To order the entire SAP Best Practices CD set – including the documentation and the preconfiguration CD – the contracts department of your local SAP office. SAP customers and partners can also order online from the SAP Software Catalog on the SAP Service Marketplace. To order additional copies of the documentation CD, go to the SAP Service Marketplace and order online from the SAP Knowledge Catalog. Information on the Web To learn more about SAP Best Practices, go to http://service.sap.com/bestpractices (the SAP Service Marketplace for customers and partners) or www.sap.com/bestpractices (our public Internet site). Or, you can send us an e-mail to [email protected]

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