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Transforming Business Requirements Into System Solutions Yongcun Zhang, Genentech, Inc., South San Francisco, CA

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Transforming Business Requirements Into System Solutions Yongcun Zhang, Genentech, Inc., South San Francisco, CA Paper MA07 Transforming Business Requirements into System Solutions Yongcun Zhang, Genentech, Inc., South San Francisco, CA The use of software products such as SAS® System has contributed to companies’ success in clinical data analysis and reporting in the Biotech/Pharmaceutical industry. However each company’s business has its own specific requirements; and no one software system can satisfy the business needs of all companies. It has been a challenge to companies to integrate commercial or other party software products into their own computer systems. Understanding the business requirements is the foundation for building a system solution for clinical data analysis and reporting. This article provides a process roadmap for developing system solutions that meet business needs via business requirements analysis, system architecture, design, implementation, testing and validation, and system deployment. It does not provide a specific system solution; however examples used in this paper are practical issues facing the industry and can be incorporated into the system solutions. INTRODUCTION In the heavily regulated industries like biotech/pharmaceutical industry, computer software systems have helped companies to enhance productivity, accuracy, reliability, consistency, authenticity, and compliance with regulatory agencies to such a high level that was never achieved before. However one of the challenges has always been how to build software systems to meet a company’s business requirements that appear to be moving targets. Factors such as long term company goals and vision, budget, time, resource constraints, and degree of utilizing off-the-shelf software products to decrease both development cost and time have increased the complexity of building the systems. Fortunately you don’t have to build your own system from scratch. What you need to do is effectively analyze your business requirements. Most probably you will be able to find some commercial products that can meet most your business needs. However even when a biotech/pharmaceutical company jumps onto the band wagon and uses software such as SAS, integration of the software product into its system is still the most prominent challenge to meeting its business needs. Often you have to create tools, utilities, and other small applications to streamline your business process. The advantage of using off-the-shelf software products is that most of these products are compliant with the relevant regulatory code. The challenge lies on the business requirements analysis. The failure to accurately and completely identify the problem to be solved is a root cause of system development failures (Sommerville and Sawyer). Therefore system development shall portray business requirements. Business problems must be evaluated in the context of strategic planning beyond the system solution being developed for any individual business need. Shortsighted solutions to immediate business needs might cause considerable long-term harm to the organization (Weinberg). This happens when your business expand so fast that you have to discard your legacy system or overhaul it. This article, using practical examples, tries to shed some light on the roadmap of software system project management in building a clinical trial data analysis and reporting system for biotech/pharmaceutical companies from the viewpoint of system development life cycle, which covers business requirements analysis, system architecture, system design, implementation, testing and validation, and system deployment, and in this order. The development life cycle schema used in the paper is generic and can be applied to all sorts of software development ranging from small utility tools to large systems. BUSINESS REQUIREMENTS ANALYSIS Understanding the targeted business is the foundation for attempting to implement any system solution for its business needs. A business requirement is what the business needs to do; what it takes to continue running the business; and what can be improved to run the business better. Business requirements analysis is a special field that covers both business and information technology (IT) worlds. Business analysts who have expertise in both business and IT are able to bridge the gap between the two worlds. The business analysts’ main tasks are 1. identifying key stakeholders, 2. understanding business process, 3. leading and coordinating the collection of business needs, 4. documenting and organizing the business process and needs, 5. analyzing the business needs and defining the business requirements, 1 6. and communicating the business requirements to an entire team for agreement. STAKEHOLDER ANALYSIS To analyze business requirements, the business analysts have to understand the sources of requirements and how to access them to elicit information. These sources are mainly the stakeholders. The stakeholders are individuals, team, or organization with interests in or concerns about the business. Concerns are those interests that are relevant to the system’s development, its operation or any other aspects that are important to stakeholders. Examples of stakeholders are customers, end users, partners, management, business policies, regulatory agencies, and others such as business domain experts who understand the business. The stakeholder analysis aims at understanding their responsibilities and needs and gaining agreement on business problems and solutions. The stakeholder analysis is often considered the first step in strategic planning activities on an organizational level. It is not hard to identify stakeholders. You can easily make an initial stakeholder list based on your business process. However identifying stakeholders' interests, impact level, and relative priority is not an easy task. The stakeholders in the list usually belong to certain groups. It is a good idea to identify representatives of stakeholders. The representatives are responsible for providing the views of the groups they represents. Your interview focus should be on the representatives with other participants in their groups. It is important to assess stakeholders for importance and influence. Only after you understand stakeholders' needs and expectations, you then can manage and influence those expectations to ensure a successful project. Failing to meet the needs or expectations of just one influential and powerful stakeholder at a critical time may ruin a project (Smith). Both internal project entities and external interfaces should be considered. This requires skills to develop coalitions with the stakeholders for agreement on what the problems and the proposed solutions are. Usually you have to compromise to reach an agreement. To build a statistical analysis and reporting system for clinical trial studies, the key stakeholders will vary depending upon organizational structures and corporate culture. Typically the stakeholder group may include: statistical programmers, biostatisticians, clinicians, medical writers, IT groups, and regulatory bodies. The other internal stakeholders include the management members in the statistical programming team. Base on the business process which is discussed in the next section, the external stakeholders could cover the clinical database management team, report publishing team, and other teams who may request data analysis such as scientists. Although external, the database management team and publishing team are important stakeholders. Any inappropriate data inconsistency or exotic formatted data from the database management team could cause troubles to the statistical programmers. Similarly disagreed analysis reports produced by the statistical programmers would be rejected by the publishing team. BUSINESS PROCESS ANALYSIS Understanding the business process is the key element in business requirements analysis. The goal of business process analysis is to find solutions to improve the processes for effectiveness and efficiency. Business process presents how a company delivers products. On the other hand, management hierarchy shows the responsibilities and reporting relationships within the company. Compare to the static administrative organizations, business process is dynamic and often cross departmental lines. Thus the efforts to improve the quality and efficiency of a business process are likely to depend on the collaboration of stakeholders from different departments. The business process may include business activities and the relationships among them such as dependencies. Gathering the data necessary for business process analysis requires a great deal of efforts. This is especially the case when a cross-functional collaboration becomes necessary. While collecting business process data people start to learn a lot more about how their business is actually done and begin to think about how to do it better. The data gathered are used to create a process map or flowchart, which is a graphic representation of the sequence of activities. The process map may be in the form of a cross- functional flowchart that includes relations among these activities. The business process of clinical data management, analysis, and reporting in the biotech/pharmaceutical industry can be described as collecting and processing Case Report Form (CRF) data (and other supporting data), storing data in a database, analyzing the data, and generating reports. The process can be illustrated as a business model. A top level view of the business process is shown in Figure 1. Based on the business process of clinical
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