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Unformatted text preview: 5. Proof-of-concept cycle--capture business requirements, define goals for proof of concept, produce conceptual system design and logic design, and construct the proof of concept, produce acceptance test plans, conduct risk analysis, and make recommendations. First-build cycle--derive system requirements, define goals for first build, produce logical system design, design and construct the first build, produce system test plans, evaluate the first build, and make recommendations. Second-build cycle--derive subsystem requirements, define goals for second build, produce physical design, construct the second build, produce subsystem test plans, evaluate the second build, and make recommendations. Final cycle--complete unit requirements and final design, construct final build, and perform unit, subsystem, system, and acceptance tests. A Guide to the Project Management Body of Knowledge (PMBOK Guide) 2000 Edition 2000 Project Management Institute, Four Campus Boulevard, Newtown Square, PA 19073-3299 USA NAVIGATION LINKS ACROYMNS LIST ACRONYMS LIST 15 ACROYMNS LIST Chapter 2--The Project Management Context Figure 24 | Figure 25 Process Development Formulation Stability Screening Lead Identified Preclinical IND Workup File IND Phase I Clinical Tests Phase II Clinical Tests Metabolism Patent Process Toxicology Phase III Clinical Tests File NDA A P P R O V A L Drug Sourcing Postregistration Activity Discovery Screening Preclinical Development Ten Plus Years Registration(s) Workup Postsubmission Activity Figure 24. Representative Life Cycle for a Pharmaceuticals Project, per Murphy ment ment 2.2 PROJECT STAKEHOLDERS
Project stakeholders are individuals and organizations that are actively involved in the project, or whose interests may be positively or negatively affected as a result of project execution or project completion; they may also exert influence over the project and its results. The project management team must identify the stakeholders, determine their requirements, and then manage and influence those requirements to ensure a successful project. Stakeholder identification is often especially difficult. For example, is an assembly-line worker whose future employment depends on the outcome of a new product-design project a stakeholder? Key stakeholders on every project include: Project manager--the individual responsible for managing the project. Customer--the individual or organization that will use the project's product. There may be multiple layers of customers. For example, the customers for a new pharmaceutical product may include the doctors who prescribe it, the patients who take it, and the insurers who pay for it. In some application areas, customer and user are synonymous, while in others customer refers to the entity purchasing the project's results and users are those who will directly use the project's product. Performing organization--the enterprise whose employees are most directly involved in doing the work of the project. Project team member...
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- Fall '13
- The American