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NEW QUESTION: 1
Scenario
Please read this scenario prior to answering the Question
You have been appointed as a consultant to the Chief Enterprise Architect of a multinational pharmaceutical corporation. The corporation includes 30 subsidiary companies with operations in over 60 countries and products sold in over 125 countries. It has major research and development sites in over 45 locations worldwide.
The management team is deeply committed to ensuring that the corporation is a world leader in socially responsible pharmaceutical development with a business strategy that focuses on profitability through environmentally friendly operating processes as well as a commitment to disease eradication.
The operations of the corporation are subject to legal and regulatory requirements for each country where they operate. The production of prescription pharmaceutical products has governmental controls that are strictly enforced and compliance is critical. Recently a competitor was heavily fined for violating the regulations in a country where it was conducting a clinical trial for a new regulated drug.
The Governing Board is concerned about the risks posed in this complex global environment. As a result the Chief Executive Officer (CEO) has appointed a Chief Compliance Officer (CCO) to be responsible for overseeing and managing compliance issues for the corporation. The CCO reports directly to the CEO.
The CCO has approved the expenditure of resources to establish an Enterprise Architecture program. He has requested to be informed about the status of projects that could impact regulatory compliance. He also wants the corporate legal staff and auditors to analyze all proposed architectures to ensure that they are within the legal guidelines for each country. In addition, the research organization should be able to see that the architecture is appropriate for its needs.
TOGAF 9 has been mandated as the framework for the development and evolution of the Enterprise Architecture practice. The Preliminary Phase has been completed to establish the enterprise architecture capability for this project.
Refer to the Scenario
You have been asked to recommend an approach that would enable the development of an architecture that addresses the needs of the Chief Compliance Officer, legal staff, auditors and the research organization.
Based on TOGAF, which of the following is the best answer?
A. You recommend that a stakeholder map be developed. This will allow the architects to define groups of stakeholders that share common concerns. A set of views should be defined to address the concerns for each group of stakeholders. Architecture models should then be created for each view to address the stakeholders' concerns.
B. You recommend that a special report be created for those groups that have sufficient power and level of interest. This report should summarize the key features of the architecture with respect to the particular location. Each of these reports should reflect the stakeholders' requirements.
C. You recommend that each project architecture activity is developed using a consistent modeling approach that is uniform across all architecture projects. Each architecture should be defined based on this fixed set of models so that all concerned parties can examine the models to ensure that their issues and concerns have been addressed.
D. You recommend that a set of models be created for each project architecture that can be used to ensure that the system will be compliant with the local regulations. Stakeholders should then view the models to verify that their concerns have been properly addressed.
Answer: D

NEW QUESTION: 2

A. Cable tester
B. Punch down tool
C. Protocol analyzer
D. Crimper
Answer: A

NEW QUESTION: 3
You discover that your company's top selling product in the last two years has been used off-label.
The off-label use is estimated to be about 70%, and it has been consistent since the product was first released to the market. Which of the following is MOST appropriate?
A. File a report to regulatory authorities and advise the marketing department to prevent future off-label use.
B. No action is required since it is an off-label use.
C. Discuss with regulatory authorities to investigate how to have the off-label indication approved.
D. Advise the senior management to send a "Dear Dr." letter.
Answer: C

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