Scenario -
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.
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?