SMG 1117.23

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF THE COMMISSIONER

OFFICE OF OPERATIONS

OFFICE OF INFORMATION MANAGEMENT

DIVISION OF SYSTEMS MANAGEMENT

Effective Date: 04/07/2008

1. DIVISION OF SYSTEMS MANAGEMENT (DAMAD).

A. Designs, develops, implements, and maintains all agency software applications, IT systems, systems support and maintenance, and their integration with other Federal agencies, state and foreign governments; and public and private entities.

B. Establishes and implements an Enterprise IT Common Component Framework containing modules/services to be shared across FDA information systems and maintains FDA enterprise applications through effective evaluation, streamlined application development, monitoring, testing, and control of agency-wide systems utilizing e-platform initiatives and interchangeable common components in order to support FDA business process needs and objectives efficiently and effectively.

C. Validates requirements for and directs the design, development and implementation of new system requirements, system enhancements and system maintenance changes for the Agency, performs systems analyses to develop and implement testing strategies, procedures and methodologies, especially automated varieties, and develops and implements system specifications, requirements, procedures and guidelines.

D. Designs, develops, implements, and maintains standards-based electronic IT data systems and repositories that provide the FDA with an integrated and interoperable information environment to receive, track, analyze, and disseminate knowledge on FDA business/program activities and directs the development and implementation of FDA Data Administration policies standards and procedures to ensure design consistency, including review of work products for compliance with standards.

E. Assists in the development and implementation of technical specifications and plans for procurement of IT equipment (HW/SW) and support resources required for the integrating of new system designs.

F. Develops and implements a program risk management plan to oversees and mitigate critical risks and vulnerabilities in the execution of the systems under its responsibility.

G. Assists CIO Support Division in development and maintenance of FDA’s policies and procedures for independent verification and validation of IT systems, as well as develop, implement, provide problem management processes for the FDA systems, including trend analysis of problems, and develops standard IT reports.

2. AUTHORITY AND EFFECTIVE DATE.

The functional statements for this office were approved by the Deputy Commissioner for Operations, Office of Operations on April 7, 2008.