Certain FDA statutory provisions designed to control the safety of marketed drugs and devices. The general controls include provisions on adulteration, misbranding, banned devices, good manufacturing practices, notification and record keeping, and other sections of the Medical Device Amendments to the Food, Drug and Cosmetic Act [21 U.S. Code §360(c) (Food, Drug and Cosmetic Act §513)].
controls, other than application controls, which relate to the environment within which computer-based application systems are developed, maintained and operated, and which are therefore applicable to all the applications. The objectives of general controls are to ensure the proper development and implementation of applications, and the integrity of program and data files and of computer operations. Like application controls, general controls may be either manual or programmed. Examples of general controls include the development and implementation of an IS strategy and an IS security policy, the organization of IS staff to separate conflicting duties and planning for disaster prevention and recovery.
Policies and procedures to assure proper operation of computer systems, including controls over data center and network operations, software acquisition and maintenance, and access security.