luezhong

Electronics deals with electrical circuits that involve active electrical components such as vacuum tubes, transistors, diodes, integrated circuits, optoelectronics, and sensors, associated passive electrical components, and interconnection technologies. The nonlinear behaviour of active components and their ability to control electron flows makes amplification of weak signals possible. Under the narrow interpretation of the scope of part 11, with respect to records required to be maintained under predicate rules or submitted to FDA, when persons choose to use records in electronic format in place of paper format, part 11 would apply. In these instances, the use of computer systems in the generation of paper records would not trigger part 11. ValidationThe Agency intends to exercise enforcement discretion regarding specific part 11 requirements for validation of computerized systems (§ 11.10 and corresponding requirements in § 11.30). Although persons must still comply with all appli