| 摘要 |
A control device for use with a computer, where the computer has one or more connectors for connecting equipment such as peripherals, human interfaces, test equipment and production facilities to the computer for communicating with the equipment. The control device has a set of first connectors for connecting the equipment to the control device, and a set of second connectors for connecting to the one or more connectors of the computer to enable the computer to communicate with equipment connected to the one or more first connectors. Communication between the computer and the equipment connected to the first set of connectors is stored in a memory of the control device. The control device thus creates an audit trail in compliance with FDA 21 CFR Part 11, whereby a conventional computer and equipment connected thereto is made 21 CFR Part 11 compliant. |
