FDA监管行业计算机2014.11.25.docxVIP

The Computer in FDA Regulated IndustriesFDA监管行业的计算机ITG SUBJECT: THE COMPUTER IN FDA REGULATED INDUSTRIES主题:FDA监管行业的计算机This ITG is the first of a series of ITGs intended to aid the Investigator in understanding computerized operations. The approach will be a simplified explanation of the basic principles of the computer with later ITG issues covering such areas as programming and details of computer operation and specific applications.这个ITG是一系列旨在帮助调查人员理解计算机操作的ITG系列的第一个。该方法将对计算机的基本原理进行简单的解释，之后将涉及到编程、计算机操作和特定应用程序等方面的问题。Computerized operations are now common in FDA regulated food, drug and medical