1. Guide to Inspection of Computerized Systems in Drug Processing, Food and Drug Administration (1983), 1. (hereinafter the “1983 Guide“). This guide does not actually explain how to validate and document computerized systems that control manufacturing processes or that automate laboratory procedures. Nor is the guide binding on pharmaceutical manufacturers or FDA inspectors. However, it is an extremely helpful ***outline of FDA's views on the important areas of the computerized systems that must be scrutinized. The agency is presently developing a more specific guide that would deal only with the inspection of software development activities (the software life cycle).