The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

Document Type:
FDA guide to inspection
This guideline of the National Center for Drugs and Biologics does not primarily address the industry but is intended as a training aid for FDA inspectors. Although no longer completely up to date, it is of interest to all who are responsible for hard- and software.

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