FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983
Title:
FDA Guide to Inspections of Computerised Systems in Drug Processing, February 1983
Origin/Publisher:
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
Content:
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.