Guideline

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.

Computerized Systems used in clinical trials
Internet:	http://www.fda.gov/cder/guidance/7359fnl.pdf
Origin/Publisher:	Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm
Content:	This FDA guideline for computer systems is strictly speaking only intended for clinical trials, but it also contains many relevant topics for GMP.
Document Type:	FDA Guidance for Industry