FDA Guidance for Industry: Computerized Systems used in clinical trials-Draft
Title:
FDA Guidance for Industry: Computerized Systems used in clinical trials-Draft
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 Guidance for Industry
Content:
This FDA guideline for computer systems is strictly speaking only intended for clinical trials, but it also contains many relevant topics for GMP.