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FDA Guidance for Industry: Computerized Systems used in clinical trials-Draft


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
This FDA guideline for computer systems is strictly speaking only intended for clinical trials, but it also contains many relevant topics for GMP.

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