Regulated Systems

The following are some references to the US Food and Drug Administration regulations covering computer systems used in a clinical research setting.

Links

Applicable Parts of Title 21, Code of Federal Regulation

21CFR11

Good Clinical Practice

Good Laboratory Practice

Good Manufacturing Practice

Good Device Practice

Note that the GxP regulations (GCP = Good Clinical Practice, etc.) are the core of the predicate rules referred to in the scope guidance.

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