FDA Guidance: Computerized Systems Used in Clinical Investigations, 5/07
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In May, 2007 the FDA issued a new version of Guidance for Industry, Computerized Systems Used in Clinical Investigations for use by study sponsors, contract research organizations, data management centers, clinical investigators, and institutional review boards.
The new version incorporates the risk-based approach to 21 CFR Part 11 described in the 2003 FDA document “Part 11, Electronic Records; Electronic Signatures ﾖ Scope and Application”.
This version also contains expanded recommendations on system SOPs, security, audit trails, time zone indicators, and training of developers.
| Issuing Body | FDA Guidance Documents |
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