<P> This document was intended to clarify how Part 11 should be implemented and would be enforced . But, as with all FDA guidances, it was not intended to convey the full force of law--rather, it expressed the FDA's "current thinking" on Part 11 compliance . Many within the industry, while pleased with the more limited scope defined in the guidance, complained that, in some areas, the 2003 guidance contradicted requirements in the 1997 Final Rule . </P> <Ul> <Li> Guidance for Industry Computerized Systems Used in Clinical Investigations </Li> </Ul> <Li> Guidance for Industry Computerized Systems Used in Clinical Investigations </Li> <P> In May 2007, the FDA issued the final version of their guidance on computerized systems in clinical investigations . This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application and the Agency's international harmonization efforts when applying these guidances to source data generated at clinical study sites . </P>

21 cfr part 11 compliance for electronic medical records