Guidance for Industry on “Part 11, Electronic Records; Electronic Signatures-Scope and Application;” Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Part 11, Electronic Records; Electronic Signatures--Scope and Application." The guidance explains FDA's current thinking regarding the requirements and application of part 11 (21 CFR part 11). FDA has begun to re-examine part 11 as it applies to all FDA regulated products. This guidance explains that we will narrowly interpret the scope of part 11. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. With respect to systems that were operational before August 20, 1997, the effective date of the final rule establishing part 11, we intend to exercise enforcement discretion with respect to all part 11 requirements under certain circumstances.