Part 11, Electronic Records; Electronic Signatures — Scope and Application
final
a5590943862cba3df7851481ce4c089e38b10421b280f7a4f5dfd7f7a042c6b4 Resolution: direct document
Recorded as final against the primary source on 31 July 2026.
No evidence record is stored for the current status.
First observed 31 July 2026. Last observed 3 August 2026. 14 observation(s) recorded.
14 of those returned a document to a standard HTTP client and produced a content hash.
No change to the retrieved text has been detected since observation began.
Each format carries the permalink and the date this instrument was observed. The observation date is part of the citation: the underlying source may have changed since.
GxPlex. Part 11, Electronic Records; Electronic Signatures — Scope and Application [instrument record]. Observed 31 July 2026. https://gxplex.com/instrument/fda-part-11-scope Primary source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
@misc{gxplexinstrumentfdapart11scope,
author = {{GxPlex}},
title = {{Part 11, Electronic Records; Electronic Signatures — Scope and Application}},
year = {2026},
note = {instrument record, observed 31 July 2026},
howpublished = {\url{https://gxplex.com/instrument/fda-part-11-scope}},
urldate = {2026-07-31},
url = {https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application}
} GxPlex. (2026). Part 11, Electronic Records; Electronic Signatures — Scope and Application [instrument record]. Retrieved 31 July 2026, from https://gxplex.com/instrument/fda-part-11-scope
Observed on 14 occasion(s) since 2026-07-31. 14 produced a content hash.
··············
One mark per observation, oldest first.
· unchanged · ! content changed ·
~ fetched but rendered client-side, no hash ·
× could not be fetched, no hash.
The words this document uses about itself, matched verbatim against its own title. Not a statement of scope, and not a judgment about which organisations or products fall under it: each value quotes the span it was read from and links to where that span was read.
This document does not call itself a regulation, a guidance or a standard, so no class is recorded. It is filed under no self-stated class.
One document's retained text contained a form another document is published under, on the date shown, with the words it was read from. This records that one document names another and states nothing about the relationship between their requirements, or the manner of the citation — a document naming another in order to exclude it produces the same entry as one adopting it.
These citations are drawn together on the citation graph, where every row carries the same quote and source.
A citation index only: both documents address the subject. This states no relationship between their requirements.
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