GxPlex

21 CFR Part 11

21 CFR Part 11 — Electronic Records; Electronic Signatures

final as of 19 August 1997

Last verified: Last observed: no observation recorded Tier: 1 · Sector: pharma
Authority
US Food and Drug Administration
Jurisdiction
US
Status
final
Effective date
Last changed
Last verified
:
Watch cadence
quarterly
Crawlable
yes · renders server-side
Text licence
freely reproducible
Primary source
Primary source (opens in new tab) ecfr.gov
Topics
electronic records · electronic signatures

Current status#

Recorded as final against the primary source on 2026-07-28. See the evidence record for the text that supported it.

Scope#

US regulation setting criteria under which electronic records and electronic signatures are considered trustworthy and reliable.

Key dates#

No dates have been verified against the primary source for this entry.

Sources#

Cite this instrument

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.

Plain text

GxPlex. 21 CFR Part 11 — Electronic Records; Electronic Signatures [instrument record]. Observed 27 July 2026. https://gxplex.com/instrument/us-21-cfr-part-11 Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

BibTeX

@misc{gxplexinstrumentus21cfrpart11,
  author       = {{GxPlex}},
  title        = {{21 CFR Part 11 — Electronic Records; Electronic Signatures}},
  year         = {2026},
  note         = {instrument record, observed 27 July 2026},
  howpublished = {\url{https://gxplex.com/instrument/us-21-cfr-part-11}},
  urldate      = {2026-07-28},
  url          = {https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11}
}

APA

GxPlex. (2026). 21 CFR Part 11 — Electronic Records; Electronic Signatures [instrument record]. Retrieved 27 July 2026, from https://gxplex.com/instrument/us-21-cfr-part-11

Observation history

No observations recorded yet.

Other instruments addressing the same subjects

A citation index only: both documents address the subject. This states no relationship between their requirements.

Change history

Sources

Last updated: