# GxPlex

> GxPlex is a dated, independently checkable record of what selected regulatory and standards sources published.

## What this site is

132 regulations, guidance documents and standards from 31 publishers
across 10 jurisdictions. 55 of 132 are marked "verified (person-ratified)": checked against the primary source by a person,
each with the date of that check. 74 of 132 are recorded as "unknown".
The other 3 carry a published status the board marks
"a register" (2) or "tool-read" (1).

## Nothing here is interpreted

This record reports what a document says and when it changed. There is no
advice here, no assessment, and no ranking. That is a deliberate limit, not an
unfinished feature. A reported status is checkable against the publisher's own
page; an interpretation is not, and a record that published both would make
the checkable half harder to trust.

## Structure

- /
- /r/<id>/
- /calendar
- /calendar.ics
- /compare/              Any two retained readings of a tracked source, diffed
                         on demand — or the condition that refused the
                         comparison.
- /archive/              Retained records: one URL and one date each, and a
                         SHA-256 where a file was retrieved.
- /concordance           Runs of words, each with the tracked entries it was
                         indexed for and, for every listing, whether the text
                         read for that entry holds those words exactly, does not
                         hold them, or is not measured, with the address the
                         text was read from and the day.
- /sources               Every primary source used by this tracker, grouped by
                         issuing authority.
- /how/                  What is tracked, what is not, who keeps it, and the way
                         any line on the board can be checked.
- /corrections/          Dated log of every correction made to a published
                         factual claim on this site.

## Machine-readable

Each `.json` address below is CORS-open, cached one hour, and carries an integer
`schema_version`.

- https://gxplex.com/api/v1/instruments.json
- https://gxplex.com/api/v1/calendar.json
- https://gxplex.com/api/v1/precedents.json
- https://gxplex.com/api/v1/archive.json
- https://gxplex.com/api/v1/diffs.json
- https://gxplex.com/api/v1/concordance.json
- https://gxplex.com/api/v1/change-events.json
- https://gxplex.com/api/v1/conformance/gxp-obs-v2-fixtures.json
- https://gxplex.com/api/v1/conformance/gxp-obs-v2-readings.json
- https://gxplex.com/changes.xml
- https://gxplex.com/change-events.xml

## Contract

One address per tracked row, each carrying that integer `schema_version`:

- https://gxplex.com/api/v1/observation-bundle/<id>.json

Described rather than versioned by that integer:

- https://gxplex.com/api/v1/openapi.json
  GxPlex API, v1
- https://gxplex.com/api/v1/schema/<name>.json
  One JSON Schema 2020-12 document per object served; 39 published
- https://gxplex.com/api/v1/schema/gxp-obs-v2.json
  GXP-OBS v2 — the observation, the signal and the evidence state
- https://gxplex.com/developers/
  Identifier contract, update cadence, citation format, verification path and
  licence boundaries for systems that consume this archive.
- https://gxplex.com/developers/#validated-system

## What the verification marks mean

- "verified (person-ratified)": checked against the primary source by a person
- "tool-read": read from the source by tooling
- "unresolved": no status recorded, on a row that is re-checked and records no person's search of the source; each row states what its status-term rule found
- "checked — no status stated": a person checked the publisher's own surfaces and none states a status
- "not re-checked": no status recorded; each row states its reason
- "a register": observed daily; no person-verification is promised

## The five positions this record holds

- The text of a paywalled standard is not taken. The licence is a boundary,
  not an obstacle to work around.
- A digest records that text changed, not that meaning changed. A typo and a
  substantive rewrite produce the same signal, and this record does not tell
  them apart.
- Search matches the words this record published, and nothing else. There is
  no synonym expansion, and nothing maps one body's vocabulary onto another's.
- Every confirmation states the act that made it. Collection is automated, and
  a confirmation is shown with the word for the act that made it: derived,
  model-read or person-ratified. A status read from the source by tooling
  before those three words were defined is shown as tool-read, and counted
  under none of them. A later word, publisher-stated, marks a revision
  candidate confirmed by a change note the publisher itself dated inside the
  candidate's window, or an entry's status where the publisher's own status
  field prints a word that spells it; either is read from the publisher's own
  field.
- It is kept by one person, and what survives that does not depend on them.
  The format is open and the record outlives its keeper.

## The licence boundary

The text of a paywalled standard is not taken. Not a sentence, not a
normalised digest of the body, not a diff. What is followed instead is the
publisher's own catalogue entry, which is public and which states the stage.

## When something here is wrong

Factual claims are never edited silently. An error can be sent to
corrections@gxplex.com.

## What is tracked

- https://gxplex.com/r/anvisa-ai/
  id: anvisa-ai
  title: ANVISA positions on computerised systems and artificial intelligence
  authority: Agência Nacional de Vigilância Sanitária
  jurisdiction: Brazil
  status: unknown
  verification: not re-checked
  source_url: https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/anvisa-ai.json
- https://gxplex.com/r/astm-e2363/
  id: astm-e2363
  title: ASTM E2363 — Terminology relating to process analytical technology
  authority: ASTM International
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://store.astm.org/e2363-23.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/astm-e2363.json
- https://gxplex.com/r/astm-e2500/
  id: astm-e2500
  title: ASTM E2500 — Specification, design and verification of manufacturing systems
  authority: ASTM International
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://store.astm.org/e2500-25.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/astm-e2500.json
- https://gxplex.com/r/astm-e2537/
  id: astm-e2537
  title: ASTM E2537 — Continuous quality verification
  authority: ASTM International
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.astm.org/e2537-16.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/astm-e2537.json
- https://gxplex.com/r/cen-jtc21-programme/
  id: cen-jtc21-programme
  title: CEN/CENELEC JTC 21 work programme
  authority: CEN/CENELEC
  jurisdiction: EU
  status: unknown
  verification: not re-checked
  source_url: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/cen-jtc21-programme.json
- https://gxplex.com/r/cisa-cpg/
  id: cisa-cpg
  title: CISA Cross-Sector Cybersecurity Performance Goals (CPG Report 2.0)
  authority: Cybersecurity and Infrastructure Security Agency
  jurisdiction: US
  status: unknown
  verification: a register
  source_url: https://www.cisa.gov/sites/default/files/2025-12/CPG_Report_2.0_508c.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/cisa-cpg.json
- https://gxplex.com/r/ema-ai-reflection/
  id: ema-ai-reflection
  title: EMA reflection paper on the use of artificial intelligence in the medicinal product lifecycle
  authority: European Medicines Agency
  jurisdiction: EU
  status: final
  verification: verified (person-ratified)
  source_url: https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle-scientific-guideline
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-ai-reflection.json
- https://gxplex.com/r/ema-annex11-concept-paper/
  id: ema-annex11-concept-paper
  title: EMA concept paper on the revision of Annex 11
  authority: European Medicines Agency
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-annex11-concept-paper.json
- https://gxplex.com/r/ema-ct-computerised-systems/
  id: ema-ct-computerised-systems
  title: EMA guideline on computerised systems and electronic data in clinical trials
  authority: European Medicines Agency
  jurisdiction: EU
  status: final
  verification: verified (person-ratified)
  source_url: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-ct-computerised-systems.json
- https://gxplex.com/r/ema-data-quality-framework/
  id: ema-data-quality-framework
  title: Data Quality Framework for EU medicines regulation
  authority: European Medicines Agency
  jurisdiction: EU
  status: final
  verification: verified (person-ratified)
  source_url: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-data-quality-framework.json
- https://gxplex.com/r/ema-pics-annex15-concept/
  id: ema-pics-annex15-concept
  title: EMA and PIC/S concept paper on the revision of GMP Annex 15
  authority: European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: unknown
  verification: unresolved
  source_url: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation-corrigendum_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-pics-annex15-concept.json
- https://gxplex.com/r/ema-pics-data-integrity-concept/
  id: ema-pics-data-integrity-concept
  title: EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity
  authority: European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-pics-data-integrity-concept.json
- https://gxplex.com/r/ema-work-programme/
  id: ema-work-programme
  title: EMA work programme and planning documents
  authority: European Medicines Agency
  jurisdiction: EU
  status: final
  verification: verified (person-ratified)
  source_url: https://www.ema.europa.eu/en/about-us/annual-reports-work-programmes
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ema-work-programme.json
- https://gxplex.com/r/eu-ai-act/
  id: eu-ai-act
  title: Regulation (EU) 2024/1689 — Artificial Intelligence Act
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-ai-act.json
- https://gxplex.com/r/eu-cyber-resilience-act/
  id: eu-cyber-resilience-act
  title: Regulation (EU) 2024/2847 — Cyber Resilience Act
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2024/2847/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-cyber-resilience-act.json
- https://gxplex.com/r/eu-cybersecurity-act/
  id: eu-cybersecurity-act
  title: Regulation (EU) 2019/881 — Cybersecurity Act
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2019/881/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-cybersecurity-act.json
- https://gxplex.com/r/eu-digital-omnibus-ai/
  id: eu-digital-omnibus-ai
  title: Regulation (EU) 2026/1744 — Digital Omnibus on AI
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2026/1744/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-digital-omnibus-ai.json
- https://gxplex.com/r/eu-gmp-annex-1/
  id: eu-gmp-annex-1
  title: EudraLex Volume 4, Annex 1 — Manufacture of Sterile Medicinal Products
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-1.json
- https://gxplex.com/r/eu-gmp-annex-10/
  id: eu-gmp-annex-10
  title: EudraLex Volume 4, Annex 10 — Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/2a19f8d5-cc25-44ea-9296-d38e3a6c278c_en?filename=anx10_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-10.json
- https://gxplex.com/r/eu-gmp-annex-11/
  id: eu-gmp-annex-11
  title: EudraLex Volume 4, Annex 11 — Computerised Systems
  authority: European Commission
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-11.json
- https://gxplex.com/r/eu-gmp-annex-11-draft/
  id: eu-gmp-annex-11-draft
  title: EudraLex Volume 4, Annex 11 — Computerised Systems (consultation draft)
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://health.ec.europa.eu/document/download/40231f18-e564-4043-94de-c031f813d38b_en?filename=mp_vol4_chap4_annex11_consultation_guideline_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-11-draft.json
- https://gxplex.com/r/eu-gmp-annex-12/
  id: eu-gmp-annex-12
  title: EudraLex Volume 4, Annex 12 — Use of Ionising Radiation in the Manufacture of Medicinal Products
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/363e435b-23cf-4cb3-9c74-322addb81340_en?filename=anx12_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-12.json
- https://gxplex.com/r/eu-gmp-annex-13/
  id: eu-gmp-annex-13
  title: EudraLex Volume 4, Annex 13 — Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/a0b206a0-5788-406b-9e20-e0525b16e712_en?filename=guideline_adopted_1_en_act_part1_v3.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-13.json
- https://gxplex.com/r/eu-gmp-annex-14/
  id: eu-gmp-annex-14
  title: EudraLex Volume 4, Annex 14 — Manufacture of Products derived from Human Blood or Human Plasma
  authority: European Commission
  jurisdiction: EU
  status: in-force
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/a28a88b2-d510-40c6-a40d-c1989819e13e_en?filename=annex14_rev30-03_2011_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-14.json
- https://gxplex.com/r/eu-gmp-annex-15/
  id: eu-gmp-annex-15
  title: EudraLex Volume 4, Annex 15 — Qualification and Validation
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-15.json
- https://gxplex.com/r/eu-gmp-annex-16/
  id: eu-gmp-annex-16
  title: EudraLex Volume 4, Annex 16 — Certification by a Qualified Person and Batch Release
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/20c41532-33d5-4635-ae80-8735d3d09fe0_en?filename=v4_an16_201510_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-16.json
- https://gxplex.com/r/eu-gmp-annex-17/
  id: eu-gmp-annex-17
  title: EudraLex Volume 4, Annex 17 — Real Time Release Testing and Parametric release
  authority: European Commission
  jurisdiction: EU
  status: in-force
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/78d31fc9-760f-4fe9-9ccd-95595ef48a71_en?filename=2018_annex17_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-17.json
- https://gxplex.com/r/eu-gmp-annex-19/
  id: eu-gmp-annex-19
  title: EudraLex Volume 4, Annex 19 — Reference and Retention Samples
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/b9b0cf46-07a6-4243-b801-446ccfcd2d72_en?filename=2005_12_14_annex19_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-19.json
- https://gxplex.com/r/eu-gmp-annex-2/
  id: eu-gmp-annex-2
  title: EudraLex Volume 4, Annex 2 — Manufacture of Biological active substances and Medicinal Products for Human Use
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/380fdf24-8a1e-4f65-809b-e08d990d5f9e_en?filename=2018_annex2_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-2.json
- https://gxplex.com/r/eu-gmp-annex-21/
  id: eu-gmp-annex-21
  title: EudraLex Volume 4, Annex 21 — Importation of medicinal products
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/e2ddfe65-7b4e-4765-b71b-4681772d2949_en
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-21.json
- https://gxplex.com/r/eu-gmp-annex-22/
  id: eu-gmp-annex-22
  title: EudraLex Volume 4, Annex 22 — Artificial Intelligence
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://health.ec.europa.eu/document/download/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-22.json
- https://gxplex.com/r/eu-gmp-annex-3/
  id: eu-gmp-annex-3
  title: EudraLex Volume 4, Annex 3 — Manufacture of Radiopharmaceuticals
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/bf281e1f-4897-469a-ba60-18d867b14a94_en?filename=2008_09_annex3_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-3.json
- https://gxplex.com/r/eu-gmp-annex-6/
  id: eu-gmp-annex-6
  title: EudraLex Volume 4, Annex 6 — Manufacture of Medicinal Gases
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/b9dfcd18-73d2-45f8-a3a7-e4558fdc2d58_en?filename=2009_07_annex6.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-6.json
- https://gxplex.com/r/eu-gmp-annex-7/
  id: eu-gmp-annex-7
  title: EudraLex Volume 4, Annex 7 — Manufacture of Herbal Medicinal Products
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0-2324825e4d90_en?filename=vol4_an7_2008_09_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-7.json
- https://gxplex.com/r/eu-gmp-annex-8/
  id: eu-gmp-annex-8
  title: EudraLex Volume 4, Annex 8 — Sampling of Starting and Packaging Materials
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/22d03c04-8512-4336-89dd-556771fca388_en?filename=anx08_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-8.json
- https://gxplex.com/r/eu-gmp-annex-9/
  id: eu-gmp-annex-9
  title: EudraLex Volume 4, Annex 9 — Manufacture of Liquids, Creams and Ointments
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/3db7d485-61e2-4f61-a16a-82a6dbf0e914_en?filename=anx09_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-annex-9.json
- https://gxplex.com/r/eu-gmp-chapter-1/
  id: eu-gmp-chapter-1
  title: EudraLex Volume 4, Chapter 1 — Pharmaceutical Quality System
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/e458c423-f564-4171-b344-030a461c567f_en?filename=vol4-chap1_2013-01_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-1.json
- https://gxplex.com/r/eu-gmp-chapter-2/
  id: eu-gmp-chapter-2
  title: EudraLex Volume 4, Chapter 2 — Personnel
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/11f4f8e6-a6e9-4897-afe3-f21e1dc56cb8_en?filename=2014-03_chapter_2.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-2.json
- https://gxplex.com/r/eu-gmp-chapter-3/
  id: eu-gmp-chapter-3
  title: EudraLex Volume 4, Chapter 3 — Premise and Equipment
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/18d76565-137b-41d2-a602-794527f708c1_en?filename=chapter_3.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-3.json
- https://gxplex.com/r/eu-gmp-chapter-4/
  id: eu-gmp-chapter-4
  title: EudraLex Volume 4, Chapter 4 — Documentation
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-4.json
- https://gxplex.com/r/eu-gmp-chapter-4-draft/
  id: eu-gmp-chapter-4-draft
  title: EudraLex Volume 4, Chapter 4 — Documentation (consultation draft)
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: unresolved
  source_url: https://health.ec.europa.eu/document/download/fa336a6e-753b-46fc-b53b-9178bacd8878_en?filename=mp_vol4_chap4_consultation_guideline_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-4-draft.json
- https://gxplex.com/r/eu-gmp-chapter-5/
  id: eu-gmp-chapter-5
  title: EudraLex Volume 4, Chapter 5 — Production
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/4a1fdb4f-6f6f-49c4-b264-8056e5bbe078_en?filename=chapter_5.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-5.json
- https://gxplex.com/r/eu-gmp-chapter-6/
  id: eu-gmp-chapter-6
  title: EudraLex Volume 4, Chapter 6 — Quality Control
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/c74c8720-27bf-4252-808f-d65a206a90bb_en?filename=2014-11_vol4_chapter_6.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-6.json
- https://gxplex.com/r/eu-gmp-chapter-7/
  id: eu-gmp-chapter-7
  title: EudraLex Volume 4, Chapter 7 — Outsourced activities
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/58b5106a-cf6f-4352-9dca-1caf5d27d97e_en?filename=vol4-chap7_2012-06_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-7.json
- https://gxplex.com/r/eu-gmp-chapter-8/
  id: eu-gmp-chapter-8
  title: EudraLex Volume 4, Chapter 8 — Complaints and Product Recall
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/b1eb2292-cb0d-4e3f-aea9-e3fe79faf6e3_en?filename=2014-08_gmp_chap8.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-8.json
- https://gxplex.com/r/eu-gmp-chapter-9/
  id: eu-gmp-chapter-9
  title: EudraLex Volume 4, Chapter 9 — Self Inspection
  authority: European Commission
  jurisdiction: EU
  status: unknown
  verification: a register
  source_url: https://health.ec.europa.eu/document/download/07195808-d02e-4d7a-b8f4-f84a83278b62_en?filename=cap9_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-gmp-chapter-9.json
- https://gxplex.com/r/eu-ivdr/
  id: eu-ivdr
  title: Regulation (EU) 2017/746 on in vitro diagnostic medical devices
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2017/746/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-ivdr.json
- https://gxplex.com/r/eu-machinery-regulation/
  id: eu-machinery-regulation
  title: Regulation (EU) 2023/1230 on machinery
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2023/1230/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-machinery-regulation.json
- https://gxplex.com/r/eu-mdr/
  id: eu-mdr
  title: Regulation (EU) 2017/745 on medical devices
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/reg/2017/745/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-mdr.json
- https://gxplex.com/r/eu-nis2/
  id: eu-nis2
  title: Directive (EU) 2022/2555 — NIS2
  authority: European Parliament and Council
  jurisdiction: EU
  status: in-force
  verification: verified (person-ratified)
  source_url: https://eur-lex.europa.eu/eli/dir/2022/2555/oj
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/eu-nis2.json
- https://gxplex.com/r/fda-ai-guidance/
  id: fda-ai-guidance
  title: Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
  authority: US Food and Drug Administration
  jurisdiction: US
  status: draft
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-ai-guidance.json
- https://gxplex.com/r/fda-aiml-device-list/
  id: fda-aiml-device-list
  title: FDA list of AI-enabled medical devices with marketing authorisation
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: not re-checked
  source_url: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-aiml-device-list.json
- https://gxplex.com/r/fda-cdrh-aiml/
  id: fda-cdrh-aiml
  title: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
  authority: US Food and Drug Administration
  jurisdiction: US
  status: draft
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-cdrh-aiml.json
- https://gxplex.com/r/fda-clinical-decision-support/
  id: fda-clinical-decision-support
  title: Clinical Decision Support Software
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-clinical-decision-support.json
- https://gxplex.com/r/fda-csa/
  id: fda-csa
  title: Computer Software Assurance for Production and Quality Management System Software
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-csa.json
- https://gxplex.com/r/fda-data-integrity/
  id: fda-data-integrity
  title: Data Integrity and Compliance With Drug CGMP — Questions and Answers
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-data-integrity.json
- https://gxplex.com/r/fda-device-cybersecurity/
  id: fda-device-cybersecurity
  title: Cybersecurity in Medical Devices — Quality System Considerations and Content of Premarket Submissions
  authority: US Food and Drug Administration
  jurisdiction: US
  status: superseded
  verification: tool-read
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-device-cybersecurity.json
- https://gxplex.com/r/fda-device-cybersecurity-2026/
  id: fda-device-cybersecurity-2026
  title: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/media/119933/download
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-device-cybersecurity-2026.json
- https://gxplex.com/r/fda-electronic-systems-clinical/
  id: fda-electronic-systems-clinical
  title: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/media/166215/download
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-electronic-systems-clinical.json
- https://gxplex.com/r/fda-ema-good-ai-practice/
  id: fda-ema-good-ai-practice
  title: Guiding Principles of Good AI Practice in Drug Development
  authority: US Food and Drug Administration and European Medicines Agency
  jurisdiction: International
  status: unknown
  verification: unresolved
  source_url: https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-ema-good-ai-practice.json
- https://gxplex.com/r/fda-etp/
  id: fda-etp
  title: FDA Emerging Technology Program
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: not re-checked
  source_url: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-etp.json
- https://gxplex.com/r/fda-gmlp/
  id: fda-gmlp
  title: Good Machine Learning Practice for Medical Device Development: Guiding Principles
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: unresolved
  source_url: https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-gmlp.json
- https://gxplex.com/r/fda-guidance-agenda/
  id: fda-guidance-agenda
  title: FDA CDER Guidance Agenda
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: not re-checked
  source_url: https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-guidance-agenda.json
- https://gxplex.com/r/fda-part-11-scope/
  id: fda-part-11-scope
  title: Part 11, Electronic Records; Electronic Signatures — Scope and Application
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-part-11-scope.json
- https://gxplex.com/r/fda-pccp/
  id: fda-pccp
  title: Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-pccp.json
- https://gxplex.com/r/fda-postmarket-cybersecurity/
  id: fda-postmarket-cybersecurity
  title: Postmarket Management of Cybersecurity in Medical Devices
  authority: US Food and Drug Administration
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-postmarket-cybersecurity.json
- https://gxplex.com/r/fda-process-analytical-framework/
  id: fda-process-analytical-framework
  title: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: unresolved
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-process-analytical-framework.json
- https://gxplex.com/r/fda-software-validation/
  id: fda-software-validation
  title: General Principles of Software Validation
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: unresolved
  source_url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/fda-software-validation.json
- https://gxplex.com/r/health-canada-ml/
  id: health-canada-ml
  title: Health Canada guidance on machine learning medical devices
  authority: Health Canada
  jurisdiction: Canada
  status: draft
  verification: verified (person-ratified)
  source_url: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/health-canada-ml.json
- https://gxplex.com/r/ich-e6r3/
  id: ich-e6r3
  title: ICH E6(R3) — Good Clinical Practice
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/efficacy-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-e6r3.json
- https://gxplex.com/r/ich-q12/
  id: ich-q12
  title: ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/quality-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-q12.json
- https://gxplex.com/r/ich-q13/
  id: ich-q13
  title: ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/quality-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-q13.json
- https://gxplex.com/r/ich-q14/
  id: ich-q14
  title: ICH Q14 — Analytical Procedure Development
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/quality-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-q14.json
- https://gxplex.com/r/ich-q2r2/
  id: ich-q2r2
  title: ICH Q2(R2) — Validation of Analytical Procedures
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/quality-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-q2r2.json
- https://gxplex.com/r/ich-q9r1/
  id: ich-q9r1
  title: ICH Q9(R1) — Quality Risk Management
  authority: International Council for Harmonisation
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://ich.org/page/quality-guidelines
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ich-q9r1.json
- https://gxplex.com/r/iec-62304/
  id: iec-62304
  title: IEC 62304 — Medical device software life cycle processes
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/38421.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iec-62304.json
- https://gxplex.com/r/iec-62443/
  id: iec-62443
  title: IEC 62443 series — Security for industrial automation and control systems
  authority: IEC / ISA
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.isa.org/standards-and-publications/isa-standards/isa-iec-62443-series-of-standards
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iec-62443.json
- https://gxplex.com/r/iec-81001-5-1/
  id: iec-81001-5-1
  title: IEC 81001-5-1 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
  authority: IEC
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://webstore.iec.ch/en/publication/63293
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iec-81001-5-1.json
- https://gxplex.com/r/ieee-7000/
  id: ieee-7000
  title: IEEE 7000 series — Ethical and systems standards for AI
  authority: Institute of Electrical and Electronics Engineers
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://standards.ieee.org/ieee/7000/6781/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ieee-7000.json
- https://gxplex.com/r/imdrf-aiml-wg/
  id: imdrf-aiml-wg
  title: IMDRF artificial intelligence working group outputs
  authority: International Medical Device Regulators Forum
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.imdrf.org/working-groups
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/imdrf-aiml-wg.json
- https://gxplex.com/r/imdrf-samd/
  id: imdrf-samd
  title: IMDRF Software as a Medical Device documents
  authority: International Medical Device Regulators Forum
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.imdrf.org/documents
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/imdrf-samd.json
- https://gxplex.com/r/iso-13485/
  id: iso-13485
  title: ISO 13485 — Medical devices, quality management systems
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/59752.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-13485.json
- https://gxplex.com/r/iso-14971/
  id: iso-14971
  title: ISO 14971 — Application of risk management to medical devices
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/72704.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-14971.json
- https://gxplex.com/r/iso-81001-1/
  id: iso-81001-1
  title: ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
  authority: ISO
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.iso.org/obp/ui/#iso:std:iso:81001:-1:ed-1:v1:en
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-81001-1.json
- https://gxplex.com/r/iso-iec-22989/
  id: iso-iec-22989
  title: ISO/IEC 22989 — Artificial intelligence concepts and terminology
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/74296.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-22989.json
- https://gxplex.com/r/iso-iec-23894/
  id: iso-iec-23894
  title: ISO/IEC 23894 — AI guidance on risk management
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/77304.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-23894.json
- https://gxplex.com/r/iso-iec-24028/
  id: iso-iec-24028
  title: ISO/IEC 24028 — Overview of trustworthiness in artificial intelligence
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/committee/6794475/x/catalogue/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-24028.json
- https://gxplex.com/r/iso-iec-27001/
  id: iso-iec-27001
  title: ISO/IEC 27001:2022 — Information security management systems
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/27001
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27001.json
- https://gxplex.com/r/iso-iec-27002/
  id: iso-iec-27002
  title: ISO/IEC 27002:2022 — Information security controls
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/75652.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27002.json
- https://gxplex.com/r/iso-iec-27017/
  id: iso-iec-27017
  title: ISO/IEC 27017 — Information security controls for cloud services
  authority: ISO/IEC
  jurisdiction: International
  status: withdrawn
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/43757.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27017.json
- https://gxplex.com/r/iso-iec-27017-2026/
  id: iso-iec-27017-2026
  title: ISO/IEC 27017:2026 — Information security controls based on ISO/IEC 27002 for cloud services
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/82878.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27017-2026.json
- https://gxplex.com/r/iso-iec-27018/
  id: iso-iec-27018
  title: ISO/IEC 27018 — Protection of personally identifiable information in public clouds
  authority: ISO/IEC
  jurisdiction: International
  status: withdrawn
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/76559.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27018.json
- https://gxplex.com/r/iso-iec-27018-2025/
  id: iso-iec-27018-2025
  title: ISO/IEC 27018:2025 — Protection of personally identifiable information in public clouds acting as PII processors
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/88150.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-27018-2025.json
- https://gxplex.com/r/iso-iec-38507/
  id: iso-iec-38507
  title: ISO/IEC 38507 — Governance implications of the use of AI
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/committee/6794475/x/catalogue/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-38507.json
- https://gxplex.com/r/iso-iec-42001/
  id: iso-iec-42001
  title: ISO/IEC 42001 — Artificial intelligence management system
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/standard/81230.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-42001.json
- https://gxplex.com/r/iso-iec-42005/
  id: iso-iec-42005
  title: ISO/IEC 42005 — AI system impact assessment
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/committee/6794475/x/catalogue/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-42005.json
- https://gxplex.com/r/iso-iec-5259/
  id: iso-iec-5259
  title: ISO/IEC 5259 series — Data quality for analytics and machine learning
  authority: ISO/IEC
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://www.iso.org/committee/6794475/x/catalogue/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-5259.json
- https://gxplex.com/r/iso-iec-sc42-programme/
  id: iso-iec-sc42-programme
  title: ISO/IEC JTC 1/SC 42 work programme
  authority: ISO/IEC
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.iso.org/committee/6794475.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/iso-iec-sc42-programme.json
- https://gxplex.com/r/ispe-gamp-ai/
  id: ispe-gamp-ai
  title: ISPE GAMP Guide: Artificial Intelligence
  authority: ISPE
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://ispe.org/publications/guidance-documents
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ispe-gamp-ai.json
- https://gxplex.com/r/ispe-gamp-rdi/
  id: ispe-gamp-rdi
  title: ISPE GAMP Guide — Records and Data Integrity
  authority: International Society for Pharmaceutical Engineering
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://ispe.org/publications/guidance-documents
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ispe-gamp-rdi.json
- https://gxplex.com/r/ispe-gamp5-2e/
  id: ispe-gamp5-2e
  title: ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)
  authority: ISPE
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ispe-gamp5-2e.json
- https://gxplex.com/r/ispe-pharma-4-0/
  id: ispe-pharma-4-0
  title: ISPE Pharma 4.0 programme outputs
  authority: International Society for Pharmaceutical Engineering
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://ispe.org/initiatives/pharma-4.0
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/ispe-pharma-4-0.json
- https://gxplex.com/r/mhra-ai/
  id: mhra-ai
  title: MHRA publications on AI and software as a medical device
  authority: Medicines and Healthcare products Regulatory Agency
  jurisdiction: UK
  status: final
  verification: verified (person-ratified)
  source_url: https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/mhra-ai.json
- https://gxplex.com/r/mhra-ai-airlock/
  id: mhra-ai-airlock
  title: MHRA AI Airlock regulatory sandbox
  authority: Medicines and Healthcare products Regulatory Agency
  jurisdiction: UK
  status: unknown
  verification: not re-checked
  source_url: https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-aiamd
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/mhra-ai-airlock.json
- https://gxplex.com/r/mhra-data-integrity/
  id: mhra-data-integrity
  title: MHRA GxP Data Integrity Guidance and Definitions
  authority: Medicines and Healthcare products Regulatory Agency
  jurisdiction: UK
  status: unknown
  verification: unresolved
  source_url: https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/mhra-data-integrity.json
- https://gxplex.com/r/nist-agent-standards/
  id: nist-agent-standards
  title: NIST standards initiative on autonomous AI agents
  authority: US National Institute of Standards and Technology
  jurisdiction: US
  status: unknown
  verification: not re-checked
  source_url: https://www.nist.gov/artificial-intelligence
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-agent-standards.json
- https://gxplex.com/r/nist-ai-600-1/
  id: nist-ai-600-1
  title: NIST AI 600-1 — Generative AI Profile
  authority: US National Institute of Standards and Technology
  jurisdiction: US
  status: unknown
  verification: unresolved
  source_url: https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.600-1.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-ai-600-1.json
- https://gxplex.com/r/nist-ai-rmf/
  id: nist-ai-rmf
  title: NIST AI Risk Management Framework 1.0
  authority: US National Institute of Standards and Technology
  jurisdiction: International
  status: unknown
  verification: checked — no status stated
  source_url: https://www.nist.gov/itl/ai-risk-management-framework
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-ai-rmf.json
- https://gxplex.com/r/nist-ai-rmf-playbook/
  id: nist-ai-rmf-playbook
  title: NIST AI RMF Playbook and crosswalks
  authority: US National Institute of Standards and Technology
  jurisdiction: US
  status: unknown
  verification: not re-checked
  source_url: https://airc.nist.gov/AI_RMF_Knowledge_Base/Playbook
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-ai-rmf-playbook.json
- https://gxplex.com/r/nist-csf/
  id: nist-csf
  title: NIST Cybersecurity Framework 2.0
  authority: US National Institute of Standards and Technology
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://csrc.nist.gov/pubs/cswp/29/the-nist-cybersecurity-framework-csf-20/final
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-csf.json
- https://gxplex.com/r/nist-sp-800-82/
  id: nist-sp-800-82
  title: NIST SP 800-82 — Guide to Operational Technology Security
  authority: US National Institute of Standards and Technology
  jurisdiction: US
  status: final
  verification: verified (person-ratified)
  source_url: https://csrc.nist.gov/pubs/sp/800/82/r3/final
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nist-sp-800-82.json
- https://gxplex.com/r/nistir-8183/
  id: nistir-8183
  title: NISTIR 8183 — Cybersecurity Framework Manufacturing Profile
  authority: National Institute of Standards and Technology
  jurisdiction: US
  status: unknown
  verification: a register
  source_url: https://csrc.nist.gov/files/pubs/ir/8183/final/docs/nist.ir.8183.pdf
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nistir-8183.json
- https://gxplex.com/r/nmpa-ai/
  id: nmpa-ai
  title: NMPA English portal — front page
  authority: National Medical Products Administration
  jurisdiction: China
  status: unknown
  verification: not re-checked
  source_url: https://english.nmpa.gov.cn/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/nmpa-ai.json
- https://gxplex.com/r/pda-tr-80/
  id: pda-tr-80
  title: PDA Technical Report No. 80 — Data Integrity Management System for Pharmaceutical Laboratories
  authority: Parenteral Drug Association
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.pda.org/bookstore/product-detail/4542-tr-80-data-integrity-management
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pda-tr-80.json
- https://gxplex.com/r/pic-s/
  id: pic-s
  title: PIC/S Guide to Good Manufacturing Practice
  authority: Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://picscheme.org/en/publications
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pic-s.json
- https://gxplex.com/r/pics-annex-11/
  id: pics-annex-11
  title: PIC/S GMP Guide, Annex 11 — Computerised Systems
  authority: Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://picscheme.org/en/publications?tri=gmp
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pics-annex-11.json
- https://gxplex.com/r/pics-pi-011/
  id: pics-pi-011
  title: PIC/S PI 011 — Good practices for computerised systems in regulated GxP environments
  authority: Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://picscheme.org/en/publications
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pics-pi-011.json
- https://gxplex.com/r/pics-pi041/
  id: pics-pi041
  title: PIC/S PI 041 — Good Practices for Data Management and Integrity
  authority: Pharmaceutical Inspection Co-operation Scheme
  jurisdiction: International
  status: final
  verification: verified (person-ratified)
  source_url: https://picscheme.org/en/publications
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pics-pi041.json
- https://gxplex.com/r/pmda-ai/
  id: pmda-ai
  title: PMDA publications on AI in medical products
  authority: Pharmaceuticals and Medical Devices Agency
  jurisdiction: Japan
  status: unknown
  verification: not re-checked
  source_url: https://www.pmda.go.jp/english/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pmda-ai.json
- https://gxplex.com/r/pren-18229-1/
  id: pren-18229-1
  title: prEN 18229-1 — Trustworthiness framework for AI (Part 1)
  authority: CEN/CENELEC JTC 21
  jurisdiction: EU
  status: unknown
  verification: not re-checked
  source_url: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pren-18229-1.json
- https://gxplex.com/r/pren-18229-2/
  id: pren-18229-2
  title: prEN 18229-2 — Trustworthiness framework for AI (Part 2)
  authority: CEN/CENELEC JTC 21
  jurisdiction: EU
  status: unknown
  verification: not re-checked
  source_url: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pren-18229-2.json
- https://gxplex.com/r/pren-18281/
  id: pren-18281
  title: prEN 18281 — AI quality management
  authority: CEN/CENELEC JTC 21
  jurisdiction: EU
  status: unknown
  verification: not re-checked
  source_url: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pren-18281.json
- https://gxplex.com/r/pren-18282/
  id: pren-18282
  title: prEN 18282 — AI conformity assessment
  authority: CEN/CENELEC JTC 21
  jurisdiction: EU
  status: unknown
  verification: not re-checked
  source_url: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/pren-18282.json
- https://gxplex.com/r/swissmedic-ai/
  id: swissmedic-ai
  title: Swissmedic publications on medical device software
  authority: Swissmedic
  jurisdiction: Switzerland
  status: unknown
  verification: not re-checked
  source_url: https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/swissmedic-ai.json
- https://gxplex.com/r/tga-samd/
  id: tga-samd
  title: TGA regulation of software as a medical device
  authority: Therapeutic Goods Administration
  jurisdiction: Australia
  status: unknown
  verification: not re-checked
  source_url: https://www.tga.gov.au/products/medical-devices/software-based-medical-devices
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/tga-samd.json
- https://gxplex.com/r/us-21-cfr-part-11/
  id: us-21-cfr-part-11
  title: 21 CFR Part 11 — Electronic Records; Electronic Signatures
  authority: US Food and Drug Administration
  jurisdiction: US
  status: in-force
  verification: verified (person-ratified)
  source_url: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/us-21-cfr-part-11.json
- https://gxplex.com/r/us-21-cfr-part-211/
  id: us-21-cfr-part-211
  title: 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals
  authority: US Food and Drug Administration
  jurisdiction: US
  status: in-force
  verification: verified (person-ratified)
  source_url: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/us-21-cfr-part-211.json
- https://gxplex.com/r/us-21-cfr-part-820/
  id: us-21-cfr-part-820
  title: 21 CFR Part 820 — Quality Management System Regulation
  authority: US Food and Drug Administration
  jurisdiction: US
  status: unknown
  verification: unresolved
  source_url: https://www.ecfr.gov/current/title-21/part-820
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/us-21-cfr-part-820.json
- https://gxplex.com/r/who-ai-health/
  id: who-ai-health
  title: WHO guidance on artificial intelligence for health
  authority: World Health Organization
  jurisdiction: International
  status: unknown
  verification: unresolved
  source_url: https://www.who.int/publications/i/item/9789240029200
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/who-ai-health.json
- https://gxplex.com/r/who-annex5-data-management/
  id: who-annex5-data-management
  title: WHO Annex 5 — Guidance on Good Data and Record Management Practices
  authority: World Health Organization
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://iris.who.int/
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/who-annex5-data-management.json
- https://gxplex.com/r/who-computerised-systems/
  id: who-computerised-systems
  title: WHO guideline on computerised systems and data integrity
  authority: World Health Organization
  jurisdiction: International
  status: unknown
  verification: not re-checked
  source_url: https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/who-computerised-systems.json
- https://gxplex.com/r/who-trs1033-annex4-data-integrity/
  id: who-trs1033-annex4-data-integrity
  title: WHO Annex 4 — Guideline on data integrity
  authority: World Health Organization
  jurisdiction: International
  status: unknown
  verification: unresolved
  source_url: https://iris.who.int/handle/10665/340323
  observation_bundle: https://gxplex.com/api/v1/observation-bundle/who-trs1033-annex4-data-integrity.json