<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title>GxPlex — changes only</title><description>Revisions detected in tracked documents, corrections, scope changes and newly recorded documents. Silent on days when none of those happened. Reports status only; no advice or interpretation.</description><link>https://gxplex.com/</link><language>en</language><item><title>crawlability: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>ispe.org — robots.txt unreachable, blocks_ai_agents false → ispe.org — disallows GPTBot and twenty other named agents. correction: a robots policy was read with a client the host refuses, and the failed read published as a permission Source: https://gxplex.com/crawlability</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>tracker: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>jurisdiction: Other (6 instruments) → Canada, Japan, Australia, China, Switzerland, Brazil. correction: a jurisdiction facet value named the complement of the others Source: https://gxplex.com/</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>archive: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>105 sources · 525 instrument-days · 12,217 observations recorded → 104 sources · 524 instrument-days · 524 observations recorded. correction: three archive figures counted populations other than the ones they named Source: https://gxplex.com/findings</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>crawlability: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>no AI-specific disallow → no robots.txt published. correction: robots policy was read from pages that are not robots.txt Source: https://gxplex.com/crawlability</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ema-qig: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>tracked as an instrument → recorded as a body (expert group). correction: the publisher&apos;s own page describes an expert group, not a document Source: https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/quality-innovation-group</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>fda-dhcoe: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>tracked as an instrument → recorded as a body (centre). correction: the publisher names a Center of Excellence, which is a unit rather than a document Source: https://www.fda.gov/medical-devices/digital-health-center-excellence</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>IMDRF AI/ML WG: correction</title><link>https://gxplex.com/instrument/imdrf-aiml-wg/</link><guid isPermaLink="true">https://gxplex.com/instrument/imdrf-aiml-wg/</guid><description>recorded in two collections under one id → one id, one record — the instrument row. correction: a body record asserted a kind no retrieved source states Source: https://www.imdrf.org/working-groups</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ispe-gamp-cop: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>no scope quoted; charter_url returning 404 → kind and scope quoted from the publisher&apos;s own page. correction: the recorded charter page was dead; a live ISPE page states what GAMP is Source: https://ispe.org/initiatives/regulatory/what-gamp</description><pubDate>Sun, 02 Aug 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 22: correction</title><link>https://gxplex.com/instrument/eu-gmp-annex-22/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-22/</guid><description>797a882ba0eafe08c329001260e2dabf7c05db82f8a5766d7f75df7569f2e85d → 07dc6a9975d123f2aa8ca9a2c0d5ba28b09b743d847d136814b6dfa555531a26. correction: observations dated 28-30 July hashed a different document Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>revision-detection: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>correction: revision detection did not run from inception until 2026-08-01 Source: https://gxplex.com/methodology</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 27001: status</title><link>https://gxplex.com/instrument/iso-iec-27001/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-27001/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/standard/27001</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 27002: status</title><link>https://gxplex.com/instrument/iso-iec-27002/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-27002/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/standard/75652.html</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 27017: status</title><link>https://gxplex.com/instrument/iso-iec-27017/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-27017/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://www.iso.org/standard/43757.html</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 27018: status</title><link>https://gxplex.com/instrument/iso-iec-27018/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-27018/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://www.iso.org/standard/76559.html</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>NIST AI RMF: status</title><link>https://gxplex.com/instrument/nist-ai-rmf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-ai-rmf/</guid><description>final → unknown. status recorded as unknown (previously final). Source: https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.100-1.pdf</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>NIST CSF 2.0: status</title><link>https://gxplex.com/instrument/nist-csf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-csf/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.29.pdf</description><pubDate>Sat, 01 Aug 2026 00:00:00 GMT</pubDate></item><item><title>ich-q10: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — a quality-management instrument, cited by tracked instruments but not itself governing computerised systems Source: https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline</description><pubDate>Fri, 31 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q11: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — a quality-management instrument, cited by tracked instruments but not itself governing computerised systems Source: https://www.ema.europa.eu/en/ich-q11-development-manufacture-drug-substances-scientific-guideline</description><pubDate>Fri, 31 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q8: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — a quality-management instrument, cited by tracked instruments but not itself governing computerised systems Source: https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline</description><pubDate>Fri, 31 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 11: correction</title><link>https://gxplex.com/instrument/eu-gmp-annex-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-11/</guid><description>correction: status withdrawn — the source is the EudraLex Volume 4 index, which cannot state one document&apos;s status Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 22: correction</title><link>https://gxplex.com/instrument/eu-gmp-annex-22/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-22/</guid><description>correction: status withdrawn — the source is the EudraLex Volume 4 index, which cannot state one document&apos;s status Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: correction</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>correction: status withdrawn — the Federal Register announces this guidance as a draft Source: https://www.federalregister.gov/documents/2025/01/07/2024-31542/considerations-for-the-use-of-artificial-intelligence-to-support-regulatory-decision-making-for-drug</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>final → unknown. correction — `final` was read from FDA&apos;s search-page help text; the entry also pointed at the search page rather than at the guidance Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>fda-dhcoe: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>correction: status withdrawn — the page states no status for any document, and is not a document Source: https://www.fda.gov/medical-devices/digital-health-center-excellence</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA guidance agenda: status</title><link>https://gxplex.com/instrument/fda-guidance-agenda/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-guidance-agenda/</guid><description>draft → unknown. correction — `draft` was read from a sentence about the guidances the agenda lists, not about the agenda; an agenda has no status Source: https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>designations-market-surveillance: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>published → withdrawn. correction: finding withdrawn — it measured an unstarted check, not a result Source: https://gxplex.com/findings</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>designations-notifying-authority: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>published → withdrawn. correction: finding withdrawn — it measured an unstarted check, not a result Source: https://gxplex.com/findings</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>designations-past-deadline: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>published → withdrawn. correction: finding withdrawn — it measured an unstarted check, not a result Source: https://gxplex.com/findings</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q2(R2): correction</title><link>https://gxplex.com/instrument/ich-q2r2/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q2r2/</guid><description>correction: status withdrawn — the source is the ICH quality-guidelines index, shared with eight other entries Source: https://ich.org/page/quality-guidelines</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>IEEE 7000: correction</title><link>https://gxplex.com/instrument/ieee-7000/</link><guid isPermaLink="true">https://gxplex.com/instrument/ieee-7000/</guid><description>correction: status withdrawn — the page states &quot;active standard&quot; three times, including in a labelled Status field Source: https://standards.ieee.org/ieee/7000/6781/</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>NIST AI RMF: correction</title><link>https://gxplex.com/instrument/nist-ai-rmf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-ai-rmf/</guid><description>correction: status withdrawn — every occurrence of &quot;draft&quot; on the page describes a PRIOR version, under a heading reading &quot;prior documents&quot; Source: https://www.nist.gov/itl/ai-risk-management-framework</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S GMP Guide: correction</title><link>https://gxplex.com/instrument/pic-s/</link><guid isPermaLink="true">https://gxplex.com/instrument/pic-s/</guid><description>correction: status withdrawn — the source is the PIC/S publications listing, which cannot state one document&apos;s status Source: https://picscheme.org/en/publications</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S PI 041: correction</title><link>https://gxplex.com/instrument/pics-pi041/</link><guid isPermaLink="true">https://gxplex.com/instrument/pics-pi041/</guid><description>correction: status withdrawn — the source is the PIC/S publications listing, which cannot state one document&apos;s status Source: https://picscheme.org/en/publications</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>easa-ai-roadmap: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — aviation is outside the AI-governance x GxP manufacturing intersection Source: https://www.easa.europa.eu/en/domains/research-innovation/ai</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>efsa-ai: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — food is outside the AI-governance x GxP manufacturing intersection Source: https://www.efsa.europa.eu/en/publications</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>eu-reach: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — chemical is outside the AI-governance x GxP manufacturing intersection Source: https://echa.europa.eu/regulations/reach/legislation</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>iaea-digital: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — nuclear is outside the AI-governance x GxP manufacturing intersection Source: https://www.iaea.org/publications</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>unece-wp29: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — automotive is outside the AI-governance x GxP manufacturing intersection Source: https://unece.org/transport/vehicle-regulations</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>us-fsma: removed from the tracker</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>removed from scope — food is outside the AI-governance x GxP manufacturing intersection Source: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma</description><pubDate>Thu, 30 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ASTM E2363: correction</title><link>https://gxplex.com/instrument/astm-e2363/</link><guid isPermaLink="true">https://gxplex.com/instrument/astm-e2363/</guid><description>https://www.astm.org/e2363-14.html → https://www.astm.org/e2363-23.html. correction: source URL repointed at the edition the publisher marks current Source: https://www.astm.org/e2363-23.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ASTM E2500: correction</title><link>https://gxplex.com/instrument/astm-e2500/</link><guid isPermaLink="true">https://gxplex.com/instrument/astm-e2500/</guid><description>https://www.astm.org/e2500-20.html → https://www.astm.org/e2500-25.html. correction: source URL repointed at the edition the publisher marks current Source: https://www.astm.org/e2500-25.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>CEN/CLC JTC 21: correction</title><link>https://gxplex.com/instrument/cen-jtc21-programme/</link><guid isPermaLink="true">https://gxplex.com/instrument/cen-jtc21-programme/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 11: correction</title><link>https://gxplex.com/instrument/eu-gmp-annex-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-11/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 22: correction</title><link>https://gxplex.com/instrument/eu-gmp-annex-22/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-22/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA CDRH AI/ML: correction</title><link>https://gxplex.com/instrument/fda-cdrh-aiml/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-cdrh-aiml/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/medical-devices/software-medical-device-samd</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA CSA: correction</title><link>https://gxplex.com/instrument/fda-csa/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-csa/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA guidance agenda: correction</title><link>https://gxplex.com/instrument/fda-guidance-agenda/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-guidance-agenda/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.fda.gov/drugs/guidances-drugs/guidance-agenda-new-and-revised-draft-guidances-cder-plans-publish-during-calendar-year</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q10: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q11: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q12: correction</title><link>https://gxplex.com/instrument/ich-q12/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q12/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q13: correction</title><link>https://gxplex.com/instrument/ich-q13/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q13/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q14: correction</title><link>https://gxplex.com/instrument/ich-q14/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q14/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q2(R2): correction</title><link>https://gxplex.com/instrument/ich-q2r2/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q2r2/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q8: correction</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q9(R1): correction</title><link>https://gxplex.com/instrument/ich-q9r1/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q9r1/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 24028: correction</title><link>https://gxplex.com/instrument/iso-iec-24028/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-24028/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 38507: correction</title><link>https://gxplex.com/instrument/iso-iec-38507/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-38507/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 42005: correction</title><link>https://gxplex.com/instrument/iso-iec-42005/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-42005/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 5259: correction</title><link>https://gxplex.com/instrument/iso-iec-5259/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-5259/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC SC 42: correction</title><link>https://gxplex.com/instrument/iso-iec-sc42-programme/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-sc42-programme/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>MHRA AI Airlock: correction</title><link>https://gxplex.com/instrument/mhra-ai-airlock/</link><guid isPermaLink="true">https://gxplex.com/instrument/mhra-ai-airlock/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-airmd</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>MHRA AI: correction</title><link>https://gxplex.com/instrument/mhra-ai/</link><guid isPermaLink="true">https://gxplex.com/instrument/mhra-ai/</guid><description>resolving → error page. correction: primary source URL no longer resolves Source: https://www.gov.uk/government/collections/software-and-artificial-intelligence-ai-as-a-medical-device</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S GMP Guide: correction</title><link>https://gxplex.com/instrument/pic-s/</link><guid isPermaLink="true">https://gxplex.com/instrument/pic-s/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://picscheme.org/en/publications</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S PI 041: correction</title><link>https://gxplex.com/instrument/pics-pi041/</link><guid isPermaLink="true">https://gxplex.com/instrument/pics-pi041/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://picscheme.org/en/publications</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>prEN 18229-1: correction</title><link>https://gxplex.com/instrument/pren-18229-1/</link><guid isPermaLink="true">https://gxplex.com/instrument/pren-18229-1/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>prEN 18229-2: correction</title><link>https://gxplex.com/instrument/pren-18229-2/</link><guid isPermaLink="true">https://gxplex.com/instrument/pren-18229-2/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>prEN 18281: correction</title><link>https://gxplex.com/instrument/pren-18281/</link><guid isPermaLink="true">https://gxplex.com/instrument/pren-18281/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>prEN 18282: correction</title><link>https://gxplex.com/instrument/pren-18282/</link><guid isPermaLink="true">https://gxplex.com/instrument/pren-18282/</guid><description>correction: status_as_of removed — the date belonged to a shared index page Source: https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH E6(R3): status</title><link>https://gxplex.com/instrument/ich-e6r3/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-e6r3/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/efficacy-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q10: status</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q11: status</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q12: status</title><link>https://gxplex.com/instrument/ich-q12/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q12/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q13: status</title><link>https://gxplex.com/instrument/ich-q13/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q13/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q14: status</title><link>https://gxplex.com/instrument/ich-q14/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q14/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q2(R2): status</title><link>https://gxplex.com/instrument/ich-q2r2/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q2r2/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ich-q8: status</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ICH Q9(R1): status</title><link>https://gxplex.com/instrument/ich-q9r1/</link><guid isPermaLink="true">https://gxplex.com/instrument/ich-q9r1/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://ich.org/page/quality-guidelines</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 24028: status</title><link>https://gxplex.com/instrument/iso-iec-24028/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-24028/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 38507: status</title><link>https://gxplex.com/instrument/iso-iec-38507/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-38507/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 42005: status</title><link>https://gxplex.com/instrument/iso-iec-42005/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-42005/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>ISO/IEC 5259: status</title><link>https://gxplex.com/instrument/iso-iec-5259/</link><guid isPermaLink="true">https://gxplex.com/instrument/iso-iec-5259/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.iso.org/committee/6794475.html</description><pubDate>Wed, 29 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EMA AI reflection paper: status</title><link>https://gxplex.com/instrument/ema-ai-reflection/</link><guid isPermaLink="true">https://gxplex.com/instrument/ema-ai-reflection/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EMA work programme: status</title><link>https://gxplex.com/instrument/ema-work-programme/</link><guid isPermaLink="true">https://gxplex.com/instrument/ema-work-programme/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ema.europa.eu/en/about-us/how-we-work/planning-reporting</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU AI Act: status</title><link>https://gxplex.com/instrument/eu-ai-act/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-ai-act/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2024/1689/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 11: status</title><link>https://gxplex.com/instrument/eu-gmp-annex-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-11/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 22: status</title><link>https://gxplex.com/instrument/eu-gmp-annex-22/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-22/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU IVDR: status</title><link>https://gxplex.com/instrument/eu-ivdr/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-ivdr/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2017/746/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU MDR: status</title><link>https://gxplex.com/instrument/eu-mdr/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-mdr/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2017/745/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA data integrity: status</title><link>https://gxplex.com/instrument/fda-data-integrity/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-data-integrity/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>fda-dhcoe: status</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.fda.gov/medical-devices/digital-health-center-excellence</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA PCCP: status</title><link>https://gxplex.com/instrument/fda-pccp/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-pccp/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>Health Canada ML: status</title><link>https://gxplex.com/instrument/health-canada-ml/</link><guid isPermaLink="true">https://gxplex.com/instrument/health-canada-ml/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>IEEE 7000: status</title><link>https://gxplex.com/instrument/ieee-7000/</link><guid isPermaLink="true">https://gxplex.com/instrument/ieee-7000/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://standards.ieee.org/ieee/7000/6781/</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>NIST AI RMF: status</title><link>https://gxplex.com/instrument/nist-ai-rmf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-ai-rmf/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.nist.gov/itl/ai-risk-management-framework</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>NMPA: status</title><link>https://gxplex.com/instrument/nmpa-ai/</link><guid isPermaLink="true">https://gxplex.com/instrument/nmpa-ai/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://english.nmpa.gov.cn/</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S GMP Guide: status</title><link>https://gxplex.com/instrument/pic-s/</link><guid isPermaLink="true">https://gxplex.com/instrument/pic-s/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://picscheme.org/en/publications</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S PI 041: status</title><link>https://gxplex.com/instrument/pics-pi041/</link><guid isPermaLink="true">https://gxplex.com/instrument/pics-pi041/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://picscheme.org/en/publications</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>21 CFR Part 11: status</title><link>https://gxplex.com/instrument/us-21-cfr-part-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/us-21-cfr-part-11/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>us-fsma: status</title><link>https://gxplex.com/changelog/</link><guid isPermaLink="true">https://gxplex.com/changelog/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item></channel></rss>