GxPlex

Additions by month

When each entry joined this record, and what evidence says so.

132 of 132 tracked instruments, each listed once under one month. Ordering within a month is newest day first, then by entry id — the id is the only tiebreak this record holds that a reader can check against the store.

What dates an addition

Two things in this record can date an admission, and they are not the same claim. Every entry below says which one dated it. Neither is a file’s modification time: a working-tree timestamp is a fact about a checkout, it moves on every clone, and it is not evidence this record keeps.

admission record — 21 of 132
a changelog entry recording this addition, with the day it was made. The act itself.
first observation — 111 of 132
the earliest day this record fetched the entry. A floor on the admission and not the admission: the entry was added on or before this day, and the record does not say how much before.
no dated basis — 0 of 132
neither an admission record nor an observation. The entry is listed and is given no date, because a date this record does not hold is not supplied from somewhere else.

Where both exist the admission record is used, because it records the act and the first fetch is a consequence of it. Where they disagree, both are shown and neither is reconciled into the other.

The join between an admission record and a row is the entry’s own instrument_id, and the entries that do not join are counted rather than dropped.

An entry naming no row is not resolved by reading its prose for a title. A matcher over titles is how a bare numeral once matched NISTIR 8183 for ISO/IEC 8183, and a false join closes a question nobody reopens. The rows such an entry describes fall to the first observation instead.

The inclusion limb

The rule a document is tested against before it is added is published in full, with its four limbs, its negative limb and its carve-out, at the inclusion rule.

That zero is structural rather than statistical, and the figure alone does not say which. The content schema declares no field of that name, and a frontmatter key the schema does not declare is stripped before any page reads it — so no entry can carry a limb until the schema gains a field for one. The column below reads “—” on every row, which is this record’s mark for a value it does not hold.

The changelog entries recording an addition are read for their date and their text. They are not parsed for a limb, and no absence over them is published here: an absence filed from a reader that did not look is not a measurement.

A limb is not derived from an entry’s topics, its stated subject or its title either. Membership here is a human judgement — it was tested twice as a predicate over publisher-stated facts and the question was closed decided-against, on the finding that most entries a predicate could not reach state no subject at all. A limb inferred from a publisher’s words would be this record’s own claim about its own judgement, printed in a column headed as though it had been read from a store.

Where the two dates disagree

Both dates are shown below and neither is reconciled into the other. The month an entry is filed under is the admission record’s.

9 entries have left this record. They are not listed here — this page publishes one month per row for rows the tracker holds — and each is on the archive page with the date it was retired. The changes feed carries the same line.

Additions, month by month

Every month from the earliest dated admission to the day this record calls today, newest first and with none skipped. A month with no additions is printed with its zero rather than omitted: a month built from its own members can only ever appear when it has some, which makes a month in which nothing was added indistinguishable from a month outside the range.

0 additions. The date an addition carries moves when an entry is added and not otherwise, so a month at zero records decisions not taken rather than a process that stopped.

47 of 132 entries.

Entries first dated to August 2026
Entry Authority Dated Basis Inclusion limb
FDA GMLP guiding principles US Food and Drug Administration first observation —
EU GMP Annex 1 European Commission first observation —
EU GMP Annex 10 European Commission first observation —
EU GMP Annex 12 European Commission first observation —
EU GMP Annex 13 European Commission first observation —
EU GMP Annex 14 European Commission first observation —
EU GMP Annex 16 European Commission first observation —
EU GMP Annex 17 European Commission first observation —
EU GMP Annex 19 European Commission first observation —
EU GMP Annex 2 European Commission first observation —
EU GMP Annex 21 European Commission first observation —
EU GMP Annex 3 European Commission first observation —
EU GMP Annex 6 European Commission first observation —
EU GMP Annex 7 European Commission first observation —
EU GMP Annex 8 European Commission first observation —
EU GMP Annex 9 European Commission first observation —
CISA CPG 2.0 Cybersecurity and Infrastructure Security Agency first observation —
NISTIR 8183 National Institute of Standards and Technology first observation —
EU GMP Chapter 1 European Commission first observation —
EU GMP Chapter 2 European Commission first observation —
EU GMP Chapter 3 European Commission first observation —
EU GMP Chapter 5 European Commission first observation —
EU GMP Chapter 6 European Commission first observation —
EU GMP Chapter 7 European Commission first observation —
EU GMP Chapter 8 European Commission first observation —
EU GMP Chapter 9 European Commission first observation —
FDA device cybersecurity US Food and Drug Administration first observation —
FDA device cybersecurity (2026) US Food and Drug Administration admission record —
IEC 81001-5-1 IEC admission record —
ISO 81001-1 ISO admission record —
ISO/IEC 27017:2026 ISO/IEC admission record —
ISO/IEC 27018:2025 ISO/IEC admission record —
PDA TR 80 Parenteral Drug Association admission record —
WHO data integrity guideline World Health Organization admission record —
EMA data quality framework European Medicines Agency admission record —
EU Cybersecurity Act European Parliament and Council admission record —
Regulation (EU) 2026/1744 European Parliament and Council admission record —
EU GMP Annex 11 (draft) European Commission admission record —
EU GMP Chapter 4 (draft) European Commission admission record —
EU Machinery Regulation European Parliament and Council admission record —
FDA clinical decision support US Food and Drug Administration admission record —
FDA electronic systems (clinical) US Food and Drug Administration admission record —
FDA postmarket cybersecurity US Food and Drug Administration admission record —
ISPE GAMP RDI International Society for Pharmaceutical Engineering admission record —
NIST AI 600-1 US National Institute of Standards and Technology admission record —
PIC/S PI 011 Pharmaceutical Inspection Co-operation Scheme admission record —
21 CFR Part 820 (QMSR) US Food and Drug Administration admission record —

85 of 132 entries.

Entries first dated to July 2026
Entry Authority Dated Basis Inclusion limb
ASTM E2537 ASTM International first observation —
Annex 11 concept paper European Medicines Agency first observation —
EMA CT computerised systems European Medicines Agency first observation —
Annex 15 revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme first observation —
DI revision concept paper European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme first observation —
EU Cyber Resilience Act European Parliament and Council first observation —
EU GMP Annex 15 European Commission first observation —
EU GMP Chapter 4 European Commission first observation —
EU NIS2 Directive European Parliament and Council first observation —
FDA/EMA AI principles US Food and Drug Administration and European Medicines Agency first observation —
FDA Part 11 scope US Food and Drug Administration first observation —
FDA process analytical framework US Food and Drug Administration first observation —
FDA software validation US Food and Drug Administration first observation —
IEC 62304 ISO/IEC first observation —
IEC 62443 IEC / ISA first observation —
ISO 13485 ISO/IEC first observation —
ISO 14971 ISO/IEC first observation —
ISO/IEC 27001 ISO/IEC first observation —
ISO/IEC 27002 ISO/IEC first observation —
ISO/IEC 27017 ISO/IEC first observation —
ISO/IEC 27018 ISO/IEC first observation —
MHRA data integrity Medicines and Healthcare products Regulatory Agency first observation —
NIST CSF 2.0 US National Institute of Standards and Technology first observation —
NIST SP 800-82 US National Institute of Standards and Technology first observation —
PIC/S Annex 11 Pharmaceutical Inspection Co-operation Scheme first observation —
21 CFR Part 211 US Food and Drug Administration first observation —
WHO data management World Health Organization first observation —
ANVISA Agência Nacional de Vigilância Sanitária first observation —
ASTM E2363 ASTM International first observation —
ASTM E2500 ASTM International first observation —
CEN/CLC JTC 21 CEN/CENELEC first observation —
EMA AI reflection paper European Medicines Agency first observation —
EMA work programme European Medicines Agency first observation —
EU GMP Annex 11 European Commission first observation —
EU GMP Annex 22 European Commission first observation —
EU IVDR European Parliament and Council first observation —
EU MDR European Parliament and Council first observation —
FDA AI guidance US Food and Drug Administration first observation —
FDA AI device list US Food and Drug Administration first observation —
FDA CDRH AI/ML US Food and Drug Administration first observation —
FDA CSA US Food and Drug Administration first observation —
FDA data integrity US Food and Drug Administration first observation —
FDA ETP US Food and Drug Administration first observation —
FDA guidance agenda US Food and Drug Administration first observation —
FDA PCCP US Food and Drug Administration first observation —
Health Canada ML Health Canada first observation —
ICH E6(R3) International Council for Harmonisation first observation —
ICH Q12 International Council for Harmonisation first observation —
ICH Q13 International Council for Harmonisation first observation —
ICH Q14 International Council for Harmonisation first observation —
ICH Q2(R2) International Council for Harmonisation first observation —
ICH Q9(R1) International Council for Harmonisation first observation —
IEEE 7000 Institute of Electrical and Electronics Engineers first observation —
IMDRF AI/ML WG International Medical Device Regulators Forum first observation —
IMDRF SaMD International Medical Device Regulators Forum first observation —
ISO/IEC 22989 ISO/IEC first observation —
ISO/IEC 23894 ISO/IEC first observation —
ISO/IEC 24028 ISO/IEC first observation —
ISO/IEC 38507 ISO/IEC first observation —
ISO/IEC 42001 ISO/IEC first observation —
ISO/IEC 42005 ISO/IEC first observation —
ISO/IEC 5259 ISO/IEC first observation —
ISO/IEC SC 42 ISO/IEC first observation —
GAMP AI Guide ISPE first observation —
GAMP 5 2nd Ed ISPE first observation —
ISPE Pharma 4.0 International Society for Pharmaceutical Engineering first observation —
MHRA AI Medicines and Healthcare products Regulatory Agency first observation —
MHRA AI Airlock Medicines and Healthcare products Regulatory Agency first observation —
NIST agent standards US National Institute of Standards and Technology first observation —
NIST AI RMF US National Institute of Standards and Technology first observation —
NIST AI RMF Playbook US National Institute of Standards and Technology first observation —
NMPA portal National Medical Products Administration first observation —
PIC/S GMP Guide Pharmaceutical Inspection Co-operation Scheme first observation —
PIC/S PI 041 Pharmaceutical Inspection Co-operation Scheme first observation —
PMDA AI Pharmaceuticals and Medical Devices Agency first observation —
prEN 18229-1 CEN/CENELEC JTC 21 first observation —
prEN 18229-2 CEN/CENELEC JTC 21 first observation —
prEN 18281 CEN/CENELEC JTC 21 first observation —
prEN 18282 CEN/CENELEC JTC 21 first observation —
Swissmedic Swissmedic first observation —
TGA SaMD Therapeutic Goods Administration first observation —
21 CFR Part 11 US Food and Drug Administration first observation —
WHO AI health World Health Organization first observation —
WHO computerised systems World Health Organization first observation —
EU AI Act European Parliament and Council admission record —

What this page does not say

It does not say that an entry absent from this record was rejected. The daily run observes the entries it already holds and does not search for documents it does not have, so an absence is either a considered exclusion or a document nobody has considered, and this page distinguishes neither — the inclusion rule’s own page states both readings.

The grid of what this record holds, by authority and by the subject each publisher’s own title states, is on coverage.

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