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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