AI, cybersecurity, computerised systems and data integrity under GxP — a dated record of what regulators published
86 instruments, observed daily and hashed where the text is public, so a change can be shown rather than asserted. It does not interpret — no recommendations, and no assessment of what any document requires of anyone.
What this record can answer
Five questions, each linked to the page that answers it. The figures are counted from the record at build time.
- What did a document say on a particular date? EMA AI reflection paper, as retrieved on 29 July 2026 18 retained snapshot(s)
- What has changed, and when? Every recorded change, dated also as a feed — changes.xml
- Which documents use a term, in their own words? “audit trail”, quoted from 3 documents 9 term(s), each quotation cited to its source
- Which documents share a stated subject? Subject: security — 7 documents matched by the publishers' own words: "information security" and "cybersecurity" both contain "security", and no synonym list is applied
- What dates has a publisher stated? Next stated date: 16 dated entries, each with its source
What these states mean
- verified
- checked against the primary source by a person
- tool-read
- read from the source by tooling, because the publisher prints no status a machine can read
- check unrecorded
- a status is recorded and no check is written against it
- checked — no status stated
- a person checked the publisher's own surfaces and none states a status
- awaiting
- not yet checked
- frozen
- no public document exists to verify — each entry states which
Ordered by the lifecycle the values themselves name.
Ordered by count, then alphabetically.
+15 more
data integrity 3 information security 3 quality management 3 trustworthiness 3 validation 3 clinical 2 cybersecurity 2 electronic records 2 electronic signatures 2 good manufacturing practice 2 machine learning 2 computer software 1 data quality 1 governance 1 in vitro diagnostic 1Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.
The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.
Two facets compose at a time.
| Instrument | Authority | Jurisdiction | Status | Last verified | Last changed | Source |
|---|---|---|---|---|---|---|
| 21 CFR Part 11 | US Food and Drug Administration | US | in force verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| 21 CFR Part 211 | US Food and Drug Administration | US | in force verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| Annex 11 concept paper | European Medicines Agency | EU | not yet verified awaiting | — | — | link (opens in new tab) |
| Annex 15 revision concept paper | European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme | International | not yet verified awaiting | — | — | link (opens in new tab) |
| ANVISA | Agência Nacional de Vigilância Sanitária | Brazil | not yet verified frozen listing only | — | — | link (opens in new tab) |
| ASTM E2363 | ASTM International | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ASTM E2500 | ASTM International | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ASTM E2537 | ASTM International | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| CEN/CLC JTC 21 | CEN/CENELEC | EU | not yet verified frozen not a document | — | — | link (opens in new tab) |
| DI revision concept paper | European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| EMA AI reflection paper | European Medicines Agency | EU | final check unrecorded | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EMA CT computerised systems | European Medicines Agency | EU | final verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| EMA work programme | European Medicines Agency | EU | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU AI Act | European Parliament and Council | EU | in force verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU Cyber Resilience Act | European Parliament and Council | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| EU GMP Annex 11 | European Commission | EU | in force verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| EU GMP Annex 15 | European Commission | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| EU GMP Annex 22 | European Commission | EU | not yet verified awaiting | — | — | link (opens in new tab) |
| EU GMP Chapter 4 | European Commission | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| EU IVDR | European Parliament and Council | EU | in force verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU MDR | European Parliament and Council | EU | in force verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU NIS2 Directive | European Parliament and Council | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA AI device list | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| FDA AI guidance | US Food and Drug Administration | US | draft — recorded as draft against the primary source verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA CDRH AI/ML | US Food and Drug Administration | US | draft — recorded as draft against the primary source verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA CSA | US Food and Drug Administration | US | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA data integrity | US Food and Drug Administration | US | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| FDA device cybersecurity | US Food and Drug Administration | US | not yet verified awaiting | — | — | link (opens in new tab) |
| FDA ETP | US Food and Drug Administration | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| FDA guidance agenda | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| FDA Part 11 scope | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA PCCP | US Food and Drug Administration | US | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| FDA process analytical framework | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA software validation | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA/EMA AI principles | US Food and Drug Administration and European Medicines Agency | International | not yet verified awaiting | — | — | link (opens in new tab) |
| GAMP 5 2nd Ed | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| GAMP AI Guide | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| Health Canada ML | Health Canada | Canada | draft — under consultation verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| ICH E6(R3) | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q12 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q13 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q14 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q2(R2) | International Council for Harmonisation | International | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| ICH Q9(R1) | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| IEC 62304 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| IEC 62443 | IEC / ISA | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| IEEE 7000 | Institute of Electrical and Electronics Engineers | International | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| IMDRF AI/ML WG | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| IMDRF SaMD | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| ISO 13485 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISO 14971 | ISO/IEC | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISO/IEC 22989 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 23894 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 24028 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27001 | ISO/IEC | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27002 | ISO/IEC | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27017 | ISO/IEC | International | withdrawn verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27018 | ISO/IEC | International | withdrawn verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 38507 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 42001 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 42005 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC 5259 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC SC 42 | ISO/IEC | International | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISPE Pharma 4.0 | International Society for Pharmaceutical Engineering | International | not yet verified frozen not a document | — | — | link (opens in new tab) |
| MHRA AI | Medicines and Healthcare products Regulatory Agency | UK | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| MHRA AI Airlock | Medicines and Healthcare products Regulatory Agency | UK | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| MHRA data integrity | Medicines and Healthcare products Regulatory Agency | UK | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| NIST agent standards | US National Institute of Standards and Technology | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| NIST AI RMF | US National Institute of Standards and Technology | International | not yet verified checked — no status stated | 2026-08-01 | — | link (opens in new tab) · retrieved |
| NIST AI RMF Playbook | US National Institute of Standards and Technology | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| NIST CSF 2.0 | US National Institute of Standards and Technology | US | final verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| NIST SP 800-82 | US National Institute of Standards and Technology | US | final verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| NMPA | National Medical Products Administration | China | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| PIC/S Annex 11 | Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| PIC/S GMP Guide | Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| PIC/S PI 041 | Pharmaceutical Inspection Co-operation Scheme | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| PMDA AI | Pharmaceuticals and Medical Devices Agency | Japan | not yet verified frozen listing only | — | — | link (opens in new tab) |
| prEN 18229-1 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18229-2 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18281 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| prEN 18282 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| Swissmedic | Swissmedic | Switzerland | not yet verified frozen listing only | — | — | link (opens in new tab) |
| TGA SaMD | Therapeutic Goods Administration | Australia | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| WHO AI health | World Health Organization | International | final tool-read | 2026-07-30 | — | link (opens in new tab) · retrieved |
| WHO computerised systems | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| WHO data management | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
Recent activity
- the landing page was reorganised: nothing removed, several things merged
- Correction — a robots policy was read with a client the host refuses, and the failed read published as a permission
- Correction — a jurisdiction facet value named the complement of the others
- Correction — three archive figures counted populations other than the ones they named
- Correction — robots policy was read from pages that are not robots.txt
- the tracked count moved from 88 to 86: two entries were bodies, not documents
- Correction — the publisher's own page describes an expert group, not a document
- Correction — the publisher names a Center of Excellence, which is a unit rather than a document
The archive
- Instruments tracked
- 86
- Observations recorded
- 621
- Instrument-days observed
- 104
- Days of continuous observation
- 7 since 28 July 2026
- Revisions detected
- 0 detection requires a prior hash; observation began 28 July 2026
- Silent revisions
- 0 a change with no version or date declared alongside it
Continuous observation began on . A revision is detected by comparing a document against a hash recorded on an earlier day, so detections become possible from the second day of observation onward. A regulator that revised a document before that date left no trace here, and this site does not claim otherwise.
Every tracked document is fetched, normalised and hashed daily. The hash is recorded whether or not anything changed — "unchanged for 7 days" is only a fact if every one of those days was observed. A silent revision is a document whose content changed with no version or date declared alongside it.
Detected revisions · Findings, each with its method · Which sources are machine-readable · Snapshots and hashes · How this is done
Current status of tracked instruments
A view of the archive, not the product. Status is recorded only after a person has checked it against the primary source.
5 of 86 statuses are awaiting verification. A further 36 are frozen: no public document exists to verify them against, and each states which. The verification strip shows 27 frozen rather than 36: 9 frozen entries carry a known status and are counted by how they were checked. Being frozen and having a status are independent facts. Observation runs for all of them regardless — observation and verification are independent.
Machine-readable
/api/v1/observations.json ·
/api/v1/revisions.json ·
/api/v1/findings.json ·
/api/v1/crawlability.json ·
/api/v1/instruments.json ·
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