Verification: verified
39 of 86 tracked instruments. checked against the primary source by a person
This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.
Verification ● verified 39 (active — select again to clear) ◐ tool-read 13 ○ check unrecorded 1 ⊘ checked — no status stated 1 · awaiting 5 ▨ frozen 27
Jurisdiction International 21 EU 6 US 9 UK 1 Canada 1 China 1
Ordered by count, then alphabetically.
Subject (as stated) no self-stated subject 8 artificial intelligence 7 software 4 medical devices 3 security 5 computerised systems 2 manufacturing 3 risk management 2
+15 more
data integrity 1 information security 3 quality management 1 trustworthiness 1 validation 1 clinical 2 cybersecurity 1 electronic records 1 electronic signatures 1 good manufacturing practice 1 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.
Class (as stated) no self-stated class 18 consensus standard 14 authority guidance 2 legal act 5
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.
Showing 39 of 86 instruments. Clear all filters
| 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 |
| 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 |
| 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 GMP Annex 11 | European Commission | EU | in force verified | 2026-07-30 | — | 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 |
| 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 PCCP | US Food and Drug Administration | US | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| 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 |
| IEEE 7000 | Institute of Electrical and Electronics Engineers | International | final verified | 2026-07-30 | — | 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 |
| MHRA AI | Medicines and Healthcare products Regulatory Agency | UK | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| 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 PI 041 | Pharmaceutical Inspection Co-operation Scheme | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
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