Status: final
31 of 86 tracked instruments.
This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.
Status unknown 6 frozen 36 draft 3 final 31 (active — select again to clear) in-force 10
Ordered by the lifecycle the values themselves name.
Subject (as stated) no self-stated subject 6 artificial intelligence 6 software 4 security 2 computerised systems 1 manufacturing 3 risk management 2 data integrity 2
+11 more
quality management 1 trustworthiness 1 validation 2 clinical 2 cybersecurity 1 electronic records 1 electronic signatures 1 machine learning 1 computer software 1 data quality 1 governance 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 19 consensus standard 10 authority guidance 2
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 31 of 86 instruments. Clear all filters
| Instrument | Authority | Jurisdiction | Status | Last verified | Last changed | Source |
|---|---|---|---|---|---|---|
| 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 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 |
| 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 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 |
| 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 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 |
| MHRA data integrity | Medicines and Healthcare products Regulatory Agency | UK | final tool-read | 2026-07-31 | — | 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 |
| WHO AI health | World Health Organization | International | final tool-read | 2026-07-30 | — | link (opens in new tab) · retrieved |
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