GxPlex

Observations

An observation is one dated read of one address: what the address answered, by which method, and, where text was retained, a digest of that text. Each tracked entry has one page holding its whole series, with an address and a citation on every record.

132 of 132 tracked entries hold at least one record, and the pages below list 16,080 records between them. Every value in the table is observed — counted or read from this record’s own observation store — and none is stated by a publisher. Rows are in alphabetical order of the entry’s name.

What each field of an observation records, and what it does not: GXP-OBS v1. The same records as data: /api/v1/series.jsonl.

Observation series, one per tracked entry
Entry Records First observed Last observed
21 CFR Part 11 159
21 CFR Part 211 116
21 CFR Part 820 (QMSR) 101
Annex 11 concept paper 117
Annex 15 revision concept paper 116
ANVISA 155
ASTM E2363 155
ASTM E2500 155
ASTM E2537 117
CEN/CLC JTC 21 155
CISA CPG 2.0 68
DI revision concept paper 116
EMA AI reflection paper 155
EMA CT computerised systems 117
EMA data quality framework 101
EMA work programme 155
EU AI Act 159
EU Cyber Resilience Act 117
EU Cybersecurity Act 101
EU GMP Annex 1 61
EU GMP Annex 10 61
EU GMP Annex 11 174
EU GMP Annex 11 (draft) 101
EU GMP Annex 12 61
EU GMP Annex 13 61
EU GMP Annex 14 61
EU GMP Annex 15 117
EU GMP Annex 16 61
EU GMP Annex 17 61
EU GMP Annex 19 61
EU GMP Annex 2 61
EU GMP Annex 21 61
EU GMP Annex 22 161
EU GMP Annex 3 61
EU GMP Annex 6 61
EU GMP Annex 7 61
EU GMP Annex 8 61
EU GMP Annex 9 61
EU GMP Chapter 1 75
EU GMP Chapter 2 75
EU GMP Chapter 3 75
EU GMP Chapter 4 117
EU GMP Chapter 4 (draft) 101
EU GMP Chapter 5 75
EU GMP Chapter 6 75
EU GMP Chapter 7 75
EU GMP Chapter 8 75
EU GMP Chapter 9 75
EU IVDR 153
EU Machinery Regulation 101
EU MDR 153
EU NIS2 Directive 117
FDA AI device list 155
FDA AI guidance 174
FDA CDRH AI/ML 154
FDA clinical decision support 101
FDA CSA 160
FDA data integrity 154
FDA device cybersecurity 95
FDA device cybersecurity (2026) 117
FDA electronic systems (clinical) 101
FDA ETP 161
FDA GMLP guiding principles 50
FDA guidance agenda 174
FDA Part 11 scope 117
FDA PCCP 154
FDA postmarket cybersecurity 101
FDA process analytical framework 117
FDA software validation 117
FDA/EMA AI principles 116
GAMP 5 2nd Ed 159
GAMP AI Guide 160
Health Canada ML 153
ICH E6(R3) 154
ICH Q12 173
ICH Q13 173
ICH Q14 173
ICH Q2(R2) 173
ICH Q9(R1) 173
IEC 62304 116
IEC 62443 117
IEC 81001-5-1 93
IEEE 7000 154
IMDRF AI/ML WG 152
IMDRF SaMD 152
ISO 13485 116
ISO 14971 116
ISO 81001-1 92
ISO/IEC 22989 152
ISO/IEC 23894 153
ISO/IEC 24028 153
ISO/IEC 27001 116
ISO/IEC 27002 116
ISO/IEC 27017 115
ISO/IEC 27017:2026 92
ISO/IEC 27018 115
ISO/IEC 27018:2025 92
ISO/IEC 38507 153
ISO/IEC 42001 159
ISO/IEC 42005 153
ISO/IEC 5259 153
ISO/IEC SC 42 153
ISPE GAMP RDI 101
ISPE Pharma 4.0 153
MHRA AI 153
MHRA AI Airlock 153
MHRA data integrity 117
NIST agent standards 153
NIST AI 600-1 101
NIST AI RMF 172
NIST AI RMF Playbook 153
NIST CSF 2.0 116
NIST SP 800-82 117
NISTIR 8183 68
NMPA portal 153
PDA TR 80 93
PIC/S Annex 11 117
PIC/S GMP Guide 159
PIC/S PI 011 101
PIC/S PI 041 153
PMDA AI 153
prEN 18229-1 159
prEN 18229-2 159
prEN 18281 159
prEN 18282 159
Regulation (EU) 2026/1744 101
Swissmedic 153
TGA SaMD 152
WHO AI health 153
WHO computerised systems 153
WHO data integrity guideline 93
WHO data management 116

Last updated: