Review log
Every change to regulatory content, with how it was published and who reviewed it. It starts on 1 Nov 2026, so the original seed research is not listed. Pull request links open for the SME Reviewer only while the repository is private.
How to read this page
- Merged: the date the change went live. Reviewed: the date the SME Reviewer checked it.
- Tier: Automatic went live first and was confirmed later. Approval waited for the SME Reviewer. SME Reviewer means the SME Reviewer made it.
- AI-drafted: Yes means AI wrote the first draft. A person still decides.
- Awaiting review: the SME Reviewer has not confirmed it yet.
| Merged | Instrument | Change | Tier | AI-drafted | Reviewer | Reviewed | Links |
|---|---|---|---|---|---|---|---|
| 3 Nov 2026 | GAMP AI guide | Added with a scope-level profile, from ISPE's public page (guide not read) | Approval | Yes | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | PIC/S PI 041-1 | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | EMA AI reflection paper | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | ICH E6(R3) GCP | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | ICH Q10 | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | ICH Q9(R1) | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 3 Nov 2026 | ICH Q10 | Link updated by the link keeper | Approval | No | David Mythen | 3 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 11 (2011) | Expanded profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 11 revision | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 (2011) | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 revision | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 22 · AI | Expanded profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S GMP Guide PE 009 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 041-1 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | 21 CFR Part 11 | Expanded profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI guidance (drugs) | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA–EMA AI principles | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI warning letter | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | MHRA GxP data integrity | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EU AI Act | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ISPE GAMP 5, 2nd ed. | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 011-3 | Expanded profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Part 11 scope guidance | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA CPG 425 series | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA electronic systems Q&A | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | 21 CFR Part 211 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA GMP Q&A: IT and DI | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA AI reflection paper | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA CS clinical trials | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA blood system validation | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA BA/BE data integrity | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA notice: CS in trials | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA eSource paper (2010) | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH E6(R3) GCP | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | MHRA AI regulation paper | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | HMA-EMA AI workplan | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | GAMP Records & DI guide | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 1 (2013) | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 1 revision | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 15 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 006-4 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA quality systems guide | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Health Canada GUI-0050 | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Japan CS guideline | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Japan PIC/S GMP notice | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | NMPA AI opinions | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 11 (2011) | Added illustrative crosswalk with eu-gmp-annex-11-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 22 · AI | Added illustrative crosswalk with fda-ai-drug-guidance | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 22 · AI | Added illustrative crosswalk with fda-ema-good-ai-practice-principles | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 (2011) | Added illustrative crosswalk with eu-gmp-chapter-4-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Added illustrative crosswalk with mhra-gxp-data-integrity | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | 21 CFR Part 211 | Added illustrative crosswalk with eu-gmp-annex-11-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 11 revision | Confirmed link with a source: will-replace eu-gmp-annex-11-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 22 · AI | Confirmed link with a source: complements eu-gmp-annex-11-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 revision | Confirmed link with a source: complements eu-gmp-annex-11-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 revision | Confirmed link with a source: will-replace eu-gmp-chapter-4-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S GMP Guide PE 009 | Confirmed link with a source: counterpart eu-gmp-annex-11-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Confirmed link with a source: related 21-cfr-part-11 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Confirmed link with a source: risk-basis eu-gmp-annex-11-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 041-1 | Confirmed link with a source: related mhra-gxp-data-integrity | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added link: complements ich-q9-r1 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added link: complements eu-gmp-chapter-1-2013 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added link: complements eu-gmp-chapter-1-revision | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 15 | Added link: complements eu-gmp-annex-11-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added link: risk-basis eu-gmp-annex-15 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added link: related eu-gmp-annex-15 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Annex 11 revision | Added link: complements eu-gmp-annex-15 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chapter 4 revision | Added link: complements eu-gmp-annex-22 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Added link: interprets 21-cfr-211 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added link: risk-basis fda-data-integrity-qa | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Added link: related fda-part-11-scope-guidance | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added link: risk-basis fda-quality-systems-approach | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI guidance (drugs) | Added link: related 21-cfr-211 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA electronic systems Q&A | Added link: complements fda-part-11-scope-guidance | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA electronic systems Q&A | Added link: interprets 21-cfr-part-11 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA BA/BE data integrity | Added link: related ich-e6-r3 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA BA/BE data integrity | Added link: related fda-electronic-systems-clinical-qa | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | MHRA GxP data integrity | Added link: related eu-gmp-annex-11-2011 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | MHRA GxP data integrity | Added link: related eu-gmp-annex-15 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added link: risk-basis mhra-gxp-data-integrity | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH E6(R3) GCP | Added link: related ema-ai-reflection-paper | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Added link: risk-basis ema-ai-reflection-paper | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q10 | Added link: related ema-ai-reflection-paper | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA notice: CS in trials | Added link: complements ema-computerised-systems-clinical-trials | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EMA notice: CS in trials | Added link: related ich-e6-r3 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | HMA-EMA AI workplan | Added link: related eu-ai-act | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | HMA-EMA AI workplan | Added link: related ema-ai-reflection-paper | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 011-3 | Added link: interprets pics-pe-009 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 006-4 | Added link: interprets pics-pe-009 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | PIC/S PI 006-4 | Added link: related eu-gmp-annex-15 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI warning letter | Added link: related 21-cfr-211 | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ICH Q9(R1) | Removed link to eu-gmp-annex-22: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EU AI Act | Removed link to eu-gmp-annex-22: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI guidance (drugs) | Removed link to eu-gmp-annex-22: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA AI warning letter | Removed link to eu-gmp-annex-22: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA data integrity Q&A | Removed link to mhra-gxp-data-integrity: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ISPE GAMP 5, 2nd ed. | Removed link to eu-gmp-annex-11-2011: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | ISPE GAMP 5, 2nd ed. | Removed link to 21-cfr-part-11: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA–EMA AI principles | Removed link to eu-gmp-annex-22: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Allay WL 2021 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Ultra Seal WL 2022 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Vi-Jon WL 2022 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Nortec WL 2022 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Medgel WL 2023 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Missouri Analytical WL 2021 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | BBC Group WL 2021 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Sanitor WL 2021 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Jost Chemical WL 2022 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Intas WL 2023 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Lex WL 2023 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Landy WL 2024 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | MMC Healthcare WL 2024 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Aspen WL 2025 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Chromatography Inst. WL 2025 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Jaloma WL 2026 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | Curia WL 2026 | Added warning letter, with profile | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | EU AI Act | Rewrote profile from the official text | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | 21 CFR Part 11 | Corrected event of 5 Sep 2003: repeated the scope guidance event | SME Reviewer | No | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA–EMA AI principles | Removed link to fda-ai-drug-guidance: no document states it | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA CSA guidance | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 2 Nov 2026 | FDA software validation | Added profile, with In practice | Approval | Yes | David Mythen | 2 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | 21 CFR Part 11 | Added earlier history: final rule and Scope and Application guidance | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | MHRA GxP data integrity | Added earlier history: 2015 GMP data integrity guidance | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | ICH Q9(R1) | Added earlier history: original Q9 and Q9(R1) consultation | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Annex 11 (2011) | Added earlier history: revision 1 publication | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Chapter 4 (2011) | Added EU GMP Chapter 4 (2011), the version in force | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | PIC/S PI 011-3 | Added PIC/S PI 011-3 | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Part 11 scope guidance | Added FDA Part 11 Scope and Application guidance | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA CPG 425 series | Added FDA CPG 425 series | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA electronic systems Q&A | Added FDA electronic systems Q&A | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | 21 CFR Part 211 | Added 21 CFR Part 211 | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | EMA GMP Q&A: IT and DI | Added EMA GMP Q&A on Annex 11 and data integrity | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | EMA AI reflection paper | Added EMA AI reflection paper | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | EMA CS clinical trials | Added EMA guideline on computerised systems in clinical trials | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Annex 11 revision | Added the Annex 11 concept paper event | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA blood system validation | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA BA/BE data integrity | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | EMA notice: CS in trials | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | EMA eSource paper (2010) | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | ICH E6(R3) GCP | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | MHRA AI regulation paper | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | HMA-EMA AI workplan | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | GAMP Records & DI guide | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Chapter 1 (2013) | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Chapter 1 revision | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Annex 15 | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | PIC/S PI 006-4 | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | ICH Q10 | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA quality systems guide | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Health Canada GUI-0050 | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Japan CS guideline | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Japan PIC/S GMP notice | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | NMPA AI opinions | Added in batch 3 from the coverage audit | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Annex 11 (2011) | Added profile | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | 21 CFR Part 11 | Added profile | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | Annex 22 · AI | Added profile | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | PIC/S PI 011-3 | Added profile | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |
| 1 Nov 2026 | FDA software validation | Added FDA General Principles of Software Validation | Approval | Yes | David Mythen | 1 Nov 2026 | Source · Pull request |