Interactive Regulatory Visual Tracker for GxP Digital Regulations
GxP Digital Atlas is a free visual tracker of the rules for computerised systems, Data Integrity and AI in regulated life sciences. It shows how 61 documents from 11 authorities relate to each other, where each one stands today, and what changed.
What you can do
- See the whole picture: interactive maps by authority and legal weight.
- Check status: each document has a status in words and a dated history.
- Read it quickly: a plain-English profile and a link to the official text.
- Compare: side-by-side pages and clause-level crosswalks.
- Keep up: a timeline and a change log.
Who it is for
QA, validation, CSV, Data Integrity and regulatory professionals who need to find the right document fast, and see what is moving.
How it stays current
A monitor is being built to check official sources. Content is drafted with AI, and a named SME Reviewer, David Mythen, reviews it. 61 of 61 records are still awaiting the SME Reviewer's verification.
What it is not
It is a map, not advice, and it does not assess your compliance. The official text always prevails, and the map is not exhaustive. How the site works
How to read this page
- Start with an area below to see its documents by authority and legal weight.
- Instrument means any rule, guideline or guide on the map. Each has its own page with status, history and the official link.
- Check the status in words: colour only supports it. See the full meanings.
- Instruments
- 61
- Authorities
- 11
- Links mapped
- 53
- Dated events
- 102
- Next expected
- 31 Dec 2026
Regulatory areas
Topics the map covers. "Available now" areas have documents, with counts by status. "Planned" areas are not built yet.
Available now
Life Science & Pharma: GxP - CSV & Data Integrity
Part 11, Annex 11 and its revision, Chapter 4, and data integrity guidance from FDA, MHRA and PIC/S, ICH Q9(R1), GAMP 5 and FDA warning letters.
- 5 Draft
- 21 Final
- 7 In force
- 1 Superseded
- 2 Industry guide
- 11 Warning letter
- 6 Warning letter (closed)
Available now
Life Science & Pharma: GxP - AI
Draft EU GMP Annex 22, FDA's draft AI guidance for drugs and biologics, the joint FDA–EMA good AI practice principles, the EU AI Act, and related enforcement.
- 2 Draft
- 6 Final
- 1 Effective · phased
- 1 Industry guide
- 1 Warning letter
Planned
Medical Devices: GxP - CSV & Data Integrity
Software validation and quality system rules for medical devices. Not built yet.
Planned
Medical Devices: GxP - AI
AI and machine learning in medical devices. Not built yet.
Latest external changes
The six newest dated changes across every document. The chip shows the status after that change.
- 29 Oct 2026EMA notice: CS in trials: Revision 1: administrative update of referencesFinal
- 1 Oct 2026PIC/S PI 006-4: Version PI 006-4 dated 1 Oct 2026Final
- 23 Sep 2026PIC/S GMP Guide PE 009: PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17In force
- 18 Sep 2026Curia WL 2026: Warning letter issuedWarning letter
- 2 Aug 2026EU AI Act: Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus)Effective · phased
- 27 Jul 2026EU AI Act: Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligationsEffective · phased
Watch next
The soonest expected date. Targets are not facts and often slip.
Target 31 Dec 2026
- Annex 11 revision: Target: final text to European Commission (Q4 2026, slipped from Q1 2026)
- Chapter 4 revision: Target: final text to European Commission (Q4 2026)
- Annex 22 · AI: Target: final text to European Commission (Q4 2026)
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