About GxP Digital Atlas
GxP rules for computerised systems, data integrity and AI — status and source in one map
Who reviews this site
David Mythen is the named SME Reviewer: CSV consultant and SME Reviewer. AI tools help research and draft content. The SME Reviewer checks it, approves every status change and interpretation, and confirms automatic updates each week.
What the map covers
61 instruments and 53 links, in Life Science & Pharma: GxP - CSV & Data Integrity and Life Science & Pharma: GxP - AI, from European Commission, PIC/S, ICH, FDA, EMA, MHRA, European Union, ISPE, Health Canada, PMDA, NMPA. 0 of 61 are verified so far.
We check official lists against the map to find what is missing, and every item gets a recorded result. The map is not exhaustive. A document can be missed, especially one whose title does not name the topic.
Warning letters are selected, not complete. We show FDA warning letters only, over a 10-year window that reflects the potential lifecycle of a product. We choose letters that show how FDA applies the rules to computerised systems, data integrity or AI. Current FDA data available via the automated system is limited to 2021 onwards. Note that this is dependent upon the FDA and thus may be impacted intermittently and historically regarding the list of related warning/close-out letters. Other regulators' enforcement records are not covered. No letter on the map means nothing about a company that is not listed.
WHO and TGA are not covered, so WHO's data integrity guideline is not on the map. Some authorities were read only partly: HPRA by the titles of its human medicines guidance, and PMDA and NMPA from their English pages only. Other GMP, GCP, GLP, GDP, GVP and device topics are limited or planned.
How sources are monitored
A monitor checks 20 official sources for changes. It will run daily from a later stage of the build. See how each change reaches the site below.
Tiered AI publishing
- Automatic: a few mechanical facts from official data feeds, such as a new publication date, can go live without waiting for the SME Reviewer. They show "AI-updated, awaiting review" until the SME Reviewer confirms them.
- Approval: everything else waits for the SME Reviewer, including every status change, new instrument, summary and interpretation.
Corrections
We do not delete events. If one is wrong, it stays in the change log, marked "Correction (SME Reviewer)" with the date and reason, and it stops counting towards status. Every change to regulatory content is in the review log.
Licences and sources
Each page links to the official text, which always prevails. Some sources do not allow their text to be reproduced, so for those we show only our own summary and a link.
Use of AI
A monitor checks the official sources every morning. Source monitor status shows when each was last checked and whether it worked.
Content on this site is AI-assisted. A named SME Reviewer approves every status change and interpretation before publication. A small number of mechanical facts from official data feeds can be published automatically, and these are labelled "AI-updated, awaiting review" until they are reviewed.
Contact
Corrections and questions: [CONTACT EMAIL]