Details: Guide Definitions

How to use each part of the site, how information gets here, and what every status, label, link and abbreviation means. These are our plain-English explanations, not legal definitions. The official text always prevails.

What this is

GxP Digital Atlas is a reference map of 61 regulatory documents on computerised systems, data integrity and AI. Each one is called an instrument, whether it is a law, a GMP annex, a guidance document or an industry guide.

It answers four questions: what applies, where it stands today, how it connects to other documents, and what changed. It does not reproduce the rules. It describes them and links to the official text.

Getting started

Find a document: open the Tool: Regulation Maps to see what exists by authority and legal weight, or search by name.
Check where it stands: each document has a status in words, a dated history and a link to the official text.
Read the profile: the sections explain context, who it applies to, what it contains and how it tends to work in practice.
See how documents connect: lines on a map, and the Related list on each page, show links. Select one to compare the documents side by side.
Go clause by clause: where a crosswalk exists, it sits below the map of its area.
Keep up: the Details: Change Log lists recent changes, and the Tool: Timeline Maps shows the whole history and what is expected.

Your Regulatory Guide

The home page. It introduces the tool and gives the totals, the regulatory areas, the latest external changes, what to watch next, and an A to Z of every document, which you can filter by status and Category.

Tool: Regulation Maps

Lists every area with its figures, and shows how many documents each authority has in each area. Open an area for its map.

Columns are authorities, and rows are legal weight, with the most binding at the top.
Point at a card to see its title, status and summary beside the map, and to highlight its links.
Select a card to focus on it: everything else fades, and its links are listed beside the map. On a touch screen this is how to see a card's links.
Double-click a card to open the item straight away.
Right-click a card, or press and hold on a touch screen, for a menu: open the item, compare it with each linked item, or clear the focus.
Click empty space or press Esc to clear the focus.
Select a line to compare two documents.
Zoom with the buttons in that panel. Fit to width shows every column at once. Row names stay in view when you scroll sideways.
Dashed cards show the co-authors of a joint publication.
On a phone, the table comes first and the map opens with a button.
Status / Category Filters & Settings is the closed panel above each map. It holds zoom, Colour by and the keys, and it says when a filter is on.
The colour keys are in that panel. Select one or more to highlight their cards and filter the crosswalks, instruments and relations below. Choices in a group widen the results, so Draft and Final shows both, and Status and Category narrow each other. Counts in titles follow the filter, and selecting again clears it.
The bar under Latest in this area jumps to the map, crosswalks, instruments or relations.
Colour by switches the cards between Status and Category. In Category mode each Category has one colour, each Sub Category is a shade of it, and a card with two colours belongs to a combined Category.

Document pages

Status and lifecycle: where it stands, drawn from dated events.
Facts: authority, legal weight, type and jurisdiction.
Profile: context and history, who it applies to, what it contains, and key points.
In practice: a general reading, always shown with a disclaimer. It is not about your situation.
Change log: every dated event, with its source.
Related: links to other documents.

Comparisons

A comparison page puts two linked documents side by side: status, authority, legal weight and the link between them. It is generated from the data and does not say which is stricter. For detail by clause, use a crosswalk.

Crosswalks

A crosswalk matches clauses in one document with clauses on the same topic in another. It sits below the map of its area, and each row gives a relationship and a short note.

Crosswalks marked Illustrative have not been reviewed clause by clause. They help you see where rules overlap, but they are not a gap assessment.

Tool: Timeline Maps

A chronological map with one row per item, so you can follow each document from start to finish. Rows run A to Z within each authority group.

Pinned columns give the Title, with its regulator in front, then Category, Sub Category and Purpose. On smaller screens only the Title stays pinned.
Time runs left to right on a real scale, and each year from 2020 is drawn wider. The red line is today.
Each marker is one event, coloured by the status after it. Dashed diamonds are targets: expected dates, which often slip.
An older version and its replacement share a row. A dashed line leads from one to the other.
Warning and close-out letters have their own group under FDA, closed until you open it.
Select a row or marker to fade the rest and list its steps, double-click to open the item, or right-click for options.
Colour keys in Status / Category Filters & Settings highlight what you select and filter the events below. Status applies to each event.
Filters narrow it to one area. The list below it also shows routine checks.

Details: Change Log

Every dated change, newest first, grouped by year, with its Change Type, Nature of Change, status and Category. Filter it by date, area, regulator, Change Type, status and Category. It also has an RSS feed. Targets and routine checks are left out. These are changes to the rules, not to this website, apart from corrections to our own records, which are in the Corrections table at the top, with a detailed reason and the impact on the item record.

Search

Searches this site, not the full official texts. Try a short name, such as Annex 22, Part 11 or data integrity.

How information gets here

Sources: each record comes from an official source, linked on its page.
Drafting: AI tools help research and draft content.
Review: the named SME Reviewer approves every status change and interpretation.
Automatic updates: a few mechanical facts from official feeds can go live first. They carry a label until reviewed.
Corrections: events are never deleted. If our record was wrong, it stays, marked Correction (SME Reviewer), with a detailed reason. If a regulator corrects its own document, that is a new event, marked Correction (Authority). Under Correction Review means a correction has been flagged but not made yet, and the original entry still stands until the SME Reviewer decides.

Every change to regulatory content goes in the review log.

How far to rely on it

Unverified means the SME Reviewer has not yet confirmed that record.
Last verified gives the date of the SME Reviewer's most recent check.
Link-only sources show our own summary and a link, because their text cannot be reproduced.
Targets are expected dates, not facts.
The map is not exhaustive, so a document can be missing. See About.

Common questions

Does this tell me if I comply?: No. It helps you find and understand documents. Compliance depends on your systems, your quality system and the official text.
Why does a document have no quotes?: Some sources do not allow their text to be reproduced. See Licences.
Why is a planned area not clickable?: It has not been built yet. Some of its documents may appear in other areas.
What is the difference between a draft and a target?: A draft is a published text. A target is an expected date for a future step.
I found a mistake. What now?: Contact details are on the About page. Corrections are recorded, not hidden.

Status

Where a document stands today. Status comes from its latest dated event, so it always has a source. Colour is only a visual aid: the word is what counts.

Concept: An early proposal, such as a concept paper. There is no draft text yet.
Draft: Published for comment or still being worked on. It does not yet apply.
Final text to EC: The drafters have finished, and the text has gone to the European Commission. It is not yet published or in operation.
Final: Issued in its finished form. Often used for guidance, which sets out expectations rather than law.
Effective · phased: Legally in effect, but its obligations start on different dates.
In force: Currently applies.
Superseded: Replaced by a newer document, so it should not be used for current requirements.
Withdrawn: Taken back by its issuer, with no direct replacement.
Industry guide: Written by an industry body. It is good practice, not a regulator's requirement.
Warning letter: A flag item, not a rule. It is a regulator's action against one company, so it binds only that company, but it shows how existing rules are applied. It appears in red wherever a status would show, and has its own row at the foot of a map. We show FDA warning letters from the last 10 years, because that reflects the potential lifecycle of a product. 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. Letters are selected for what they show about computerised systems, data integrity or AI, so this is not a complete record of FDA enforcement.
Warning letter (closed): FDA has issued a close-out letter for this warning letter, saying that it appears the firm has addressed the violations, and that future inspections will assess this further. The item stays on the map, turns light green and shows (closed). The close-out letter is linked as a second official source, tagged Close-out letter. It applies to that letter only, and it is not a statement about the firm's other activities or current compliance.

Legal weight

How binding a document is. These are the rows on the area maps.

Law & regulation: Legally binding, such as a regulation or a section of the US Code of Federal Regulations.
GMP guide & annexes: The detailed GMP rules that inspectors apply. In the EU they carry weight through the GMP directives.
Guidance & Q&A: A regulator's current thinking. Not binding in itself, but widely expected in inspections.
Industry good practice: Written by industry bodies. Useful for meeting requirements, but not a requirement itself.

Category and Sub Category

Each item has one Category, its main subject. A document that truly covers two gets a combined Category, shown on the maps as a card with both colours. Sub Category is the type of document, listed under Document types, and each one is a shade of its Category's colour.

AI: Mainly about artificial intelligence and machine learning.
CSV: Mainly about validating computerised systems and software.
CSV & Data Integrity: Equally about computerised systems and the reliability of their data, so it needs both.
Data Integrity: Mainly about keeping data and records complete, accurate and reliable.
Quality foundations: Broader quality or GMP documents that the others build on, such as risk management and quality systems.

Event kinds

The dated steps in a document's life. They appear in lifecycle strips, change logs and the timeline.

Concept paper: The issuer sets out why and how it plans to write or revise a document.
Draft published: A draft text was released.
Consultation open: Public comments began to be accepted.
Consultation closed: The deadline for public comments passed.
Workshop: A meeting with stakeholders about the document.
Final text to EC: The finished text went to the European Commission.
Published: The issuer released the document.
Adopted: A formal body approved the document.
In force: The document began to apply legally.
In operation: The document began to apply in practice, for example on its stated operation date.
Updated: The issuer changed the document or issued a new version.
Superseded: A newer document replaced this one.
Withdrawn: The issuer took the document back.
Checked: Someone looked at the official source and recorded what it showed. This does not change the status.
Enforcement: A regulator took action, such as issuing a warning letter.
Closed out: The regulator issued a close-out letter for a warning letter. The close-out letter is linked as a second official source.
Correction (Authority): The regulator corrected its own document, such as with a corrigendum. Our record was right, and this is a new dated event with its own official source.
Target: An expected date, not a fact. Targets often slip.

Links between documents

The lines on the maps. A link reads from one document to the other, such as "Annex 11 revision will replace Annex 11 (2011)".

Replaces: This document has taken the place of the other.
Will replace: This document is due to take the place of the other once it is published and in operation.
Complements: The two are meant to be read together.
Interprets: This document explains how the other should be understood or applied.
Scopes: This document sets out what the other covers.
Implements: This document puts the other into practice, or adopts it locally.
Counterpart: Another authority's document on the same subject.
Risk basis: This document provides the risk management approach the other relies on.
Horizontal: General law across many sectors that sits alongside a sector-specific document.
Related: Connected in subject. This is the weakest link and does not imply any formal tie.
Informs: Non-binding principles that are expected to shape later guidance.

Document types

Regulation: Binding law.
Annex: A topic-specific part of a GMP guide.
Chapter: A main part of a GMP guide.
Guidance: A regulator's document on how it reads or applies requirements.
Questions and answers: A regulator's answers to common questions.
Guideline: A formal technical document from a regulator or harmonisation body.
Industry guide: A guide from an industry body.
Enforcement: A regulator's action against a company, such as a warning letter.
Principles: High-level, non-binding principles.

Licences

What we are allowed to show from each source. This is why some pages quote nothing and only link out.

Public domain: US government work. Short quotes are allowed with attribution.
CC BY 4.0: Reuse is allowed with attribution.
EMA reuse: Reuse is allowed if EMA is acknowledged, and adapted text is labelled as adapted.
ICH reuse: Reuse is allowed if ICH is acknowledged, and adapted text is labelled as adapted.
Open Government Licence v3.0: UK government reuse licence. Attribution is required.
Link only: We do not reproduce the text. You get our own summary and a link to the official source.

Labels and review

Unverified: The SME Reviewer has not yet checked this record against the official source. Treat it as a draft.
Unverified link: The SME Reviewer has not yet confirmed this link between two documents.
Last verified: The date the SME Reviewer last checked the record against the official source.
AI-updated, awaiting review: Published automatically from an official data feed, and not yet confirmed by the SME Reviewer.
Medical Device Item Related to CSV, DI or AI: This comes from the medical device regulatory environment, not the rules for medicines. It is included for reference, because it relates to CSV, Data Integrity or AI, and it is not a GxP requirement for medicines.
Under Correction Review: A possible correction has been flagged but not made yet. The original entry still stands until the SME Reviewer decides.
Correction (SME Reviewer): Our own record was wrong, and the regulator changed nothing. It stays visible with the reason, and it no longer counts towards status.
Illustrative: A starting point that has not been reviewed clause by clause. It is not a gap assessment.
~ before a date: The source gives only the month or a rough date.
Automatic tier: A mechanical fact from an official data feed, published without waiting and confirmed by the SME Reviewer afterwards.
Approval tier: A change that goes live only after the SME Reviewer approves it.
SME Reviewer tier: A change made by the SME Reviewer directly.

Crosswalk relationships

How a clause in one document compares with a clause in another.

Equal: The two clauses cover the same ground.
Intersects: They overlap, but each covers something the other does not.
Superset: The first document's clause covers everything in the second, and more.
Subset: The first document's clause covers only part of the second.
No match: One document has no matching clause.

Authorities

European Commission: Publishes the EU GMP Guide in EudraLex.
European Union: Used here for EU legislation.
EMA: European Medicines Agency.
PIC/S: Pharmaceutical Inspection Co-operation Scheme.
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
FDA: US Food and Drug Administration.
MHRA: UK Medicines and Healthcare products Regulatory Agency.
ISPE: International Society for Pharmaceutical Engineering, an industry body.
HPRA: Health Products Regulatory Authority, Ireland.
Health Canada: Canada's federal health department.
PMDA: Pharmaceuticals and Medical Devices Agency, Japan. Some Japanese documents are issued by the health ministry (MHLW).
NMPA: National Medical Products Administration, China.

Abbreviations

GxP: A shorthand for "good practice" rules, where x is the area, such as manufacturing or clinical.
GMP: Good Manufacturing Practice.
GCP: Good Clinical Practice.
GLP: Good Laboratory Practice.
GDP: Good Distribution Practice.
GVP: Good Pharmacovigilance Practice.
CSV: Computerised system validation: showing that a system does what it should, reliably.
CSA: Computer Software Assurance, FDA's risk-based approach to assuring software.
Data Integrity: Data stays complete, consistent and accurate throughout its life.
ALCOA: Data should be Attributable, Legible, Contemporaneous, Original and Accurate.
PQS: Pharmaceutical quality system.
QMS: Quality management system.
QMSR: FDA's Quality Management System Regulation for medical devices.
CFR: US Code of Federal Regulations.
CGMP: Current Good Manufacturing Practice, the US term.
GAMP: Good Automated Manufacturing Practice, ISPE's guidance for computerised systems.
EudraLex: The European Commission's collection of rules for medicines. Volume 4 is the EU GMP Guide.
SaMD: Software as a medical device.
PCCP: Predetermined change control plan, agreed in advance for planned changes to a device.
GMLP: Good machine learning practice.
ML: Machine learning.
STRM: Set theory relationship mapping, a method for comparing documents (NIST IR 8477).