ISPE · Life Science & Pharma: GxP - AI
ISPE GAMP Guide: Artificial Intelligence
Industry guide AI · Industry guide Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- ISPE
- Category
- AI
- Sub Category
- Industry guide
- Legal weight
- Industry good practice
- Reuse
- Link only
The industry's guide to developing and using AI-enabled computerised systems in GxP work. It is good practice, not law.
How to read this page
- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
- Related shows links to other documents. Select Compare to see two side by side.
Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Published (July 2025, month only on ISPE's public page)
In plain English
ISPE industry guide on AI-enabled computerised systems in GxP work. Link only: ISPE guides are not reproduced here.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
ISPE's GAMP Guide: Artificial Intelligence was published in July 2025, according to ISPE's public page. It is an industry guide of about 290 pages, sold by ISPE. This site has not read it, so this profile describes only its scope as ISPE presents it publicly, and treats it as link-only.
Who and what it applies to
Regulated companies, their suppliers and service providers, and regulators, for computerised systems that use AI in GxP work.
What it contains
- Scope
- Developing and using AI-enabled computerised systems across their life cycle, for standard, configurable and custom systems. Consult ISPE for its contents.
Key points
- It is good practice, not a legal requirement.
- ISPE describes it as designed to be used alongside GAMP 5, second edition.
- Its date is known only to the month, from ISPE's public page.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Use it alongside GAMP 5, second edition, and regulators' guidance on AI.
Read from the source document on 3 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| ~1 Jul 2025 | Published (July 2025, month only on ISPE's public page) | Industry guide | Source for Published (July 2025, month only on ISPE's public page) |
Related
How other documents connect to this one. Links explained
- Complements ISPE GAMP 5, 2nd ed.· Compare with ISPE GAMP 5, 2nd ed. Unverified link
Official source
The official text always prevails over anything on this site.
Summary in our own words. See the official text from ISPE.
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