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ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd edition)
Industry guide CSV · Industry guide Last verified: not yet · Source last checked 3 Nov 2026
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The industry's best-known guide to a risk-based way of validating GxP computerised systems. 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.
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Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Second edition published (29 Jul 2022)
In plain English
Industry good-practice guide for the lifecycle of GxP computerised systems, widely referenced by regulators and companies. Proprietary: cite and link only.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
GAMP 5 is the ISPE industry guide to a risk-based approach to compliant GxP computerised systems. The second edition was published in July 2022. It is an industry guide, not a regulation, but it is widely used to meet Annex 11 and Part 11. This site treats it as link-only, so this profile stays at a general level.
Who and what it applies to
Regulated companies and suppliers of GxP computerised systems.
What it contains
- Structure
- A paid ISPE publication. Consult ISPE for its contents.
Key points
- It is good practice, not a legal requirement.
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 as a method, and cite the regulation as the requirement.
Read from the source document on 1 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 |
|---|---|---|---|
| 29 Jul 2022 | Second edition published (29 Jul 2022) | Industry guide | Source for Second edition published (29 Jul 2022) |
Related
How other documents connect to this one. Links explained
- Related to FDA CSA guidance· Compare with FDA CSA guidance Unverified link
- Complemented by GAMP AI guide· Compare with GAMP AI guide 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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