ISPE · Life Science & Pharma: GxP - CSV & Data Integrity
ISPE GAMP Guide: Records and Data Integrity
Industry guide Data Integrity · Industry guide Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- ISPE
- Category
- Data Integrity
- Sub Category
- Industry guide
- Legal weight
- Industry good practice
- Reuse
- Link only
The industry's guide to records and data integrity. 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 (March 2017)
In plain English
ISPE industry guide on records and data integrity. 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: Records and Data Integrity was published in March 2017. It is an industry guide. This site treats it as link-only.
Who and what it applies to
Regulated companies working on data integrity.
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 alongside regulators' data integrity guidance.
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 |
|---|---|---|---|
| ~1 Mar 2017 | Published (March 2017) | Industry guide | Source for Published (March 2017) |
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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