EMA · Life Science & Pharma: GxP - CSV & Data Integrity
EMA GMP Questions and Answers: Annex 11 and Data integrity
Final CSV & Data Integrity · Questions and answers Last verified: not yet · Source last checked 3 Nov 2026
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Questions and answers from EU inspectors explaining how they read Annex 11 and data integrity in practice.
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.
- Annex 11 questions dated February 2011
In plain English
EMA questions and answers on applying EU GMP. The Annex 11 section covers spreadsheets, database security, validation and storage of electronic data. The data integrity section covers data risk, the data lifecycle, audit trails, review of electronic data, ALCOA and supply chains.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
These are sections of the EMA and EU inspectors' long-running questions and answers on GMP and GDP. The Annex 11 questions are dated February 2011, and the Data integrity section has 23 questions with no date shown. They explain how inspectors read Annex 11 and data integrity in practice.
Who and what it applies to
Manufacturers, importers and others under EU GMP, including senior management, contract givers and acceptors, and Qualified Persons.
What it contains
- Annex 11 questions
- Spreadsheets, database security, risk management across the lifecycle, retrospective validation of legacy systems, revalidation, electronic data storage time, small devices and printouts.
- Data risk and criticality
- How to assess each, including what decision the data influence and their impact on quality or safety.
- Data lifecycle
- What it means, why it matters, and what to consider when reviewing it.
- Data integrity procedures and paper control
- Whether a specific procedure is required, and how to control paper systems against unauthorised re-creation of data.
- Electronic data
- How to preserve originals, why to review electronic data, and whether risk-based review is acceptable.
- Self-inspection and contracting
- Self-inspection, contract activities, building confidence in certificates of analysis, and supply chain responsibility.
Key points
- Spreadsheets are in scope and need controls.
- Data integrity failures at contractors matter to the contract giver.
- Review of electronic data should be risk-based, and exception-based review has conditions.
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.
- Add these to your procedures' references, as they show inspectors' current reading.
- Use the data criticality questions in a structured review of your systems.
- Check your paper controls against the unauthorised re-creation question.
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 Nov 2026 | Data integrity section (23 questions) listed; no date shown | Final | Source for Data integrity section (23 questions) listed; no date shown |
| ~1 Feb 2011 | Annex 11 questions dated February 2011 | Final | Source for Annex 11 questions dated February 2011 |
Related
How other documents connect to this one. Links explained
- Interprets Annex 11 (2011)· Compare with Annex 11 (2011) Unverified link
Official source
The official text always prevails over anything on this site.
Source: EMA. Summary adapted from the original.
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