Compare EMA GMP Q&A: IT and DI and Annex 11 (2011)
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- EMA GMP Q&A: IT and DI interprets Annex 11 (2011) · Source Unverified link
Side by side
| EMA GMP Q&A: IT and DI | Annex 11 (2011) | |
|---|---|---|
| Authority | EMA | European Commission |
| Legal weight | Guidance & Q&A | GMP guide & annexes |
| Status | Final | In force |
| Last verified | Not yet | Not yet |
| Summary | 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. | The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation. |
| Lifecycle |
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| Source | Official text Source: EMA. | Official text Source: European Commission. Licensed under CC BY 4.0. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.