Compare Annex 15 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
- Annex 15 complements Annex 11 (2011) · Source Unverified link
Side by side
| Annex 15 | Annex 11 (2011) | |
|---|---|---|
| Authority | European Commission | European Commission |
| Legal weight | GMP guide & annexes | GMP guide & annexes |
| Status | In force | In force |
| Last verified | Not yet | Not yet |
| Summary | The EU GMP annex on qualification and validation. | 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: European Commission. Licensed under CC BY 4.0. | 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.