Document:EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011
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| Document information | |
|---|---|
| Reference | EU Eudralex - volume 4
GMP Guidelines Annex 11 Jan-2011 |
| Validity area | EU |
| Scope(s) | G |
| Document name | Eudralex - volume 4
GMP Guidelines Annex 11 |
| Version / Revision | Jan-2011 |
| Status | N.A. |
| Document type | Corpus of texts |
| Language(s) | EN |
| Description | Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Annex 11 Computerised Systems |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14 | G | 14 | EN | Annex 11: Computerised Systems
14. Electronic Signature Electronic records may be signed electronically. Electronic signatures are expected to: a. ha… |