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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

 ScopeDocument partLanguagePreview
EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011 14G14ENAnnex 11: Computerised Systems

14. Electronic Signature Electronic records may be signed electronically. Electronic signatures are expected to:

a. ha…