Statements (23)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
regulatory guideline
|
| gptkbp:appliesTo |
gptkb:European_Union
pharmaceutical industry |
| gptkbp:focusesOn |
computerised systems
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU GMP Annex 11
|
| gptkbp:language |
English
|
| gptkbp:partOf |
EU GMP Guidelines
|
| gptkbp:publishedBy |
gptkb:European_Parliament
|
| gptkbp:regulates |
use of computerised systems in GMP environments
|
| gptkbp:requires |
risk management
audit trails data integrity incident management security controls business continuity change control user access management periodic evaluation validation of computerised systems supplier and service provider management |
| gptkbp:startDate |
2011
|
| gptkbp:bfsParent |
gptkb:GAMP
|
| gptkbp:bfsLayer |
7
|