Statements (24)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:appliesTo |
pharmaceutical manufacturers
clinical trial sponsors contract laboratories Good Manufacturing Practice (GMP) regulated activities |
| gptkbp:enforcedBy |
gptkb:European_Medicines_Agency
|
| gptkbp:firstIssueDate |
1992
|
| gptkbp:focusesOn |
computerised systems in pharmaceutical manufacturing
|
| gptkbp:fullName |
Annex 11: Computerised Systems
|
| gptkbp:jurisdiction |
gptkb:European_Union
|
| gptkbp:language |
English
|
| gptkbp:latestReleaseVersion |
2011
|
| gptkbp:partOf |
EU GMP Guidelines
|
| gptkbp:purpose |
ensure integrity and reliability of electronic records
|
| gptkbp:relatedTo |
gptkb:21_CFR_Part_11
|
| gptkbp:requires |
audit trails
data integrity security controls user access management validation of computerised systems |
| gptkbp:website |
https://ec.europa.eu/health/documents/eudralex/vol-4_en
|
| gptkbp:bfsParent |
gptkb:OpenText_Life_Sciences_Smart_View
|
| gptkbp:bfsLayer |
7
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU Annex 11
|