Computerized system validation (original) (raw)
Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules.
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| dbo:abstract | Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules. (en) Computer System Validation (CSV) ist ein dokumentierter Validierungs-Prozess, der konsistent und reproduzierbar nachweist, dass ein computergestütztes System seine Prozesse so ausführt, wie sie von ihm gefordert werden (Prüfung der Zweckbestimmung). Der gesamte Validierungsprozess begleitet den kompletten Lebenszyklus des Systems von der Definition der Anforderungen über den Betrieb bis zur Außerbetriebnahme. (de) |
| dbo:wikiPageExternalLink | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf |
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| dbo:wikiPageLength | 2116 (xsd:nonNegativeInteger) |
| dbo:wikiPageRevisionID | 1099199602 (xsd:integer) |
| dbo:wikiPageWikiLink | dbr:System_requirements dbr:Quality_assurance dbr:Software_engineering dbc:Quality_control dbc:Software_quality dbr:Software_testing dbr:User_requirements_specification dbr:List_of_software_engineering_topics |
| dbp:wikiPageUsesTemplate | dbt:Reflist |
| dcterms:subject | dbc:Quality_control dbc:Software_quality |
| gold:hypernym | dbr:Process |
| rdf:type | dbo:Election |
| rdfs:comment | Computerized system validation (CSV) (usually referred to as "Computer Systems Validation") is the process of testing/validating/qualifying a regulated (E.g., FDA 21CFR11) computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records. This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with the system proposal/requirements definition and continues until system retirement and retention of the e-records based on regulatory rules. (en) Computer System Validation (CSV) ist ein dokumentierter Validierungs-Prozess, der konsistent und reproduzierbar nachweist, dass ein computergestütztes System seine Prozesse so ausführt, wie sie von ihm gefordert werden (Prüfung der Zweckbestimmung). Der gesamte Validierungsprozess begleitet den kompletten Lebenszyklus des Systems von der Definition der Anforderungen über den Betrieb bis zur Außerbetriebnahme. (de) |
| rdfs:label | Computerized System Validation (de) Computerized system validation (en) |
| owl:sameAs | freebase:Computerized system validation wikidata:Computerized system validation dbpedia-de:Computerized system validation https://global.dbpedia.org/id/4iHvE |
| prov:wasDerivedFrom | wikipedia-en:Computerized_system_validation?oldid=1099199602&ns=0 |
| foaf:isPrimaryTopicOf | wikipedia-en:Computerized_system_validation |
| is dbo:wikiPageDisambiguates of | dbr:CSV |
| is dbo:wikiPageWikiLink of | dbr:CSV dbr:V-Model |
| is foaf:primaryTopic of | wikipedia-en:Computerized_system_validation |