{"id":11026,"date":"2024-12-11T15:17:19","date_gmt":"2024-12-11T14:17:19","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-16-steuerung-von-entwurfsaenderungen\/"},"modified":"2025-02-04T13:38:13","modified_gmt":"2025-02-04T12:38:13","slug":"5-2-16-gestion-des-modifications-de-la-conception","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-16-steuerung-von-entwurfsaenderungen\/","title":{"rendered":"5.2.16 Contr\u00f4le des modifications de conception"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">But et objectif<\/h2>\n\n\n\n<p>D\u00e9terminer comment identifier et documenter les besoins de changement ou de modification des proc\u00e9dures, comment faire en sorte qu'une r\u00e9vision soit effectu\u00e9e, quand la proc\u00e9dure sera \u00e0 nouveau v\u00e9rifi\u00e9e et comment la proc\u00e9dure sera v\u00e9rifi\u00e9e et approuv\u00e9e par le personnel autoris\u00e9 avant d'\u00eatre utilis\u00e9e en cours d'exploitation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Application<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description du d\u00e9roulement<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risques<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Ressources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Mat\u00e9riau<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Temps n\u00e9cessaire<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentation<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Comp\u00e9tence et qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Remarques et commentaires<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documents \u00e0 joindre<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documents de validation<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Termes<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Placements<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel Festzulegen ist, wie der Bedarf an \u00c4nderungen oder Modifikationen der Verfahren identifiziert und dokumentiert wird, wie eine \u00dcberarbeitung veranlasst, wann das Verfahren erneut gepr\u00fcft wird und wie das Verfahren vor dem Einsatz im laufenden Betrieb durch befugtes Personal gepr\u00fcft und freigegeben wird. Anwendung Beschreibung des Ablaufes Risiken Ressourcen Material Zeitbedarf Dokumentation Zust\u00e4ndigkeit [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":51,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11026","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11026","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/comments?post=11026"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11026\/revisions"}],"predecessor-version":[{"id":15106,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11026\/revisions\/15106"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/media?parent=11026"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_tag?post=11026"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_badge?post=11026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}