{"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-control-de-los-cambios-de-diseno","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/es\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-16-steuerung-von-entwurfsaenderungen\/","title":{"rendered":"5.2.16 Control de los cambios de dise\u00f1o"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Finalidad y objetivo<\/h2>\n\n\n\n<p>Debe especificarse c\u00f3mo se identifica y documenta la necesidad de introducir cambios o modificaciones en los procedimientos, c\u00f3mo se inicia una revisi\u00f3n, cu\u00e1ndo se revisa el procedimiento y c\u00f3mo lo comprueba y aprueba el personal autorizado antes de utilizarlo en las operaciones en curso.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Aplicaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Descripci\u00f3n del proceso<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Riesgos<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Recursos <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Tiempo necesario<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Responsabilidad y cualificaci\u00f3n<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notas y comentarios<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documentos aplicables<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documentos de validaci\u00f3n<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">T\u00e9rminos<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Archivos adjuntos<\/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\/es\/wp-json\/wp\/v2\/docs\/11026","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/comments?post=11026"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11026\/revisions"}],"predecessor-version":[{"id":15106,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/11026\/revisions\/15106"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/media?parent=11026"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_tag?post=11026"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/es\/wp-json\/wp\/v2\/doc_badge?post=11026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}