{"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-of-design-changes","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-16-steuerung-von-entwurfsaenderungen\/","title":{"rendered":"5.2.16 Control of design changes"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>It must be specified how the need for changes or modifications to the procedures is identified and documented, how a revision is initiated, when the procedure is reviewed and how the procedure is checked and approved by authorised personnel before it is used in ongoing operations.<\/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 of the process<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risks<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Resources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Time required<\/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\">Responsibility and qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Validation documents<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Terms<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/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\/en\/wp-json\/wp\/v2\/docs\/11026","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11026"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11026\/revisions"}],"predecessor-version":[{"id":15106,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11026\/revisions\/15106"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11026"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11026"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11026"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}