{"id":11024,"date":"2024-12-11T15:17:07","date_gmt":"2024-12-11T14:17:07","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-15-einfuehrung-neuer-oder-geaenderter-produkte\/"},"modified":"2025-02-04T13:38:12","modified_gmt":"2025-02-04T12:38:12","slug":"5-2-15-introduction-of-new-or-modified-products","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-15-einfuehrung-neuer-oder-geaenderter-produkte\/","title":{"rendered":"5.2.15 Introduction of new or modified products"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>The introduction of new and modified products must be comprehensively coordinated within the organisation. The training requirements must be defined and the provision of resources must be checked. The requirements for the records must be defined and integrated into the HIS. Communication along the process flow must be ensured. Information for employees.<\/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 Die Einf\u00fchrung neuer und ge\u00e4nderter Produkte muss inner-halb der Organisation umfassen abgestimmt werden. Der Schulungsbedarf ist festzulegen, die Bereitstellung der Res-sourcen muss \u00fcberpr\u00fcft werden. Die Anforderungen an die Aufzeichnungen m\u00fcssen festgelegt und in das KIS integriert werden. Die Kommunikation entlang des Prozessverlaufes muss gesichert werden. Information der Mitarbeiter. Anwendung Beschreibung des Ablaufes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":50,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11024","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\/11024","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=11024"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11024\/revisions"}],"predecessor-version":[{"id":15105,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11024\/revisions\/15105"}],"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=11024"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11024"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11024"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}