{"id":4656,"date":"2020-01-30T15:07:09","date_gmt":"2020-01-30T14:07:09","guid":{"rendered":"http:\/\/wordpress.p526553.webspaceconfig.de\/?p=4656"},"modified":"2023-02-15T11:00:13","modified_gmt":"2023-02-15T10:00:13","slug":"biotechnik-und-pharma","status":"publish","type":"post","link":"https:\/\/www.delphinco.com\/?p=4656","title":{"rendered":"Projektbeispiel \u2013 Biotechnik &#038; Pharma"},"content":{"rendered":"<p>[vc_row gap=&#8221;15&#8243; type=&#8221;vc_default&#8221; margin_top=&#8221;-50&#8243; el_class=&#8221;box_1&#8243;][vc_column offset=&#8221;vc_col-lg-12 vc_col-md-12&#8243; css=&#8221;.vc_custom_1580982463699{background-color: #f4f4f4 !important;}&#8221;][vc_icon type=&#8221;linecons&#8221; icon_linecons=&#8221;vc_li vc_li-lab&#8221; color=&#8221;custom&#8221; size=&#8221;xl&#8221; custom_color=&#8221;#3d79bd&#8221;]<div id=\"ultimate-heading-64606a1e01c18e0a8\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-64606a1e01c18e0a8 uvc-5242 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-64606a1e01c18e0a8 h2'  data-responsive-json-new='{\"font-size\":\"desktop:26px;tablet:26px;tablet_portrait:26px;mobile_landscape:26px;mobile:26px;\",\"line-height\":\"desktop:30px;tablet:30px;tablet_portrait:30px;mobile_landscape:30px;mobile:30px;\"}' ><h2 style=\"font-family:&#039;Roboto&#039;;font-weight:500;color:#3d79bd;\">Projektbeispiel: Biotechnik &amp; Pharma<\/h2><\/div><div class=\"uvc-sub-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-64606a1e01c18e0a8 .uvc-sub-heading '  data-responsive-json-new='{\"font-size\":\"desktop:28px;tablet:28px;tablet_portrait:28px;mobile_landscape:28px;mobile:28px;\",\"line-height\":\"\"}'  style=\"font-family:&#039;Montserrat&#039;;font-weight:300;color:#183e7a;margin-top:10px;\">Technische Unterst\u00fctzung f\u00fcr die Erf\u00fcllung regulatorischer Anforderungen bei der Herstellung medizinischer Produkte<\/div><\/div>[vc_empty_space height=&#8221;30px&#8221;][vc_column_text]<b>Projektbeschreibung und Herausforderungen<\/b><\/p>\n<p>Unser Kunde ist ein f\u00fchrendes Pharma-Unternehmen in Ostfrankfreich. In dieser komplexen Branche werden die Herstellungsprozesse immmer wieder neu \u00fcberdacht und optimiert. Hierf\u00fcr m\u00fcssen, unter Ber\u00fccksichtigung der geltenden regulatorischen Anforderungen, neue ma\u00dfgeschneiderte digitale Werkzeuge entwickelt und validiert werden.[\/vc_column_text][\/vc_column][\/vc_row][vc_row gap=&#8221;15&#8243; equal_height=&#8221;yes&#8221;][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1580488965461{background-color: #f4f4f4 !important;}&#8221;]<div id=\"ultimate-heading-87856a1e01c18e0d8\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-87856a1e01c18e0d8 uvc-1851 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-87856a1e01c18e0d8 h2'  data-responsive-json-new='{\"font-size\":\"desktop:28px;tablet:28px;tablet_portrait:28px;mobile_landscape:28px;mobile:28px;\",\"line-height\":\"\"}' ><h2 style=\"font-family:&#039;Roboto&#039;;font-weight:500;color:#183e7a;\">Zust\u00e4ndigkeitsbereich:<\/h2><\/div><\/div>[vc_empty_space height=&#8221;30px&#8221;][vc_column_text]<b>Technische Unterst\u00fctzung\u00a0 in Compliance, <\/b><b>Requirements<\/b><b> &amp; Methods <\/b><\/p>\n<p>(CFR 21, Part 11 &amp; GAMP Compliance)<\/p>\n<ul>\n<li>Risikoanalyse\/-management nach ISO 14971 &amp; GAMP, FMEA<\/li>\n<li>CSV: Strategien, Planung &amp; Durchf\u00fchrung\u2026<\/li>\n<li>Pr\u00fcfung der unternehmenseigenen Prozesse, die eine Validierung ben\u00f6tigen, um diese dann im Verlauf zu validieren<\/li>\n<li>Analyse und Aufbau eines Methodenansatzes<\/li>\n<li>Prozessmodellierung der Arbeitsabl\u00e4ufe<\/li>\n<li>Betreuung der IT-Validierung nach GAMP 5<\/li>\n<li>Dokumentation<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243; css=&#8221;.vc_custom_1580488996781{background-color: #f4f4f4 !important;}&#8221;]<div id=\"ultimate-heading-89456a1e01c18e0f4\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-89456a1e01c18e0f4 uvc-8328 \" data-hspacer=\"no_spacer\"  data-halign=\"left\" style=\"text-align:left\"><div class=\"uvc-heading-spacer no_spacer\" style=\"top\"><\/div><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-89456a1e01c18e0f4 h2'  data-responsive-json-new='{\"font-size\":\"desktop:28px;tablet:28px;tablet_portrait:28px;mobile_landscape:28px;mobile:28px;\",\"line-height\":\"\"}' ><h2 style=\"font-family:&#039;Roboto&#039;;font-weight:500;color:#183e7a;\">Gewinn f\u00fcr den Kunden:<\/h2><\/div><\/div>[vc_empty_space height=&#8221;30px&#8221;][vc_column_text]<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>Vervollst\u00e4ndigung bzw. Abschluss der notwendigen Dokumentation f\u00fcr den GAMP Validierungsprozess<\/li>\n<li>Validierung einiger IT-Werkzeuge<\/li>\n<li>Einf\u00fchrung der digitalen Prozessmodellierung von Arbeitsabl\u00e4ufen<\/li>\n<li>Optimierung der Regelwerke &amp; Vorschriften bei der Herstellung &amp; Validierung von digitalen Werkzeugen<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column]<div class=\" ubtn-ctn-left \"><a class=\"ubtn-link ult-adjust-bottom-margin ubtn-left ubtn-normal \" href=\"http:\/\/delphinco.com\/unsere-kunden\/\" ><button type=\"button\" id=\"ubtn-5297\"  class=\"ubtn ult-adjust-bottom-margin ult-responsive ubtn-normal ubtn-no-hover-bg  none  ubtn-sep-icon ubtn-sep-icon-right-push  ubtn-left   tooltip-6a1e01c18e10f\"  data-hover=\"#ffffff\" data-border-color=\"\" data-bg=\"#183e7a\" data-hover-bg=\"#6ca9f2\" data-border-hover=\"\" data-shadow-hover=\"\" data-shadow-click=\"none\" data-shadow=\"\" data-shd-shadow=\"\"  data-ultimate-target='#ubtn-5297'  data-responsive-json-new='{\"font-size\":\"desktop:16px;tablet:16px;tablet_portrait:16px;mobile_landscape:16px;mobile:16px;\",\"line-height\":\"\"}'  style=\"font-family:&#039;Roboto&#039;;font-weight:normal;border:none;background: #183e7a;color: #ffffff;\"><span class=\"ubtn-data ubtn-icon\"><i class=\"icomoon-the7-font-the7-arrow-28\" style=\"font-size:32px;color:#ffffff;\"><\/i><\/span><span class=\"ubtn-hover\" style=\"background-color:#6ca9f2\"><\/span><span class=\"ubtn-data ubtn-text \" >zur\u00fcck zur \u00dcbersicht<\/span><\/button><\/a><\/div>[\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[vc_row gap=&#8221;15&#8243; type=&#8221;vc_default&#8221; margin_top=&#8221;-50&#8243; el_class=&#8221;box_1&#8243;][vc_column offset=&#8221;vc_col-lg-12 vc_col-md-12&#8243; css=&#8221;.vc_custom_1580982463699{background-color: #f4f4f4 !important;}&#8221;][vc_icon type=&#8221;linecons&#8221; icon_linecons=&#8221;vc_li vc_li-lab&#8221; color=&#8221;custom&#8221; size=&#8221;xl&#8221; custom_color=&#8221;#3d79bd&#8221;][vc_empty_space height=&#8221;30px&#8221;][vc_column_text]Projektbeschreibung und Herausforderungen Unser Kunde ist ein f\u00fchrendes Pharma-Unternehmen in Ostfrankfreich. In dieser komplexen Branche werden die Herstellungsprozesse immmer wieder neu \u00fcberdacht und optimiert. Hierf\u00fcr m\u00fcssen, unter Ber\u00fccksichtigung der geltenden regulatorischen Anforderungen, neue ma\u00dfgeschneiderte digitale Werkzeuge entwickelt und validiert&hellip;<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[1],"tags":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/posts\/4656"}],"collection":[{"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4656"}],"version-history":[{"count":37,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/posts\/4656\/revisions"}],"predecessor-version":[{"id":6269,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=\/wp\/v2\/posts\/4656\/revisions\/6269"}],"wp:attachment":[{"href":"https:\/\/www.delphinco.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4656"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4656"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delphinco.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4656"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}