{"id":4570,"date":"2019-05-13T14:27:25","date_gmt":"2019-05-13T17:27:25","guid":{"rendered":"http:\/\/passarini.com.br\/hospitalar-fair-2019-2\/"},"modified":"2021-08-24T20:26:10","modified_gmt":"2021-08-24T23:26:10","slug":"systems-validation","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/systems-validation\/","title":{"rendered":"Systems Validation"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left center;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"http:\/\/passarini.com.br\/wp-content\/uploads\/2017\/06\/1920x500_informativos_noticias.png\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:10px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><p><strong>Systems Validation<\/strong><\/p>\n<p>With the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company.<\/p>\n<p>The counterpoint to such an approach is that, with the system storing critical data in terms of traceability of products and processes, and because of this, the whole system must undergo a validation process, where this validation must contemplate a detailed qualification of each point that impact directly on the product, such as: risk management system and documentation related to installation, staff training, version control and company\u2019s requirements and how they were implemented.<\/p>\n<p>To help companies carry out validation, there are several guides: <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">ANVISA<\/a> offers the &#8220;computer <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/computer-systems-validation\/\">systems validation<\/a> guide&#8221; for free; the FDA has 21 CRF Part11 dealing with the same subject; and the European Union has the GMP Annex 11.<\/p>\n<p>In addition to the guides provided by regulatory agencies, ISPE (International Society of Pharmaceutical Engineering) produces a guide called GAMP 5 (Good Automated Manufacturing Practice) that addresses all global software validation requirements.<\/p>\n<p>For more information and explanations about it, send us an e-mail:<span style=\"color: #0000ff;\">\u00a0<strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span><\/p>\n<p>Published: 05\/13\/2019<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"Systems Validation\r\n\r\nWith the great supply of management software available along with the relatively low cost of deployment, many medical companies started to control everything via system, eliminating much of the printed documentation, bringing great benefits in the management of the company.\r\n\r\nThe counterpoint to such an approach is that, with the system\" data-link=\"http:\/\/passarini.com.br\/en\/systems-validation\/\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a href=\"https:\/\/www.facebook.com\/sharer.php?u=http%3A%2F%2Fpassarini.com.br%2Fen%2Fsystems-validation%2F&amp;t=Passarini%20Regulatory%20Affairs\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/x.com\/intent\/post?text=Passarini%20Regulatory%20Affairs&amp;url=http%3A%2F%2Fpassarini.com.br%2Fen%2Fsystems-validation%2F\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"X\" aria-label=\"X\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"X\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-twitter awb-icon-twitter\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":4566,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68,73,159],"tags":[70,154,155,149],"class_list":["post-4570","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","category-cheers","category-regulatory","tag-brazil","tag-cheers","tag-health","tag-regulatory"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4570","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=4570"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4570\/revisions"}],"predecessor-version":[{"id":6911,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4570\/revisions\/6911"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/4566"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=4570"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=4570"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=4570"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}