{"id":4694,"date":"2019-07-31T10:11:27","date_gmt":"2019-07-31T13:11:27","guid":{"rendered":"http:\/\/passarini.com.br\/consulting-in-clinical-research-2\/"},"modified":"2021-11-17T15:59:24","modified_gmt":"2021-11-17T18:59:24","slug":"iso-13485-2016-and-its-relationship-with-computer-systems-validation","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/iso-13485-2016-and-its-relationship-with-computer-systems-validation\/","title":{"rendered":"ISO 13485: 2016 and its relationship with Computer 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=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp\" \/><\/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\"><h2><span style=\"color: #000000;\"><strong style=\"font-size: 56px;\" data-fusion-font=\"true\">ISO 13485: 2016 and its relationship with Computer Systems Validation<\/strong><\/span><\/h2>\n<p>The newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production control systems (MES) to more rudimentary systems such as industrial equipment managed via PLCs, CNCs and computerized machining units.<\/p>\n<h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 46; line-height: 1.25; font-size: 34px;\" data-fontsize=\"46\" data-lineheight=\"57.5px\" data-fusion-font=\"true\">A summary of the requirements of ISO 13485: 2016 for Computer Systems Validation is described below:<\/h2>\n<ul>\n<li>An organization should document procedures for validating the application of quality management system monitoring software, such as using monitoring software for product monitoring and measurement requirements, on systems used in the production and delivery of service. Such software must be validated prior to initial use and, as appropriate, after the change of software or its application.<\/li>\n<li>The approach and tasks specific to software validation and validation should be proportionate to the risk associated with the use of the software, including the effect on the ability to conform to specifications.<\/li>\n<li>Records that the results of validation, validation and validation of the information should be kept.<\/li>\n<li>An organization shall document the installation requirements necessary to comply with the requirements of the product, prevent a mixture of products and ensure orderly handling. The infrastructure includes process equipment and \/ or support services, such as information systems.<\/li>\n<\/ul>\n<p>ISO 13485: 2016 despite these requirements does not indicate or reference any guide or standard for these computer systems validation processes. ANVISA has published a manual to help Brazilian manufacturers and distributors in their <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/portal.anvisa.gov.br\/documents\/33836\/2501339\/Guia+de+valida%C3%A7%C3%A3o+de+sistemas+computadorizados\/034889a7-6b3f-439d-b8e5-32a0061ab395\">Guide to Computer Systems Validation<\/a><\/strong><\/span> (in portuguese), 2010 with great tact to introduce the theme.<\/p>\n<p>The best validation guides for operating systems are:<\/p>\n<ul>\n<li><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/www.fda.gov\/regulatoryinformation\/guidances\/ucm125067.htm\">FDA Code of Federal Regulations Title 21 (21 CFR Part 11)<\/a><\/strong><\/span><\/li>\n<li><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/ispe.org\/publications\/guidance-documents\">ISPE \u2013 International Society for Pharmaceutical Engineering (GAMP 5)<\/a><\/strong><\/span><\/li>\n<li><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/ec.europa.eu\/health\/documents\/eudralex\/vol-4_en\">2\u00ba EMA Eudralex \u2013 EU Legislation \u2013 European Commission (Annex 11)<\/a><\/strong><\/span><\/li>\n<\/ul>\n<p>For more information and explanations about it, send us an e-mail:<span style=\"color: #0000ff;\"> <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: 07\/31\/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=\"ISO 13485: 2016 and its relationship with Computer Systems Validation\r\nThe newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production control systems\" data-link=\"https:\/\/passarini.com.br\/en\/iso-13485-2016-and-its-relationship-with-computer-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=https%3A%2F%2Fpassarini.com.br%2Fen%2Fiso-13485-2016-and-its-relationship-with-computer-systems-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 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":3903,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[68,72,73,159],"tags":[70,170,154,155,149],"class_list":["post-4694","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-brazil","category-ce-mark","category-cheers","category-regulatory","tag-brazil","tag-ce-mark","tag-cheers","tag-health","tag-regulatory"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4694","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=4694"}],"version-history":[{"count":12,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4694\/revisions"}],"predecessor-version":[{"id":6978,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/4694\/revisions\/6978"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/3903"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=4694"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=4694"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=4694"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}