{"id":7088,"date":"2021-09-14T07:54:47","date_gmt":"2021-09-14T10:54:47","guid":{"rendered":"https:\/\/passarini.com.br\/?post_type=avada_portfolio&#038;p=7088"},"modified":"2022-12-02T09:58:19","modified_gmt":"2022-12-02T12:58:19","slug":"computer-systems-validation","status":"publish","type":"avada_portfolio","link":"https:\/\/passarini.com.br\/en\/portfolio-items\/computer-systems-validation\/","title":{"rendered":"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:center top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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-bottom:0px;--awb-flex-wrap:wrap;\" id=\"quem-somos-banner-container\" ><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-bg-size:cover;\"><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%;\" id=\"quem-somos-slider\"><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\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados.webp\" alt=\"validation of computadorized systems\" width=\"1920\" height=\"500\" class=\"wp-image-7083\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2017\/05\/1920x500_banner_validacao-de-sistemas-computadorizados.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/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 fusion-equal-height-columns\" style=\"--awb-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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:60px;--awb-padding-bottom:100px;--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_2_3 2_3 fusion-two-third fusion-column-first\" style=\"--awb-padding-top:40px;--awb-padding-right:40px;--awb-padding-bottom:40px;--awb-padding-left:40px;--awb-bg-color:#ffffff;--awb-bg-color-hover:#ffffff;--awb-bg-size:cover;--awb-border-color:#dddddd;--awb-border-top:1px;--awb-border-right:1px;--awb-border-bottom:1px;--awb-border-left:1px;--awb-border-style:solid;width:65.3333%; margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h1 style=\"font-size: 40px;\">Computer Systems Validation<\/h1>\n<p>The Computerized Systems Validation is a documental process that has as purpose to protect the integrity of the related data to the automated industrial production, guaranteeing a complete traceability of information assuring the compliance of the standards and requirements of the main regulatory agencies in the world (Guidelines to GMP Volume 4 \u2013 European Commission; EMA Annex 11;<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/fda-registration\/\"> FDA<\/a> 21 CFR Part 11, etc), besides the implementation of the Good Practices rules and optimization of the production, the validation reflects also in the reduction of costs, lifting of the product quality, and helps to assure the health of the final user.<\/p>\n<p>In Brazil, the Computer Systems Validation is an <a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">ANVISA<\/a> (National Agency of Public Health Vigilance) requirement, as well in several others important regulators bodies around the world.<\/p>\n<p><strong>MAIN ADVANTAGES OF THE VALIDATION<\/strong><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;margin-bottom:0px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><ul style=\"--awb-size:13px;--awb-line-height:22.1px;--awb-icon-width:22.1px;--awb-icon-height:22.1px;--awb-icon-margin:9.1px;--awb-content-margin:31.2px;--awb-circlecolor:#3bafbf;--awb-circle-yes-font-size:11.44px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Guarantees the integrity of the productive process\u2019 information;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Contributes to improvement of the final product\u2019s quality;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Allows the utilization of all automated resources available in the system;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Allows that the whole technical team be holder of deep knowledge about the systems studied;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Avoids the loose of knowledge if eventually a professional leaves the company, reducing the business risks;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Optimizes the utilization of computer systems, allowing great automation of the processes and increasing reliability;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Directs the team to necessary actions based on risks, reducing the production downtime and consequently, reducing loses;<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">Increases the reliability of the recorded data in processes, avoiding operational mistakes.<\/div><\/li><\/ul><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:30px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p><a href=\"http:\/\/passarini.com.br\/en\/contact\/\">Contact us for more information.<\/a><\/p>\n<p>You may also be interested in Computerized Systems Validation:<\/p>\n<p><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">ANVISA Registration<\/a><br \/>\n<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anatel-approval\/\">ANATEL Approval<\/a><br \/>\n<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/inmetro-certification\/\">INMETRO Certification<\/a><\/p>\n<\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_3 1_3 fusion-one-third fusion-column-last\" 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