{"id":7507,"date":"2021-06-30T15:29:32","date_gmt":"2021-06-30T13:29:32","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=7507"},"modified":"2021-06-30T15:29:32","modified_gmt":"2021-06-30T13:29:32","slug":"validation-of-computer-based-systems-and-software-how-to-make-the-process-efficient","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2021\/06\/30\/validation-of-computer-based-systems-and-software-how-to-make-the-process-efficient\/","title":{"rendered":"Validation of computer-based systems and software: how to make the process efficient"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-6ce9208f6cc12465478de2afd45cd9de\">\n.avia-section.av-kkwbho9e-6ce9208f6cc12465478de2afd45cd9de{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/06\/shutterstock_1100114120-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-kkwbho9e-6ce9208f6cc12465478de2afd45cd9de .av-section-color-overlay{\nopacity:0.5;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-6ce9208f6cc12465478de2afd45cd9de main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7507'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-bjkpou-4d21ae85a694f724a081997bbbff889f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7507'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r4r66-90380a229f4631b5c0d2990376471ae0\">\n.flex_column.av-9r4r66-90380a229f4631b5c0d2990376471ae0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9r4r66-90380a229f4631b5c0d2990376471ae0 av_four_fifth  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kqjicqx8-a70769c615d906dd9da5f6da199325c7\">\n#top .av-special-heading.av-kqjicqx8-a70769c615d906dd9da5f6da199325c7{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kqjicqx8-a70769c615d906dd9da5f6da199325c7 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kqjicqx8-a70769c615d906dd9da5f6da199325c7 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kqjicqx8-a70769c615d906dd9da5f6da199325c7 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Validation of computer-based systems and software: how to make the process efficient<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-4  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Can a computer-based system or software achieve its intended use? This is a fundamental question for manufacturers of medical devices, which must be answered by validating these systems. EN ISO 13485:2016 requires the validation of software applications and computer systems used for the development and manufacture of medical devices.<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The aim is to check by objective means whether specified users achieve the specified usage goals in the specified usage context. Validation is to prove that the installed software system functions as expected in the intended operating environment and that the process requirements are fulfilled in a comprehensible way.<\/p>\n<p>Process validation is intended to ensure that conceivable hazards for patients, users or third parties are not overlooked as soon as software systems are used. This ensures the quality of medical devices.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6ypsa6-753f5b54e3592c9b8ca58115dc628cb0\">\n.avia-section.av-6ypsa6-753f5b54e3592c9b8ca58115dc628cb0{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/03\/shutterstock_682989595-scaled.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-753f5b54e3592c9b8ca58115dc628cb0 .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-753f5b54e3592c9b8ca58115dc628cb0 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7507'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-8  el_before_av_three_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kq9k1iff-30180044fdd3575dfb8c24e01dba568c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a component of the technical documentation, validation is not only subject to the requirements of the ISO 13485 standard, but also to the detailed specifications of the MDR 2017\/745 and the continuous obligation to keep it up to date.<\/p>\n<p>How you can accelerate the validation process efficiently and sustainably? BAYOOSOFT Risk Manager is based on the GAMP 5 guidelines for computer-aided validation and is validated as Category 4 software. In comparison: If you use solutions such as Microsoft Excel or Word files for development in risk management or product documentation, you have to validate them.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-a4f7320a8115fc754f9d474f62324c3c\">\n.flex_column.av-bcmscg-a4f7320a8115fc754f9d474f62324c3c{\nborder-width:2px;\nborder-color:#92afab;\nborder-style:solid;\nborder-radius:0px 0px 0px 0px;\npadding:20px 20px 20px 20px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-a4f7320a8115fc754f9d474f62324c3c av_three_fourth  avia-builder-el-10  el_after_av_three_fourth  el_before_av_one_fourth  first flex_column_div  column-top-margin'     ><article  class='iconbox iconbox_left av-kqjhyjkb-2a414575bfb204ed23354b8edb53baf4  avia-builder-el-11  el_before_av_textblock  avia-builder-el-first '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Do you already know the Pre-Validation Package?\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue864' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Do you already know the Pre-Validation Package?<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><ul>\n<li>Time saving: As part of the Pre-Validation Package, you receive a Quick Start Guide which supports you in carrying out the validation process quickly and effectively.<\/li>\n<li>Streamline processes, save costs: You receive over 500 pages of prepared validation work for your sustainable and standard-compliant documents.<\/li>\n<li>Sustainability included: All necessary updates are included with every software update for re-validation<\/li>\n<li>Special Service: With a special service package, we can take over the validation of BAYOOSOFT Risk Manager according to GAMP 5 for you on request.<\/li>\n<\/ul>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><br \/>\n<section  class='av_textblock_section av-kq9k1iff-30180044fdd3575dfb8c24e01dba568c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>We support you with the validation of the software: Learn more <a href=\"https:\/\/www.riskmanager.net\/en\/services\/#validation_services\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-85b3d8d408f80152e13fe296657fc778\">\n.flex_column.av-bcmscg-85b3d8d408f80152e13fe296657fc778{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-85b3d8d408f80152e13fe296657fc778 av_one_fourth  avia-builder-el-13  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-6ypsa6-98695f771d14b674197121c82d95ada8 main_color avia-section-default avia-no-border-styling  avia-builder-el-14  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7507'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-15  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-kq9jrf76-09c46e0ddb9a931dc0912195d8e908e2 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As a validated approval accelerator, the BAYOOSOFT Risk Manager supports you in the compliant creation of technical documentation. In a clearly structured environment, all relevant information is recorded, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner.<\/p>\n<\/div><\/section><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_5'  class='avia-section av-2uan7g-c1b018ca26da418793c3f2e314294a46 main_color avia-section-default avia-no-border-styling  avia-builder-el-17  el_after_av_section  avia-builder-el-last  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7507'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2idrex-88c32c232d676c42e245bf6d4703b9be\">\n.flex_column.av-2idrex-88c32c232d676c42e245bf6d4703b9be{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2idrex-88c32c232d676c42e245bf6d4703b9be av_three_fourth  avia-builder-el-18  el_before_av_hr  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><div  class='av_promobox av-kp6yhpxv-8b67304c8ca6d50575fd74cf0b215ee7 avia-button-yes  avia-builder-el-19  avia-builder-el-no-sibling '><div class='avia-promocontent'><p>\nYou would like to get to know the BAYOOSOFT Risk Manager without obligation? Take advantage of our 30-day TRIAL.<\/p>\n<\/div><div  class='avia-button-wrap av-kp6yhpxv-1752a43663a67a143c89cb74dbc24504-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now\/'  class='avia-button av-kp6yhpxv-1752a43663a67a143c89cb74dbc24504 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'   aria-label=\"Test now\"><span class='avia_iconbox_title' >Test now<\/span><\/a><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kqji9t5u-18e8a8b69d73da27b4bb86643162e699\">\n#top .hr.hr-invisible.av-kqji9t5u-18e8a8b69d73da27b4bb86643162e699{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-kqji9t5u-18e8a8b69d73da27b4bb86643162e699 hr-invisible  avia-builder-el-20  el_after_av_three_fourth  el_before_av_codeblock '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":42,"featured_media":7501,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[15],"tags":[],"class_list":["post-7507","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-editorial-en"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7507","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=7507"}],"version-history":[{"count":3,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7507\/revisions"}],"predecessor-version":[{"id":8244,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7507\/revisions\/8244"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/7501"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=7507"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/categories?post=7507"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/tags?post=7507"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}