{"id":3237,"date":"2020-06-29T14:44:52","date_gmt":"2020-06-29T12:44:52","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=3237"},"modified":"2021-08-17T13:08:51","modified_gmt":"2021-08-17T11:08:51","slug":"services","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-534ve2d-3adb648519ee365c8f6c672b5372cef0\">\n.avia-section.av-534ve2d-3adb648519ee365c8f6c672b5372cef0{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/shutterstock_610931219.jpg);\nbackground-position:50% 0%;\nbackground-attachment:scroll;\n}\n.avia-section.av-534ve2d-3adb648519ee365c8f6c672b5372cef0 .av-section-color-overlay{\nopacity:0.4;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section 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'><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4z18bh1-157d837ebc46a496ae37e156c69cb5ac\">\n.avia-section.av-4z18bh1-157d837ebc46a496ae37e156c69cb5ac .av-extra-border-element .av-extra-border-inner{\nbackground-color:#ffffff;\n}\n<\/style>\n<div id='av_section_2'  class='avia-section av-4z18bh1-157d837ebc46a496ae37e156c69cb5ac main_color avia-section-default avia-no-border-styling  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-scroll av-arrow-down-section 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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4xqlv39-04a31f079d614a3d115fe6534d06a96f\">\n#top .av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f{\npadding-bottom:10px;\nfont-size:40px;\n}\nbody .av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f .av-special-heading-tag{\nfont-size:40px;\n}\n.av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-4xqlv39-04a31f079d614a3d115fe6534d06a96f .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-4xqlv39-04a31f079d614a3d115fe6534d06a96f av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-3  el_before_av_one_fifth  avia-builder-el-first  av-inherit-size'><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Do you want to accelerate your approval process, but unsure how?<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4wq2hp1-84ff407dff6952550e06e329925adda8\">\n.flex_column.av-4wq2hp1-84ff407dff6952550e06e329925adda8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4wq2hp1-84ff407dff6952550e06e329925adda8 av_one_fifth  avia-builder-el-4  el_after_av_heading  el_before_av_three_fifth  first flex_column_div av-zero-column-padding  '     ><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4ui6c11-411a31380b003eb1846ebc04723032c6\">\n.flex_column.av-4ui6c11-411a31380b003eb1846ebc04723032c6{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4ui6c11-411a31380b003eb1846ebc04723032c6 av_three_fifth  avia-builder-el-5  el_after_av_one_fifth  el_before_av_one_fifth  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4tfbst1-e3d73029411a78c9a289a8db64070ce2\">\n#top .hr.hr-invisible.av-4tfbst1-e3d73029411a78c9a289a8db64070ce2{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-4tfbst1-e3d73029411a78c9a289a8db64070ce2 hr-invisible  avia-builder-el-6  el_before_av_textblock  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-4rby3wl-3cdc02630e83f55941415105091c1b7c '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">We will be happy to help you get started in generating faultless technical documentation using our extensive range of services \u2013 such as user or validation package training. Learn more about our optional services:<\/p>\n<\/div><\/section><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4pca5th-2a157756cb353d5c4865e5844b2b6619\">\n#top .hr.hr-invisible.av-4pca5th-2a157756cb353d5c4865e5844b2b6619{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-4pca5th-2a157756cb353d5c4865e5844b2b6619 hr-invisible  avia-builder-el-8  el_after_av_textblock  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4ndgnet-9330c8898caaed92b1da70fc4287f3ba\">\n.flex_column.av-4ndgnet-9330c8898caaed92b1da70fc4287f3ba{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4ndgnet-9330c8898caaed92b1da70fc4287f3ba av_one_fifth  avia-builder-el-9  el_after_av_three_fifth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><div class='av-extra-border-element border-extra-arrow-down'><div class='av-extra-border-outer'><div class='av-extra-border-inner'><\/div><\/div><\/div><\/div><div id='services_selection'  class='avia-section av-4mwgxt1-3e73c900417bb63012902afbe66d0bc2 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-10  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-gfjal1-44f79d89b624d3f1fa7a2f211c84a99b\">\n#top .hr.hr-invisible.av-gfjal1-44f79d89b624d3f1fa7a2f211c84a99b{\nheight:50px;\n}\n<\/style>\n<div  class='hr av-gfjal1-44f79d89b624d3f1fa7a2f211c84a99b hr-invisible  avia-builder-el-11  el_before_av_one_third  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div class='flex_column_table av-4jc1yc5-c58ad32fc1bb1fdacefdb7394a689997 sc-av_one_third av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4jc1yc5-c58ad32fc1bb1fdacefdb7394a689997\">\n.flex_column.av-4jc1yc5-c58ad32fc1bb1fdacefdb7394a689997{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4jc1yc5-c58ad32fc1bb1fdacefdb7394a689997 av_one_third  avia-builder-el-12  el_after_av_hr  el_before_av_one_third  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4gxqyhh-aeda24f6d1660431f731d8e214d9729b\">\n.av_font_icon.av-4gxqyhh-aeda24f6d1660431f731d8e214d9729b{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-4gxqyhh-aeda24f6d1660431f731d8e214d9729b .av-icon-char{\nfont-size:100px;\nline-height:100px;\n}\n<\/style>\n<span  class='av_font_icon av-4gxqyhh-aeda24f6d1660431f731d8e214d9729b avia_animate_when_visible av-icon-style- avia-icon-pos-center avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue808' data-av_iconfont='entypo-fontello' ><\/span><\/span><br \/>\n<section  class='av_textblock_section av-4fy8g91-2d9dfc88c67d3ad2bcfe96b79dcbd169 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Get to know the full scope of BAYOOSOFT Risk Manager as part of an intensive 30-day TRIAL. Download the approval accelerator now and activate your test environment \u2013 with no obligation!<\/p>\n<\/div><\/section><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-fru0zp-93539bbf4b8552b4ab83e0edea397485\">\n.flex_column.av-fru0zp-93539bbf4b8552b4ab83e0edea397485{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-fru0zp-93539bbf4b8552b4ab83e0edea397485 av_one_third  avia-builder-el-15  el_after_av_one_third  el_before_av_one_third  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4cttt8l-2c9e146820e88665019a727bed0579eb\">\n.av_font_icon.av-4cttt8l-2c9e146820e88665019a727bed0579eb{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-4cttt8l-2c9e146820e88665019a727bed0579eb .av-icon-char{\nfont-size:100px;\nline-height:100px;\n}\n<\/style>\n<span  class='av_font_icon av-4cttt8l-2c9e146820e88665019a727bed0579eb avia_animate_when_visible av-icon-style- avia-icon-pos-center avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue849' data-av_iconfont='entypo-fontello' ><\/span><\/span><br \/>\n<section  class='av_textblock_section av-4b6vwcl-f99dd9e6968ae16e71a44043c4c6968a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Do you need a basic introduction to aspects of validation or would you like to keep the internal costs of software validation as low as possible? Our team of validation experts will be happy to support you with handling the pre-validation package and take care of specific adjustments for your company.<\/p>\n<\/div><\/section><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-49swced-5692a620a6e4d01f3d35c4d9075646aa\">\n.flex_column.av-49swced-5692a620a6e4d01f3d35c4d9075646aa{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-49swced-5692a620a6e4d01f3d35c4d9075646aa av_one_third  avia-builder-el-18  el_after_av_one_third  el_before_av_one_third  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1ii37p-9f44b8887e9cca891ac590ed1b00db08\">\n.av_font_icon.av-1ii37p-9f44b8887e9cca891ac590ed1b00db08{\ncolor:#4abaab;\nborder-color:#4abaab;\n}\n.av_font_icon.av-1ii37p-9f44b8887e9cca891ac590ed1b00db08 .av-icon-char{\nfont-size:100px;\nline-height:100px;\n}\n<\/style>\n<span  class='av_font_icon av-1ii37p-9f44b8887e9cca891ac590ed1b00db08 avia_animate_when_visible av-icon-style- avia-icon-pos-center avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue8c9' data-av_iconfont='entypo-fontello' ><\/span><\/span><br \/>\n<section  class='av_textblock_section av-4636dxh-93c8b44d11d686a2f64df3e836e06b8e '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p style=\"text-align: center\">Naturally, we will also help with the implementation of projects \u2013 such as onboarding your staff. Compose your own individual service package from our extensive range of services.<\/p>\n<\/div><\/section><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-44iz2f9-e66c2387ef91730f0f568addd126b575\">\n.flex_column.av-44iz2f9-e66c2387ef91730f0f568addd126b575{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-44iz2f9-e66c2387ef91730f0f568addd126b575 av_one_third  avia-builder-el-21  el_after_av_one_third  el_before_av_one_third  first flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='avia-button-wrap av-42zv6o5-24753f07e7806429a748fdeaffde31d9-wrap avia-button-center  avia-builder-el-22  avia-builder-el-no-sibling '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now\/'  class='avia-button av-42zv6o5-24753f07e7806429a748fdeaffde31d9 av-link-btn avia-icon_select-yes-left-icon avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"TEST NOW\"><span class='avia_button_icon avia_button_icon_left' aria-hidden='true' data-av_icon='\ue8b7' data-av_iconfont='entypo-fontello'><\/span><span class='avia_iconbox_title' >TEST NOW<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4155kc5-d2c7fde25d25a9f684722fe7af0cbfc5\">\n.flex_column.av-4155kc5-d2c7fde25d25a9f684722fe7af0cbfc5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-4155kc5-d2c7fde25d25a9f684722fe7af0cbfc5 av_one_third  avia-builder-el-23  el_after_av_one_third  el_before_av_one_third  flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='avia-button-wrap av-e9j2wl-69f6b417ac081f933e6164469614a6df-wrap avia-button-center  avia-builder-el-24  avia-builder-el-no-sibling '><a href='https:\/\/www.riskmanager.net\/en\/services\/#validation_services'  class='avia-button av-e9j2wl-69f6b417ac081f933e6164469614a6df av-link-btn avia-icon_select-yes-left-icon avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Discover our validation services\"><span class='avia_button_icon avia_button_icon_left' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><span class='avia_iconbox_title' >Discover our validation services<\/span><\/a><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3y32il1-f31a466cd110bf8261548d6ff1c395b5\">\n.flex_column.av-3y32il1-f31a466cd110bf8261548d6ff1c395b5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3y32il1-f31a466cd110bf8261548d6ff1c395b5 av_one_third  avia-builder-el-25  el_after_av_one_third  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><div  class='avia-button-wrap av-3vanjp1-5808b659ecd274c3a370aeb695773235-wrap avia-button-center  avia-builder-el-26  avia-builder-el-no-sibling '><a href='\/en\/services\/#individual'  class='avia-button av-3vanjp1-5808b659ecd274c3a370aeb695773235 av-link-btn avia-icon_select-yes-left-icon avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Individual services\"><span class='avia_button_icon avia_button_icon_left' aria-hidden='true' data-av_icon='\ue8a5' data-av_iconfont='entypo-fontello'><\/span><span class='avia_iconbox_title' >Individual services<\/span><\/a><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='individual'  class='avia-section av-3udzx5x-34ec9767bb140c2f0494b7c6db560657 main_color avia-section-default avia-no-shadow  avia-builder-el-27  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3t1p0ut-8aa679c3f0078a137d52adb870cc2894\">\n#top .av-special-heading.av-3t1p0ut-8aa679c3f0078a137d52adb870cc2894{\npadding-bottom:20px;\n}\nbody .av-special-heading.av-3t1p0ut-8aa679c3f0078a137d52adb870cc2894 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-3t1p0ut-8aa679c3f0078a137d52adb870cc2894 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-3t1p0ut-8aa679c3f0078a137d52adb870cc2894 av-special-heading-h2 blockquote modern-quote  avia-builder-el-28  el_before_av_two_fifth  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Individual Services<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div class='flex_column_table av-dgvhk5-74279a23c3eff907a3a4daa5d24ab79b sc-av_two_fifth av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-dgvhk5-74279a23c3eff907a3a4daa5d24ab79b\">\n.flex_column.av-dgvhk5-74279a23c3eff907a3a4daa5d24ab79b{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-dgvhk5-74279a23c3eff907a3a4daa5d24ab79b av_two_fifth  avia-builder-el-29  el_after_av_heading  el_before_av_three_fifth  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3ozhtjp-49d1eff59198820263f4e27e55dccf48\">\n#top .hr.hr-invisible.av-3ozhtjp-49d1eff59198820263f4e27e55dccf48{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-3ozhtjp-49d1eff59198820263f4e27e55dccf48 hr-invisible  avia-builder-el-30  el_before_av_image  avia-builder-el-first '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-d65wdx-ecdaa8743dd406a6169650fc683f91f3\">\n.avia-image-container.av-d65wdx-ecdaa8743dd406a6169650fc683f91f3 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-d65wdx-ecdaa8743dd406a6169650fc683f91f3 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-d65wdx-ecdaa8743dd406a6169650fc683f91f3 av-styling- avia-align-center  avia-builder-el-31  el_after_av_hr  el_before_av_hr '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2883 avia-img-lazy-loading-not-2883 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen.png\" alt='' title='Risk Manager Services'  height=\"892\" width=\"963\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen.png 963w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen-300x278.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen-768x711.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen-705x653.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Baum_Dienstleistungen-450x417.png 450w\" sizes=\"(max-width: 963px) 100vw, 963px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3meicad-5f5b48d302b620dfac2bc2c068501c7d\">\n#top .hr.hr-invisible.av-3meicad-5f5b48d302b620dfac2bc2c068501c7d{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-3meicad-5f5b48d302b620dfac2bc2c068501c7d hr-invisible  avia-builder-el-32  el_after_av_image  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-3klsb45-060a37401387ae16a5549502252dcafd\">\n.flex_column.av-3klsb45-060a37401387ae16a5549502252dcafd{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-3klsb45-060a37401387ae16a5549502252dcafd av_three_fifth  avia-builder-el-33  el_after_av_two_fifth  el_before_av_hr  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p><div  class='avia-content-slider-element-container av-3j1dhjp-08986be1ad583a0b548c8ed690ff3636 avia-content-slider-element-slider avia-content-slider avia-smallarrow-slider avia-content-slider-active avia-content-slider-odd  avia-builder-el-34  el_before_av_button  avia-builder-el-first  av-slideshow-ui av-control-default av-nav-arrows-visible av-nav-dots-visible av-hide-nav-arrows av-slideshow-autoplay av-loop-endless av-loop-manual-endless avia-content-slider1' data-slideshow-options=\"{&quot;animation&quot;:&quot;slide&quot;,&quot;autoplay&quot;:true,&quot;loop_autoplay&quot;:&quot;endless&quot;,&quot;interval&quot;:5,&quot;loop_manual&quot;:&quot;manual-endless&quot;,&quot;autoplay_stopper&quot;:false,&quot;noNavigation&quot;:false,&quot;bg_slider&quot;:false,&quot;keep_padding&quot;:&quot;&quot;,&quot;hoverpause&quot;:false,&quot;show_slide_delay&quot;:30}\"><div class='avia-smallarrow-slider-heading  no-content-slider-heading '><div class='new-special-heading'>&nbsp;<\/div><div class='avia-slideshow-arrows avia-slideshow-controls' ><a href='#prev' class='prev-slide ' aria-hidden='true' data-av_icon='\ue87c' data-av_iconfont='entypo-fontello'  tabindex='-1'>Previous<\/a><a href='#next' class='next-slide ' aria-hidden='true' data-av_icon='\ue87d' data-av_iconfont='entypo-fontello'  tabindex='-1'>Next<\/a><\/div><div class='avia-slideshow-dots avia-slideshow-controls'><a href='#1' class='goto-slide active' >1<\/a><a href='#2' class='goto-slide ' >2<\/a><a href='#3' class='goto-slide ' >3<\/a><\/div><\/div><div class=\"avia-content-slider-inner\"><div class=\"slide-entry-wrap\"><section class='slide-entry av-3hhm8qt-b1bb48592319f418754a49b56230878b flex_column av_fullwidth post-entry slide-entry-overview slide-loop-1 slide-parity-odd  first'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><h3 class='slide-entry-title entry-title '  itemprop=\"headline\" >User Training<\/h3><div class='slide-entry-excerpt entry-content'  itemprop=\"text\" ><p>Participate in a user training day and gain in-depth insight in how to use BAYOOSOFT Risk Manager with confidence. The targeted training provided by our qualified consultants helps you with extensive knowledge in application and the core functionalities. Theoretical and practical instruction go hand in hand, allowing you to achieve these learning objectives. Besides training on the layout, structure and authorization concept, focus is placed on the approach and practical implementation of a risk analysis with participants using an example project.<\/p>\n<\/div><\/section><\/div><div class=\"slide-entry-wrap\"><section class='slide-entry av-3euqe2d-a6338b6ae210603478ebcb6b5c8f2346 flex_column av_fullwidth post-entry slide-entry-overview slide-loop-2 slide-parity-odd  first'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><h3 class='slide-entry-title entry-title '  itemprop=\"headline\" >Risk Management Workshops<\/h3><div class='slide-entry-excerpt entry-content'  itemprop=\"text\" ><p>We will be happy to support you with our qualified trainers as part of risk management workshops. Workshops are tailored to your individual situation and help to develop solution approaches for your specific application cases. They apply a cooperative and moderated method, promoting participant interaction. The aim here is to provide a regulatory overview and a basic introduction to working with BAYOOSOFT Risk Manager. The workshops also cover the relationships between medical device monitoring and reporting systems, compliant handling and risk management, raising awareness of risk management as a supportive tool for product development.<\/p>\n<\/div><\/section><\/div><div class=\"slide-entry-wrap\"><section class='slide-entry av-3ds657p-48445623887ae5cd864e4c70129e2255 flex_column av_fullwidth post-entry slide-entry-overview slide-loop-3 slide-parity-odd  post-entry-last  first'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><h3 class='slide-entry-title entry-title '  itemprop=\"headline\" >Individual Workshop Topics<\/h3><div class='slide-entry-excerpt entry-content'  itemprop=\"text\" ><p>We will work together with you to develop solution approaches for your specific application cases. The workshops frequently focus on topics like usability or requirements engineering, or provide a regulatory overview. They apply a cooperative and moderated method, promoting participant interaction. The time frame is based on your requirements. We will be happy to present you with a suitable workshop agenda for your individual needs. Simply get in touch with us.<\/p>\n<\/div><\/section><\/div><\/div><\/div><br \/>\n<div  class='avia-button-wrap av-3cp4r2t-ff163724c7fcc5341f9e3ad3c685c6a0-wrap avia-button-center  avia-builder-el-35  el_after_av_content_slider  avia-builder-el-last '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact\/'  class='avia-button av-3cp4r2t-ff163724c7fcc5341f9e3ad3c685c6a0 av-link-btn avia-icon_select-no avia-size-small avia-position-center avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Inquire now\"><span class='avia_iconbox_title' >Inquire now<\/span><\/a><\/div><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bu4nat-4b304e104a81930bc56d6de77a1bbe7d\">\n#top .hr.hr-invisible.av-bu4nat-4b304e104a81930bc56d6de77a1bbe7d{\nheight:15px;\n}\n<\/style>\n<div  class='hr av-bu4nat-4b304e104a81930bc56d6de77a1bbe7d hr-invisible  avia-builder-el-36  el_after_av_three_fifth  avia-builder-el-last '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-37yguit-298e27711c4db3b3946e5d884c678022\">\n.avia-section.av-37yguit-298e27711c4db3b3946e5d884c678022{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/shutterstock_524089942-1500x571.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n<\/style>\n<div id='mdr-class'  class='avia-section av-37yguit-298e27711c4db3b3946e5d884c678022 main_color avia-section-default avia-no-shadow  avia-builder-el-37  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll container_wrap fullsize'  data-section-bg-repeat='stretch'><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-3237'><div class='entry-content-wrapper clearfix'>\n<div class='flex_column_table av-37jjidx-5fc17dfae89572d0f91e7d47c66e463c sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-37jjidx-5fc17dfae89572d0f91e7d47c66e463c\">\n.flex_column.av-37jjidx-5fc17dfae89572d0f91e7d47c66e463c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-37jjidx-5fc17dfae89572d0f91e7d47c66e463c av_one_half  avia-builder-el-38  el_before_av_one_half  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-355nqdh-6fbbfd2e990b95393ef8089841d5a29d\">\n#top .av-special-heading.av-355nqdh-6fbbfd2e990b95393ef8089841d5a29d{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-355nqdh-6fbbfd2e990b95393ef8089841d5a29d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-355nqdh-6fbbfd2e990b95393ef8089841d5a29d .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-355nqdh-6fbbfd2e990b95393ef8089841d5a29d av-special-heading-h3  avia-builder-el-39  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >Medical device classification<\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-337j311-d0f0d8d64e14e02c52f15179f03fab50 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Whether seeking ideas for a product innovation, planning development or coordinating the approval strategy \u2013 correctly classifying the medical device is important and indeed also complex.<\/p>\n<p>To simplify this step, we have developed an app that quickly and reliably classifies your medical device.<\/p>\n<p>Download our new app from the app store now:<\/p>\n<\/div><\/section><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-31xwmxx-08ccb2eb666d1e00ece36325211f66ea\">\n.flex_column.av-31xwmxx-08ccb2eb666d1e00ece36325211f66ea{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-31xwmxx-08ccb2eb666d1e00ece36325211f66ea av_one_half  avia-builder-el-41  el_after_av_one_half  el_before_av_one_fourth  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-30ef1d1-a102114c36bb262497c8238ab553950a\">\n.avia-image-container.av-30ef1d1-a102114c36bb262497c8238ab553950a img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-30ef1d1-a102114c36bb262497c8238ab553950a .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-30ef1d1-a102114c36bb262497c8238ab553950a av-styling- avia-align-center  avia-builder-el-42  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2777 avia-img-lazy-loading-not-2777 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/05\/MDR_Titel_deutsch_1141.png\" alt='' title='MDR_Titel_deutsch_1141'  height=\"87\" width=\"238\"  itemprop=\"thumbnailUrl\"  \/><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2yjo4qd-8c62ae1929689c41d95638544171cbda\">\n.flex_column.av-2yjo4qd-8c62ae1929689c41d95638544171cbda{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2yjo4qd-8c62ae1929689c41d95638544171cbda av_one_fourth  avia-builder-el-43  el_after_av_one_half  el_before_av_one_fourth  first flex_column_div av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2wr3ggl-0b2f77d27c0f7a41e735eacb01d9b551\">\n.avia-image-container.av-2wr3ggl-0b2f77d27c0f7a41e735eacb01d9b551 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-2wr3ggl-0b2f77d27c0f7a41e735eacb01d9b551 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-2wr3ggl-0b2f77d27c0f7a41e735eacb01d9b551 av-styling- av-img-linked avia-align-center  avia-builder-el-44  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><a href=\"https:\/\/apps.apple.com\/de\/app\/mdr-class\/id1298551120\" class='avia_image '  target=\"_blank\"  rel=\"noopener noreferrer\" aria-label='apple-appstore_logo'><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2885 avia-img-lazy-loading-not-2885 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/apple-appstore_logo-300x98.png\" alt='' title='apple-appstore_logo'  height=\"98\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/apple-appstore_logo-300x98.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/apple-appstore_logo-450x147.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/apple-appstore_logo.png 577w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-abe9np-bb660140eb668821a1508d690c61633c\">\n.flex_column.av-abe9np-bb660140eb668821a1508d690c61633c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-abe9np-bb660140eb668821a1508d690c61633c av_one_fourth  avia-builder-el-45  el_after_av_one_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  column-top-margin'     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-a3z7gl-ee5c7b3b5bb14b82226b52c1c8e2bb3b\">\n.avia-image-container.av-a3z7gl-ee5c7b3b5bb14b82226b52c1c8e2bb3b img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-a3z7gl-ee5c7b3b5bb14b82226b52c1c8e2bb3b .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-a3z7gl-ee5c7b3b5bb14b82226b52c1c8e2bb3b av-styling- av-img-linked avia-align-center  avia-builder-el-46  avia-builder-el-no-sibling '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><a href=\"https:\/\/play.google.com\/store\/apps\/details?id=net.bayoo.mdrclass\" class='avia_image '  target=\"_blank\"  rel=\"noopener noreferrer\" aria-label='get_it_on Google Play'><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2886 avia-img-lazy-loading-not-2886 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/get_it_on-Google-Play-300x116.png\" alt='' title='get_it_on Google Play'  height=\"116\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/get_it_on-Google-Play-300x116.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/get_it_on-Google-Play-450x174.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/get_it_on-Google-Play.png 646w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a><\/div><\/div><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='validation_services'  class='avia-section av-2rz1ts5-511c0952e4ea7a78a9541e1ae36564d0 main_color avia-section-default avia-no-shadow  avia-builder-el-47  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2qqp8xh-de163c27601d0713dbe539106321eb72\">\n#top .av-special-heading.av-2qqp8xh-de163c27601d0713dbe539106321eb72{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-2qqp8xh-de163c27601d0713dbe539106321eb72 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-2qqp8xh-de163c27601d0713dbe539106321eb72 .av-subheading{\nfont-size:18px;\n}\n<\/style>\n<div  class='av-special-heading av-2qqp8xh-de163c27601d0713dbe539106321eb72 av-special-heading-h2 blockquote modern-quote  avia-builder-el-48  el_before_av_textblock  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Software Validation \u2013 Your Service Options<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-2om3eit-8542ded6f191dea413511b14b10e8096 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>All systems involved in the process need to be validated in accordance with DIN EN ISO 13485:2017. BAYOOSOFT Risk Manager has a validation process based on the GAMP 5 guidelines for computerized validation according to these requirements and is validated as category-four software.<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2nh2unp-b811b23b9423d560c786db7d2d75b60c\">\n#top .hr.hr-invisible.av-2nh2unp-b811b23b9423d560c786db7d2d75b60c{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-2nh2unp-b811b23b9423d560c786db7d2d75b60c hr-invisible  avia-builder-el-50  el_after_av_textblock  el_before_av_one_half '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<div class='flex_column_table av-9ddk5h-50b83ae74eca35c4e970b8bc150f2099 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9ddk5h-50b83ae74eca35c4e970b8bc150f2099\">\n.flex_column.av-9ddk5h-50b83ae74eca35c4e970b8bc150f2099{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9ddk5h-50b83ae74eca35c4e970b8bc150f2099 av_one_half  avia-builder-el-51  el_after_av_hr  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2kcahth-7e8f3d57982ea9833a2d525aaff2b658\">\n.avia-image-container.av-2kcahth-7e8f3d57982ea9833a2d525aaff2b658 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-2kcahth-7e8f3d57982ea9833a2d525aaff2b658 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-2kcahth-7e8f3d57982ea9833a2d525aaff2b658 av-styling- avia-align-center  avia-builder-el-52  el_before_av_image  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2890 avia-img-lazy-loading-not-2890 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package.png\" alt='' title='Pre-Validation Package'  height=\"487\" width=\"1547\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package.png 1547w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-300x94.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-768x242.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-1030x324.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-1500x472.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-705x222.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Pre-Validation-Package-450x142.png 450w\" sizes=\"(max-width: 1547px) 100vw, 1547px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2i9i0t1-c7aded4945d9318f8cbc5e2a8cd508f0\">\n.avia-image-container.av-2i9i0t1-c7aded4945d9318f8cbc5e2a8cd508f0 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-2i9i0t1-c7aded4945d9318f8cbc5e2a8cd508f0 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-2i9i0t1-c7aded4945d9318f8cbc5e2a8cd508f0 av-styling- avia-align-center  avia-builder-el-53  el_after_av_image  avia-builder-el-last '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2896 avia-img-lazy-loading-not-2896 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png\" alt='' title='RISKMANAGER-LOGO-COLOR_II'  height=\"133\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-300x133.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-768x340.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1030x456.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-1500x664.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-705x312.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR_II-450x199.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><\/p><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2gysztx-92a0426a97ad2d22f7c2881b7f8340df\">\n.flex_column.av-2gysztx-92a0426a97ad2d22f7c2881b7f8340df{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2gysztx-92a0426a97ad2d22f7c2881b7f8340df av_one_half  avia-builder-el-54  el_after_av_one_half  el_before_av_promobox  flex_column_table_cell av-equal-height-column av-align-top av-zero-column-padding  '     ><div  class='avia-icon-list-container av-8pgks5-abde0af36798355006b12cb1f72d0401  avia-builder-el-55  avia-builder-el-no-sibling '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-8pgks5-abde0af36798355006b12cb1f72d0401 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-2dh5w1h-e49afba57ea94b4cd0c8ac64fe32bafa avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue8c9' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Quick-start training\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Quick-start training<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Do you need a basic introduction to aspects of validation or would you like an overview covering 500 pages of validation? We will be happy to help you through your first steps in BAYOOSOFT Risk Manager validation as part of a full-day training course. Following an introduction to the basics, you and one of our trainers will look at the existing documents and start directly with the first aspects of validation.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-2b0cvg5-efb1c5edcbcefab02b92ead1702653ba avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Individual customer validation \u2013 project support\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Individual customer validation \u2013 project support<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><p>Would you like to keep the internal costs of validation as low as possible? Our team of validation experts will be happy to support you with handling the Pre-Validation Package and take care of specific adjustments for your company.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><div  class='av_promobox av-29hdhqd-6121dff99c9f0adb74e389641128bc3b avia-button-yes  avia-builder-el-56  el_after_av_one_half  avia-builder-el-last '><div class='avia-promocontent'><p>Have you heard about the BAYOOSOFT Risk Manager Pre-Validation Package? It provides you with all necessary content for standard-compliant validation. You save more than 500 pages of validation work.<\/p>\n<\/div><div  class='avia-button-wrap av-29hdhqd-fe2c612c431661e02763b3e6d046c310-wrap avia-button-right '><a href='\/en\/modules-features\/modules\/#gamp5-validation'  class='avia-button av-29hdhqd-fe2c612c431661e02763b3e6d046c310 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-silver'   aria-label=\"Learn more\"><span class='avia_iconbox_title' >Learn more<\/span><\/a><\/div><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2869w2d-2050a3559e540c99cce6de9bb170aba1\">\n.avia-section.av-2869w2d-2050a3559e540c99cce6de9bb170aba1{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/shutterstock_682989595-1500x1000.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-2869w2d-2050a3559e540c99cce6de9bb170aba1 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:rgba(61,61,61,0.33);\n}\n<\/style>\n<div id='license-model'  class='avia-section av-2869w2d-2050a3559e540c99cce6de9bb170aba1 alternate_color avia-section-default avia-no-shadow  avia-builder-el-57  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-26b1705-aac77d88b75910d1b895918463d90c47\">\n#top .av-special-heading.av-26b1705-aac77d88b75910d1b895918463d90c47{\npadding-bottom:20px;\ncolor:#ffffff;\n}\nbody .av-special-heading.av-26b1705-aac77d88b75910d1b895918463d90c47 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-26b1705-aac77d88b75910d1b895918463d90c47 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-26b1705-aac77d88b75910d1b895918463d90c47 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-26b1705-aac77d88b75910d1b895918463d90c47 av-special-heading-h2 custom-color-heading blockquote modern-quote  avia-builder-el-58  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >License Model<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div class='flex_column_table av-24k9oet-fe7e61169fc4b3d7c94f16f8980d1dc1 sc-av_one_half av-equal-height-column-flextable'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-24k9oet-fe7e61169fc4b3d7c94f16f8980d1dc1\">\n.flex_column.av-24k9oet-fe7e61169fc4b3d7c94f16f8980d1dc1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-24k9oet-fe7e61169fc4b3d7c94f16f8980d1dc1 av_one_half  avia-builder-el-59  el_after_av_heading  el_before_av_one_half  first flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><article  class='iconbox iconbox_top av-23dxrat-1285abd779e224c0f75d09a7aa3d400a  avia-builder-el-60  avia-builder-el-no-sibling  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Concurrent User Model\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Concurrent User Model<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager is based on a concurrent user model and promotes cross-location collaboration of users in companies thanks to multi-user access. Users access the SQL server via the network connection. Information and data are recorded centrally on this SQL server and stored in an auditable manner.<\/p>\n<p>You can install the BAYOOSOFT Risk Manager client on end user PCs in the company as often as required. Only the users concurrently working in the system are counted as licenses.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div><div class='av-flex-placeholder'><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-220f4x1-5c0bfc305ea35785add0c2ab8c681b52\">\n.flex_column.av-220f4x1-5c0bfc305ea35785add0c2ab8c681b52{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-220f4x1-5c0bfc305ea35785add0c2ab8c681b52 av_one_half  avia-builder-el-61  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2007wdx-e7dde8c554e8143b94110dc534ea17f7\">\n.avia-image-container.av-2007wdx-e7dde8c554e8143b94110dc534ea17f7 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-2007wdx-e7dde8c554e8143b94110dc534ea17f7 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-2007wdx-e7dde8c554e8143b94110dc534ea17f7 av-styling- avia-align-left  avia-builder-el-62  el_before_av_image  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2899 avia-img-lazy-loading-not-2899 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-300x127.png\" alt='' title='RISKMANAGER-LOGO-COLOR-W_II'  height=\"127\" width=\"300\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-300x127.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-768x326.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-1030x437.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-1500x637.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-705x299.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/08\/RISKMANAGER-LOGO-COLOR-W_II-450x191.png 450w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1yecs3p-cf2d7239c7337069bf8f7afa8f27e2c7\">\n.avia-image-container.av-1yecs3p-cf2d7239c7337069bf8f7afa8f27e2c7 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-1yecs3p-cf2d7239c7337069bf8f7afa8f27e2c7 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-1yecs3p-cf2d7239c7337069bf8f7afa8f27e2c7 av-styling- avia-align-center  avia-builder-el-63  el_after_av_image  el_before_av_textblock '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-2889 avia-img-lazy-loading-not-2889 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1.png\" alt='' title='Module des Zulassungsbeschleunigers'  height=\"763\" width=\"1940\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1.png 1940w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-300x118.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-768x302.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-1030x405.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-1500x590.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-705x277.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2019\/07\/Module-des-Zulassungsbeschleunigers-1-450x177.png 450w\" sizes=\"(max-width: 1940px) 100vw, 1940px\" \/><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-1wzb2p1-6adf73d24976920ece3b17357c264341 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>As an essential component of the technical documentation for medical devices, <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/#risk-management-iso14971\">risk management<\/a> provides the foundations of the validated approval accelerator. Depending on the type of your medical device, this can be expanded with various <a href=\"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\">additional modules<\/a>.<\/p>\n<\/div><\/section><\/p><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='system-requirements'  class='avia-section av-1vocehx-55ca53adbe06e13f0c0189391b3c0a22 alternate_color avia-section-default avia-no-shadow  avia-builder-el-65  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-df65f57c0e55204a2fad34f58c515323\">\n#top .av-special-heading.av-av_heading-df65f57c0e55204a2fad34f58c515323{\npadding-bottom:20px;\n}\nbody .av-special-heading.av-av_heading-df65f57c0e55204a2fad34f58c515323 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-df65f57c0e55204a2fad34f58c515323 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-df65f57c0e55204a2fad34f58c515323 av-special-heading-h2 blockquote modern-quote  avia-builder-el-66  el_before_av_one_half  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >System Requirements<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6f097p-d960575e0e871ff08e1c48754c0e1f79\">\n.flex_column.av-6f097p-d960575e0e871ff08e1c48754c0e1f79{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-6f097p-d960575e0e871ff08e1c48754c0e1f79 av_one_half  avia-builder-el-67  el_after_av_heading  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-71e07b92e2a9dc40997b1d9f2e7b7c23\">\n#top .av-special-heading.av-av_heading-71e07b92e2a9dc40997b1d9f2e7b7c23{\npadding-bottom:4px;\n}\nbody .av-special-heading.av-av_heading-71e07b92e2a9dc40997b1d9f2e7b7c23 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-71e07b92e2a9dc40997b1d9f2e7b7c23 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-71e07b92e2a9dc40997b1d9f2e7b7c23 av-special-heading-h4 blockquote modern-quote  avia-builder-el-68  el_before_av_table  avia-builder-el-first '><h4 class='av-special-heading-tag '  itemprop=\"headline\"  >Client<\/h4><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='avia-data-table-wrap av-1nyl9d1-342242dc178cd0613cc519bae4bade10 avia_responsive_table avia-table-1'><table  class='avia-table avia-data-table avia_pricing_default  avia-builder-el-69  el_after_av_heading  el_before_av_textblock '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Table\" ><tbody><tr class=''><td class='avia-highlight-col'>Hardware:<\/td><td class=''>Processor\/CPU: min. 1.5 GHz dual core<br \/>\nWorking memory: min. 1 GB RAM<br \/>\nGraphics resolution: min. 800&#215;600 (recommended: min. 1280&#215;1024)<br \/>\nHard disk space: 150 MB for Risk Manager + .NET framework (32bit: 880 MB \/ 64bit: 2 GB)<br \/>\n<\/td><\/tr><tr class=''><td class='avia-highlight-col'>Operating systems:<\/td><td class=''>Windows 8.1<br \/>\nWindows 10<\/td><\/tr><tr class=''><td class='avia-highlight-col'>Required software components:<\/td><td class=''>Microsoft .NET 4.8 Framework<br \/>\nWindows Installer 4.5<br \/>\nMSQL Native Client 11<br \/>\n<\/td><\/tr><\/tbody><\/table><\/div><br \/>\n<section  class='av_textblock_section av-18il6np-ffdfec9f4f88c3bd51fb37a3c03d10fd '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>If the required software components do not exist on the client, they will be automatically installed during installation.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-16rx3it-1fba669cdcd4159711783d1f355b1e31\">\n.flex_column.av-16rx3it-1fba669cdcd4159711783d1f355b1e31{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-16rx3it-1fba669cdcd4159711783d1f355b1e31 av_one_half  avia-builder-el-71  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-e4986e9c350ba5c47f5f8bd2314aa5b5\">\n#top .av-special-heading.av-av_heading-e4986e9c350ba5c47f5f8bd2314aa5b5{\npadding-bottom:4px;\n}\nbody .av-special-heading.av-av_heading-e4986e9c350ba5c47f5f8bd2314aa5b5 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-e4986e9c350ba5c47f5f8bd2314aa5b5 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-e4986e9c350ba5c47f5f8bd2314aa5b5 av-special-heading-h4 blockquote modern-quote  avia-builder-el-72  el_before_av_table  avia-builder-el-first '><h4 class='av-special-heading-tag '  itemprop=\"headline\"  >SQL Server<\/h4><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<div class='avia-data-table-wrap av-135bnz9-e0c4f61ae99848fd8d5ca7433fae268a avia_responsive_table avia-table-2'><table  class='avia-table avia-data-table avia_pricing_default  avia-builder-el-73  el_after_av_heading  el_before_av_textblock '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/Table\" ><tbody><tr class=''><td class='avia-highlight-col'>Hardware:<\/td><td class=''>Processor\/CPU: min. 2 GHz dual core<br \/>\nWorking memory: min. 4 GB RAM<br \/>\nHard disk space: min. 1,5 GB (data volume of the standard database after installation: approx. 200 MB)<\/td><\/tr><tr class=''><td class='avia-highlight-col'>Operating systems:<\/td><td class=''>Windows Server 2012 \/ 2016 \/ 2019<\/td><\/tr><tr class=''><td class='avia-highlight-col'>Required software components:<\/td><td class=''>SQL Server 2012 or higher<\/td><\/tr><\/tbody><\/table><\/div><br \/>\n<section  class='av_textblock_section av-mqa8bp-90388d6cd2b5f07db34f82a42790e4e4 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>If an existing SQL Server is used, it needs to run in the authentication mode \u201cmixed mode\u201d to permit an SQL-integrated user registration.<\/p>\n<\/div><\/section><\/p><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='frequently-asked-questions'  class='avia-section av-lagvjp-c4f3a3a8ef1ad328723613a2ab43edca main_color avia-section-default avia-no-shadow  avia-builder-el-75  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-3237'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1xqsat-ee81a926e70ea40514ff86201a104d82\">\n#top .av-special-heading.av-1xqsat-ee81a926e70ea40514ff86201a104d82{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-1xqsat-ee81a926e70ea40514ff86201a104d82 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-1xqsat-ee81a926e70ea40514ff86201a104d82 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-1xqsat-ee81a926e70ea40514ff86201a104d82 av-special-heading-h2 blockquote modern-quote  avia-builder-el-76  el_before_av_toggle_container  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Frequently Asked Questions<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<div  class='togglecontainer av-hmyfqd-11fda96ba72a27a55dcc1e8936e82429  avia-builder-el-77  el_after_av_heading  el_before_av_promobox ' >\n<section class='av_toggle_section av-f1u8px-82cfdd4df62fc5ed0daf27b270f6b816'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"Is BAYOOSOFT Risk Manager validated?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Is BAYOOSOFT Risk Manager validated?\" data-aria_expanded=\"Click to collapse: Is BAYOOSOFT Risk Manager validated?\">Is BAYOOSOFT Risk Manager validated?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager is validated according to ISO 13485. Based on the GAMP 5 guidelines for computerized validation, the market-leading software solution was validated as category-four software and successfully passed all aspects \u2013 from the requirements and configuration specifications through to the acceptance test. To simplify the validation process, we offer a <a href=\"\/en\/modules-features\/modules\/#gamp5-validation\">pre-validation package<\/a> with all necessary documents<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-dlk639-9f29f95771e13aa5e11e8e0b3f647627'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?\" data-aria_expanded=\"Click to collapse: Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?\">Can reports generated in BAYOOSOFT Risk Manager be submitted to the FDA?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The reports generated in BAYOOSOFT Risk Manager can be submitted to designated bodies in Europe as well as the FDA in accordance with FDA 21 CFR Part 11. The software solution meets the requirements of the guideline through the specific system settings in the application, with the three criteria \u201cApply Password Rules\u201d, \u201cUse Audit Trail\u201d and \u201cUse Digital Signature\u201d.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-cdmdn9-20514a1a406d0dd4096f6401457a6652'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"What is the knowledge database and what advantages does it offer?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What is the knowledge database and what advantages does it offer?\" data-aria_expanded=\"Click to collapse: What is the knowledge database and what advantages does it offer?\">What is the knowledge database and what advantages does it offer?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>The integrated knowledge database allows synergies to be used and reduces loss of knowledge associated with staff turnover. Continuously developing a knowledge platform allows efficient, cross-project work. When creating new elements, BAYOOSOFT Risk Manager recognizes whether they already exist in the same or other projects or in the knowledge database and automatically suggests them. This prevents redundant data and enables cross-project knowledge transfer. CSV imports are also available.<\/p>\n<p>Working with the knowledge database takes place in template management and the user must be assigned the right \u201cDefine Templates\u201d or role \u201cTemplate Manager\u201d to this end.<\/p>\n<p>Suggestion lists can support you by providing frequently recurring elements for preparing a new risk analysis. They help contribute to utilizing company knowledge as efficiently as possible. Groups are used as suggestion lists for new elements in the analysis program section.<\/p>\n<p>Groups are managed depending on the device type. For this reason, you first always need to select the desired device type in the corresponding list fields.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-b3ccsl-09e9ff7b84ac18c7f1e2dfe5d36d07de'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"Does the system include content-based rights management?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: Does the system include content-based rights management?\" data-aria_expanded=\"Click to collapse: Does the system include content-based rights management?\">Does the system include content-based rights management?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>BAYOOSOFT Risk Manager includes fine-grained user and role management, which meets the requirements of MDR 2017\/745 and implements content-based rights management. Depending on the role, users can be assigned certain rights. As a team member of individual project versions, the rights of this global configuration are adopted, but can still be individually adjusted in each project version. The standard roles are as follows:<\/p>\n<ul>\n<li>Observer<\/li>\n<li>Administrator<\/li>\n<li>Analyst<\/li>\n<li>Measure Manager<\/li>\n<li>Project Lead<\/li>\n<li>Template Manager<\/li>\n<li>Requirements Engineer<\/li>\n<li>Clinical Evaluation Manager<\/li>\n<\/ul>\n<p>Roles and rights are managed in the administration area \/ user management or role management and can be further specified for individual projects if needed.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-8plpyt-7d57395e24777236ed1799e6e49a7237'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-5' data-fake-id='#toggle-id-5' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5' data-slide-speed=\"200\" data-title=\"What does \u201cinherit rights\u201d mean in a project?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What does \u201cinherit rights\u201d mean in a project?\" data-aria_expanded=\"Click to collapse: What does \u201cinherit rights\u201d mean in a project?\">What does \u201cinherit rights\u201d mean in a project?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' aria-labelledby='toggle-toggle-id-5' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>If you have placed a checkmark for \u201cinherit rights\u201d, the rights indicated in the administration area under user management will be assigned automatically. To issue rights to a user that deviate from those entered in the administration area, remove the checkmark on the project team page and click on the user. The rights available will then be displayed and can be adjusted accordingly for the opened project.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-84h1ph-9e0757505c1ca1eab9792706aef8e4ef'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-6' data-fake-id='#toggle-id-6' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-6' data-slide-speed=\"200\" data-title=\"After installing the software, I am asked for my user name and password. How can I register in the system?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: After installing the software, I am asked for my user name and password. How can I register in the system?\" data-aria_expanded=\"Click to collapse: After installing the software, I am asked for my user name and password. How can I register in the system?\">After installing the software, I am asked for my user name and password. How can I register in the system?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-6' aria-labelledby='toggle-toggle-id-6' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><div class=\"wpb_toggle_content\">\n<p>The risk analyses prepared using BAYOOSOFT Risk Manager can contain sensitive company data. For this reason, access to the system is protected by user registration. In order to test the software, the following demo users are provided with the installation:<\/p>\n<p>Demo user \u2013 project management:<br \/>\nUser name: sieber<br \/>\nPassword: peter<\/p>\n<p>Demo user \u2013 administration:<br \/>\nUser name: admin<br \/>\nPassword: admin<\/p>\n<\/div>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-6a2klx-a554c887110f1c7c38bb44233cb5afdf'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-7' data-fake-id='#toggle-id-7' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-7' data-slide-speed=\"200\" data-title=\"What import and export options does the system offer?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: What import and export options does the system offer?\" data-aria_expanded=\"Click to collapse: What import and export options does the system offer?\">What import and export options does the system offer?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-7' aria-labelledby='toggle-toggle-id-7' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>All project versions of BAYOOSOFT Risk Manager can be exported and imported for conversion into QRM4e format. In addition, numerous import functions via CSV or Excel are available \u2013 such as requirements templates.<\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-4x9o5h-f68114848fc74cacb780cbf7d4d91189'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{All} \"  ><p id='toggle-toggle-id-8' data-fake-id='#toggle-id-8' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-8' data-slide-speed=\"200\" data-title=\"How do I activate our full license?\" data-title-open=\"\" data-aria_collapsed=\"Click to expand: How do I activate our full license?\" data-aria_expanded=\"Click to collapse: How do I activate our full license?\">How do I activate our full license?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-8' aria-labelledby='toggle-toggle-id-8' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p>If you have purchased a full license of BAYOOSOFT Risk Manager, you can either carry out a new installation or update your existing test version. In the case of a new installation, the registration form appears directly after opening the system. For test versions, you can do so by clicking on the BAYOOSOFT Risk Manager logo in the top left and then \u201cRegister\u201d.<\/p>\n<p>You can enter your license key in the \u201cFull Version\u201d area in the registration form. Then click on \u201cActivate full version\u201d. Following activation, you can find the license information for your company under \u201cLicense Details\u201d.<\/p>\n<\/div><\/div><\/div><\/section>\n<\/div>\n<div  class='av_promobox av-28d5qd-823083447d6736e1bd48b2f5830131a9 avia-button-yes  avia-builder-el-78  el_after_av_toggle_container  avia-builder-el-last '><div class='avia-promocontent'><p>Is your question not shown here? We will be happy to help you as part of a personal consultation.<\/p>\n<\/div><div  class='avia-button-wrap av-28d5qd-a442660ee5757dea1a1f31f7bd6e5926-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/contact\/'  class='avia-button av-28d5qd-a442660ee5757dea1a1f31f7bd6e5926 av-link-btn avia-icon_select-no avia-size-medium avia-position-right avia-color-grey'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Contact us now\"><span class='avia_iconbox_title' >Contact us now<\/span><\/a><\/div><\/div>\n<\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":39,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3237","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3237","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=3237"}],"version-history":[{"count":10,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3237\/revisions"}],"predecessor-version":[{"id":7926,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/pages\/3237\/revisions\/7926"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=3237"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}