{"id":4906,"date":"2021-03-02T14:45:10","date_gmt":"2021-03-02T13:45:10","guid":{"rendered":"https:\/\/q-finity.de\/bereiche\/validierung-und-betrieb-von-erp-systemen\/"},"modified":"2024-04-03T13:03:43","modified_gmt":"2024-04-03T11:03:43","slug":"validation-and-operation-of-erp-systems","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/service-areas\/validation-and-operation-of-erp-systems\/","title":{"rendered":"Validation and Operation of ERP-Systems"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-136b1qj-1bd00dba7b97f8206cf424efc0fbd8ad\">\n.avia-section.av-136b1qj-1bd00dba7b97f8206cf424efc0fbd8ad{\nbackground-color:#ea5a0c;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/hero_company_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n#top .avia-section.av-136b1qj-1bd00dba7b97f8206cf424efc0fbd8ad .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-136b1qj-1bd00dba7b97f8206cf424efc0fbd8ad .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_1\" class=\"avia-section av-136b1qj-1bd00dba7b97f8206cf424efc0fbd8ad alternate_color avia-section-large avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-contain avia-bg-style-scroll av-minimum-height av-minimum-height-50 av-height-50  container_wrap fullsize\" data-section-bg-repeat=\"contain\" data-av_minimum_height_pc=\"50\" data-av_min_height_opt=\"50\"><div class=\"av-section-color-overlay-wrap\"><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-1\" aria-describedby=\"av-svg-desc-1\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-1\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-1\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><div class=\"container av-section-cont-open\"><main role=\"main\" itemprop=\"mainContentOfPage\" class=\"template-page content  av-content-full alpha units\"><div class=\"post-entry post-entry-type-page post-entry-4906\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a\">\n#top .av-special-heading.av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a .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-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a .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-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-kls29k29-61ffc2a9287f36aa8beb24b97b434f3a av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-1  avia-builder-el-no-sibling  shadoworange av-inherit-size\"><h1 class=\"av-special-heading-tag \" itemprop=\"headline\"><span class=\"firstheading\">Validation and Operation of ERP-Systems<\/span><\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/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-11gttt7-21cd3e953cff43212478739752c082d9\">\n.avia-section.av-11gttt7-21cd3e953cff43212478739752c082d9 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-11gttt7-21cd3e953cff43212478739752c082d9 .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-11gttt7-21cd3e953cff43212478739752c082d9 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ea5b0c;\nfill:#ea5b0c;\n}\n<\/style>\n<div id=\"av_section_2\" class=\"avia-section av-11gttt7-21cd3e953cff43212478739752c082d9 main_color avia-section-default avia-no-border-styling  avia-builder-el-2  el_after_av_section  el_before_av_section  avia-bg-style-parallax av-section-color-overlay-active container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-2\" aria-describedby=\"av-svg-desc-2\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-2\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-2\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><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-4906\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-z81qgb-f4457293f33814f29cdc2ca5f23c4a1e sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-z81qgb-f4457293f33814f29cdc2ca5f23c4a1e\">\n.flex_column.av-z81qgb-f4457293f33814f29cdc2ca5f23c4a1e{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-z81qgb-f4457293f33814f29cdc2ca5f23c4a1e av_one_half  avia-builder-el-3  el_before_av_one_half  avia-builder-el-first  first flex_column_table_cell av-equal-height-column av-align-middle  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3\">\n#top .av-special-heading.av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 .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-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 .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-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-kls29z2w-a8cc0cf2b4d264dca601541bda4c42c3 av-special-heading-h2 blockquote modern-quote  avia-builder-el-4  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">GxP-compliant processes<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-kl0mtsgh-a8ce22d973a47cc5a6fa182f3b715e07 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>We help our customers with the validation and operation of ERP-systems and GxP-compliant processes.<\/p>\n<p>The increasing number of&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>&nbsp;violations is causing a paradigm shift in the GxP-regulated environment. In collaboration with our clients, we develop the optimal strategies for the prevention, detection and monitoring of&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>&nbsp;violations.<\/p>\n<p><strong>GxP-compliant processes!?<\/strong><\/p>\n<p>ERP systems (e.g. SAP S4\/HANA) are the most critical systems in a company due to their complexity and their use, above all, for the core&nbsp;processes such as production, release and distribution of drugs or medical devices. Distinctive issues usually arise in connection with the centralization or deliberate decentralization of&nbsp;processes and master&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a>&nbsp;as well as very complex authorization concepts. The separation between business departments and IT or the ERP team often poses a great challenge, as this constitutes a break in the availability of knowledge and expectations. This makes coordinated, easily understandable&nbsp;processes all the more important.<\/p>\n<p>According to GAMP&copy; ERP systems usually fall into category 4 as configured software or, in the case of the in-house development portion, into category 5, and thus into the highest level with regard to validation requirements for a system. In addition, the ERP system is often used across multiple countries, companies, many&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a>&nbsp;variants and distributed system landscapes.<\/p>\n<\/div><\/section><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-xx6pff-ba92a7767452b728e8cc42f32dc205fb\">\n.flex_column.av-xx6pff-ba92a7767452b728e8cc42f32dc205fb{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-xx6pff-ba92a7767452b728e8cc42f32dc205fb av_one_half  avia-builder-el-6  el_after_av_one_half  avia-builder-el-last  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-wd5tej-27b05bf1b82d3e812a6d29898acbdebc\">\n.avia-image-container.av-wd5tej-27b05bf1b82d3e812a6d29898acbdebc img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-wd5tej-27b05bf1b82d3e812a6d29898acbdebc .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-wd5tej-27b05bf1b82d3e812a6d29898acbdebc av-styling- avia-align-center  avia-builder-el-7  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 data-opt-id=23593126  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-4777 avia-img-lazy-loading-not-4777 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/SYSTEM-LEBENSZYKLUS_de_V.svg\" alt=\"\" title=\"SYSTEM LEBENSZYKLUS_de_V\" height=\"500\" width=\"700\" itemprop=\"thumbnailUrl\"><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-t4h2jv-7d2c0b0e1fa7e74e29601b51d41a22d5\">\n.avia-section.av-t4h2jv-7d2c0b0e1fa7e74e29601b51d41a22d5{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:auto\/h:auto\/q:mauto\/f:best\/ig:avif\/https:\/\/q-finity.de\/wp-content\/uploads\/2021\/03\/hero_company_yellow.svg);\nbackground-position:50% 50%;\nbackground-attachment:fixed;\n}\n#top .avia-section.av-t4h2jv-7d2c0b0e1fa7e74e29601b51d41a22d5 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-t4h2jv-7d2c0b0e1fa7e74e29601b51d41a22d5 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_3\" class=\"avia-section av-t4h2jv-7d2c0b0e1fa7e74e29601b51d41a22d5 alternate_color avia-section-default avia-no-border-styling  avia-builder-el-8  el_after_av_section  el_before_av_section  avia-full-contain avia-bg-style-fixed container_wrap fullsize\" data-section-bg-repeat=\"contain\"><div class=\"av-section-color-overlay-wrap\"><a href=\"#next-section\" title=\"\" class=\"scroll-down-link av-custom-scroll-down-color avia-svg-icon avia-font-svg_entypo-fontello\" data-av_svg_icon=\"down-open-mini\" data-av_iconset=\"svg_entypo-fontello\"><svg version=\"1.1\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"15\" height=\"32\" viewbox=\"0 0 15 32\" preserveaspectratio=\"xMidYMid meet\" aria-labelledby=\"av-svg-title-3\" aria-describedby=\"av-svg-desc-3\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-3\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-3\">Scroll to next section<\/desc>\n<path d=\"M12.96 12.16q0.704-0.832 1.536 0 0.832 0.704 0 1.536l-6.272 6.144q-0.704 0.704-1.536 0l-6.272-6.144q-0.832-0.832 0-1.536 0.768-0.768 1.6 0l5.44 4.992z\"><\/path>\n<\/svg><\/a><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-4906\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-qzd0a3-783ae651c2edf06b24bf4e9f667e105e sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-qzd0a3-783ae651c2edf06b24bf4e9f667e105e\">\n.flex_column.av-qzd0a3-783ae651c2edf06b24bf4e9f667e105e{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-qzd0a3-783ae651c2edf06b24bf4e9f667e105e av_one_half  avia-builder-el-9  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  \"><\/div><div class=\"av-flex-placeholder\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-p6dbvv-194f8a169b73a6b9e1843a081416c128\">\n.flex_column.av-p6dbvv-194f8a169b73a6b9e1843a081416c128{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\nbackground-color:rgba(234,91,12,0.5);\n}\n<\/style>\n<div class=\"flex_column av-p6dbvv-194f8a169b73a6b9e1843a081416c128 av_one_half  avia-builder-el-10  el_after_av_one_half  avia-builder-el-last  flex_column_table_cell av-equal-height-column av-align-middle  \"><section class=\"av_textblock_section av-kl0mtsgh-a8ce22d973a47cc5a6fa182f3b715e07 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>These factors make the validation and valid operation of an ERP system unlike any other system. The challenge is to find an adapted, optimized method that considers all aspects of implementation, validation and operation, including all interfaces between the parties involved. There is no magic formula here, but the internal conditions of the company, including its organizational structure and procedures, must be taken into account.<\/p>\n<h2><strong>QFINITY<sup>&infin;<\/sup>&nbsp;supports ERP compliance, particularly through the following services:<\/strong><\/h2>\n<ul>\n<li class=\"translation-block\">Auditing of the current approach to validation and operation of the ERP system<\/li>\n<li><a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">Process<\/a>-oriented design of documentation including owner concept (local\/global)<\/li>\n<li>Design and optimization of templates and instructions for validation and operation incl. change management and&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a>&nbsp;management aspects<\/li>\n<li class=\"translation-block\">Definition of the interface between the business department and the IT or ERP team incl.&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a>&nbsp;assurance agreement \/ service level agreements<\/li>\n<li>Requirements management as a central element of implementation and validation<\/li>\n<li class=\"translation-block\">Analysis and assurance of&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data-integrity\/\" target=\"_self\" title=\"Data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. The collected data should meet the ALCOA criteria. Ensuring data integrity requires appropriate quality and risk management systems and compliance with good documentation practices. If you need more information about data integrity contact us here.\" class=\"encyclopedia\">data integrity<\/a>&nbsp;incl. 21 CFR Part 11 analysis with definition of&nbsp;electronic records\/necessary&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/audit\/\" target=\"_self\" title=\"An Audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled. If you need more information about audits please contact us here.\" class=\"encyclopedia\">audit<\/a>&nbsp;trail settings, access and master&nbsp;<a href=\"https:\/\/q-finity.de\/en\/glossar\/data\/\" target=\"_self\" title=\"Data generally denotes facts, values (numerical or otherwise) or recordable findings, such as those obtained by measurements or observation. If you need more information about data contact us here.\" class=\"encyclopedia\">data<\/a>&nbsp;management<\/li>\n<li>Facilitation and execution of risk analyses in order to define meaningful risks and measures<\/li>\n<li>Development and optimization of the test strategy for the use of synergies between different test phases including authorization tests, simplified regression tests and possibly test automation<\/li>\n<li>Support for the periodic evaluation as per EU GMP Annex 11<\/li>\n<li>Project management for validation projects<\/li>\n<li class=\"translation-block\">Development of the basis for IT qualification for the ERP system, including core application management&nbsp;processes such as transportation, authorization management, development\/configuration management.<\/li>\n<li class=\"translation-block\">Auditing of external service providers (IT and ERP Application Management)<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 -->\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mmnxkr-9e7f70d65843d8a79110a04cf6fdc415\">\n.avia-section.av-mmnxkr-9e7f70d65843d8a79110a04cf6fdc415 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-mmnxkr-9e7f70d65843d8a79110a04cf6fdc415 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-mmnxkr-9e7f70d65843d8a79110a04cf6fdc415 .scroll-down-link.avia-svg-icon svg:first-child{\nstroke:#ffffff;\nfill:#ffffff;\n}\n<\/style>\n<div id=\"av_section_4\" class=\"avia-section av-mmnxkr-9e7f70d65843d8a79110a04cf6fdc415 main_color avia-section-default avia-no-border-styling  avia-builder-el-12  el_after_av_section  el_before_av_postcontent  avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize\"><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><a 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clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kspj6j-a52ad4473ad2873f59d6c18af2a85383\">\n.flex_column.av-kspj6j-a52ad4473ad2873f59d6c18af2a85383{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-kspj6j-a52ad4473ad2873f59d6c18af2a85383 av_one_half  avia-builder-el-13  el_before_av_one_half  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-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15\">\n#top .av-special-heading.av-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15{\npadding-bottom:30px;\nfont-size:50px;\n}\nbody .av-special-heading.av-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 .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-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 .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-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-j47oej-a4cbe1ee6bf11b48d4723ccaabbcae15 av-special-heading-h2 blockquote modern-quote  avia-builder-el-14  avia-builder-el-no-sibling  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Q_NEWS<\/h2><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-h7vbvf-e600fe64c24e770df7a04a7b55bc1625\">\n.flex_column.av-h7vbvf-e600fe64c24e770df7a04a7b55bc1625{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-h7vbvf-e600fe64c24e770df7a04a7b55bc1625 av_one_half  avia-builder-el-15  el_after_av_one_half  el_before_av_one_full  flex_column_div av-zero-column-padding  \"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f4oa63-b2c78ceddf767d86bf709ccb5992ff09\">\n.flex_column.av-f4oa63-b2c78ceddf767d86bf709ccb5992ff09{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-f4oa63-b2c78ceddf767d86bf709ccb5992ff09 av_one_full  avia-builder-el-16  el_after_av_one_half  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><div id=\"av-masonry-1\" class=\"av-masonry av-dxs7qz-1cef848078fe0eda2a72fecc730ce939 noHover av-fixed-size av-large-gap av-hover-overlay-active av-masonry-animation-active av-masonry-col-4 av-caption-always av-caption-style-overlay av-masonry-entries \" data-post_id=\"4906\"><div class=\"av-masonry-container isotope av-js-disabled\"><div class=\"av-masonry-entry isotope-item av-masonry-item-no-image \"><\/div><a href=\"https:\/\/q-finity.de\/en\/it-quality-management\/\" id=\"av-masonry-1-item-14481\" data-av-masonry-item=\"14481\" class=\"av-masonry-entry isotope-item post-14481 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">IT Quality Management for Secure System Restoration: Recovery from Ransomeware attack in GxP-Regulated Environments<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">In this case study, the focus is on the restoration of IT systems&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/global-qms-concept-case-study\/\" id=\"av-masonry-1-item-14470\" data-av-masonry-item=\"14470\" class=\"av-masonry-entry isotope-item post-14470 post type-post status-publish format-standard hentry category-project-news  av-masonry-item-no-image\" title=\"Global QMS concept for an international pharmaceutical company: design and implementation\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">Global QMS concept for an international pharmaceutical company: design and implementation<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">This case study focuses on the design and implementation of a&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. April 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/ispe-ai-in-life-sciences-summit-with-qfinity-22-23-june-2026\/\" id=\"av-masonry-1-item-14452\" data-av-masonry-item=\"14452\" class=\"av-masonry-entry isotope-item post-14452 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">ISPE AI in Life Sciences Summit with QFINITY| 22.-23. June 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">QFINITY will be represented at the ISPE AI in Life Sciences Summit&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">23. March 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><a href=\"https:\/\/q-finity.de\/en\/ispe-eu-annual-conference-20-22-april-2026\/\" id=\"av-masonry-1-item-14436\" data-av-masonry-item=\"14436\" class=\"av-masonry-entry isotope-item post-14436 post type-post status-publish format-standard hentry category-meet-qfinity-en  av-masonry-item-no-image\" title=\"ISPE EU Annual Conference | 20.-22. April 2026\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"av-inner-masonry-sizer\"><\/div><figure class=\"av-inner-masonry main_color\"><figcaption class=\"av-inner-masonry-content site-background\"><div class=\"av-inner-masonry-content-pos\"><div class=\"av-inner-masonry-content-pos-content\"><div class=\"avia-arrow\"><\/div><h3 class=\"av-masonry-entry-title entry-title \" itemprop=\"headline\">ISPE EU Annual Conference | 20.-22. April 2026<\/h3><div class=\"av-masonry-entry-content entry-content\" itemprop=\"text\">Meet QFINITY on site at the ISPE EU Annual Conference 2026 in&hellip;<\/div><span class=\"av-masonry-date meta-color updated\">8. March 2026<\/span><span class=\"av-masonry-text-sep text-sep-author\">\/<\/span><span class=\"av-masonry-author meta-color author\"><span class=\"fn\">by Maike Henrichmann<\/span><\/span><\/div><\/div><\/figcaption><\/figure><\/a><!--end av-masonry entry--><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-ca02wb-eb933bbe31e4c1cbda5d87e38bb7966a\">\n.flex_column.av-ca02wb-eb933bbe31e4c1cbda5d87e38bb7966a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-ca02wb-eb933bbe31e4c1cbda5d87e38bb7966a av_one_half  avia-builder-el-18  el_after_av_one_full  el_before_av_one_half  first flex_column_div av-zero-column-padding  column-top-margin\"><p><\/p><div class=\"avia-buttonrow-wrap av-ab7n2j-75cae74c0845fabeff4c93ecb875d951 avia-buttonrow-left  avia-builder-el-19  el_before_av_hr  avia-builder-el-first \">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9qo6p7-cff6fccf4376124dcfb5f6112ef0aab5\">\n#top #wrap_all .avia-button.av-9qo6p7-cff6fccf4376124dcfb5f6112ef0aab5{\nmargin-bottom:5px;\nmargin-right:5px;\n}\n#top #wrap_all .avia-button.av-9qo6p7-cff6fccf4376124dcfb5f6112ef0aab5:hover{\ncolor:#ffffff;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-9qo6p7-cff6fccf4376124dcfb5f6112ef0aab5:hover .avia-svg-icon svg:first-child{\nfill:#ffffff;\nstroke:#ffffff;\n}\n<\/style>\n<a href=\"\" class=\"avia-button av-9qo6p7-cff6fccf4376124dcfb5f6112ef0aab5 avia-icon_select-yes-right-icon avia-size-x-large av-icon-on-hover avia-color-theme-color avia-font-color-theme-color\" aria-label=\"all news\"><span class=\"avia_iconbox_title\">all news<\/span><span class=\"avia_button_icon avia_button_icon_right avia-iconfont avia-font-entypo-fontello\" data-av_icon=\"&#59517;\" data-av_iconfont=\"entypo-fontello\"><\/span><span class=\"avia_button_background avia-button avia-color-theme-color-highlight\"><\/span><\/a>\n<\/div><br>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7umzej-288f5f795bd46838783c64609d7fe5a0\">\n#top .hr.hr-invisible.av-7umzej-288f5f795bd46838783c64609d7fe5a0{\nheight:50px;\n}\n<\/style>\n<div class=\"hr av-7umzej-288f5f795bd46838783c64609d7fe5a0 hr-invisible  avia-builder-el-20  el_after_av_buttonrow  avia-builder-el-last \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-5l7qpn-b0c6dab688b5628eeb940ae5336dd620\">\n.flex_column.av-5l7qpn-b0c6dab688b5628eeb940ae5336dd620{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-5l7qpn-b0c6dab688b5628eeb940ae5336dd620 av_one_half  avia-builder-el-21  el_after_av_one_half  el_before_av_hr  flex_column_div av-zero-column-padding  column-top-margin\"><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-4x5tvf-0fa38aba32fd0ac30a94e09a66973509\">\n#top .hr.hr-invisible.av-4x5tvf-0fa38aba32fd0ac30a94e09a66973509{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-4x5tvf-0fa38aba32fd0ac30a94e09a66973509 hr-invisible  avia-builder-el-22  el_after_av_one_half  avia-builder-el-last \"><span class=\"hr-inner \"><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":4876,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4906","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Validation and Operation of ERP-Systems<\/title>\n<meta name=\"description\" content=\"We help our customers with the validation and operation of ERP-systems and GxP-compliant processes. 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