{"id":4918,"date":"2021-03-12T13:48:42","date_gmt":"2021-03-12T12:48:42","guid":{"rendered":"https:\/\/q-finity.de\/company\/referenzen\/drug-safety-implementation\/"},"modified":"2024-04-03T13:16:32","modified_gmt":"2024-04-03T11:16:32","slug":"drug-safety-implementation","status":"publish","type":"page","link":"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/","title":{"rendered":"Drug Safety Implementation"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6acxy8-330ed29dfc0b140d419b727024ba6054\">\n.avia-section.av-km6acxy8-330ed29dfc0b140d419b727024ba6054 .av-parallax .av-parallax-inner{\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\/illu_company_yellow.svg);\nbackground-repeat:no-repeat;\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n#top .avia-section.av-km6acxy8-330ed29dfc0b140d419b727024ba6054 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-km6acxy8-330ed29dfc0b140d419b727024ba6054 .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-km6acxy8-330ed29dfc0b140d419b727024ba6054 alternate_color avia-section-large avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch av-parallax-section avia-bg-style-parallax av-minimum-height av-minimum-height-50 av-height-50  container_wrap fullsize\" data-section-bg-repeat=\"stretch\" data-av_minimum_height_pc=\"50\" data-av_min_height_opt=\"50\"><div class=\"av-parallax\" data-avia-parallax-ratio=\"0.3\"><div class=\"av-parallax-inner alternate_color avia-full-stretch\"><\/div><\/div><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-4918\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6abike-0fd775a5e55d0610fa53ed21d52bd056\">\n#top .av-special-heading.av-km6abike-0fd775a5e55d0610fa53ed21d52bd056{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6abike-0fd775a5e55d0610fa53ed21d52bd056 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6abike-0fd775a5e55d0610fa53ed21d52bd056 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6abike-0fd775a5e55d0610fa53ed21d52bd056 .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-km6abike-0fd775a5e55d0610fa53ed21d52bd056 .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-km6abike-0fd775a5e55d0610fa53ed21d52bd056 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div class=\"av-special-heading av-km6abike-0fd775a5e55d0610fa53ed21d52bd056 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\">Case Study: Drug Safety Implementation<\/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-mc27sk-73a78f803614f2eccff97d717eb23039\">\n.avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 .scroll-down-link{\ncolor:#ea5b0c;\n}\n#top .avia-section.av-mc27sk-73a78f803614f2eccff97d717eb23039 .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-mc27sk-73a78f803614f2eccff97d717eb23039 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-4918\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-l3bpec-e2acebc4e129e9864747e34e8ea9f957 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-l3bpec-e2acebc4e129e9864747e34e8ea9f957\">\n.flex_column.av-l3bpec-e2acebc4e129e9864747e34e8ea9f957{\nborder-radius:0px 0px 0px 0px;\npadding:10px 10px 10px 10px;\n}\n<\/style>\n<div class=\"flex_column av-l3bpec-e2acebc4e129e9864747e34e8ea9f957 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-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3\">\n#top .av-special-heading.av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .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-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .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-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6aei91-9f23aed62e5c5d732e1aa90df17c70b3 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\">Problem<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-km6af419-87790699b19893b3a17703ef633af32e \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>This page explains a case study on the topic of drug safety implementation.<\/p>\n<p>The customer is an international CRO for pharmaceutical companies. The services include the processing of (serious) adverse reactions \/ events from clinical studies according to customer requirements. Daily activities range from entering adverse reaction reports, <a href=\"https:\/\/q-finity.de\/en\/glossar\/coding\/\" target=\"_self\" title=\"Generating the program code to create software modules. The coding is subject to programming guidelines, which define the quality requirements for code generation and thus ensure the traceability of the program code. The correctness of the generated code is verified in the module test. Compliance with programming standards is verified on the basis of code&hellip;\" class=\"encyclopedia\">coding<\/a> and <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> management to medical assessment and regulatory submissions that the customer performed with an outdated and customized COTS drug safety solution. Since a major upgrade was necessary anyway in order to continuously meet the regulatory requirements, e.g. for E2B reporting, the customer wanted:<\/p>\n<ul>\n<li>Creation of a catalog of requirements to prepare for the market analysis<\/li>\n<li>Evaluation of the leading drug safety solutions on the market as potential replacements for the existing solution in order to prepare an informed decision<\/li>\n<li>Updating the existing drug safety solution or implementing a new system<\/li>\n<li>Assess and redesign workflows to get the most out of the system and meet customer expectations<\/li>\n<li><a href=\"https:\/\/q-finity.de\/en\/glossar\/integration\/\" target=\"_self\" title=\"Integration describes the building of hardware and\/or implementation of software components to create a complete system. Integration tests check the function and interaction of the individual components. For more information about integration contact us here.\" class=\"encyclopedia\">Integration<\/a> of the drug safety solution into the customer&rsquo;s IT landscape for the automated exchange of <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> from and to EDC or CTMS systems<\/li>\n<li>Validation of the system using the risk-based approach based on GAMP 5, taking into account the new processes, integrations and the new functionalities to meet international regulatory requirements<\/li>\n<\/ul>\n<\/div><\/section><\/div><div class=\"av-flex-placeholder\"><\/div><div class=\"flex_column av-av_one_half-58a6369d5c19d308284fa729d91312fa 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  \"><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lsiz1ygx-65a7d2fbe2918ecd8eea0de776659a45\">\n.avia-image-container.av-lsiz1ygx-65a7d2fbe2918ecd8eea0de776659a45 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-lsiz1ygx-65a7d2fbe2918ecd8eea0de776659a45 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div class=\"avia-image-container av-lsiz1ygx-65a7d2fbe2918ecd8eea0de776659a45 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=482184576  decoding=\"async\" fetchpriority=\"high\" class=\"wp-image-10458 avia-img-lazy-loading-not-10458 avia_image \" src=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:226\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png\" alt=\"QFINITY Drug safety Implementation\" title=\"signet_PAN_orange 2\" height=\"226\" width=\"300\" itemprop=\"thumbnailUrl\" srcset=\"https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:300\/h:226\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 300w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1030\/h:777\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 1030w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:768\/h:579\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 768w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1432\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 1536w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1431\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 2048w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:1432\/h:1080\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 1500w, https:\/\/mlsqau6zetur.i.optimole.com\/cb:frAi.c2d9\/w:705\/h:532\/q:mauto\/f:best\/https:\/\/q-finity.de\/wp-content\/uploads\/2023\/07\/signet_PAN_orange-2.png 705w\" sizes=\"(max-width: 300px) 100vw, 300px\"><\/div><\/div><\/div><\/div><\/div><!--close column table wrapper. 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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-4918\"><div class=\"entry-content-wrapper clearfix\">\n<div class=\"flex_column_table av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1 sc-av_one_half av-equal-height-column-flextable\">\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1\">\n.flex_column.av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-f5bg04-4c55d75c6e41ff608f9116814d19f7a1 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-1fjlg4-b4c654a793cb903a830729e08d3da27e\">\n.flex_column.av-1fjlg4-b4c654a793cb903a830729e08d3da27e{\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-1fjlg4-b4c654a793cb903a830729e08d3da27e 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  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d\">\n#top .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .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-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .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-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6afn7l-a1556a8a768ac107a02c23e5b690ec6d av-special-heading-h2 blockquote modern-quote  avia-builder-el-11  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Project execution<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-bx6f10-87a96478d1a851a7de851674a28ff9c9 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>In the first phase, the leading drug safety solutions on the market were checked for compliance with pharmacovigilance and clinical trial regulations and conformity to customer expectations. A new drug safety solution was selected to replace the existing solution. During the following implementation project, <a href=\"https:\/\/q-finity.de\/en\/glossar\/qfinity\/\" target=\"_self\" title=\"QFINITY provides expertise and support for pharmaceutical and medical device companies along the entire product or service lifecycle. Our focus is on developing and optimizing quality management system and IT system strategies to support continuous improvement, (business) process management and optimization through application of technology, ensuring (e)data quality and data integrity, as well as validation&hellip;\" class=\"encyclopedia\">QFINITY<\/a> employees organized the system validation. We supported the following areas in particular:<\/p>\n<ul>\n<li>Supplier evaluation (<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>) to assess the supplier&rsquo;s QMS as well as the system functionality and controls for compliance with regulatory requirements.<\/li>\n<li>Design of new workflows to increase efficiency as well as compliance; risk assessment of the processes and the supporting system in order to enable a lean validation approach<\/li>\n<li>Development of integrations to reduce processing times, manual reconciliations and to increase <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><\/li>\n<li>Planning, execution and summary of the system validation including:\n<ul>\n<li>Requirements acquisition taking into account business, regulatory, <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> protection and IT aspects<\/li>\n<li>Risk assessment and development of the validation strategy<\/li>\n<li>Validation planning, including the scaling of activities, based on the risk assessment<\/li>\n<li>Installation qualification in close cooperation with the IT department of the CRO<\/li>\n<li>Configuration review as part of operational qualification<\/li>\n<li>Design and creation of the user acceptance test<\/li>\n<li>Validation of the system integrations developed by the customer<\/li>\n<li>Design of lean validation and documentation approaches for recurring changes, e.g. MedDRA updates<\/li>\n<li>Planning and support of E2B test activities with regulatory authorities<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><\/section><\/div><\/div><!--close column table wrapper. Autoclose: 1 --><\/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-90b4j8-e7507ec90d65299aa8b580a8a1904797\">\n.avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .av-section-color-overlay{\nopacity:0.7;\nbackground-color:#ffffff;\n}\n#top .avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .scroll-down-link{\ncolor:#ffffff;\n}\n#top .avia-section.av-90b4j8-e7507ec90d65299aa8b580a8a1904797 .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-90b4j8-e7507ec90d65299aa8b580a8a1904797 main_color avia-section-default avia-no-border-styling  avia-builder-el-13  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 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-4\" aria-describedby=\"av-svg-desc-4\" role=\"graphics-symbol\" aria-hidden=\"true\">\n<title id=\"av-svg-title-4\">Scroll to next section<\/title>\n<desc id=\"av-svg-desc-4\">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-4918\"><div class=\"entry-content-wrapper clearfix\">\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5\">\n.flex_column.av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-87oe1w-3ecc571bef3e50ec0837e4121fda1ed5 av_one_half  avia-builder-el-14  el_before_av_one_half  avia-builder-el-first  first flex_column_div av-zero-column-padding  \"><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-km6apft7-9dbbd08d0ad163ccee8a470965c13504\">\n#top .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504{\npadding-bottom:10px;\nfont-size:50px;\n}\nbody .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag{\nfont-size:50px;\n}\n.av-special-heading.av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .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-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .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-km6apft7-9dbbd08d0ad163ccee8a470965c13504 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<\/p><div class=\"av-special-heading av-km6apft7-9dbbd08d0ad163ccee8a470965c13504 av-special-heading-h2 blockquote modern-quote  avia-builder-el-15  el_before_av_textblock  avia-builder-el-first  av-inherit-size\"><h2 class=\"av-special-heading-tag \" itemprop=\"headline\">Result and benefit<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br>\n<section class=\"av_textblock_section av-km6ajolx-1342035eff2c03b193cfb3998754f1ef \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>The project was completed on time and within budget as the validation activities were scaled appropriately. The test activities were well prepared and could be carried out without major problems.<\/p>\n<p>As expected the implemented solution increased efficiency and compliance significantly. The improved <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> control as well as the reduction of manual steps, such as manual <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> transcriptions, increase the <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> for the entire area considerably.<\/p>\n<p>Also the validation approach and the documents were checked by the internal <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> assurance of the CRO after the project and no problems were identified.<\/p>\n<\/div><\/section><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6lb9mc-a7a669272479fd5f4676da8b5121530a\">\n.flex_column.av-6lb9mc-a7a669272479fd5f4676da8b5121530a{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div class=\"flex_column av-6lb9mc-a7a669272479fd5f4676da8b5121530a av_one_half  avia-builder-el-17  el_after_av_one_half  el_before_av_textblock  flex_column_div av-zero-column-padding  \"><\/div><section class=\"av_textblock_section av-lr7lx3in-d1dcca89dcf8ce5f82288b636c686506 \" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\"><div class=\"avia_textblock\" itemprop=\"text\"><p>Do you also need help with drug safety implementation? We can help you find the perfect solution. Contact us now <a href=\"https:\/\/q-finity.de\/en\/contact\/?swcfpc=1\">here<\/a>!<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4\">\n#top .hr.hr-invisible.av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4{\nheight:100px;\n}\n<\/style>\n<div class=\"hr av-45u9f8-f727a45618f9258d51c199fd4c5ce4f4 hr-invisible  avia-builder-el-19  el_after_av_textblock  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":5479,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-4918","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>Drug Safety Implementation with QFINITY<\/title>\n<meta name=\"description\" content=\"This is a case study which shows how QFINITY helped a customer who wanted a new Drug Safety Implementation.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Drug Safety Implementation\" \/>\n<meta property=\"og:description\" content=\"This is a case study which shows how QFINITY helped a customer who wanted a new Drug Safety Implementation.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2024-04-03T11:16:32+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/\",\"url\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/\",\"name\":\"Drug Safety Implementation with QFINITY\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2021-03-12T12:48:42+00:00\",\"dateModified\":\"2024-04-03T11:16:32+00:00\",\"description\":\"This is a case study which shows how QFINITY helped a customer who wanted a new Drug Safety Implementation.\",\"breadcrumb\":{\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/drug-safety-implementation\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/q-finity.de\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Company\",\"item\":\"https:\/\/q-finity.de\/en\/company\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"References\",\"item\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"Case Studies\",\"item\":\"https:\/\/q-finity.de\/en\/company\/successful-collaboration\/case-studies\/\"},{\"@type\":\"ListItem\",\"position\":5,\"name\":\"Drug Safety Implementation\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/q-finity.de\/en\/#website\",\"url\":\"https:\/\/q-finity.de\/en\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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