{"id":3986,"date":"2023-01-11T13:07:46","date_gmt":"2023-01-11T12:07:46","guid":{"rendered":"https:\/\/dev.e-vis.se\/?page_id=3986"},"modified":"2023-10-02T08:49:38","modified_gmt":"2023-10-02T06:49:38","slug":"quality","status":"publish","type":"page","link":"https:\/\/e-vis.se\/en\/about-us\/quality\/","title":{"rendered":"Quality"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h3 class=\"wp-block-heading\"><a>Quality Management in e-VIS<\/a><\/h3>\n\n\n\n<p>The Quality Management System in e-VIS ensures compliance in e-VIS activities with regards to the requirements in EU Directive 2011\/62\/EU (Falsified Medicines Directive) as well as the Delegated Regulation 2016\/161\/EU. e-VIS must also be in compliance with the requirements of ISO\/IEC 27001:2013 Standard, applicable parts of EU-GMP Annex 11 and 15 and GAMP (Good Automated Manufacturing Practice) i.e. quality assurance for computerised systems.<\/p>\n\n\n\n<p>Our Quality Management System consists of policies, SOPs and working instructions that describe the core processes as well as supporting processes and clarify responsibilities. In order to continously improve e-VIS activities and the quality management system, quality objectives have been defined and are reviewed. We work proactively to identify and follow-up risks, provide training and periodically perform review of e-VIS activities as well as the activities of our IT supplier.<\/p>\n\n\n\n<p>The Medical Products Agency (MPA) is responsible for supervising e-VIS. A voluntary assessment was performed by the MPA and EDQM (European Directorate for the Quality of Medicines) at e-VIS in August 2018 before implementation of FMD. In March 2020 e-VIS was again inspected by the MPA and EDQM, this time based on the implemented regulation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><a>Mock exercise in the alert management process<\/a><\/h3>\n\n\n\n<p>An alert management exercise for Swedish stakeholders was arranged by e-VIS in November 2021. The value of performing mock exercises was identified following dialogue with the Medical Products Agency. The purpose of performing this kind of exercise is:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>To show the importance of sharing information between stakeholders and to improve associated processes<\/li>\n\n\n\n<li>To increase e-VIS and all stakeholder preparedness<\/li>\n\n\n\n<li>To rehearse and learn from each other within the EMVS community as a real situation with a confirmed falsification will be rare<\/li>\n<\/ul>\n\n\n\n<p><strong><a href=\"https:\/\/e-vis.se\/wp-content\/uploads\/2022\/04\/Report-e-VIS-Mock-Exercise-2021.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Report from the Mock Exercise 12 November 2021<\/a><\/strong><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33%\"><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Quality Management in e-VIS The Quality Management System in e-VIS ensures compliance in e-VIS activities with regards to the requirements in EU Directive 2011\/62\/EU (Falsified Medicines Directive) as well as the Delegated Regulation 2016\/161\/EU. e-VIS must also be in compliance with the requirements of ISO\/IEC 27001:2013 Standard, applicable parts of EU-GMP Annex 11 and 15&hellip;&nbsp;<a href=\"https:\/\/e-vis.se\/en\/about-us\/quality\/\" rel=\"bookmark\">Read More &raquo;<span class=\"screen-reader-text\">Quality<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":3504,"parent":3977,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"neve_meta_sidebar":"","neve_meta_container":"","neve_meta_enable_content_width":"on","neve_meta_content_width":100,"neve_meta_title_alignment":"","neve_meta_author_avatar":"","neve_post_elements_order":"","neve_meta_disable_header":"","neve_meta_disable_footer":"","neve_meta_disable_title":"on","neve_meta_reading_time":"","footnotes":""},"class_list":["post-3986","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"featured_image_src":"https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/evis-std-2.jpg","yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality - e-VIS<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/e-vis.se\/en\/about-us\/quality\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality - e-VIS\" \/>\n<meta property=\"og:description\" content=\"Quality Management in e-VIS The Quality Management System in e-VIS ensures compliance in e-VIS activities with regards to the requirements in EU Directive 2011\/62\/EU (Falsified Medicines Directive) as well as the Delegated Regulation 2016\/161\/EU. e-VIS must also be in compliance with the requirements of ISO\/IEC 27001:2013 Standard, applicable parts of EU-GMP Annex 11 and 15&hellip;&nbsp;Read More &raquo;Quality\" \/>\n<meta property=\"og:url\" content=\"https:\/\/e-vis.se\/en\/about-us\/quality\/\" \/>\n<meta property=\"og:site_name\" content=\"e-VIS\" \/>\n<meta property=\"article:modified_time\" content=\"2023-10-02T06:49:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/e-vis.se\/wp-content\/uploads\/2022\/12\/evis-std-2.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1024\" \/>\n\t<meta property=\"og:image:height\" content=\"768\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/e-vis.se\/en\/about-us\/quality\/\",\"url\":\"https:\/\/e-vis.se\/en\/about-us\/quality\/\",\"name\":\"Quality - 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