{"id":1804,"date":"2020-02-28T15:19:14","date_gmt":"2020-02-28T14:19:14","guid":{"rendered":"https:\/\/www.medsyscon.com\/?p=1804"},"modified":"2021-04-06T16:23:49","modified_gmt":"2021-04-06T14:23:49","slug":"blog-integrity","status":"publish","type":"post","link":"https:\/\/www.medsyscon.com\/en\/blog-integrity\/","title":{"rendered":"Don&#8217;t Let Data Integrity Be Your Achilles&#8217; Heel"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">MasterControl recently published an article by Gina Guido-Redden showing that the FDA has been actively defining detailed expectations for data integrity since 1997 when they supplemented 21 CFR Part 211\u2019s predicate rules on records and record keeping, by publishing Title 21\u2019s first set of regulations directly defining the rules for electronic records and electronic signatures (21 CFR part 11). However, more than a decade passed before their first guidance document on this topic was released. In addition to the FDA\u2019s recently published guidance on data integrity, industry has also received formal guidance documents from The Pharmaceutical Inspection Co-operation Scheme (PIC\/S), the Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the World Health Organization (WHO). It\u2019s clear that everyone is publishing on the same topic, at the same time and they are saying the same thing. Our data lacks integrity and the regulators want that to change.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Please read the full article <strong><a href=\"https:\/\/www.mastercontrol.com\/gxp-lifeline\/in-a-data-driven-ecosystem-don't-let-data-integrity-be-your-achilles'-heel\/\">here<\/a><\/strong> <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Please get in touch\nwith us for any further support:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.medsyscon.com\/en\">www.medsyscon.com\/en<\/a> <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"mailto:info@medsyscon.com\">info@medsyscon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">+49-176-57694801<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"74\" src=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/06\/logo-medsyscon.png\" alt=\"\" class=\"wp-image-1681\"\/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>MasterControl recently published an article by Gina Guido-Redden showing that the FDA has been actively defining detailed expectations for data integrity since 1997 when they supplemented 21 CFR Part 211\u2019s predicate rules on records and record keeping, by publishing Title 21\u2019s first set of regulations directly defining the rules for electronic records and electronic signatures (21 CFR part 11). However, more than a decade passed \u2026<\/p>\n","protected":false},"author":5,"featured_media":1805,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[75],"tags":[],"class_list":["post-1804","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-quality-management"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Don&#039;t Let Data Integrity Be Your Achilles&#039; Heel - MedSysCon Medizintechnik GmbH<\/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:\/\/www.medsyscon.com\/en\/blog-integrity\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Don&#039;t Let Data Integrity Be Your Achilles&#039; Heel - MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"og:description\" content=\"MasterControl recently published an article by Gina Guido-Redden showing that the FDA has been actively defining detailed expectations for data integrity since 1997 when they supplemented 21 CFR Part 211\u2019s predicate rules on records and record keeping, by publishing Title 21\u2019s first set of regulations directly defining the rules for electronic records and electronic signatures (21 CFR part 11). However, more than a decade passed \u2026\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.medsyscon.com\/en\/blog-integrity\/\" \/>\n<meta property=\"og:site_name\" content=\"MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-28T14:19:14+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T14:23:49+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/pictext_700_435.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"700\" \/>\n\t<meta property=\"og:image:height\" content=\"435\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@MedSysCon\" \/>\n<meta name=\"twitter:site\" content=\"@MedSysCon\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-integrity\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-integrity\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/#\\\/schema\\\/person\\\/d77306be517a6c2e602e58c10e0246de\"},\"headline\":\"Don&#8217;t Let Data Integrity Be Your Achilles&#8217; 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