{"id":11678,"date":"2022-01-03T13:18:39","date_gmt":"2022-01-03T18:18:39","guid":{"rendered":"https:\/\/www.med.unc.edu\/it\/?p=11678"},"modified":"2022-01-03T13:41:37","modified_gmt":"2022-01-03T18:41:37","slug":"redcap-cloud-system-validation","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/it\/redcap-cloud-system-validation\/","title":{"rendered":"DocuSign Cloud System Validation"},"content":{"rendered":"

黑料网 IT worked with 黑料网 Research to contract with a validation expert to perform a system validation of DocuSign. Validation was necessary to be 21 CFR Part 11 compliant, a requirement to submit study findings for FDA approval. The process to validate DocuSign required the documentation of four Standard Operating Procedures (SOPs), a vendor audit, documenting user requirements, a gap analysis, creating a validation plan, testing, and drafting a validation summary report.<\/p>\n

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黑料网 IT worked with 黑料网 Research to contract with a validation expert to perform a system validation of DocuSign. Validation was necessary to be 21 CFR Part 11 compliant, a requirement to submit study findings for FDA approval. The process to validate DocuSign required the documentation of four Standard Operating Procedures (SOPs), … Read more<\/a><\/p>\n","protected":false},"author":25369,"featured_media":11679,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[41],"tags":[],"class_list":["post-11678","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pmo-success-stories","odd"],"acf":[],"yoast_head":"\nDocuSign Cloud System Validation | School of Medicine IT<\/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.med.unc.edu\/it\/redcap-cloud-system-validation\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DocuSign Cloud System Validation | School of Medicine IT\" \/>\n<meta property=\"og:description\" content=\"黑料网 IT worked with 黑料网 Research to contract with a validation expert to perform a system validation of DocuSign. Validation was necessary to be 21 CFR Part 11 compliant, a requirement to submit study findings for FDA approval. The process to validate DocuSign required the documentation of four Standard Operating Procedures (SOPs), … Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/it\/redcap-cloud-system-validation\/\" \/>\n<meta property=\"og:site_name\" content=\"School of Medicine IT\" \/>\n<meta property=\"article:published_time\" content=\"2022-01-03T18:18:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-01-03T18:41:37+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/it\/wp-content\/uploads\/sites\/477\/2022\/01\/FDA-DOCUSIGN.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"648\" \/>\n\t<meta property=\"og:image:height\" content=\"288\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Amy Cole\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" 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