[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-191493-105":53,"doc-detail-191493-en":127},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":120,"head_meta":122,"extra_data":124,"updated_unix":126},105,"en","certification-of-compliance-with-21-cfr-part-11","Certification of Compliance with 21 CFR Part 11","","This document serves as a Certification of Compliance with 21 CFR Part 11, pertaining to electronic records and electronic signatures. It is issued by St. Luke's Hospital & Health Network, attesting that the software used has been validated to ensure reliable, accurate, and consistent performance in accordance with Part 11 requirements. The software is identified as a \"closed system\" as defined in Part 11. Furthermore, it incorporates features that facilitate compliance with requirements applicable to \"closed Systems\" as set forth in Section 11.10 of Part 11. The certifications are signed by Chad Bringardine, VP, CIO, and Nicole Huff, Chief Compliance Officer, affirming the adherence to regulatory standards for electronic record-keeping and signatures within the healthcare network.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/certification-of-compliance-with-21-cfr-part-11/191493/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/certification-of-compliance-with-21-cfr-part-11/191493.png","ImageObject",442,249,{"name":88,"@type":89},"Felix Montgomery","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-29","2026-09-03",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",7,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of this document?","Question",{"text":109,"@type":110},"This document certifies that the software used by St. Luke's Hospital & Health Network is in compliance with 21 CFR Part 11 regulations for electronic records and electronic signatures.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What are the key features of the software mentioned in relation to 21 CFR Part 11?",{"text":114,"@type":110},"The software has been validated for reliable, accurate, and consistent performance. It operates as a \"closed system\" and includes features designed to ensure compliance with requirements for \"closed Systems\" as outlined in Section 11.10 of Part 11.",{"name":116,"@type":107,"acceptedAnswer":117},"Who has certified this compliance?",{"text":118,"@type":110},"The compliance has been certified by Chad Bringardine, VP, CIO, and Nicole Huff, Chief Compliance Officer, at St. Luke's Hospital & Health Network.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},191493,1788408913,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":131,"file_id":132,"file_url":133,"file_type":134,"file_size":135,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":136,"language":137,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":138,"faqs":139,"seo_title":140,"seo_description":61,"update_tm":126,"read_time":73},549768064778,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","| Role | Step | Activity |\n| --- | --- | --- |\n| Principal Investigator | 1.0 | Sign Certification of Verification of Copies (Attachment A) at time of SIV. |\n| Research Nurse/Coordinator or designee | 1.1 | Make copies of information needed for source documents directly from the EMR with no alterations.\u003Cbr>NOTE: Research shadow charts shall only |\n\n\n|  |  | contain study-relevant information from the EMR. |\n| --- | --- | --- |\n| Research Nurse/Coordinator or designee | 1.2 | File and maintain EMR copies in patient-specific research shadow chart. |\n\n\n| Role | Step | Activity |\n| --- | --- | --- |\n| Research Nurse/Coordinator or designee | 2.0 | Retain copies of Certification of Compliance with 21 CFR 11(Attachment B)and Certification of Verification of Copies (Attachment A) . |\n| Research Nurse/Coordinator or designee | 2.1 | Provide copy of SLUHN Certification of Compliance with 21 CFR Part 11 (Attachment B) to monitor upon request. |\n| Research Nurse/Coordinator or designee | 2.2 | Provide copy of SLUHN Certification of Verification of Copies (Attachment A)if the monitor requests access to EMR.\u003Cbr>NOTE: An exception to this policy is trauma or other long length of stay inpatient studies where limited access may be granted upon approval (See Steps 3.0 and 3.1) . |\n\n\n| Role | Step | Activity |\n| --- | --- | --- |\n| Research Nurse/Coordinator or designee | 3.0 | Contact Director of Medical Records with a list of patients to be monitored and the date of admission. |\n| Research Nurse/Coordinator or designee | 3.1 | Obtain generic access from Director of Medical Records and provide to the monitor for viewonly access of those patients identified from Step 3.0. |","cbCaiahH6b7Yxptq","https://ap.wps.com/l/cbCaiahH6b7Yxptq","pdf",234913,6,"English","# Certification of Compliance with 21 CFR Part 11\n## Statement of Software Compliance","[{\"question\":\"What is the purpose of this document?\",\"answer\":\"This document certifies that the software used by St. Luke's Hospital \\u0026 Health Network is in compliance with 21 CFR Part 11 regulations for electronic records and electronic signatures.\"},{\"question\":\"What are the key features of the software mentioned in relation to 21 CFR Part 11?\",\"answer\":\"The software has been validated for reliable, accurate, and consistent performance. It operates as a \\\"closed system\\\" and includes features designed to ensure compliance with requirements for \\\"closed Systems\\\" as outlined in Section 11.10 of Part 11.\"},{\"question\":\"Who has certified this compliance?\",\"answer\":\"The compliance has been certified by Chad Bringardine, VP, CIO, and Nicole Huff, Chief Compliance Officer, at St. Luke's Hospital \\u0026 Health Network.\"}]","Certification of Compliance with 21 CFR Part 11 | PDF"]