{"id":7236,"date":"2021-04-23T00:14:56","date_gmt":"2021-04-23T00:14:56","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7236"},"modified":"2024-01-11T16:06:04","modified_gmt":"2024-01-11T16:06:04","slug":"fda-part-11-requirements","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/","title":{"rendered":"FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7236\" class=\"elementor elementor-7236\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6dd05cd3\" data-id=\"6dd05cd3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-6ea4084d\" data-id=\"6ea4084d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2021\/04\/23\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tApril 23, 2021\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements?<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1200\" height=\"630\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11.png\" class=\"attachment-full size-full wp-image-5389\" alt=\"fda-21-cfr-part-11\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11.png 1200w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11-300x158.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11-1024x538.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11-768x403.png 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>The first paragraph of\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11\">21 CFR Part 11<\/a>\u00a0seems disarmingly straightforward. It says: \u201cThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.\u201d\u00a0So simple\u2026or so it seems. But as you are discovering, the \u201cdevil is in the details.\u201d<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Top Four Part 11 Compliance Requirements <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Part 11 can apply to a wide variety of electronic records, including testing reports, quality control testing results, production records, design drawings, specifications, premarket submission content, and much more. Those records are not just documents containing text \u2013 these records also include images, drawings, and other electronic files. It\u2019s important to note that FDA differentiates between \u201cclosed systems\u201d with inherently controlled access (e.g., closed section of the company intranet only accessible to internal personnel) versus an \u201copen system\u201d that allows any access or external access like connections to the internet (e.g., in the \u201cCloud\u201d storage, Google Drive, etc.). Requirements for both systems are shown\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11&amp;showFR=1&amp;subpartNode=21:1.0.1.1.8.2\">here<\/a>.<\/p><p>Let\u2019s walk through four important aspects of Part 11 compliance that you need to consider.<\/p><p>\u00a0<\/p><h3>1. Maintaining Security and User Access Controls<\/h3><p>The key point here is that you need to conduct authority checks to make sure only authorized people can use the system, sign records, change records, or access the system and electronic records in some way. You\u2019ll also need to keep close watch over documentation that shows how to operate and maintain the system. If an unauthorized person does access your system, there needs to be a means of automatically and immediately reporting the breach to the system security unit or organizational management. Best practices, and good compliance with Part 11, dictate that passwords must be changed periodically.<\/p><p>Here\u2019s are two real life examples of noncompliance taken from actual FDA Warning Letters:<\/p><h6>\u00a0<\/h6><h6><em>\u201cFirm failed to exercise appropriate controls over computer or related systems to ensure that only authorized personnel institute changes in master production and control records, or other records.\u201d<\/em><\/h6><p>\u00a0<\/p><h6><em>\u201cIT staff share user names and passwords to access your electronic storage system for data \u2013 your IT staff can delete or change directories and files without identifying individuals making changes.\u201d<\/em><\/h6><p>\u00a0<\/p><h3>2. Complying with Electronic Signature Requirements<\/h3><p>There\u2019s more to this than meets the eye. Electronic signatures must include the printed name of the signer, the date and time of the signature, and the relevance of the signature (reviewed, approved, drafted by, etc.). There are a few other important points to note. First, an electronic signature must be unique to a specific individual and cannot be signed as \u201cQA Manager\u201d or \u201cRegulatory Department.\u201d Second, you are required to have a written policy that holds signatories accountable for any actions initiated under their signature. Third, the signature must be linked to a specific document and include the date and time signed.<\/p><p>A common red flag that could catch the attention of an FDA inspector includes a mixture of documented reviews and approvals, some of which are electronically scanned while others are paper based and only stored in binders. This commonly occurs between different areas of the organization.\u00a0 There is a difference between electronic signatures and scanning signatures on hard copy documents; those scanned documents become electronic records.\u00a0 Organizations must be clear on when they are truly using electronic signatures versus when a signed document becomes an electronic record.<\/p><p>The problem with this scenario is that because the paper records were scanned and stored electronically \u2013 and those documents are used to perform regulated activities \u2013 the company is obligated to comply with Part 11. Electronic signatures and handwritten signatures executed to electronic records are held to the same standard of compliance.<\/p><p>\u00a0<\/p><h3>What is an FDA predicate rule?<\/h3><p>\u201cPredicate rule\u201d is an FDA term that refers to the underlying requirements set forth in the Food, Drug, and Cosmetic Act; the Public Health Service Act; and other FDA regulations. It refers to any FDA regulation that includes record-keeping requirements such as what records must be maintained, the contents of those records, signature requirements, and duration of record retention. Any requirement in Part 11 is always associated with a predicate rule; this means that if another regulation requires records to be maintained electronically, then Part 11 would apply.<\/p><p><em><strong>\u00a0<\/strong><\/em><\/p><p><em><strong>Here\u2019s a brief example.<\/strong><\/em>\u00a021 CFR Part 820.80(e)(4) says, \u201cEach manufacturer shall document acceptance activities required by this part. These records shall include the signature of the individual(s) conducting the acceptance activities.\u201d As such, this \u201cpredicate rule\u201d would apply appropriate parts of Part 11 if the manufacturer is using electronic signature(s) for recording acceptance activities.<\/p><h3>\u00a0<\/h3><h3>3. Validating Your Process<\/h3><p>You know the drill. Once you have implemented a process you need to validate it. FDA makes this pretty clear in Subpart B of Part 11, noting that procedures and controls for closed systems shall include: \u201cvalidation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.\u201d Once a system is identified, its validation should be planned. Part 11 System Validation Process includes activities such as project management, system risk assessment, validation planning, system design and specifications, system description, testing, traceability, and validation reporting. Part of your validation process should include testing to ensure that only authorized people can access electronic records and make changes. Also, you must have documented training in place for everyone using the system. For more on this, see\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11&amp;showFR=1&amp;subpartNode=21:1.0.1.1.8.2\">Part 11, Subpart B<\/a>.<\/p><h3>\u00a0<\/h3><h3>4. Creating an Audit Trail<\/h3><p>Part 11 mandates that you can generate accurate and complete records for review and identify any changes made to these electronic records.\u00a0 As an example, if a database maintaining customer complaint data is changed for any reason, an audit trail is created to identify who made the change, the type of change made, and the date of the change. This audit trail needs to be computer generated and time-stamped so that an entire sequence of document development and modification is clear. The audit trail part of an electronic system is designed so the audit trail cannot be tampered with and remains permanent. You\u2019ll need to make sure that your system is set up so that the author or person making the change cannot claim that the document is not genuine. This is important because nobody wants to be in a \u201cI never signed that\u201d or \u201cI never changed that\u201d situation. The need to implement audit trails should really be based on the underlying need to meet specific predicate rules in other regulations.<\/p><p>Mobile technology can make audit trails tricky. Many medical device and pharmaceutical manufacturers are integrating mobile technology such as tablets and smartphones into the QMS processes for activities, including design and development, inventory control, receiving\/shipping, equipment\/facility maintenance, and more. When this technology is used it can sometimes obscure the originator of the record or compromise the security of the electronic record.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d78be8 elementor-widget elementor-widget-heading\" data-id=\"6d78be8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FDA Part 11 Compliance Checklist<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed9a568 elementor-widget elementor-widget-text-editor\" data-id=\"ed9a568\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>The\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=11\">Part 11 regulation<\/a>\u00a0is deceptively short and, as a result, people underestimate what it takes to comply. In summary, the regulation requires that you make sure\u2026<\/p><ul><li>No electronic records are missing.<\/li><li>Backups of electronic records are verifiable.<\/li><li>Operations personnel don\u2019t all have admin rights.<\/li><li>Audit trails can be reviewed by an independent unit\/entity.<\/li><li>Personnel are adequately trained to audit electronic data and regulated systems.<\/li><li>Legacy computer systems have adequate validation or controls.<\/li><li>Formal risk analysis is performed for changes to the system.<\/li><li>Databases for analysis, tracking, and trending are validated.<\/li><li>Not to blindly trust suppliers for validation activities.<\/li><li>Changes to data cannot be made by unauthorized personnel.<\/li><li>Electronic data remains secure, especially with open systems.<\/li><li>Audit trails show deletion\/changing of data and audit trail reviews are conducted.<\/li><li>Raw data may need to be maintained for review.<\/li><li>Controls are established to prevent deletion of raw data and unauthorized access to data changes.<\/li><\/ul><p>Keep in mind that FDA\u2019s core focus is on patient safety. We most often see that manufacturers get dinged for lack of Part 11 compliance as the inspector encounters these issues. Citations typically reference predicate rules.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c822fb5 elementor-widget elementor-widget-heading\" data-id=\"c822fb5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to Learn More?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b959ace elementor-widget elementor-widget-text-editor\" data-id=\"b959ace\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>We have only scratched the surface of this topic and there is so much more to know about Part 11 compliance and data integrity. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements? The first paragraph of\u00a021 CFR Part 11\u00a0seems disarmingly straightforward. It says: \u201cThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5389,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[33,14],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements? The first paragraph of\u00a021 CFR Part 11\u00a0seems disarmingly straightforward. It says: \u201cThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2021-04-23T00:14:56+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:06:04+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11.png\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\r\n\t<meta property=\"og:image:height\" content=\"630\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/","og_locale":"en_US","og_type":"article","og_description":"FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements? The first paragraph of\u00a021 CFR Part 11\u00a0seems disarmingly straightforward. It says: \u201cThe regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2021-04-23T00:14:56+00:00","article_modified_time":"2024-01-11T16:06:04+00:00","og_image":[{"width":1200,"height":630,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/04\/fda-21-cfr-part-11.png","type":"image\/png"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"FDA 21 CFR Part 11 Compliance: Are You Complying With These Four Critical Electronic Records Requirements?","datePublished":"2021-04-23T00:14:56+00:00","dateModified":"2024-01-11T16:06:04+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/"},"wordCount":1437,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["Design Control","FDA 21 CFR Part 820"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/","url":"https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2021-04-23T00:14:56+00:00","dateModified":"2024-01-11T16:06:04+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/fda-part-11-requirements\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7236"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=7236"}],"version-history":[{"count":9,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7236\/revisions"}],"predecessor-version":[{"id":7886,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7236\/revisions\/7886"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/5389"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=7236"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=7236"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=7236"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}