{"id":13079,"date":"2022-05-17T13:33:33","date_gmt":"2022-05-17T20:33:33","guid":{"rendered":"https:\/\/www.cloudbyz.com\/blog\/?p=13079"},"modified":"2024-05-28T00:55:11","modified_gmt":"2024-05-28T07:55:11","slug":"regulatory-compliance-coverage-reference-between-fda-21-cfr-part-11-and-eu-annex-11","status":"publish","type":"post","link":"https:\/\/www.cloudbyz.com\/resources\/clinical-operations\/regulatory-compliance-coverage-reference-between-fda-21-cfr-part-11-and-eu-annex-11\/","title":{"rendered":"Regulatory Compliance Coverage & Reference between FDA 21 CFR Part 11 and EU Annex 11"},"content":{"rendered":"

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures\u00a0<\/b>to support these processes. Though the regulations around electronic records and signatures, such as\u00a0FDA 21 CFR part 11 and EU Annex 11<\/i>, have been published for a long time, their application has amplified manyfold in the recent times. To ensure continued compliance to these regulations, it is imperative for clinical researchers to understand the similarities and differences between these regulations.<\/p>\n

\"\"<\/p>\n\n\n

Cloudbyz Unified Clinical Trial Management<\/a> (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations. Built on the Salesforce cloud platform, our CTMS provides real-time visibility and analytics across study planning, budgeting, start-up, study management, and close-out. Cloudbyz CTMS can help you achieve greater efficiency, compliance, and quality in your clinical operations with features like automated workflows, centralized data management, and seamless collaboration. Contact us today to learn how Cloudbyz CTMS can help your organization optimize its clinical trial management processes.<\/p>\n\n\n\n

To know more about the Cloudbyz <\/strong><\/a> Unified Clinical Trial Management Solution contact info@cloudbyz.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Until recently, clinical trials have been performed in a mostly paper-based processes. Advancements in technology, surge in remote work and digitization of the processes is driving the clinical research industry and consequently, there is increased use of electronic records and electronic signatures\u00a0to support these processes. Though the regulations around electronic records and signatures, such as\u00a0FDA […]<\/p>\n","protected":false},"author":30,"featured_media":13104,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"content-type":"","ocean_post_layout":"","ocean_both_sidebars_style":"","ocean_both_sidebars_content_width":0,"ocean_both_sidebars_sidebars_width":0,"ocean_sidebar":"0","ocean_second_sidebar":"0","ocean_disable_margins":"enable","ocean_add_body_class":"","ocean_shortcode_before_top_bar":"","ocean_shortcode_after_top_bar":"","ocean_shortcode_before_header":"","ocean_shortcode_after_header":"","ocean_has_shortcode":"","ocean_shortcode_after_title":"","ocean_shortcode_before_footer_widgets":"","ocean_shortcode_after_footer_widgets":"","ocean_shortcode_before_footer_bottom":"","ocean_shortcode_after_footer_bottom":"","ocean_display_top_bar":"default","ocean_display_header":"default","ocean_header_style":"","ocean_center_header_left_menu":"0","ocean_custom_header_template":"0","ocean_custom_logo":0,"ocean_custom_retina_logo":0,"ocean_custom_logo_max_width":0,"ocean_custom_logo_tablet_max_width":0,"ocean_custom_logo_mobile_max_width":0,"ocean_custom_logo_max_height":0,"ocean_custom_logo_tablet_max_height":0,"ocean_custom_logo_mobile_max_height":0,"ocean_header_custom_menu":"0","ocean_menu_typo_font_family":"0","ocean_menu_typo_font_subset":"","ocean_menu_typo_font_size":0,"ocean_menu_typo_font_size_tablet":0,"ocean_menu_typo_font_size_mobile":0,"ocean_menu_typo_font_size_unit":"px","ocean_menu_typo_font_weight":"","ocean_menu_typo_font_weight_tablet":"","ocean_menu_typo_font_weight_mobile":"","ocean_menu_typo_transform":"","ocean_menu_typo_transform_tablet":"","ocean_menu_typo_transform_mobile":"","ocean_menu_typo_line_height":0,"ocean_menu_typo_line_height_tablet":0,"ocean_menu_typo_line_height_mobile":0,"ocean_menu_typo_line_height_unit":"","ocean_menu_typo_spacing":0,"ocean_menu_typo_spacing_tablet":0,"ocean_menu_typo_spacing_mobile":0,"ocean_menu_typo_spacing_unit":"","ocean_menu_link_color":"","ocean_menu_link_color_hover":"","ocean_menu_link_color_active":"","ocean_menu_link_background":"","ocean_menu_link_hover_background":"","ocean_menu_link_active_background":"","ocean_menu_social_links_bg":"","ocean_menu_social_hover_links_bg":"","ocean_menu_social_links_color":"","ocean_menu_social_hover_links_color":"","ocean_disable_title":"default","ocean_disable_heading":"default","ocean_post_title":"","ocean_post_subheading":"","ocean_post_title_style":"","ocean_post_title_background_color":"","ocean_post_title_background":0,"ocean_post_title_bg_image_position":"","ocean_post_title_bg_image_attachment":"","ocean_post_title_bg_image_repeat":"","ocean_post_title_bg_image_size":"","ocean_post_title_height":0,"ocean_post_title_bg_overlay":0.5,"ocean_post_title_bg_overlay_color":"","ocean_disable_breadcrumbs":"default","ocean_breadcrumbs_color":"","ocean_breadcrumbs_separator_color":"","ocean_breadcrumbs_links_color":"","ocean_breadcrumbs_links_hover_color":"","ocean_display_footer_widgets":"default","ocean_display_footer_bottom":"default","ocean_custom_footer_template":"0","ocean_post_oembed":"","ocean_post_self_hosted_media":"","ocean_post_video_embed":"","ocean_link_format":"","ocean_link_format_target":"self","ocean_quote_format":"","ocean_quote_format_link":"post","ocean_gallery_link_images":"off","ocean_gallery_id":[13084],"footnotes":"","spc_primary_category":0},"categories":[267,6,171,35],"tags":[],"acf":[],"aioseo_notices":[],"secondary_thumbnail":null,"_links":{"self":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/13079"}],"collection":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/comments?post=13079"}],"version-history":[{"count":2,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/13079\/revisions"}],"predecessor-version":[{"id":16735,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/13079\/revisions\/16735"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media\/13104"}],"wp:attachment":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media?parent=13079"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/categories?post=13079"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/tags?post=13079"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}