{"id":1469,"date":"2019-05-16T22:15:26","date_gmt":"2019-05-17T05:15:26","guid":{"rendered":"https:\/\/www.cloudbyz.com\/blog\/?p=1469"},"modified":"2023-06-06T10:18:47","modified_gmt":"2023-06-06T17:18:47","slug":"five-ways-to-avoid-fda-warning-letters-through-automated-ctms-solution","status":"publish","type":"post","link":"https:\/\/www.cloudbyz.com\/resources\/ctms\/five-ways-to-avoid-fda-warning-letters-through-automated-ctms-solution\/","title":{"rendered":"Five Ways to Avoid FDA Warning Letters Through Automated CTMS Solution"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The violations of regulatory compliance may lead to the issue of a Warning Letter FDA WARNING LETTER AND FDA FORM 483.\u00a0 Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices.<\/span><\/p>\n<p><b>Most frequent reasons to Issue FDA warning letters<\/b><\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-1472\" src=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/04\/Blog-2.png\" alt=\"\" width=\"974\" height=\"472\" srcset=\"https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/04\/Blog-2.png 974w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/04\/Blog-2-300x145.png 300w, https:\/\/www.cloudbyz.com\/resources\/wp-content\/uploads\/2020\/04\/Blog-2-768x372.png 768w\" sizes=\"(max-width: 974px) 100vw, 974px\" \/><\/p>\n<p><b>Document control best practices to help companies avoid FDA warning letters<\/b><\/p>\n<ol>\n<li><b> Establish Document Control Procedures: <\/b><span style=\"font-weight: 400;\">The FDA commonly issues warning letters over the lack of document control procedures:<\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The means no backdating records, which the agency has noted as a problem in the past.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">The old copies of SOPs taped up next to a workstation.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Permissions need to be set up that prevent unauthorized individuals from changing key documents such as SOPs, specifications and testing methods.<\/span><\/li>\n<\/ul>\n<ol start=\"2\">\n<li><b> Integrate Document Control with Quality Processes:\u00a0 <\/b><span style=\"font-weight: 400;\">The written procedures should be effectively integrated document Control systems and procedures into their larger quality process.<\/span><\/li>\n<li><b> Protect Data Integrity: <\/b><span style=\"font-weight: 400;\">The\u00a0 FDA expects data to be attributable, legible, complete, an original or true copy and accurate. Essential document control practices for protecting data integrity include:<\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Retaining original records or true copies.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Documenting all data from every test.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Real-time data recording.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">An automated QMS can help protect data integrity by pulling the research results data directly from the LIMS.<\/span><\/p>\n<ol start=\"4\">\n<li><b> Control Paper Records: <\/b><span style=\"font-weight: 400;\">Best practices for controlling paper records include:<\/span><\/li>\n<\/ol>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Treating forms, worksheets, and notebooks as controlled documents.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Making sure all blank forms issued are numbered and reconciled.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Retaining incomplete forms and recording why they were replaced.<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Identifying unofficial notebooks, stamping notebooks for official use and inspecting pages for gaps.<\/span><\/li>\n<\/ul>\n<p><b>Cloudbyz CTMS Solutions integrated with Documents control best practices to avoid FDA warning letters<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\"><b>Be Inspection Ready: <\/b><span style=\"font-weight: 400;\">Cloudbyz CTMS meets operational needs and compliance requirements, the audits trial features are enabled that helps to conduct internal and external audits on a regular basis.\u00a0 Cloudbyz CTMS enabled to inform the employees about audits, resources needed and staff recruitment to accompany auditors through email communication.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>eTMF for enhanced documentation system: <\/b><span style=\"font-weight: 400;\">The eTMF feature in Cloudbyz CTMS enables to store the essential documents with a click of a button and through drag &amp; drop facility. The folders can be structured according to the DIA or customized, with audit tracking and automated document approval process hassle-free.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>Access controlled documentation Feature: <\/b><span style=\"font-weight: 400;\">\u00a0Cloudbyz CTMS ensures an automated document control system including SOPs with a proper version that eliminates the possibility of human errors. Cloudbyz CTMS also establishes proper permissions to prevent unauthorized access and changes the documents.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>Develop an audit trial compliance culture: <\/b><span style=\"font-weight: 400;\">Cloudbyz CTMS ensures simplified audit trail management in the initial meeting of an audit, during the audit process, and all subsequent communications with the FDA.<\/span><\/li>\n<li style=\"font-weight: 400;\"><b>A Hyper-Adaptive Quality Management Software: <\/b><span style=\"font-weight: 400;\">Cloudbyz CTMS ensures a modern and hyper-adaptive quality automation solution that will ensure compliance today and into the future that addresses new business and regulatory changes.<\/span><\/li>\n<\/ol>\n<p><b>Abbreviations:<\/b><\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">FDA: Food and Drug Administration<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">CTMS: Clinical Trial Management System<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SOP: Standard Operating Procedure<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">QMS: Quality Management System<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">LIMS: Laboratory Information Management System<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">eTMF: Electronic Trial Master File<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">DIA: Drug Information Association<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">References<\/span><\/p>\n<p><a href=\"https:\/\/www.biospace.com\/article\/fda-warning-letters-an-overview-of-2019-s-letters-so-far\/\"><span style=\"font-weight: 400;\">https:\/\/www.biospace.com\/article\/fda-warning-letters-an-overview-of-2019-s-letters-so-far\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/supplementcounsel.com\/department-of-justice-enjoins-dietary-supplement-manufacturers-operations-fda-issues-warning-letters-over-alleged-cgmp-violations\/\"><span style=\"font-weight: 400;\">https:\/\/supplementcounsel.com\/department-of-justice-enjoins-dietary-supplement-manufacturers-operations-fda-issues-warning-letters-over-alleged-cgmp-violations\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/default.htm\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/blog.etq.com\/avoid-fda-warning-letters-with-these-4-document-control-best-practices\"><span style=\"font-weight: 400;\">https:\/\/blog.etq.com\/avoid-fda-warning-letters-with-these-4-document-control-best-practices<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.intellect.com\/blog\/6-tips-to-avoid-483-letters\"><span style=\"font-weight: 400;\">https:\/\/www.intellect.com\/blog\/6-tips-to-avoid-483-letters<\/span><\/a><\/p>\n<p><a href=\"https:\/\/rescop.com\/blog\/2018\/03\/01\/fda-warning-letters\/\"><span style=\"font-weight: 400;\">https:\/\/rescop.com\/blog\/2018\/03\/01\/fda-warning-letters\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.vaisala.com\/en\/events\/webinars\/lp\/data-integrity-pharmaceutical-environmental-monitoring-beyond-bytes-and-signatures\"><span style=\"font-weight: 400;\">https:\/\/www.vaisala.com\/en\/events\/webinars\/lp\/data-integrity-pharmaceutical-environmental-monitoring-beyond-bytes-and-signatures<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.softwaresuggest.com\/blog\/document-management-best-practices\/\"><span style=\"font-weight: 400;\">https:\/\/www.softwaresuggest.com\/blog\/document-management-best-practices\/<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm636172.htm\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm636172.htm<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm635686.htm\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm635686.htm<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm635684.ht\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/ucm635684.ht<\/span><\/a><\/p>\n<p><a href=\"https:\/\/www.pharmaceuticalonline.com\/doc\/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003\"><span style=\"font-weight: 400;\">https:\/\/www.pharmaceuticalonline.com\/doc\/an-analysis-of-fda-fy-drug-gmp-warning-letters-0003<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The violations of regulatory compliance may lead to the issue of a Warning Letter FDA WARNING LETTER AND FDA FORM 483.\u00a0 Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices. Most frequent reasons to Issue FDA warning letters Document control best practices to [&hellip;]<\/p>\n","protected":false},"author":30,"featured_media":8554,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","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":[],"footnotes":"","spc_primary_category":0},"categories":[267,171,271,174],"tags":[64,75,65,55,9,13,73,74,71,104,72,91,105],"acf":[],"aioseo_notices":[],"secondary_thumbnail":null,"_links":{"self":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/1469"}],"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=1469"}],"version-history":[{"count":1,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/1469\/revisions"}],"predecessor-version":[{"id":15336,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/posts\/1469\/revisions\/15336"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media\/8554"}],"wp:attachment":[{"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/media?parent=1469"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/categories?post=1469"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.cloudbyz.com\/resources\/wp-json\/wp\/v2\/tags?post=1469"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}