{"id":261,"date":"2019-05-07T17:15:59","date_gmt":"2019-05-07T17:15:59","guid":{"rendered":"http:\/\/sankbio.com\/?page_id=261"},"modified":"2020-01-20T13:43:48","modified_gmt":"2020-01-20T13:43:48","slug":"quality-assurance","status":"publish","type":"page","link":"https:\/\/sankbio.com\/index.php\/mesmerize\/quality-assurance\/","title":{"rendered":"Quality Assurance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"261\" class=\"elementor elementor-261\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-eb3266d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"eb3266d\" data-element_type=\"section\" data-e-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-95adcd3\" data-id=\"95adcd3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1d6bf2c elementor-widget elementor-widget-heading\" data-id=\"1d6bf2c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">A<b>udit Plans<\/b><\/h3>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-74059ba elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"74059ba\" data-element_type=\"section\" data-e-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-52860d8\" data-id=\"52860d8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6a773c9 elementor-widget elementor-widget-text-editor\" data-id=\"6a773c9\" data-element_type=\"widget\" data-e-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\t\t<p>The quality of a clinical trial depends on data integrity and the assurance of subject\u2019s protection. With the globalization to developing countries, the outsourcing and the complexity of clinical trials, <strong>reaching quality has become challenging<\/strong>. It is therefore essential for a Sponsor to develop quality systems during the planning stages of clinical trials. The quality system requirements include: personnel role and responsibilities, training, policies and procedures, <strong>quality assurance and auditing<\/strong>, document management, record retention and reporting, and <strong>Corrective And Preventive Actions (CAPA).<\/strong> Such systems require the development and implementation of standards for each step.<\/p><p><strong>An audit<\/strong> <strong>plan<\/strong> should be prepared beforehand and based on results of the risk-based assessment of the protocol and the Sponsor\u2019s written auditing procedures.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ec90c78 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ec90c78\" data-element_type=\"section\" data-e-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-69c7635\" data-id=\"69c7635\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c81f769 elementor-widget elementor-widget-text-editor\" data-id=\"c81f769\" data-element_type=\"widget\" data-e-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\t\t<p><strong>At San.K.Bio Consulting, we can support you on developing and updating the audit plan of your clinical study.<\/strong><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ca6dd37 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ca6dd37\" data-element_type=\"section\" data-e-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-03f972e\" data-id=\"03f972e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a573b8d elementor-widget elementor-widget-heading\" data-id=\"a573b8d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>GCP Site Audits<\/b><\/h3>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2caa025 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2caa025\" data-element_type=\"section\" data-e-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-7f1ba83\" data-id=\"7f1ba83\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-13c50e8 elementor-widget elementor-widget-text-editor\" data-id=\"13c50e8\" data-element_type=\"widget\" data-e-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\t\t<p><strong>The audit of a clinical study<\/strong> is an important element of GCP and is independent of and separate from monitoring and quality control functions. Its purpose is to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.<\/p><p>The Quality of a clinical study depends in particular on how the investigational site conducts the study. Monitoring is not enough to ensure the site\u2019s quality. FDA warning letters and EMA inspections cite monitoring deficiency as the most frequent finding. Therefore, GCP audit of the investigational site is an indispensable step in ensuring a high-quality standard of the clinical study.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-b47e80f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"b47e80f\" data-element_type=\"section\" data-e-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-ab7a98c\" data-id=\"ab7a98c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-64a0b2f elementor-widget elementor-widget-text-editor\" data-id=\"64a0b2f\" data-element_type=\"widget\" data-e-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\t\t<p><strong>At San.K.Bio Consulting, we can perform GCP investigational site audits anywhere in the world.<\/strong><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e9e6d14 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e9e6d14\" data-element_type=\"section\" data-e-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-00cd7bb\" data-id=\"00cd7bb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-66cd711 elementor-widget elementor-widget-heading\" data-id=\"66cd711\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\"><b>CAPA Management<\/b><\/h3>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5e88695 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5e88695\" data-element_type=\"section\" data-e-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-528f215\" data-id=\"528f215\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-79e354e elementor-widget elementor-widget-text-editor\" data-id=\"79e354e\" data-element_type=\"widget\" data-e-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\t\t<p><strong>Corrective and preventive action\u00a0(CAPA, also called\u00a0corrective action\/preventive action\u00a0or simply\u00a0corrective action) <\/strong>consists of improvements to an organization&#8217;s processes taken to eliminate causes of\u00a0non-conformities\/non-compliance\u00a0or other undesirable situations. With recent issue of ICH E6(R2), if noncompliance that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results is discovered, the Sponsor should perform a root-cause analysis and implement appropriate corrective and preventive action.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1592a2d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1592a2d\" data-element_type=\"section\" data-e-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-6791af3\" data-id=\"6791af3\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7f62a61 elementor-widget elementor-widget-text-editor\" data-id=\"7f62a61\" data-element_type=\"widget\" data-e-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\t\t<p><strong>At San.K.Bio Consulting, we can support your company on CAPA writing and on the identification of root causes. We have followed-up and worked on + 100 CAPA.<\/strong><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9b42362 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9b42362\" data-element_type=\"section\" data-e-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-d930337\" data-id=\"d930337\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c2cb850 elementor-widget elementor-widget-text-editor\" data-id=\"c2cb850\" data-element_type=\"widget\" data-e-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\t\t<p><strong>Our GCP Auditor is certified. The training she received was FDA and BIMO inspections-focused.\u00a0<\/strong><\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Audit Plans The quality of a clinical trial depends on data integrity and the assurance of subject\u2019s protection. With the globalization to developing countries, the outsourcing and the complexity of clinical trials, reaching quality has become challenging. It is therefore essential for a Sponsor to develop quality systems during the planning stages of clinical trials.&hellip; <br \/> <a class=\"read-more\" href=\"https:\/\/sankbio.com\/index.php\/mesmerize\/quality-assurance\/\">Read more<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":183,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-261","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Quality Assurance | GCP Cinical Site Audits | Audit plans | CAPA plans<\/title>\n<meta name=\"description\" content=\"We perform GCP audits anywhere in the world. We support you with your audit plan and assist you with CAPAs writing and resolution.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sankbio.com\/index.php\/mesmerize\/quality-assurance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Quality Assurance | GCP Cinical Site Audits | Audit plans | CAPA plans\" \/>\n<meta property=\"og:description\" content=\"We perform GCP audits anywhere in the world. 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