{"id":324564,"date":"2025-09-08T17:55:42","date_gmt":"2025-09-08T15:55:42","guid":{"rendered":"https:\/\/www.bassetti-group.com\/?p=324564"},"modified":"2025-09-08T17:55:58","modified_gmt":"2025-09-08T15:55:58","slug":"fda-precheck-quality-management-system","status":"publish","type":"post","link":"https:\/\/www.bassetti-group.com\/en\/fda-precheck-quality-management-system\/","title":{"rendered":"FDA PreCheck and Quality Management Systems: Accelerating U.S. Drug Production"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"324564\" class=\"elementor elementor-324564\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5b93505 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"5b93505\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-60e49a2\" data-id=\"60e49a2\" 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-28b9fe2 elementor-widget elementor-widget-heading\" data-id=\"28b9fe2\" 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<h1 class=\"elementor-heading-title elementor-size-default\">FDA PreCheck and Quality Management Systems: Accelerating U.S. Drug Production\n<\/h1>\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-4bcfc6e elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"4bcfc6e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-806ba57\" data-id=\"806ba57\" 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-83307e2 elementor-widget elementor-widget-heading\" data-id=\"83307e2\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Introduction<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fe43266 elementor-widget elementor-widget-text-editor\" data-id=\"fe43266\" 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><span style=\"font-weight: 400;\">On August 7, 2025, the U.S. Food and Drug Administration (FDA) unveiled the <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing\" target=\"_blank\" rel=\"noopener\"><b>FDA PreCheck program<\/b><\/a><span style=\"font-weight: 400;\">, a strategic initiative designed to strengthen domestic pharmaceutical manufacturing. By accelerating facility readiness and regulatory approvals, FDA PreCheck addresses the nation\u2019s reliance on overseas production while improving the resilience, security, and quality of the U.S. drug supply chain.<\/span><\/p><p><span style=\"font-weight: 400;\">At the core of this program is the requirement for a robust <\/span><a href=\"https:\/\/www.bassetti-group.com\/en\/teexma-software-solutions\/teexma-for-quality-quality-management-software-quality-management-software-teexma-for-quality-fmea-design-fmea-audit-risk-analysis-risk-anaylsis\/\"><b>quality management system (QMS)<\/b><\/a><span style=\"font-weight: 400;\">. A QMS ensures that pharmaceutical manufacturers can meet strict compliance standards, maintain consistent product quality, and demonstrate regulatory maturity\u2014key factors in gaining FDA confidence.<\/span><\/p><p><span style=\"font-weight: 400;\">This article explores how FDA PreCheck works, why a quality management system is essential for success, and how digital solutions like TEEXMA for Quality can help manufacturers achieve compliance, efficiency, and long-term operational excellence.<\/span><\/p>\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-483f688 elementor-widget__width-inherit elementor-widget elementor-widget-image\" data-id=\"483f688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"560\" src=\"https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2025\/09\/art_bassetti_1200x627_V2-12.jpg\" class=\"attachment-full size-full wp-image-324590\" alt=\"FDA PreCheck and Quality Management Systems\" srcset=\"https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2025\/09\/art_bassetti_1200x627_V2-12.jpg 1000w, https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2025\/09\/art_bassetti_1200x627_V2-12-300x168.jpg 300w, https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2025\/09\/art_bassetti_1200x627_V2-12-768x430.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/>\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-775ada9 elementor-widget elementor-widget-heading\" data-id=\"775ada9\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Understanding the FDA PreCheck Program\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d07b182 elementor-widget elementor-widget-text-editor\" data-id=\"d07b182\" 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><span style=\"font-weight: 400;\">The FDA PreCheck program introduces a <\/span><b>two-phase framework<\/b><span style=\"font-weight: 400;\"> designed to facilitate faster establishment and approval of new U.S. manufacturing sites. The phases include:<\/span><\/p>\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-6cd5028 elementor-widget elementor-widget-heading\" data-id=\"6cd5028\" 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\">1. Facility Readiness Phase<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7c57a7 elementor-widget elementor-widget-text-editor\" data-id=\"f7c57a7\" 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><span style=\"font-weight: 400;\">This phase focuses on <\/span><b>pre-production readiness<\/b><span style=\"font-weight: 400;\"> by promoting early communication between manufacturers and the FDA. Companies are encouraged to submit a <\/span><b>Type V Drug Master File (DMF)<\/b><span style=\"font-weight: 400;\">, detailing:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Facility layout and operations workflow<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Equipment specifications and process flow diagrams<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Pharmaceutical Quality System elements<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Quality Management Maturity practices<\/span><p>\u00a0<\/p><\/li><\/ul><p><span style=\"font-weight: 400;\">By sharing these details early, manufacturers receive guidance from the FDA to preempt potential compliance issues. This proactive approach significantly reduces delays associated with inspections and regulatory review later in the production lifecycle.<\/span><\/p>\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-c79a849 elementor-widget elementor-widget-heading\" data-id=\"c79a849\" 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\">2. Application Submission Phase<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-41434b3 elementor-widget elementor-widget-text-editor\" data-id=\"41434b3\" 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><span style=\"font-weight: 400;\">The second phase facilitates <\/span><b>pre-application meetings<\/b><span style=\"font-weight: 400;\"> and provides early FDA feedback on manufacturing processes and quality controls. By streamlining application submissions and regulatory reviews, the FDA aims to accelerate approval timelines for drugs produced in domestic facilities.<\/span><\/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-1ac5ad5 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"1ac5ad5\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-355d2c4\" data-id=\"355d2c4\" 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-1927d06 elementor-widget elementor-widget-heading\" data-id=\"1927d06\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Why Domestic Pharmaceutical Manufacturing Needs FDA PreCheck\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d8a3c67 elementor-widget elementor-widget-text-editor\" data-id=\"d8a3c67\" 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><span style=\"font-weight: 400;\">Currently, more than <\/span><b>50% of pharmaceuticals distributed in the U.S. are manufactured overseas<\/b><span style=\"font-weight: 400;\">, with only 11% of active pharmaceutical ingredient (API) manufacturers located domestically. This heavy reliance on international suppliers has become a <\/span><b>national security concern<\/b><span style=\"font-weight: 400;\">, especially in light of recent global supply chain disruptions.<\/span><\/p><p><span style=\"font-weight: 400;\">The FDA PreCheck program addresses this vulnerability by incentivizing domestic production. However, building a new manufacturing facility is not just about infrastructure; it also requires <\/span><b>robust quality management practices<\/b><span style=\"font-weight: 400;\"> to ensure compliance, consistency, and safety. This is where <\/span><b>a Quality Management System<\/b><span style=\"font-weight: 400;\"> becomes a critical asset.<\/span><\/p>\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-12ddddc elementor-align-center elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"12ddddc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-shrink\" href=\"https:\/\/www.bassetti-group.com\/en\/request-a-demo\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Book a QMS demo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-d206a91 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"d206a91\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-be9e6f4\" data-id=\"be9e6f4\" 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-86cd1fd elementor-widget elementor-widget-heading\" data-id=\"86cd1fd\" 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<h2 class=\"elementor-heading-title elementor-size-default\">The Role of a Quality Management System in FDA PreCheck Success\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d18bcfd elementor-widget elementor-widget-text-editor\" data-id=\"d18bcfd\" 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><span style=\"font-weight: 400;\">A <\/span><a href=\"https:\/\/www.bassetti-group.com\/en\/teexma-software-solutions\/teexma-for-quality-quality-management-software-quality-management-software-teexma-for-quality-fmea-design-fmea-audit-risk-analysis-risk-anaylsis\/\"><b>Quality Management System (QMS)<\/b><\/a><span style=\"font-weight: 400;\"> is the backbone of pharmaceutical manufacturing. QMS ensures that every step of production, from raw material sourcing to final product release, meets strict regulatory requirements and internal quality standards.<\/span><\/p>\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-8de7105 elementor-widget elementor-widget-heading\" data-id=\"8de7105\" 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\">Key Components of a Pharmaceutical Quality Management System\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ea888c1 elementor-widget elementor-widget-text-editor\" data-id=\"ea888c1\" 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<ol><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Document Control<\/b><span style=\"font-weight: 400;\"> \u2013 <\/span><span style=\"font-weight: 400;\">Centralized storage and controlled access to critical documents, including Certificates of Analysis (CoA).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Change Management<\/b><span style=\"font-weight: 400;\"> \u2013 Structured processes for implementing changes in equipment, materials, or procedures.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Deviation Management<\/b><span style=\"font-weight: 400;\"> \u2013 Identification, investigation, and resolution of non-conformities.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>CAPA (Corrective and Preventive Action)<\/b><span style=\"font-weight: 400;\"> \u2013 Systematic handling of issues to prevent recurrence.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Risk Management<\/b><span style=\"font-weight: 400;\"> \u2013 Assessment and mitigation of risks across manufacturing processes.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Audit Management<\/b><span style=\"font-weight: 400;\"> \u2013 Scheduling, executing, and tracking internal and external audits.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Regulatory Compliance Monitoring<\/b><span style=\"font-weight: 400;\"> \u2013 Ensuring adherence to cGMP, FDA regulations, and international standards.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Manufacturing Consistency<\/b> \u2013 Ensuring uniform production processes and product quality across batches.<\/li><\/ol><p><span style=\"font-weight: 400;\">A well-implemented QMS provides <\/span><b>traceability, accountability, and predictability<\/b><span style=\"font-weight: 400;\"> which are key factors for regulatory approvals and operational efficiency.<\/span><\/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-ff1de6f elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"ff1de6f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-3b15ae0\" data-id=\"3b15ae0\" 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-4e62871 elementor-widget elementor-widget-heading\" data-id=\"4e62871\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Enhancing Quality Management System Implementation with TEEXMA\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f1ebde elementor-widget elementor-widget-text-editor\" data-id=\"0f1ebde\" 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><a href=\"https:\/\/www.bassetti-group.com\/en\/teexma-software-solutions\/teexma-for-quality-quality-management-software-quality-management-software-teexma-for-quality-fmea-design-fmea-audit-risk-analysis-risk-anaylsis\/\"><b>TEEXMA for Quality<\/b><\/a><span style=\"font-weight: 400;\"> is a <\/span><b>comprehensive digital solution<\/b><span style=\"font-weight: 400;\"> that enhances every aspect of a pharmaceutical manufacturer\u2019s QMS. By integrating document management, process control, and regulatory compliance into a single platform, TEEXMA enables manufacturers to operate more efficiently, reduce errors, and maintain rigorous quality standards.<\/span><\/p>\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-a33da24 elementor-widget elementor-widget-heading\" data-id=\"a33da24\" 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\">Centralized Documentation for Compliance\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dbedc45 elementor-widget elementor-widget-text-editor\" data-id=\"dbedc45\" 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><span style=\"font-weight: 400;\">TEEXMA allows organizations to <\/span><b>store all quality-related documents in a centralized, secure repository<\/b><span style=\"font-weight: 400;\">. This includes:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">SOPs (Standard Operating Procedures)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Batch records<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Equipment qualification protocols<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Regulatory submissions<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Certificates of Analysis (CoA)<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Centralized documentation ensures that all stakeholders have access to the most up-to-date information, reducing the risk of errors and non-compliance. It also facilitates <\/span><b>real-time collaboration<\/b><span style=\"font-weight: 400;\"> between quality teams, production staff, and regulatory personnel.<\/span><\/p>\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-31fa748 elementor-widget elementor-widget-heading\" data-id=\"31fa748\" 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\">Audit Trail Capabilities Supporting FDA PreCheck\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45f5a1d elementor-widget elementor-widget-text-editor\" data-id=\"45f5a1d\" 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><span style=\"font-weight: 400;\">TEEXMA provides <\/span><b>comprehensive audit trails<\/b><span style=\"font-weight: 400;\"> for all actions performed within the system. Every document modification, approval, or workflow action is recorded, creating <\/span><b>transparent traceability<\/b><span style=\"font-weight: 400;\"> that satisfies FDA and ISO regulatory requirements.<\/span><\/p><p><span style=\"font-weight: 400;\">Audit trails simplify internal and external inspections, reduce the administrative burden, and ensure accountability across the organization.<\/span><\/p>\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-c3a0db0 elementor-widget elementor-widget-heading\" data-id=\"c3a0db0\" 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\">Risk Management and CAPA Integration in a QMS\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a41789a elementor-widget elementor-widget-text-editor\" data-id=\"a41789a\" 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><span style=\"font-weight: 400;\">One of TEEXMA\u2019s strengths is its integrated <\/span><b>risk management framework<\/b><span style=\"font-weight: 400;\">. The system allows manufacturers to:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify potential risks in processes, equipment, and supply chains<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assess the severity and probability of risks<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Implement preventive measures and corrective actions<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">TEEXMA links <\/span><b>risk assessment directly to CAPA workflows<\/b><span style=\"font-weight: 400;\">, ensuring that identified issues are systematically addressed and mitigated. This proactive approach aligns with the FDA PreCheck program\u2019s emphasis on quality management maturity.<\/span><\/p>\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-4a3d917 elementor-widget elementor-widget-heading\" data-id=\"4a3d917\" 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\">Regulatory Compliance Monitoring with a Digital QMS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9531116 elementor-widget elementor-widget-text-editor\" data-id=\"9531116\" 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><span style=\"font-weight: 400;\">TEEXMA ensures that all quality processes comply with <\/span><b>cGMP, FDA, and international standards<\/b><span style=\"font-weight: 400;\">. The system provides <\/span><b>real-time monitoring<\/b><span style=\"font-weight: 400;\">, automated alerts, and compliance dashboards that help manufacturers:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Track deviations and non-conformances<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Monitor corrective and preventive actions<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ensure that all documentation is audit-ready<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">By maintaining continuous compliance, TEEXMA helps manufacturers reduce regulatory risks and expedite product approvals.<\/span><\/p>\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-ec4a2e0 elementor-widget elementor-widget-heading\" data-id=\"ec4a2e0\" 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\">Continuous Improvement Through a Quality Management System\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4e32b3b elementor-widget elementor-widget-text-editor\" data-id=\"4e32b3b\" 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><span style=\"font-weight: 400;\">Beyond compliance, TEEXMA enables <\/span><b>continuous improvement<\/b><span style=\"font-weight: 400;\"> by analyzing performance metrics across quality processes. The system can track:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Process efficiency and bottlenecks<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Batch yield and defect rates<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Audit and inspection outcomes<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">Data-driven insights allow organizations to make informed decisions, enhance process efficiency, and maintain high product quality over time.<\/span><\/p>\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-fd5716f elementor-align-center elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"fd5716f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-shrink\" href=\"https:\/\/www.bassetti-group.com\/en\/request-a-demo\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Book a TEEXMA for Quality demo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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-3deab43 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"3deab43\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-ba12f82\" data-id=\"ba12f82\" 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-075b710 elementor-widget elementor-widget-heading\" data-id=\"075b710\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Integrating TEEXMA for Quality with FDA PreCheck\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c341a6f elementor-widget elementor-widget-text-editor\" data-id=\"c341a6f\" 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><span style=\"font-weight: 400;\">The FDA PreCheck program emphasizes early engagement with regulatory authorities and the importance of <\/span><b>quality management maturity<\/b><span style=\"font-weight: 400;\">. <a href=\"https:\/\/www.bassetti-group.com\/en\/teexma-software-solutions\/teexma-for-quality-quality-management-software-quality-management-software-teexma-for-quality-fmea-design-fmea-audit-risk-analysis-risk-anaylsis\/\">TEEXMA for Quality<\/a> directly supports these objectives:<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Early Facility Design and Process Planning: <\/b><span style=\"font-weight: 400;\">TEEXMA allows manufacturers to <\/span><b>document and model facility processes<\/b><span style=\"font-weight: 400;\">, linking them to quality controls and regulatory requirements. This ensures that facility readiness meets FDA expectations during the PreCheck phase.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Streamlined Documentation for Type V DMFs: <\/b><span style=\"font-weight: 400;\">TEEXMA\u2019s centralized repository facilitates <\/span><b>rapid preparation of DMF submissions<\/b><span style=\"font-weight: 400;\">, including detailed process flow diagrams, equipment specifications, and QMS elements.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Enhanced Communication and Feedback Loops: <\/b><span style=\"font-weight: 400;\">The system enables <\/span><b>cross-functional collaboration<\/b><span style=\"font-weight: 400;\"> between production, quality, and regulatory teams, allowing rapid incorporation of FDA feedback during pre-application meetings.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Comprehensive Audit Readiness: <\/b><span style=\"font-weight: 400;\">TEEXMA maintains a <\/span><b>complete audit trail<\/b><span style=\"font-weight: 400;\"> for all quality activities, ensuring that manufacturers can demonstrate compliance during FDA inspections.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Risk-Based Decision Making: <\/b>With integrated risk management and CAPA workflows, TEEXMA helps organizations proactively address potential issues, aligning with the FDA\u2019s focus on <b>quality maturity<\/b> and regulatory robustness.<\/li><\/ol>\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-0a77934 elementor-section-boxed elementor-section-height-default elementor-section-height-default wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no\" data-id=\"0a77934\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\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-a6ac922\" data-id=\"a6ac922\" 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-f15206b elementor-widget elementor-widget-heading\" data-id=\"f15206b\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Strengthening Pharma Manufacturing with FDA PreCheck and a Quality Management System<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66ebba6 elementor-widget elementor-widget-text-editor\" data-id=\"66ebba6\" 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><span style=\"font-weight: 400;\">The <\/span><b>FDA PreCheck program<\/b><span style=\"font-weight: 400;\"> marks a pivotal shift in U.S. pharmaceutical manufacturing, prioritizing domestic production, faster approvals, and quality management maturity. But success with FDA PreCheck depends on more than new infrastructure\u2014it requires a strong <\/span><b>quality management system (QMS)<\/b><span style=\"font-weight: 400;\"> to ensure compliance, product consistency, and regulatory confidence.<\/span><\/p><p><span style=\"font-weight: 400;\">By integrating a QMS with the FDA PreCheck framework, pharmaceutical manufacturers can reduce approval delays, strengthen their supply chain, and deliver safe, high-quality medications to patients. Digital solutions like TEEXMA for Quality make this integration seamless, empowering organizations to stay audit-ready, improve efficiency, and continuously enhance performance.<\/span><\/p><p><span style=\"font-weight: 400;\">FDA PreCheck sets the framework, but your quality management system makes it sustainable.<\/span><\/p><p>\u00a0<\/p><p><span style=\"font-weight: 400;\">Ready to align your pharmaceutical operations with <\/span><b>FDA PreCheck<\/b><span style=\"font-weight: 400;\">? Discover how TEEXMA for Quality can strengthen your <\/span><b>quality management system<\/b><span style=\"font-weight: 400;\"> and accelerate compliance.\u00a0<\/span><\/p>\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-f48d25e elementor-align-center elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"f48d25e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm elementor-animation-shrink\" href=\"https:\/\/www.bassetti-group.com\/en\/request-a-demo\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Book a TEEXMA for Quality demo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<div class=\"elementor-element elementor-element-c88b59d e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no e-con e-parent\" data-id=\"c88b59d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<aside class=\"elementor-element elementor-element-0d5a155 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-column-slider-no wpr-equal-height-no e-con e-child\" data-id=\"0d5a155\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<\/aside>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA PreCheck and Quality Management Systems: Accelerating U.S. Drug Production Introduction On August 7, 2025, the U.S. Food and Drug Administration (FDA) unveiled the FDA PreCheck program, a strategic initiative&#8230;<\/p>\n","protected":false},"author":79,"featured_media":324590,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[464],"class_list":["post-324564","post","type-post","status-publish","format-standard","has-post-thumbnail","category-blog-posts","tag-blog-post"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts\/324564","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/users\/79"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/comments?post=324564"}],"version-history":[{"count":0,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts\/324564\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/media\/324590"}],"wp:attachment":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/media?parent=324564"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/categories?post=324564"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/tags?post=324564"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}