{"id":377278,"date":"2026-04-14T22:48:53","date_gmt":"2026-04-14T20:48:53","guid":{"rendered":"https:\/\/www.bassetti-group.com\/?p=377278"},"modified":"2026-04-14T22:49:14","modified_gmt":"2026-04-14T20:49:14","slug":"quality-control-in-life-sciences-qms","status":"publish","type":"post","link":"https:\/\/www.bassetti-group.com\/en\/quality-control-in-life-sciences-qms\/","title":{"rendered":"Mastering Quality Control in Life Sciences with QMS Software"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"377278\" class=\"elementor elementor-377278\" 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-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-6720d33 elementor-widget elementor-widget-heading\" data-id=\"6720d33\" 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\">Mastering Quality Control in Life Sciences with QMS Software<\/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-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-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;\">Pharmaceuticals, biotechnology, and medical device manufacturing are industries with some of the lowest margins for error. The regulatory environment has shifted from a paper-friendly past to a digital-first future, and digital transformation is a fundamental requirement for maintaining a license to operate.<\/span><\/p><p><span style=\"font-weight: 400;\">The transition from manual, paper-based Quality Management Systems (QMS) and fragmented Quality Control (QC) processes to an integrated digital ecosystem represents a seismic shift in how value is delivered to patients. This blog explores the critical intersections of digitalization, regulatory compliance, 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<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=\"1188\" height=\"665\" src=\"https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2026\/04\/art_bassetti_1200x627_V2-72.jpg\" class=\"attachment-full size-full wp-image-377282\" alt=\"Quality Control in Life Sciences\" srcset=\"https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2026\/04\/art_bassetti_1200x627_V2-72.jpg 1188w, https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2026\/04\/art_bassetti_1200x627_V2-72-300x168.jpg 300w, https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2026\/04\/art_bassetti_1200x627_V2-72-1024x573.jpg 1024w, https:\/\/www.bassetti-group.com\/wp-content\/uploads\/2026\/04\/art_bassetti_1200x627_V2-72-768x430.jpg 768w\" sizes=\"(max-width: 1188px) 100vw, 1188px\" \/>\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-31c0836 elementor-widget elementor-widget-spacer\" data-id=\"31c0836\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-f90ac18 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-equal-height-no\" data-id=\"f90ac18\" 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-7a43d73\" data-id=\"7a43d73\" 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-bec077d elementor-widget elementor-widget-heading\" data-id=\"bec077d\" 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 Limitations of Legacy Systems: Why Paper is a Liability<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-29680ca elementor-widget elementor-widget-text-editor\" data-id=\"29680ca\" 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;\">Many organizations still rely on hybrid systems: a mix of Excel spreadsheets, paper binders, and disconnected legacy software. While these may have sufficed a decade ago, they create significant risks in today\u2019s fast-paced market:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Data Silos:<\/b><span style=\"font-weight: 400;\"> Information trapped in physical folders or local hard drives cannot be analyzed holistically.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Version Control Chaos:<\/b><span style=\"font-weight: 400;\"> Using an outdated Standard Operating Procedure (SOP) is one of the most common findings in FDA Warning Letters.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Delayed Decision Making:<\/b><span style=\"font-weight: 400;\"> Waiting for manual data entry and physical signatures slows down batch releases and time-to-market.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>The &#8220;Human Error&#8221; Variable:<\/b><span style=\"font-weight: 400;\"> Manual transcription is inherently flawed. In Life Sciences, a single typo in a lab report can lead to a million-dollar product recall.<\/span><\/li><\/ul>\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-a89c0c6 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-equal-height-no\" data-id=\"a89c0c6\" 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-673584a\" data-id=\"673584a\" 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-900634b elementor-widget elementor-widget-heading\" data-id=\"900634b\" 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\">Defining the Digital QMS: Beyond Simple Document Storage<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-748d170 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"748d170\" 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 modern Quality Management System (QMS) must be more than a digital filing cabinet. In the North American market, the focus is heavily on <\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/part-11-electronic-records-electronic-signatures-scope-and-application\" target=\"_blank\" rel=\"noopener\"><b>FDA 21 CFR Part 11<\/b><\/a><span style=\"font-weight: 400;\"> and <\/span><a href=\"https:\/\/www.iso.org\/standard\/59752.html\" target=\"_blank\" rel=\"noopener\"><b>ISO 13485<\/b><\/a><span style=\"font-weight: 400;\"> standards. A truly optimized digital QMS provides a unified framework for the following pillars:<\/span><\/p><h3>1. Automated CAPA (Corrective and Preventive Actions)<\/h3><p><span style=\"font-weight: 400;\">The CAPA process is the heart of continuous improvement. A digital system ensures that every deviation is logged, investigated, and resolved. By using automated workflows, a QMS ensures that deadlines are met and that the &#8220;effectiveness check&#8221; phase is never forgotten, which is a common point of failure in manual systems.<\/span><\/p><h3>2. Comprehensive Change Control<\/h3><p><span style=\"font-weight: 400;\">In Life Sciences, change is constant, whether it&#8217;s a raw material supplier shift or a manufacturing process adjustment. Digitalizing change control allows stakeholders to assess the impact of a change across the entire organization before it is implemented, ensuring that all regulatory filings remain accurate.<\/span><\/p><h3>3. Risk Management and FMEA<\/h3><p><span style=\"font-weight: 400;\">Risk-based thinking is central to ISO 9001:2015 and ISO 13485. By integrating Failure Mode and Effects Analysis (FMEA) directly into the QMS, companies can identify potential failure points in the design or manufacturing phase, quantifying risk through automated scoring and triggering mitigation plans instantly.<\/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-bef3755 elementor-widget elementor-widget-spacer\" data-id=\"bef3755\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-d0e3045 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-equal-height-no\" data-id=\"d0e3045\" 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-37cf8d3\" data-id=\"37cf8d3\" 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-ce755c5 elementor-widget elementor-widget-heading\" data-id=\"ce755c5\" 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\">Quality Control (QC) and the Laboratory of the Future<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-aed140a elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"aed140a\" 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;\">While the QMS manages the <\/span><i><span style=\"font-weight: 400;\">framework<\/span><\/i><span style=\"font-weight: 400;\">, quality control manages the <\/span><i><span style=\"font-weight: 400;\">product<\/span><\/i><span style=\"font-weight: 400;\">. The digitalization of the laboratory environment is where the most significant gains in data integrity are made.<\/span><\/p><h3>The Role of LIMS in Global Compliance<\/h3><p><span style=\"font-weight: 400;\">A Laboratory Information Management System (LIMS) is essential for modern QC. Integration between your LIMS and QMS creates a &#8220;closed loop&#8221; quality environment.<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Sample Management:<\/b><span style=\"font-weight: 400;\"> Tracking a sample from reception to final disposal with a full audit trail.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Instrument Interfacing:<\/b><span style=\"font-weight: 400;\"> Directly capturing data from scales, chromatographs, and spectrometers. This eliminates transcription errors and ensures that the data is <\/span><b>ALCOA+<\/b><span style=\"font-weight: 400;\"> (Attributable, Legible, Contemporaneous, Original, and Accurate).<\/span><\/li><\/ul><h3>Addressing the ALCOA+ Standard<\/h3><p><span style=\"font-weight: 400;\">The ALCOA+ acronym is the gold standard for data integrity. Digitalization ensures that data is:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Contemporaneous:<\/b><span style=\"font-weight: 400;\"> Recorded at the moment it is generated.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Enduring:<\/b><span style=\"font-weight: 400;\"> Protected from loss or unauthorized alteration for the duration of the product&#8217;s shelf life.<\/span><\/li><\/ul>\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-d37eaa5 elementor-widget elementor-widget-spacer\" data-id=\"d37eaa5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-f7b6cff 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-equal-height-no\" data-id=\"f7b6cff\" 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-f46e914\" data-id=\"f46e914\" 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-862a170 elementor-widget elementor-widget-heading\" data-id=\"862a170\" 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\">Navigating Global Regulations: FDA and EMA Requirements<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae4505b elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"ae4505b\" 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;\">For organizations expanding their footprint between Europe and North America, software must be flexible enough to handle varied regulatory demands simultaneously.<\/span><\/p><h3>FDA 21 CFR Part 11: The Gold Standard<\/h3><p><span style=\"font-weight: 400;\">For the North American market, compliance hinges on the trustworthiness of electronic records. Comprehensive QMS software like TEEXMA is engineered to provide the technical controls necessary to satisfy 21 CFR Part 11, including:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Secure Electronic Signatures:<\/b><span style=\"font-weight: 400;\"> Linked to individual records to ensure accountability.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><b>Computer-Generated Audit Trails:<\/b><span style=\"font-weight: 400;\"> Time-stamped logs that record the date, time, and operator for every action taken within the system.<\/span><\/li><\/ul><h3>Annex 11 and ISO 13485<\/h3><p><span style=\"font-weight: 400;\">While 21 CFR Part 11 is the US benchmark, EU Annex 11 and ISO 13485 provide the global framework for computerized systems and medical device quality. A unified platform allows companies to scale across borders without the need to manage multiple, localized software installations.<\/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-917cff7 elementor-widget elementor-widget-spacer\" data-id=\"917cff7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-ff7f0c9 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-equal-height-no\" data-id=\"ff7f0c9\" 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-f9329d8\" data-id=\"f9329d8\" 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-f6d11de elementor-widget elementor-widget-heading\" data-id=\"f6d11de\" 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 Benefits of Digitalization for Stakeholders<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b176277 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"b176277\" 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;\">Digital transformation impacts more than just the Quality Department; it drives value across the entire C-suite.<\/span><\/p><h3>ROI and Scalability<\/h3><p><span style=\"font-weight: 400;\">Digitalization reduces the &#8220;Cost of Quality.&#8221; By preventing recalls, shortening batch release cycles, and optimizing resource allocation in the laboratory, companies see a direct impact on profitability. A digital infrastructure allows an organization to scale production volumes without a linear increase in quality-management headcount.<\/span><\/p><h3>Permanent Audit Readiness<\/h3><p><span style=\"font-weight: 400;\">The stress of a surprise audit is significantly mitigated when your data is organized and accessible. With a digital solution, you can filter and export the exact audit trail or SOP history requested by an inspector within seconds. This shifts the organization from &#8220;preparing for audits&#8221; to a permanent &#8220;state of compliance.&#8221;<\/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-64546a4 elementor-widget elementor-widget-spacer\" data-id=\"64546a4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-8e4757c 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-equal-height-no\" data-id=\"8e4757c\" 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-efd360d\" data-id=\"efd360d\" 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-9d5badf elementor-widget elementor-widget-heading\" data-id=\"9d5badf\" 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 Future: Quality 4.0 and AI Integration\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-63a9582 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"63a9582\" 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;\">As we look toward the future of Life Sciences, we enter the era of <\/span><b>Quality 4.0<\/b><span style=\"font-weight: 400;\">. This involves leveraging Big Data, Machine Learning, and AI to move from <\/span><i><span style=\"font-weight: 400;\">reactive<\/span><\/i><span style=\"font-weight: 400;\"> quality management to <\/span><i><span style=\"font-weight: 400;\">predictive<\/span><\/i><span style=\"font-weight: 400;\"> quality management.<\/span><\/p><p><span style=\"font-weight: 400;\">By collecting years of digital data within a platform like TEEXMA, companies can begin to use AI to:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Predict equipment failures before they happen (Predictive Maintenance).<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Identify subtle trends in deviations that might indicate a systemic issue with a raw material supplier.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Automate the initial screening of document reviews.<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">This level of insight is only possible if the foundational data is digital, structured, and accessible.<\/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-5616095 elementor-widget elementor-widget-spacer\" data-id=\"5616095\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-275466e 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-equal-height-no\" data-id=\"275466e\" 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-b604d00\" data-id=\"b604d00\" 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-8abd763 elementor-widget elementor-widget-heading\" data-id=\"8abd763\" 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\">Starting Your Digital Transformation Journey\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-52bda6d elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"52bda6d\" 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 QMS <\/b><\/a><span style=\"font-weight: 400;\">\u00a0by Bassetti Group is engineered specifically to meet these challenges. By unifying QMS and QC processes into a single, scalable, and compliant platform, we empower life sciences companies to focus on what they do best: innovating to save lives.<\/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-a7e3155 elementor-widget elementor-widget-spacer\" data-id=\"a7e3155\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3e3294d elementor-align-center elementor-mobile-align-justify elementor-widget elementor-widget-button\" data-id=\"3e3294d\" 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\/teexma-software-solutions\/teexma-for-quality-quality-management-software-quality-management-software-teexma-for-quality-fmea-design-fmea-audit-risk-analysis-risk-anaylsis\/\">\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 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<div class=\"elementor-element elementor-element-4dc9e12 elementor-widget elementor-widget-spacer\" data-id=\"4dc9e12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\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-4d753fbe e-flex e-con-boxed wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-parent\" data-id=\"4d753fbe\" 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-53f6a98e e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"53f6a98e\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9cd5515 elementor-widget elementor-widget-spacer\" data-id=\"9cd5515\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68fcf366 elementor-widget elementor-widget-heading\" data-id=\"68fcf366\" 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-large\">FAQs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71455a79 elementor-widget elementor-widget-n-accordion\" data-id=\"71455a79\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1900\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-1900\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <h3>What is the difference between a Quality Management System (QMS) and Quality Control (QC)?<\/h3> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1900\" class=\"elementor-element elementor-element-21ae64b9 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"21ae64b9\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1900\" class=\"elementor-element elementor-element-5b01d04 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"5b01d04\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-492de782 elementor-widget elementor-widget-text-editor\" data-id=\"492de782\" 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 QMS manages the overarching <\/span><i><span style=\"font-weight: 400;\">framework<\/span><\/i><span style=\"font-weight: 400;\"> of quality, while Quality Control (QC) manages the <\/span><i><span style=\"font-weight: 400;\">product<\/span><\/i><span style=\"font-weight: 400;\"> itself. Digitalization is where the QMS manages processes like CAPA and Change Control, and QC manages laboratory processes and data integrity<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1901\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1901\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <h3>What are the key regulatory standards a modern digital QMS must meet?<\/h3> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1901\" class=\"elementor-element elementor-element-28f90e42 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"28f90e42\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1901\" class=\"elementor-element elementor-element-56e3943d e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"56e3943d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6214cb51 elementor-widget elementor-widget-text-editor\" data-id=\"6214cb51\" 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;\">For the North American market, the focus is heavily on <\/span><b>FDA 21 CFR Part 11<\/b><span style=\"font-weight: 400;\">, which dictates the criteria for trustworthy electronic records and electronic signatures, and <\/span><b>ISO 13485<\/b><span style=\"font-weight: 400;\">. A global solution like TEEXMA is also designed to satisfy the European counterpart, Annex 11, providing a &#8220;Global Compliance&#8221; footprint.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1902\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1902\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <h3>Why is a paper-based QMS considered a liability in Life Sciences?<\/h3> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1902\" class=\"elementor-element elementor-element-4edd77a4 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"4edd77a4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1902\" class=\"elementor-element elementor-element-7720f71c e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"7720f71c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7708ddc5 elementor-widget elementor-widget-text-editor\" data-id=\"7708ddc5\" 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;\">Legacy, paper-based, or &#8220;hybrid&#8221; systems introduce significant risks, including data silos, version control chaos (a common FDA Warning Letter finding), delayed decision making, and the &#8220;human error&#8221; variable in manual transcription, which can lead to expensive product recalls.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1903\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1903\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <h3>What is the ALCOA+ standard and how does digitalization help meet it?<\/h3> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1903\" class=\"elementor-element elementor-element-56d6af8a e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"56d6af8a\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1903\" class=\"elementor-element elementor-element-2454d4c7 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"2454d4c7\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-644c44ab elementor-widget elementor-widget-text-editor\" data-id=\"644c44ab\" 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;\">ALCOA+ is the gold standard for data integrity, ensuring that data is Attributable, Legible, Contemporaneous, Original, and Accurate. Digitalization ensures data is <\/span><b>Contemporaneous<\/b><span style=\"font-weight: 400;\"> (recorded as it is generated) and <\/span><b>Enduring<\/b><span style=\"font-weight: 400;\"> (protected from loss or alteration for the product&#8217;s shelf life).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1904\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1904\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> <h3>What does Quality 4.0 mean for Life Sciences organizations?<\/h3> <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1904\" class=\"elementor-element elementor-element-12034198 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"12034198\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t<section role=\"region\" aria-labelledby=\"e-n-accordion-item-1904\" class=\"elementor-element elementor-element-45c373c8 e-con-full e-flex wpr-particle-no wpr-jarallax-no wpr-parallax-no wpr-sticky-section-no wpr-equal-height-no e-con e-child\" data-id=\"45c373c8\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;_ha_eqh_enable&quot;:false}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-68f7d76b elementor-widget elementor-widget-text-editor\" data-id=\"68f7d76b\" 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;\">Quality 4.0 is the future state where companies move from <\/span><i><span style=\"font-weight: 400;\">reactive<\/span><\/i><span style=\"font-weight: 400;\"> to <\/span><i><span style=\"font-weight: 400;\">predictive<\/span><\/i><span style=\"font-weight: 400;\"> quality management by leveraging Big Data, Machine Learning, and AI. This level of insight allows companies to predict equipment failures (Predictive Maintenance) or identify subtle trends in deviations that suggest systemic issues.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/section>\n\t\t\t\t<\/section>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\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>Mastering Quality Control in Life Sciences with QMS Software Pharmaceuticals, biotechnology, and medical device manufacturing are industries with some of the lowest margins for error. The regulatory environment has shifted&#8230;<\/p>\n","protected":false},"author":79,"featured_media":377282,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[10],"tags":[464],"class_list":{"0":"post-377278","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-blog-posts","8":"tag-blog-post"},"acf":[],"_links":{"self":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts\/377278","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=377278"}],"version-history":[{"count":5,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts\/377278\/revisions"}],"predecessor-version":[{"id":377291,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/posts\/377278\/revisions\/377291"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/media\/377282"}],"wp:attachment":[{"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/media?parent=377278"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/categories?post=377278"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.bassetti-group.com\/en\/wp-json\/wp\/v2\/tags?post=377278"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}