{"id":343,"date":"2026-11-02T15:41:47","date_gmt":"2026-11-02T10:11:47","guid":{"rendered":"https:\/\/incepbio.com\/blog\/?p=343"},"modified":"2026-11-02T15:44:28","modified_gmt":"2026-11-02T10:14:28","slug":"computer-software-assurance","status":"publish","type":"post","link":"https:\/\/incepbio.com\/blog\/computer-software-assurance\/","title":{"rendered":"Computer Software Assurance: 5 Easy Steps to Move From CSV"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"343\" class=\"elementor elementor-343\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a44324c e-flex e-con-boxed e-con e-parent\" data-id=\"a44324c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-631b5f7 elementor-widget elementor-widget-heading\" data-id=\"631b5f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">What Is Computer Software Assurance?<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-24ea161 elementor-widget elementor-widget-text-editor\" data-id=\"24ea161\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/www.incepbio.com\/csa-csv\">Computer software assurance<\/a><\/strong> is changing how GMP teams validate software. For years, <strong>Computer System Validation (CSV)<\/strong> has been the standard way to prove that <strong>GxP software<\/strong> works as intended. <strong>Computer Software Assurance (CSA)<\/strong> keeps the same goal. It simply focuses effort where the risk to <strong>patient safety, product quality and data integrity<\/strong> is highest.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8cdc334 elementor-widget elementor-widget-text-editor\" data-id=\"8cdc334\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong>In this blog, you will learn:<\/strong><\/p><ul><li>What CSV and CSA mean<\/li><li>Why computer software assurance matters now<\/li><li>How risk-based testing works, with examples<\/li><li>5 steps to move from CSV to computer software assurance<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71050e0 elementor-widget elementor-widget-heading\" data-id=\"71050e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CSV and Computer Software Assurance<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-77d4162 elementor-widget elementor-widget-text-editor\" data-id=\"77d4162\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">Computer system validation (CSV)<\/a>, also called <strong>computerized or computerised system validation<\/strong>, proves that a GxP system is fit for its intended use. It applies across the full life cycle of systems such as LIMS, CDS, MES, ERP, SCADA and GMP spreadsheets.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f4c71e elementor-widget elementor-widget-text-editor\" data-id=\"5f4c71e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>GMP computer system validation requirements come from three main references:<\/p><ul><li><strong>21 CFR Part 11:<\/strong> electronic records, electronic signatures and audit trails<\/li><li><strong>EU GMP Annex 11:<\/strong> computerised systems, risk management and data integrity<\/li><li><strong>ISPE GAMP 5:<\/strong> the <strong>GAMP 5 risk-based approach<\/strong> to GxP software<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f5c866 elementor-widget elementor-widget-text-editor\" data-id=\"0f5c866\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>A typical CSV package covers the core <strong>CSV documentation requirements<\/strong>:<\/p><ul><li><strong>URS<\/strong>, functional and design specifications<\/li><li><strong>Risk assessment<\/strong> and <strong>validation plan<\/strong><\/li><li><strong>Test scripts for IQ, OQ and PQ<\/strong><\/li><li><strong>Traceability matrix<\/strong> and <strong>validation summary report<\/strong><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9a91d82 elementor-widget elementor-widget-text-editor\" data-id=\"9a91d82\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/www.incepbio.com\/csa-csv\">Computer software assurance<\/a> (CSA)<\/strong> does not replace these. It puts <strong>critical thinking before documentation<\/strong>. Instead of asking &#8220;Have we documented everything?&#8221;, it asks &#8220;Have we tested what matters?&#8221; CSV spreads effort evenly. CSA puts more effort on critical functions and less on low-risk ones. <strong>CSA means more focused testing, not less testing.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-56323dd elementor-widget elementor-widget-heading\" data-id=\"56323dd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Why Computer Software Assurance Matters Now<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f27c778 elementor-widget elementor-widget-text-editor\" data-id=\"f27c778\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Two developments have made computer software assurance a practical decision:<\/p><ul><li><strong>FDA CSA guidance:<\/strong> the <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/computer-software-assurance-production-and-quality-system-software\" target=\"_blank\" rel=\"noopener\">FDA Computer Software Assurance guidance<\/a> was finalised in September 2025 and updated in February 2026. It was written for medical devices, but its principles are now widely applied to <a href=\"https:\/\/www.incepbio.com\/csa-csv\">computer software assurance in pharma<\/a>.<\/li><li><strong>Data integrity inspections:<\/strong> in India, Revised Schedule M applies to every drug manufacturer. Inspectors now check audit trails, user access and electronic records directly in the system.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7298bf8 elementor-widget elementor-widget-text-editor\" data-id=\"7298bf8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>At the same time, many CSV programmes have become document-heavy:<\/p><ul><li>The same scripted tests are run on every function<\/li><li>Supplier testing is repeated at site<\/li><li>Real <strong>data integrity<\/strong> gaps are still missed<\/li><\/ul><p>A risk-based approach is designed to fix exactly this.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3f0185b elementor-widget elementor-widget-heading\" data-id=\"3f0185b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Computer Software Assurance in Practice: Risk-Based Testing<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0b82ef3 elementor-widget elementor-widget-text-editor\" data-id=\"0b82ef3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">Risk-based computer system validation<\/a> starts with a <strong>computer system validation risk assessment<\/strong>. First, confirm the <strong>intended use<\/strong>. Production and quality system software is in scope. General business software, such as email or accounting, is not.<\/p><p>A function is usually <strong>high risk<\/strong> when it:<\/p><ul><li>Decides <strong>batch release<\/strong><\/li><li>Maintains <strong>critical process parameters<\/strong><\/li><li>Judges product acceptability without human review<\/li><li>Applies <strong>electronic signatures<\/strong> to GMP records<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eaf63cf elementor-widget elementor-widget-text-editor\" data-id=\"eaf63cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Functions such as CAPA routing or complaint tracking are often not high risk. <a href=\"https:\/\/www.incepbio.com\/csa-csv\"><strong>Computer software assurance testing<\/strong><\/a> then follows the risk level:<\/p><ul><li><strong>High risk:<\/strong> robust <strong>scripted testing<\/strong>, fully documented and traceable<\/li><li><strong>Medium risk:<\/strong> limited scripted testing, plus unscripted checks<\/li><li><strong>Low risk:<\/strong> <strong>unscripted testing<\/strong>, such as exploratory or ad hoc tests<\/li><\/ul><p>Reliable supplier testing can be used instead of repeating it at site. The final record stays lean: intended use, risk level, what was tested, issues found, conclusion, date and tester.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-82ebb08 elementor-widget elementor-widget-text-editor\" data-id=\"82ebb08\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Some computer software assurance examples:<\/p><ul><li><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">LIMS validation in pharma<\/a>: result calculations and approvals are tested in depth<\/li><li><strong>MES and ERP system validation:<\/strong> batch record steps and release decisions get scripted tests<\/li><li><strong>SCADA system validation:<\/strong> alarm handling and critical process data come first<\/li><li><strong>Spreadsheet validation:<\/strong> GMP formulas are verified and locked<\/li><\/ul><p>A risk-based review also shows the gaps that matter. In a typical CDS review, common high-risk findings are <strong>audit trails not reviewed before batch release<\/strong> and <strong>shared analyst logins<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1ba30a2 elementor-widget elementor-widget-text-editor\" data-id=\"1ba30a2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<style>\n.ib-cta{max-width:760px;margin:28px auto;display:flex;align-items:center;justify-content:space-between;gap:20px;padding:20px 24px;border-radius:14px;background:linear-gradient(135deg,#004D88 0%,#009C8D 100%);box-shadow:0 14px 30px -18px rgba(0,77,136,.55);box-sizing:border-box}\n.ib-cta .ib-cta-t{flex:1;min-width:0}\n.ib-cta .ib-cta-h{display:block;font-size:18px !important;font-weight:700 !important;line-height:1.3 !important;color:#ffffff !important;-webkit-text-fill-color:#ffffff !important;margin:0 0 4px !important}\n.ib-cta .ib-cta-s{display:block;font-size:14.5px !important;line-height:1.5 !important;color:rgba(255,255,255,.9) !important;-webkit-text-fill-color:rgba(255,255,255,.9) !important;margin:0 !important}\n.ib-cta a.ib-cta-b{flex:0 0 auto;display:inline-block;padding:11px 20px;border-radius:9px;background:#ffffff !important;color:#004D88 !important;-webkit-text-fill-color:#004D88 !important;font-size:14.5px !important;font-weight:700 !important;text-decoration:none !important;white-space:nowrap}\n.ib-cta a.ib-cta-b:hover{background:#EAF5F4 !important}\n@media (max-width:600px){\n.ib-cta{flex-direction:column;align-items:stretch;text-align:center;gap:14px;padding:18px 16px;margin:22px 0}\n.ib-cta .ib-cta-h{font-size:16.5px !important}\n.ib-cta .ib-cta-s{font-size:14px !important}\n.ib-cta a.ib-cta-b{display:block;text-align:center;white-space:normal;padding:12px 16px}\n}\n<\/style>\n<div class=\"ib-cta\">\n  <div class=\"ib-cta-t\">\n    <span class=\"ib-cta-h\">Is your next audit coming up?<\/span>\n    <span class=\"ib-cta-s\">Get a 21 CFR Part 11 and Annex 11 gap assessment, with every finding ranked by risk.<\/span>\n  <\/div>\n  <a class=\"ib-cta-b\" href=\"https:\/\/www.incepbio.com\/gmp-csv-services\" title=\"Book a CSV gap assessment\">Book a CSV Gap Assessment &rarr;<\/a>\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a5d8cb elementor-widget elementor-widget-heading\" data-id=\"4a5d8cb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">5 Easy Steps to Move From CSV to Computer Software Assurance<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-86c8fa2 elementor-widget elementor-widget-text-editor\" data-id=\"86c8fa2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>You can update your computer system validation process step by step:<\/p><ul><li><strong>List your GxP systems:<\/strong> build an inventory with each system&#8217;s intended use<\/li><li><strong>Assess the risk:<\/strong> run a system impact and functional risk assessment<\/li><li><strong>Start with a pilot:<\/strong> pick one system due for an upgrade or periodic review<\/li><li><strong>Agree the plan with QA:<\/strong> confirm scope, deliverables and test approach<\/li><li><strong>Update your CSV SOP:<\/strong> apply the risk-based approach site-wide<\/li><\/ul><p>The biggest challenge is cultural, not technical. QA and IT teams need training to think in terms of risk. CSV structure still stays where a system truly needs it.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0f905d6 elementor-widget elementor-widget-image\" data-id=\"0f905d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1600\" height=\"900\" src=\"https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps.png\" class=\"attachment-full size-full wp-image-346\" alt=\"Computer software assurance vs computer system validation\" srcset=\"https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps.png 1600w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps-300x169.png 300w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps-1024x576.png 1024w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps-768x432.png 768w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/11\/CSV-to-Computer-Software-Assurance-5-Steps-1536x864.png 1536w\" sizes=\"(max-width: 1600px) 100vw, 1600px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e452a7e elementor-widget elementor-widget-text-editor\" data-id=\"e452a7e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div class=\"ib-cta\">\n  <div class=\"ib-cta-t\">\n    <span class=\"ib-cta-h\">Planning to adopt computer software assurance?<\/span>\n    <span class=\"ib-cta-s\">Our GAMP 5-trained consultants will review your systems and share a clear CSA plan.<\/span>\n  <\/div>\n  <a class=\"ib-cta-b\" href=\"https:\/\/www.incepbio.com\/request-service?service=csv&amp;source=blog-csa-consultation\" title=\"Request a CSA consultation\">Request a CSA Consultation &rarr;<\/a>\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78e6443 elementor-widget elementor-widget-heading\" data-id=\"78e6443\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Computer System Validation Services From IncepBio<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ec21412 elementor-widget elementor-widget-text-editor\" data-id=\"ec21412\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><strong><a href=\"https:\/\/www.incepbio.com\/\">IncepBio<\/a><\/strong> is a <strong>computer system validation company in India<\/strong>. We provide <a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">computer system validation services<\/a> for pharma, biotech and life sciences. Our GAMP 5-trained consultants support both <a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">GxP computer system validation<\/a> and risk-based CSA.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c412a9d elementor-widget elementor-widget-text-editor\" data-id=\"c412a9d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">CSV gap assessment<\/a>: <strong>21 CFR Part 11 compliance<\/strong> and Annex 11 review with a remediation plan<\/li><li><strong>New system validation:<\/strong> URS to summary report, including the traceability matrix<\/li><li><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">CSV to CSA transition services<\/a>: pilot system, risk classification and SOP update<\/li><li><strong>Change control and periodic review:<\/strong> systems stay validated after go-live<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f8c46f1 elementor-widget elementor-widget-text-editor\" data-id=\"f8c46f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Our <strong>CSV validation services for pharma<\/strong> are delivered on site. Our team stays until the project is complete:<\/p><ul><li><a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">GMP CSV services in Bangalore<\/a> and <a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">GMP CSV services in Hyderabad<\/a><\/li><li><strong>Computer system validation services in India<\/strong>, with experienced <strong>CSV consultants in India<\/strong><\/li><li><strong>CSV and CSA services in Malaysia and Singapore<\/strong><\/li><\/ul><p>CSV also works alongside our <a href=\"https:\/\/www.incepbio.com\/commissioning-qualification-validation\">CQV services<\/a> for new facilities. Explore our <a href=\"https:\/\/www.incepbio.com\/gmp-csv-services\">computer system validation consulting<\/a> for your GxP systems.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b58f26 elementor-widget elementor-widget-text-editor\" data-id=\"5b58f26\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<style>\n.ib-cta{max-width:760px;margin:28px auto;display:flex;align-items:center;justify-content:space-between;gap:20px;padding:20px 24px;border-radius:14px;background:linear-gradient(135deg,#004D88 0%,#009C8D 100%);box-shadow:0 14px 30px -18px rgba(0,77,136,.55);box-sizing:border-box}\n.ib-cta .ib-cta-t{flex:1;min-width:0}\n.ib-cta .ib-cta-h{display:block;font-size:18px !important;font-weight:700 !important;line-height:1.3 !important;color:#ffffff !important;-webkit-text-fill-color:#ffffff !important;margin:0 0 4px !important}\n.ib-cta .ib-cta-s{display:block;font-size:14.5px !important;line-height:1.5 !important;color:rgba(255,255,255,.9) !important;-webkit-text-fill-color:rgba(255,255,255,.9) !important;margin:0 !important}\n.ib-cta a.ib-cta-b{flex:0 0 auto;display:inline-block;padding:11px 20px;border-radius:9px;background:#ffffff !important;color:#004D88 !important;-webkit-text-fill-color:#004D88 !important;font-size:14.5px !important;font-weight:700 !important;text-decoration:none !important;white-space:nowrap}\n.ib-cta a.ib-cta-b:hover{background:#EAF5F4 !important}\n@media (max-width:600px){\n.ib-cta{flex-direction:column;align-items:stretch;text-align:center;gap:14px;padding:18px 16px;margin:22px 0}\n.ib-cta .ib-cta-h{font-size:16.5px !important}\n.ib-cta .ib-cta-s{font-size:14px !important}\n.ib-cta a.ib-cta-b{display:block;text-align:center;white-space:normal;padding:12px 16px}\n}\n<\/style>\n<div class=\"ib-cta\">\n  <div class=\"ib-cta-t\">\n    <span class=\"ib-cta-h\">Need a CSV partner for your site?<\/span>\n    <span class=\"ib-cta-s\">Share your systems and timeline. We will send a scope and quote for on-site validation.<\/span>\n  <\/div>\n  <a class=\"ib-cta-b\" href=\"https:\/\/www.incepbio.com\/request-service?service=csv&amp;source=blog-computer-software-assurance\" title=\"Request a CSV quote\">Request a CSV Quote &rarr;<\/a>\n<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21ff5d5 elementor-widget elementor-widget-heading\" data-id=\"21ff5d5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Frequently Asked Questions<\/h2>\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-4da67a0 e-flex e-con-boxed e-con e-parent\" data-id=\"4da67a0\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-58c8b65 elementor-widget elementor-widget-n-accordion\" data-id=\"58c8b65\" 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\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-9300\" 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-9300\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Will inspectors accept a CSA approach? <\/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-9300\" class=\"elementor-element elementor-element-105640f e-con-full e-flex e-con e-child\" data-id=\"105640f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ead25ef elementor-widget elementor-widget-text-editor\" data-id=\"ead25ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Yes, if every risk decision is justified and documented. CSA changes how you test, not what 21 CFR Part 11, EU Annex 11 and GAMP 5 require.<\/p>\t\t\t\t\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-9301\" 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-9301\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Do we need to revalidate our existing systems to adopt CSA? <\/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-9301\" class=\"elementor-element elementor-element-ae04572 e-con-full e-flex e-con e-child\" data-id=\"ae04572\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d25b226 elementor-widget elementor-widget-text-editor\" data-id=\"d25b226\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>No. Existing validated systems stay valid. Apply the risk-based approach at the next upgrade, change or periodic review.<\/p>\t\t\t\t\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-9302\" 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-9302\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Does IncepBio provide CSV and CSA services on site? <\/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-9302\" class=\"elementor-element elementor-element-24dabb8 e-con-full e-flex e-con e-child\" data-id=\"24dabb8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c957fe elementor-widget elementor-widget-text-editor\" data-id=\"5c957fe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Yes. Our GAMP 5-trained consultants provide on-site computer system validation services in Bangalore, Hyderabad and across India, as well as in Malaysia and Singapore.<\/p>\t\t\t\t\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-9303\" 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-9303\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which system should we start with? <\/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-9303\" class=\"elementor-element elementor-element-280ecfb e-con-full e-flex e-con e-child\" data-id=\"280ecfb\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-56261d6 elementor-widget elementor-widget-text-editor\" data-id=\"56261d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Start with one system that is due for an upgrade or periodic review, such as LIMS or CDS. This gives your team a pilot before you apply CSA site-wide.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\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\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Computer software assurance made simple: learn the key CSA and CSV differences, smarter risk-based testing and 5 easy steps to move from CSV with confidence.<\/p>\n","protected":false},"author":1,"featured_media":345,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,95],"tags":[62,99,101,97,100,98,96,102],"class_list":["post-343","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-csv-csa","tag-computer-system-validation","tag-computer-system-validation-services","tag-csv-gap-assessment","tag-csv-requirements","tag-csv-validation-services-for-pharma","tag-fda-csa-guidance","tag-gmp-and-gxp-computer-system-validation","tag-gmp-csv-services-in-bangalore"],"_links":{"self":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/343","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/comments?post=343"}],"version-history":[{"count":4,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/343\/revisions"}],"predecessor-version":[{"id":349,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/343\/revisions\/349"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media\/345"}],"wp:attachment":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media?parent=343"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/categories?post=343"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/tags?post=343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}