{"id":327,"date":"2026-10-30T16:16:13","date_gmt":"2026-10-30T10:46:13","guid":{"rendered":"https:\/\/incepbio.com\/blog\/?p=327"},"modified":"2026-10-30T17:20:58","modified_gmt":"2026-10-30T11:50:58","slug":"digital-validation-software-guide","status":"publish","type":"post","link":"https:\/\/incepbio.com\/blog\/digital-validation-software-guide\/","title":{"rendered":"7 Essential Tips to Choose Digital Validation Software"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"327\" class=\"elementor elementor-327\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fdd22a1 e-flex e-con-boxed e-con e-parent\" data-id=\"fdd22a1\" 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-bc8b666 elementor-widget elementor-widget-heading\" data-id=\"bc8b666\" 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\">Why This Guide Matters for Validation Teams<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cdd0b59 elementor-widget elementor-widget-text-editor\" data-id=\"cdd0b59\" 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>Digital validation software<\/strong> moves the full validation lifecycle (planning, protocols, execution, approvals and requalification) from paper and Excel into one controlled system. This blog explains what digital validation software is, why life sciences teams are moving to it now, how to choose the right one, and how <a href=\"https:\/\/incepbio.com\/incepone\">IncepOne<\/a>, IncepBio&#8217;s digital validation software, meets that checklist.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a16e72 elementor-widget elementor-widget-heading\" data-id=\"6a16e72\" 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\">What Is Digital Validation Software?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-65b3567 elementor-widget elementor-widget-text-editor\" data-id=\"65b3567\" 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\/incepone\"><strong>Digital validation software<\/strong><\/a> is a controlled system where validation protocols, test data, approvals, reports and requalification are managed online, with a full audit trail. Instead of printed protocols, wet signatures and Excel trackers, the whole workflow runs inside one platform.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71b6e1c elementor-widget elementor-widget-text-editor\" data-id=\"71b6e1c\" 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>It is important to know what it is not:<\/p><ul><li><strong>Not scanned PDFs:<\/strong> scanning stores a picture of a paper process. The workflow is still paper.<\/li><li><strong>Not a shared Excel tracker:<\/strong> spreadsheets have no controlled signatures, version control or audit trail.<\/li><li><strong>Not a generic project tool:<\/strong> task boards don&#8217;t understand protocols, acceptance criteria or requalification.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d6c9777 elementor-widget elementor-widget-heading\" data-id=\"d6c9777\" 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 Everyone Is Moving to Digital Validation Now<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57f8528 elementor-widget elementor-widget-text-editor\" data-id=\"57f8528\" 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 data-pm-slice=\"1 1 []\">Consider a site with 40 cleanrooms undergoing annual HVAC requalification. Each room requires tests such as ACPH, HEPA filter integrity, particle count and differential pressure. Managing these tests manually creates recurring challenges:<\/p><ul data-spread=\"false\" data-pm-slice=\"3 3 []\"><li><p>Handwritten readings are re-entered into Excel, increasing errors.<\/p><\/li><li><p>Copy-paste and calculation mistakes affect reports.<\/p><\/li><li><p>Protocol approvals get delayed across engineering and QA teams.<\/p><\/li><li><p>Multiple printed protocol versions create confusion.<\/p><\/li><li><p>Retrieving old validation records for audits takes hours.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b8ac38a elementor-widget elementor-widget-text-editor\" data-id=\"b8ac38a\" 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 data-pm-slice=\"1 3 []\"><strong>Digital validation software<\/strong> helps address these issues by reducing manual work, improving data integrity and streamlining approvals.<\/p><p>Three key factors are accelerating this shift:<\/p><ul data-spread=\"false\"><li><p><strong>Data integrity:<\/strong> Maintaining records that follow ALCOA++ principles.<\/p><\/li><li><p><strong>Risk-based CSA:<\/strong> Supporting structured, searchable evidence for software assurance.<\/p><\/li><li><p><strong>Multi-site growth:<\/strong> Helping manufacturers and CDMOs manage validation across sites without relying on spreadsheets.<\/p><p>This is why paperless validation in pharma, biotech and medical devices is now a priority. Teams moving from CSV to CSA can also read about <a href=\"https:\/\/incepbio.com\/csa-csv\">CSA and CSV services at IncepBio<\/a>.<\/p><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0aa7cba elementor-widget elementor-widget-text-editor\" data-id=\"0aa7cba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<style>\n\/* CTA Card *\/\n.incepone-cta {\n  width: 100%;\n  box-sizing: border-box;\n  padding: 20px 26px;\n  border-radius: 10px;\n  background: linear-gradient(120deg, #004D88 0%, #006B85 65%, #009C8D 100%);\n  display: flex;\n  align-items: center;\n  justify-content: space-between;\n  gap: 18px;\n  font-family: 'Roboto', sans-serif;\n  overflow: hidden;\n}\n\n\/* Force heading to white *\/\n.incepone-cta h3,\n.incepone-cta h3.elementor-heading-title,\n.elementor-widget-html .incepone-cta h3 {\n  color: #FFFFFF !important;\n  -webkit-text-fill-color: #FFFFFF !important;\n  opacity: 1 !important;\n  margin: 0 0 6px !important;\n  font-size: 20px !important;\n  line-height: 1.3 !important;\n  font-weight: 700 !important;\n}\n\n.incepone-cta p {\n  color: #EAF7F8 !important;\n  -webkit-text-fill-color: #EAF7F8 !important;\n  margin: 0 !important;\n  font-size: 14px;\n  line-height: 1.5;\n}\n\n.incepone-cta-content {\n  flex: 1;\n  min-width: 0;\n}\n\n.incepone-cta-btn {\n  display: inline-flex;\n  align-items: center;\n  justify-content: center;\n  flex-shrink: 0;\n  padding: 11px 17px;\n  border-radius: 7px;\n  background: #FFFFFF;\n  color: #004D88 !important;\n  font-size: 13px;\n  font-weight: 700;\n  text-decoration: none !important;\n  white-space: nowrap;\n  transition: all 0.25s ease;\n}\n\n.incepone-cta-btn:hover {\n  background: #E6FFFB;\n  color: #007C70 !important;\n}\n\n\/* Mobile Responsive *\/\n@media (max-width: 600px) {\n  .incepone-cta {\n    flex-direction: column;\n    align-items: flex-start;\n    padding: 18px;\n    gap: 14px;\n  }\n\n  .incepone-cta h3,\n  .elementor-widget-html .incepone-cta h3 {\n    font-size: 18px !important;\n  }\n\n  .incepone-cta p {\n    font-size: 13px;\n  }\n\n  .incepone-cta-btn {\n    width: 100%;\n    box-sizing: border-box;\n  }\n}\n<\/style>\n\n<div class=\"incepone-cta\">\n  <div class=\"incepone-cta-content\">\n    <h3>Still running validation on paper and Excel?<\/h3>\n    <p>Move protocols, approvals and tracking into one Part 11-ready digital validation software.<\/p>\n  <\/div>\n\n  <a class=\"incepone-cta-btn\"\n     href=\"https:\/\/www.incepbio.com\/incepone\"\n     target=\"_blank\"\n     rel=\"noopener noreferrer\">\n    Explore IncepOne \u2192\n  <\/a>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a29154d elementor-widget elementor-widget-heading\" data-id=\"a29154d\" 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\">Key Guidelines for Digital Validation Software<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a7c506d elementor-widget elementor-widget-text-editor\" data-id=\"a7c506d\" 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>Digital validation software holds GMP records, so it must follow the same regulations as any computerised system. These are the main guidelines to know:<\/p><ul><li><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-11\" target=\"_blank\" rel=\"noopener\">US FDA 21 CFR Part 11<\/a>: rules for electronic records and electronic signatures, including audit trails, access control and signature manifestation<\/li><li><a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2016-11\/annex11_01-2011_en_0.pdf\" target=\"_blank\" rel=\"noopener\">EU GMP Annex 11<\/a>: computerised systems in EU GMP, covering risk management, validation, data integrity, audit trails and electronic signatures<\/li><li><a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/gamp-5-guide-2nd-edition\" target=\"_blank\" rel=\"noopener\">ISPE GAMP 5 (Second Edition)<\/a>: the industry&#8217;s risk-based approach to validating GxP computerised systems, by software category<\/li><li><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 (CSA)<\/a>: risk-based assurance that focuses testing effort on what affects product quality and patient safety<\/li><li><strong>ALCOA++ data integrity principles:<\/strong> records must be attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available, as expected by regulators including MHRA, PIC\/S and WHO<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf849f9 elementor-widget elementor-widget-heading\" data-id=\"cf849f9\" 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\">How to Choose Good Digital Validation Software<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7eb0440 elementor-widget elementor-widget-text-editor\" data-id=\"7eb0440\" 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>Many tools are called &#8220;digital&#8221;, but not all are built for regulated work. Check these points before you choose.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-172de3b elementor-widget elementor-widget-image\" data-id=\"172de3b\" 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=\"1024\" height=\"576\" src=\"https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software-1024x576.png\" class=\"attachment-large size-large wp-image-330\" alt=\"\" srcset=\"https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software-1024x576.png 1024w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software-300x169.png 300w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software-768x432.png 768w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software-1536x864.png 1536w, https:\/\/incepbio.com\/blog\/wp-content\/uploads\/2026\/10\/How-to-Choose-Digital-Validation-Software.png 1600w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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-854513c elementor-widget elementor-widget-text-editor\" data-id=\"854513c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<style>\n.incep-selection, .incep-selection * {\n  box-sizing: border-box;\n}\n\n.incep-selection {\n  font-family: 'Roboto', sans-serif;\n  color: #334155;\n  width: 100%;\n}\n\n.incep-selection .intro {\n  font-size: 15px;\n  line-height: 1.7;\n  margin-bottom: 22px;\n  color: #526273;\n}\n\n.incep-selection .intro strong {\n  color: #004D88;\n}\n\n.incep-selection .criteria-grid {\n  display: grid;\n  grid-template-columns: repeat(2, minmax(0, 1fr));\n  gap: 16px;\n}\n\n.incep-selection .criteria-card {\n  padding: 22px;\n  border: 1px solid #E2EAF0;\n  border-radius: 11px;\n  background: #FFFFFF;\n  transition: border-color .2s ease, transform .2s ease;\n}\n\n.incep-selection .criteria-card:hover {\n  border-color: #009C8D;\n  transform: translateY(-2px);\n}\n\n.incep-selection .criteria-card:first-child {\n  grid-column: 1 \/ -1;\n}\n\n.incep-selection .card-top {\n  display: flex;\n  align-items: center;\n  gap: 12px;\n  margin-bottom: 14px;\n}\n\n.incep-selection .number {\n  width: 36px;\n  height: 36px;\n  flex-shrink: 0;\n  display: flex;\n  align-items: center;\n  justify-content: center;\n  border-radius: 9px;\n  background: #EAF5FA;\n  color: #004D88;\n  font-size: 15px;\n  font-weight: 700;\n}\n\n.incep-selection h3 {\n  color: #004D88 !important;\n  -webkit-text-fill-color: #004D88 !important;\n  font-size: 18px;\n  line-height: 1.4;\n  font-weight: 700;\n  margin: 0 !important;\n}\n\n.incep-selection p {\n  font-size: 14px;\n  line-height: 1.7;\n  color: #526273;\n  margin: 0 0 14px;\n}\n\n.incep-selection .highlight {\n  background: #F0F8F7;\n  border-left: 3px solid #009C8D;\n  padding: 11px 13px;\n  border-radius: 4px;\n  font-size: 13px;\n  line-height: 1.6;\n  color: #285A59;\n}\n\n.incep-selection .criteria-card a {\n  color: #008C80;\n  font-weight: 700;\n  text-decoration: underline;\n  text-underline-offset: 3px;\n}\n\n.incep-selection .feature-list {\n  display: grid;\n  grid-template-columns: repeat(2, minmax(0, 1fr));\n  gap: 9px;\n  margin-top: 14px;\n}\n\n.incep-selection .feature {\n  background: #F5F8FA;\n  padding: 11px 12px;\n  border-radius: 7px;\n  font-size: 13px;\n  line-height: 1.5;\n  color: #34495A;\n}\n\n.incep-selection .feature strong {\n  display: block;\n  color: #004D88;\n  margin-bottom: 3px;\n}\n\n.incep-selection .cta {\n  margin-top: 24px;\n  padding: 22px 24px;\n  border-radius: 11px;\n  background: linear-gradient(115deg, #004D88, #006D83 65%, #009C8D);\n  display: flex;\n  align-items: center;\n  justify-content: space-between;\n  gap: 18px;\n}\n\n.incep-selection .cta h3 {\n  color: #FFFFFF !important;\n  -webkit-text-fill-color: #FFFFFF !important;\n  font-size: 19px;\n  margin: 0 0 6px !important;\n}\n\n.incep-selection .cta p {\n  color: #EAF7F8 !important;\n  -webkit-text-fill-color: #EAF7F8 !important;\n  font-size: 13px;\n  margin: 0;\n}\n\n.incep-selection .cta-button {\n  flex-shrink: 0;\n  display: inline-block;\n  background: #FFFFFF;\n  color: #004D88 !important;\n  text-decoration: none !important;\n  font-size: 13px;\n  font-weight: 700;\n  padding: 12px 17px;\n  border-radius: 7px;\n  white-space: nowrap;\n  transition: .2s ease;\n}\n\n.incep-selection .cta-button:hover {\n  background: #E4FFFA;\n  color: #007C70 !important;\n}\n\n@media(max-width: 650px) {\n  .incep-selection .criteria-grid {\n    grid-template-columns: 1fr;\n  }\n\n  .incep-selection .criteria-card:first-child {\n    grid-column: auto;\n  }\n\n  .incep-selection .criteria-card {\n    padding: 18px;\n  }\n\n  .incep-selection .feature-list {\n    grid-template-columns: 1fr 1fr;\n  }\n\n  .incep-selection .cta {\n    flex-direction: column;\n    align-items: flex-start;\n    padding: 20px;\n  }\n\n  .incep-selection .cta h3 {\n    font-size: 18px;\n  }\n\n  .incep-selection .cta-button {\n    width: 100%;\n    text-align: center;\n  }\n}\n\n@media(max-width: 380px) {\n  .incep-selection .feature-list {\n    grid-template-columns: 1fr;\n  }\n}\n<\/style>\n\n<div class=\"incep-selection\">\n\n  <p class=\"intro\">\n    Choosing the right <strong>digital validation software<\/strong> involves more than document storage. Evaluate these five essential capabilities before making a decision.\n  <\/p>\n\n  <div class=\"criteria-grid\">\n\n    <!-- 01 -->\n    <div class=\"criteria-card\">\n      <div class=\"card-top\">\n        <span class=\"number\">01<\/span>\n        <h3>Part 11, Annex 11 &#038; ALCOA++ Compliance<\/h3>\n      <\/div>\n      <p>\n        Look for support for 21 CFR Part 11 and EU GMP Annex 11, including compliant electronic signatures, role-based access and audit trails.\n      <\/p>\n      <div class=\"highlight\">\n        <strong>Key checks:<\/strong> Signature meaning, signer identity, date and time, linked records, ALCOA++ data integrity and GAMP 5 risk-based approach.\n      <\/div>\n    <\/div>\n\n    <!-- 02 -->\n    <div class=\"criteria-card\">\n      <div class=\"card-top\">\n        <span class=\"number\">02<\/span>\n        <h3>Built Specifically for Validation<\/h3>\n      <\/div>\n      <p>\n        Choose software designed for validation workflows, not just generic document management.\n      <\/p>\n      <div class=\"highlight\">\n        Protocol templates \u00b7 Approval workflows \u00b7 Version control \u00b7 Built-in calculations\n      <\/div>\n      <p style=\"margin-top:12px;\">\n        These features support <a href=\"https:\/\/www.incepbio.com\/incepone\">digital validation<\/a> and validation lifecycle management.\n      <\/p>\n    <\/div>\n\n    <!-- 03 -->\n    <div class=\"criteria-card\">\n      <div class=\"card-top\">\n        <span class=\"number\">03<\/span>\n        <h3>Connected Modules<\/h3>\n      <\/div>\n      <p>\n        Bring validation activities, training, protocols and equipment records together in one platform.\n      <\/p>\n      <div class=\"feature-list\">\n        <div class=\"feature\">\n          <strong>Validation Management<\/strong>\n          Live tracking and dashboards\n        <\/div>\n        <div class=\"feature\">\n          <strong>Protocol Management<\/strong>\n          Templates and controlled versions\n        <\/div>\n        <div class=\"feature\">\n          <strong>GMP Training<\/strong>\n          Assignments and assessments\n        <\/div>\n        <div class=\"feature\">\n          <strong>Asset Management<\/strong>\n          Equipment and lifecycle tracking\n        <\/div>\n      <\/div>\n    <\/div>\n\n    <!-- 04 -->\n    <div class=\"criteria-card\">\n      <div class=\"card-top\">\n        <span class=\"number\">04<\/span>\n        <h3>Client &#038; Partner Visibility<\/h3>\n      <\/div>\n      <p>\n        A secure client portal helps CDMOs and CQV service providers share project progress and reports with external clients.\n      <\/p>\n      <div class=\"highlight\">\n        Centralised visibility without relying on email-based file sharing.\n      <\/div>\n    <\/div>\n\n    <!-- 05 -->\n    <div class=\"criteria-card\">\n      <div class=\"card-top\">\n        <span class=\"number\">05<\/span>\n        <h3>Security &#038; Availability<\/h3>\n      <\/div>\n      <p>\n        Review the vendor&#8217;s approach to data hosting, encryption, backups and GxP system classification.\n      <\/p>\n      <div class=\"highlight\">\n        Evaluate security controls, data protection and system availability.\n      <\/div>\n    <\/div>\n\n  <\/div>\n\n  <!-- CTA -->\n  <div class=\"cta\">\n    <div>\n      <h3>Shortlisting Digital Validation Software?<\/h3>\n      <p>Explore IncepOne with a 30-minute walkthrough built around your validation projects.<\/p>\n    <\/div>\n    <a class=\"cta-button\" href=\"https:\/\/www.incepbio.com\/request-service?service=incepone&amp;source=blog-digital-validation-software\" target=\"_blank\" rel=\"noopener noreferrer\">\n      Book a Free Demo \u2192\n    <\/a>\n  <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b78d510 elementor-widget elementor-widget-heading\" data-id=\"b78d510\" 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\">IncepOne: Digital Validation Software Built for HVAC and CQV<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-99f8300 elementor-widget elementor-widget-text-editor\" data-id=\"99f8300\" 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:\/\/incepbio.com\/incepone\">IncepOne<\/a> is IncepBio&#8217;s cloud-hosted <a href=\"https:\/\/incepbio.com\/incepone\">pharma validation software<\/a>. It is built around real-world HVAC and CQV workflows by a team that runs validation projects on site, with validation calculations and report structures built in. Here is how it meets the checklist above.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-686b2d2 elementor-widget elementor-widget-text-editor\" data-id=\"686b2d2\" 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>About IncepBio:<\/strong> IncepBio is a validation and compliance company that built and owns IncepOne. Alongside the software, our teams deliver <a href=\"https:\/\/incepbio.com\/commissioning-qualification-validation\">CQV<\/a>, <a href=\"https:\/\/incepbio.com\/cleanroomvalidation\">cleanroom validation<\/a> and <a href=\"https:\/\/incepbio.com\/thermalvalidation\">thermal validation<\/a> on site, so IncepOne is shaped by real project work.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cec2288 elementor-widget elementor-widget-text-editor\" data-id=\"cec2288\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<h3>Four connected modules<\/h3><ul><li><strong>Validation Management (VMS):<\/strong> plan, execute, review and report every qualification and validation activity, with task tracking and report generation<\/li><li><strong>Protocol Management (PMS):<\/strong> prepare protocols from standard templates, with review and approval workflows and version control<\/li><li><strong>Learning Management (LMS):<\/strong> assign, track and record GMP training, with assessments and certificates<\/li><li><strong>Asset Management:<\/strong> a central asset and equipment register with lifecycle tracking<br \/><h3>Compliance and security<\/h3><ul><li>Designed to support <strong>21 CFR Part 11<\/strong> and <strong>ALCOA++<\/strong><\/li><li>Electronic-signature controls, role-based access and a full audit trail<\/li><li>GxP indirect-impact system classification<\/li><li>SSL\/TLS encryption with daily backup and recovery<\/li><\/ul><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b3e41fa elementor-widget elementor-widget-text-editor\" data-id=\"b3e41fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<style>\n.ib-workspace-section,\n.ib-workspace-section * {\n  box-sizing: border-box;\n}\n\n.ib-workspace-section {\n  width: 100%;\n  font-family: 'Roboto', sans-serif;\n}\n\n\/* Workspace Cards *\/\n.ib-workspace-grid {\n  display: grid;\n  grid-template-columns: repeat(2, minmax(0, 1fr));\n  gap: 16px;\n}\n\n.ib-workspace-card {\n  padding: 21px;\n  background: #FFFFFF;\n  border: 1px solid #E2EAF0;\n  border-radius: 9px;\n  transition: border-color .25s ease, transform .25s ease;\n}\n\n.ib-workspace-card:hover {\n  border-color: #009C8D;\n  transform: translateY(-2px);\n}\n\n.ib-workspace-card .ib-card-label {\n  display: block;\n  color: #009C8D;\n  font-size: 11px;\n  font-weight: 700;\n  letter-spacing: .8px;\n  margin-bottom: 11px;\n}\n\n.ib-workspace-card h3 {\n  color: #004D88 !important;\n  font-family: 'Roboto', sans-serif !important;\n  font-size: 17px !important;\n  font-weight: 700 !important;\n  line-height: 1.4 !important;\n  margin: 0 0 8px !important;\n}\n\n.ib-workspace-card p {\n  color: #526273 !important;\n  font-size: 14px !important;\n  line-height: 1.65 !important;\n  margin: 0 !important;\n}\n\n\/* CTA Card *\/\n.ib-workspace-cta {\n  margin-top: 20px;\n  padding: 24px 27px;\n  border-radius: 9px;\n  background: linear-gradient(115deg, #004D88 0%, #006B85 60%, #009C8D 100%);\n  display: flex;\n  align-items: center;\n  justify-content: space-between;\n  gap: 20px;\n}\n\n.ib-workspace-cta-content {\n  flex: 1;\n  min-width: 0;\n}\n\n.ib-workspace-cta h3 {\n  color: #FFFFFF !important;\n  -webkit-text-fill-color: #FFFFFF !important;\n  font-family: 'Roboto', sans-serif !important;\n  font-size: 19px !important;\n  font-weight: 700 !important;\n  line-height: 1.4 !important;\n  margin: 0 0 7px !important;\n}\n\n.ib-workspace-cta p {\n  color: #EAF7F8 !important;\n  -webkit-text-fill-color: #EAF7F8 !important;\n  font-size: 14px !important;\n  line-height: 1.6 !important;\n  margin: 0 !important;\n}\n\n.ib-workspace-cta a {\n  flex-shrink: 0;\n  display: inline-flex;\n  align-items: center;\n  justify-content: center;\n  padding: 12px 19px;\n  background: #FFFFFF;\n  color: #004D88 !important;\n  -webkit-text-fill-color: #004D88 !important;\n  border-radius: 6px;\n  font-size: 13px;\n  font-weight: 700;\n  text-decoration: none !important;\n  white-space: nowrap;\n  transition: all .25s ease;\n}\n\n.ib-workspace-cta a:hover {\n  background: #E6FFFB;\n  transform: translateY(-2px);\n}\n\n\/* Mobile *\/\n@media(max-width: 600px) {\n  .ib-workspace-grid {\n    grid-template-columns: 1fr;\n    gap: 12px;\n  }\n\n  .ib-workspace-card {\n    padding: 18px;\n  }\n\n  .ib-workspace-cta {\n    flex-direction: column;\n    align-items: flex-start;\n    padding: 21px 19px;\n    gap: 15px;\n  }\n\n  .ib-workspace-cta h3 {\n    font-size: 18px !important;\n  }\n\n  .ib-workspace-cta a {\n    width: 100%;\n  }\n}\n<\/style>\n\n<div class=\"ib-workspace-section\">\n\n  <div class=\"ib-workspace-grid\">\n\n    <div class=\"ib-workspace-card\">\n      <span class=\"ib-card-label\">01 \/ INTERNAL WORKSPACE<\/span>\n      <h3>Internal Workspace<\/h3>\n      <p>Your team plans, executes and approves validation activities in one central workspace.<\/p>\n    <\/div>\n\n    <div class=\"ib-workspace-card\">\n      <span class=\"ib-card-label\">02 \/ CLIENT PORTAL<\/span>\n      <h3>Client Portal<\/h3>\n      <p>Clients access live project progress, reports and documents through a secure portal.<\/p>\n    <\/div>\n\n  <\/div>\n\n  <div class=\"ib-workspace-cta\">\n\n    <div class=\"ib-workspace-cta-content\">\n      <h3>Ready to Simplify Your Validation Workflows?<\/h3>\n      <p>Explore IncepOne and discover a smarter way to manage validation, protocols and client collaboration.<\/p>\n    <\/div>\n\n    <a href=\"https:\/\/www.incepbio.com\/incepone\" target=\"_blank\" rel=\"noopener noreferrer\">\n      Explore IncepOne \u2192\n    <\/a>\n\n  <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ec1a7d elementor-widget elementor-widget-text-editor\" data-id=\"2ec1a7d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<style>\n\/* INCEPBIO PREMIUM COMPARISON TABLE *\/\n.ib-premium-table,\n.ib-premium-table * {\n  box-sizing: border-box;\n}\n\n.ib-premium-table {\n  width: 100%;\n  margin: 24px 0;\n  font-family: 'Roboto', sans-serif;\n}\n\n.ib-premium-table h2 {\n  color: #004D88 !important;\n  -webkit-text-fill-color: #004D88 !important;\n  font-family: 'Roboto', sans-serif !important;\n  font-size: 21px !important;\n  font-weight: 700 !important;\n  line-height: 1.4 !important;\n  margin: 0 0 16px !important;\n}\n\n\/* Table wrapper *\/\n.ib-premium-table .table-wrapper {\n  width: 100%;\n  overflow-x: auto;\n  border: 1px solid #DDE7ED;\n  border-radius: 10px;\n  background: #FFFFFF;\n  box-shadow: 0 4px 16px rgba(0, 55, 90, 0.05);\n  scrollbar-width: thin;\n  scrollbar-color: #009C8D #F1F5F7;\n}\n\n\/* Table *\/\n.ib-premium-table table {\n  width: 100%;\n  min-width: 620px;\n  border-collapse: separate;\n  border-spacing: 0;\n  table-layout: fixed;\n  font-family: 'Roboto', sans-serif;\n  text-align: left;\n}\n\n\/* Column widths *\/\n.ib-premium-table th:first-child,\n.ib-premium-table td:first-child {\n  width: 22%;\n}\n\n.ib-premium-table th:nth-child(2),\n.ib-premium-table td:nth-child(2) {\n  width: 36%;\n}\n\n.ib-premium-table th:nth-child(3),\n.ib-premium-table td:nth-child(3) {\n  width: 42%;\n}\n\n\/* Header *\/\n.ib-premium-table thead th {\n  padding: 17px 16px;\n  background: #F2F6F9;\n  color: #004D88 !important;\n  font-size: 13px;\n  font-weight: 700;\n  line-height: 1.5;\n  border-bottom: 1px solid #DDE7ED;\n}\n\n.ib-premium-table thead th:nth-child(3) {\n  background: linear-gradient(120deg, #004D88 0%, #006B85 55%, #009C8D 100%);\n  color: #FFFFFF !important;\n  border-bottom: none;\n}\n\n.ib-premium-table thead th:first-child {\n  border-radius: 9px 0 0 0;\n}\n\n.ib-premium-table thead th:last-child {\n  border-radius: 0 9px 0 0;\n}\n\n\/* Body cells *\/\n.ib-premium-table tbody td {\n  padding: 16px;\n  font-size: 13px;\n  line-height: 1.65;\n  color: #526273;\n  vertical-align: middle;\n  border-bottom: 1px solid #E8EEF2;\n  background: #FFFFFF;\n}\n\n.ib-premium-table tbody td:first-child {\n  color: #004D88;\n  font-weight: 700;\n}\n\n\/* IncepOne gradient column *\/\n.ib-premium-table tbody td:nth-child(3) {\n  background: linear-gradient(120deg, #004D88 0%, #006B85 55%, #009C8D 100%);\n  color: #FFFFFF !important;\n  font-weight: 500;\n  border-bottom: 1px solid rgba(255,255,255,0.16);\n}\n\n\/* Row hover *\/\n.ib-premium-table tbody tr:hover td:first-child,\n.ib-premium-table tbody tr:hover td:nth-child(2) {\n  background: #F5F9FB;\n}\n\n.ib-premium-table tbody tr:hover td:nth-child(3) {\n  background: linear-gradient(120deg, #00558F 0%, #00788A 55%, #00A493 100%);\n}\n\n\/* Last row *\/\n.ib-premium-table tbody tr:last-child td {\n  border-bottom: none;\n}\n\n.ib-premium-table tbody tr:last-child td:first-child {\n  border-radius: 0 0 0 9px;\n}\n\n.ib-premium-table tbody tr:last-child td:last-child {\n  border-radius: 0 0 9px 0;\n}\n\n\/* Mobile *\/\n@media (max-width: 600px) {\n  .ib-premium-table h2 {\n    font-size: 19px !important;\n  }\n\n  .ib-premium-table table {\n    min-width: 580px;\n  }\n\n  .ib-premium-table thead th {\n    padding: 14px 12px;\n    font-size: 12px;\n  }\n\n  .ib-premium-table tbody td {\n    padding: 13px 12px;\n    font-size: 12px;\n  }\n}\n<\/style>\n\n<div class=\"ib-premium-table\">\n\n  <h2>Paper vs IncepOne Digital Validation Software<\/h2>\n\n  <div class=\"table-wrapper\">\n    <table>\n      <thead>\n        <tr>\n          <th>Area<\/th>\n          <th>Paper and Excel<\/th>\n          <th>IncepOne<\/th>\n        <\/tr>\n      <\/thead>\n\n      <tbody>\n        <tr>\n          <td>Protocol Approval<\/td>\n          <td>Printed, signed and scanned<\/td>\n          <td>Electronic signatures with audit trail<\/td>\n        <\/tr>\n\n        <tr>\n          <td>Version Control<\/td>\n          <td>Multiple uncontrolled copies<\/td>\n          <td>One controlled version in a central vault<\/td>\n        <\/tr>\n\n        <tr>\n          <td>Calculations<\/td>\n          <td>Separate Excel sheets<\/td>\n          <td>Built-in domain-specific calculations<\/td>\n        <\/tr>\n\n        <tr>\n          <td>Project Status<\/td>\n          <td>Manual tracker<\/td>\n          <td>Live validation dashboard<\/td>\n        <\/tr>\n\n        <tr>\n          <td>Audit Retrieval<\/td>\n          <td>Hours of searching<\/td>\n          <td>Documents and audit trails found instantly<\/td>\n        <\/tr>\n\n        <tr>\n          <td>Data Integrity<\/td>\n          <td>Scattered records, uncontrolled edits<\/td>\n          <td>Role-based access and full audit trail<\/td>\n        <\/tr>\n      <\/tbody>\n    <\/table>\n  <\/div>\n\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-93f70b7 elementor-widget elementor-widget-text-editor\" data-id=\"93f70b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<style>\n.ib-table-cta {\n  width: 100%;\n  box-sizing: border-box;\n  margin-top: 20px;\n  padding: 23px 26px;\n  border-radius: 9px;\n  background: linear-gradient(115deg, #004D88 0%, #006B85 60%, #009C8D 100%);\n  display: flex;\n  align-items: center;\n  justify-content: space-between;\n  gap: 20px;\n  font-family: 'Roboto', sans-serif;\n}\n\n.ib-table-cta-content {\n  flex: 1;\n  min-width: 0;\n}\n\n.ib-table-cta h3 {\n  color: #FFFFFF !important;\n  -webkit-text-fill-color: #FFFFFF !important;\n  font-family: 'Roboto', sans-serif !important;\n  font-size: 18px !important;\n  font-weight: 700 !important;\n  line-height: 1.4 !important;\n  margin: 0 0 6px !important;\n}\n\n.ib-table-cta p {\n  color: #EAF7F8 !important;\n  -webkit-text-fill-color: #EAF7F8 !important;\n  font-size: 14px !important;\n  line-height: 1.6 !important;\n  margin: 0 !important;\n}\n\n.ib-table-cta a {\n  flex-shrink: 0;\n  display: inline-flex;\n  align-items: center;\n  justify-content: center;\n  padding: 12px 19px;\n  background: #FFFFFF;\n  color: #004D88 !important;\n  -webkit-text-fill-color: #004D88 !important;\n  border-radius: 6px;\n  font-size: 13px;\n  font-weight: 700;\n  text-decoration: none !important;\n  white-space: nowrap;\n  transition: all .25s ease;\n}\n\n.ib-table-cta a:hover {\n  background: #E6FFFB;\n  transform: translateY(-2px);\n}\n\n@media(max-width: 600px) {\n  .ib-table-cta {\n    flex-direction: column;\n    align-items: flex-start;\n    padding: 20px;\n    gap: 15px;\n  }\n\n  .ib-table-cta h3 {\n    font-size: 17px !important;\n  }\n\n  .ib-table-cta a {\n    width: 100%;\n  }\n}\n<\/style>\n\n<div class=\"ib-table-cta\">\n  <div class=\"ib-table-cta-content\">\n    <h3>Planning Your Next HVAC or Cleanroom Requalification?<\/h3>\n    <p>Run it in IncepOne with templates, e-signatures and live tracking from day one.<\/p>\n  <\/div>\n\n  <a href=\"https:\/\/incepbio.com\/request-service?service=incepone&amp;source=blog-digital-validation-software\" target=\"_blank\" rel=\"noopener noreferrer\">\n    Talk to Our Team \u2192\n  <\/a>\n<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c88b987 elementor-widget elementor-widget-heading\" data-id=\"c88b987\" 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\">Frequently Asked Questions<\/h4>\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-9ec09d4 e-flex e-con-boxed e-con e-parent\" data-id=\"9ec09d4\" 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-ac84108 elementor-widget elementor-widget-n-accordion\" data-id=\"ac84108\" 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-1800\" 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-1800\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is digital validation software? <\/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-1800\" class=\"elementor-element elementor-element-4a2f448 e-con-full e-flex e-con e-child\" data-id=\"4a2f448\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7c752d2 elementor-widget elementor-widget-text-editor\" data-id=\"7c752d2\" 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>Digital validation software manages protocols, test data, approvals, reports and requalification online in one controlled system with a full audit trail, instead of paper and Excel.<\/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-1801\" 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-1801\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How do we replace Excel in validation? <\/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-1801\" class=\"elementor-element elementor-element-64ae491 e-con-full e-flex e-con e-child\" data-id=\"64ae491\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cde0124 elementor-widget elementor-widget-text-editor\" data-id=\"cde0124\" 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>Move protocols, test data, calculations and tracking into <a href=\"https:\/\/incepbio.com\/incepone\">digital validation software<\/a> such as IncepOne, starting with one repeat activity like yearly HVAC requalification.<\/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-1802\" 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-1802\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is IncepOne? <\/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-1802\" class=\"elementor-element elementor-element-43b509b e-con-full e-flex e-con e-child\" data-id=\"43b509b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9f2f729 elementor-widget elementor-widget-text-editor\" data-id=\"9f2f729\" 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>IncepOne is <a href=\"https:\/\/incepbio.com\/incepone\">cloud-hosted digital validation software<\/a> built and owned by IncepBio, a validation and compliance company, with Validation, Protocol, Learning and Asset Management in one platform.<\/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-1803\" 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-1803\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which guidelines apply to digital validation software? <\/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-1803\" class=\"elementor-element elementor-element-adf5154 e-con-full e-flex e-con e-child\" data-id=\"adf5154\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-91f5df6 elementor-widget elementor-widget-text-editor\" data-id=\"91f5df6\" 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>The main ones are US FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, FDA Computer Software Assurance (CSA) and ALCOA++ data integrity principles.<\/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-1804\" 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-1804\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How can I see an IncepOne demo? <\/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-1804\" class=\"elementor-element elementor-element-3a42fdf e-con-full e-flex e-con e-child\" data-id=\"3a42fdf\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-fa83c33 elementor-widget elementor-widget-text-editor\" data-id=\"fa83c33\" 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:\/\/incepbio.com\/request-service?service=incepone&amp;source=blog-digital-validation-software\">Request an IncepOne demo<\/a> and our team will give you a 30-minute walkthrough built around your projects.<\/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>Look inside IncepOne digital validation software: online protocols, built-in calculations, Part 11 e-signatures, audit trails and live validation tracking.<\/p>\n","protected":false},"author":1,"featured_media":329,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[89],"tags":[92,93,65,85,94,90,91],"class_list":["post-327","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-incepone","tag-21-cfr-part-11-compliance-software","tag-alcoa-data-integrity-in-validation","tag-digital-validation-software","tag-incepone","tag-incepone-21-cfr-part-11","tag-paperless-validation-software","tag-pharma-validation-software"],"_links":{"self":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/327","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=327"}],"version-history":[{"count":7,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/327\/revisions"}],"predecessor-version":[{"id":342,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/posts\/327\/revisions\/342"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media\/329"}],"wp:attachment":[{"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/media?parent=327"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/categories?post=327"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/incepbio.com\/blog\/wp-json\/wp\/v2\/tags?post=327"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}