{"id":93,"date":"2026-02-04T16:48:01","date_gmt":"2026-02-04T16:48:01","guid":{"rendered":"http:\/\/eolusinc.com\/Staging\/?page_id=93"},"modified":"2026-03-27T15:21:48","modified_gmt":"2026-03-27T15:21:48","slug":"data-integrity","status":"publish","type":"page","link":"https:\/\/eolusinc.com\/?page_id=93","title":{"rendered":"Data Integrity"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Eolus has extensive experience helping our clients to understand and comply with Electronic Records &amp; Electronic Signatures regulations. Our consultants stay abreast with the latest FDA guidance for Data Integrity.  Our services&nbsp;range in scope from Audits, Training, Risk Assessments, Software Evaluations, Project Planning &amp; Management, to Software Validation projects to ensure compliance of software applications, systems and infrastructure. We provide end to end data integrity assessments and reviews. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Standards and References<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>FDA Glossary of Computerized System and Software Development Terminology<\/li>\n\n\n\n<li>General Principles of Software Validation; Final Guidance for Industry, FDA<\/li>\n\n\n\n<li>Data Integrity and Compliance, FDA<\/li>\n\n\n\n<li>GAMP 5, A Risk-Based Approach to Compliant GXP Computerized Systems, 2nd Edition<\/li>\n\n\n\n<li>Good Documentation Practices (GDP)<\/li>\n\n\n\n<li>GAMP Data Integrity Guide<\/li>\n\n\n\n<li>International Conference on Harmonization (ICH) E6, Good Clinical Practices (GCPs)<\/li>\n\n\n\n<li>Pharmaceutical Inspection Co-operation Scheme (PIC\/S) Guidance for Computerized Systems<\/li>\n\n\n\n<li>21 CFR 11, Electronic Records; Electronic Signatures<\/li>\n\n\n\n<li>21 CFR 312, Investigational New Drug Application<\/li>\n\n\n\n<li>21 CFR 50, Protection of Human Subjects<\/li>\n\n\n\n<li>21 CFR 54 Financial Disclosure by Clinical Investigators<\/li>\n\n\n\n<li>21 CFR 56 Institutional Review Boards (IRB)<\/li>\n\n\n\n<li>21 CFR 211 Current Good Manufacturing Process (cGMP)<\/li>\n\n\n\n<li>21 CFR 820, Quality&nbsp; System Regulation (QSR)<\/li>\n\n\n\n<li>21 CFR Part 58, Good Laboratory Practices (GLP)<\/li>\n\n\n\n<li>ISO 27001: Information Security Management System (ISMS)<\/li>\n\n\n\n<li>ISO 27701: Information Security, Cybersecurity, Privacy<\/li>\n\n\n\n<li>ISO 13485: Quality Management System (QMS)<\/li>\n\n\n\n<li>ISO 14971: Medical Devices, Application of Risk Management<\/li>\n\n\n\n<li>ICH Q9 (R1) Pharmaceutical Risk Management<\/li>\n\n\n\n<li>ICH Q10 Pharmaceutical Quality System<\/li>\n\n\n\n<li>ICH E6 (R3), Good Clinical Practices (GCP)<\/li>\n\n\n\n<li>IEC 62304 Medical Device Software, Software Lifecycle&nbsp;<\/li>\n\n\n\n<li>EU Good Data Privacy Regulation (GDPR)<\/li>\n\n\n\n<li>EU GMP Annex 11, Computerized Systems<\/li>\n\n\n\n<li>PICs\/GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP\/GDP ENVIRONMENTS<\/li>\n\n\n\n<li>EMA Guideline on Computerized systems and electronic data in clinical trials<\/li>\n\n\n\n<li>Medicine &amp; Healthcare Products Regulatory Agency (MHRA) \u2018GXP\u2019 Data Integrity Guidance and Definitions<\/li>\n\n\n\n<li><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Key Industry Association Presentations<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>DIA Conference on EDC-October 1999: <\/strong><strong><em>\u201c<\/em><\/strong><em>Electronic Data Capture;a Lotus on Onion Blossom?\u201d<\/em><\/li>\n\n\n\n<li><strong>Fraser Williams Users Group Meeting &#8211; May 2000: <\/strong><em>\u201cTo Validate or not to Validate, That is the Question\u201d<\/em><\/li>\n\n\n\n<li><strong>Barnett &amp; PDA\/FDA conference &#8211; June 2000: \u201cElectronic Records: Real Life Scenarios\u201d<\/strong><\/li>\n\n\n\n<li><strong>PDA Annual Meeting &#8211; Dec 2000: <\/strong><em>A Project Management Approach to Compliance Programs\u201d<\/em><\/li>\n\n\n\n<li><strong>DIA Annual Meeting &#8211; July 2001: <\/strong><em>\u201c<\/em>IVR Case Study for Success\u201d<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Patents<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">US Patent serial number 10\/132,537 (Weldon et al) filed April 25, 2002, related to systems, methods and computer program products for designing, deploying and managing interactive voice response (IVR) systems for Clinical Research &#8211; April, 2002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Key Publications <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>&#8220;Electronic Records: An &#8220;IVR Cast Study for Success&#8221;. Quality Assurance Journal, volume 6, issues 2 &#8211; June 2002, Wiley &amp; Sons, LTD.<\/li>\n\n\n\n<li>&#8220;<em>Good Practice and Compliance for Electronic Records and Signatures (Part 1) Good Electronic Records Management (GERM)<\/em>&#8220;, <strong>CoAuthor and PDA Task Force member, 2002<\/strong><\/li>\n\n\n\n<li><strong>&#8220;<\/strong><strong><em>Good Practice and Compliance for Electronic Records and Signatures (Part 2) Complying with 21 CFR Part 11, Electronic Records and Signatures<\/em><\/strong><strong>&#8220;, GAMP Forum, PDA Task Force, 2001<\/strong><\/li>\n\n\n\n<li><em>\u201cGood Practice and Compliance for Electronic Records and Signatures (Part 3) Models for Systems Implementation and Evolution<\/em>&#8220;, <strong>CoAuthor and PDA Task Force member, 2004<\/strong><\/li>\n\n\n\n<li><em>\u201cCurrent Concepts in Validation and Compliance, Computerized Systems Used in Non Clinical Safety Assessment\u201d; GLP, <\/em><strong>DIA RED Apple II Committee Member, Collaborator and Co-Author. 2007&nbsp;&nbsp;<\/strong><\/li>\n\n\n\n<li><em>\u201cSystem and Data Integrity for Clinical Trials\u201d; GCP<\/em><strong>, DIA Peach Committee member and Co-Author, 2008<\/strong><\/li>\n\n\n\n<li><strong>Good Clinical Practice, A Question and Answer Guide, Section 10, FDA inspections, Quality Assurance Activities, and Study Auditing, 2020 CoEditor with Earl Hulihan, Section 10<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Current and Previous Professional Associations <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ASQ, <\/strong>American Society of Quality<\/li>\n\n\n\n<li><strong>CDISC, <\/strong>Clinical Data Interchange Standards Consortium<\/li>\n\n\n\n<li><strong>DIA,<\/strong> Drug Information Association<\/li>\n\n\n\n<li><strong>PDA, <\/strong>Parental Drug Association<\/li>\n\n\n\n<li><strong>Medical Device Engineers and Consultants<\/strong><\/li>\n\n\n\n<li><strong>NCCSQA; <\/strong>NC Society of Quality Associates<\/li>\n\n\n\n<li><strong>TTEC, <\/strong>Triangle Technology Executive Committee&nbsp;<\/li>\n\n\n\n<li><strong>ANSI RAB<\/strong> Accredited ISO9001 Lead Auditor&nbsp;<\/li>\n\n\n\n<li><strong>PDA\/ARC <\/strong>Computer Supplier Auditor Certificate #1064&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<\/li>\n\n\n\n<li><strong>Triangle PEERS:<\/strong> Electronic Records\/Data Integrity<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Eolus has extensive experience helping our clients to understand and comply with Electronic Records &amp; Electronic Signatures regulations. Our consultants [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-93","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/pages\/93","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eolusinc.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=93"}],"version-history":[{"count":23,"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/pages\/93\/revisions"}],"predecessor-version":[{"id":760,"href":"https:\/\/eolusinc.com\/index.php?rest_route=\/wp\/v2\/pages\/93\/revisions\/760"}],"wp:attachment":[{"href":"https:\/\/eolusinc.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=93"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}