{"id":36292,"date":"2025-03-10T14:18:05","date_gmt":"2025-03-10T14:18:05","guid":{"rendered":"https:\/\/www.oxfordcorp.com\/?p=36292"},"modified":"2025-03-10T14:18:05","modified_gmt":"2025-03-10T14:18:05","slug":"fmea-and-computer-system-validation-for-18-laboratory-systems","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/en\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/","title":{"rendered":"FMEA and Computer System Validation for 18 Laboratory Systems"},"content":{"rendered":"<div class=\"post-info\">\n<strong>INDUSTRY<\/strong><br \/>\nHealthcare<br \/>\nLife Sciences<\/p>\n<p><strong>SERVICES<\/strong><br \/>\nFMEA Development<br \/>\nGap Assessment<br \/>\nComputer System Validation (CSV)<br \/>\nProject Management<\/p>\n<p><strong>SKILLS<\/strong><br \/>\nRegulatory<br \/>\nValidation execution<br \/>\nTechnical writing<br \/>\nProject management\n<\/div>\n<p><strong>The Challenge<\/strong><br \/>\nOur client was seeking to evaluate and assess existing systems, procedures and controls for potential gaps. They also desired a partner that could begin implementation of any corrective actions identified during the evaluation. The partner needed to be able to evaluate, plan and manage Failure Mode and Effects Analysis (FMEA) related activities including:<\/p>\n<ul>\n<li>E-record and e-signature compliance<\/li>\n<li>Evaluation of laboratory systems to determine compliance gaps based on the FMEA<\/li>\n<li>Development of data processing maps for each lab system<\/li>\n<li>Computer system validation support.<\/li>\n<\/ul>\n<p><strong>The Solution<\/strong><br \/>\nOur engagement team was comprised of one validation lead and two validation engineers.\u00a0 We developed and\u00a0 executed the FMEA, followed by the development of a Computerized System Gap Analysis checklist for laboratory system evaluations. Data processing map development and Computer System Validation work ran in parallel to the lab system evaluations. Our engagement manager provided oversight of the team, scope, deliverable production, budget, contract compliance and maintained consistent communication with the team and Client via weekly status reports and monthly Engagement Review meetings.<\/p>\n<p><strong>The Result<br \/>\n<\/strong>We successfully delivered an FMEA with appropriately focused content, completed evaluations and development of data processing maps for 18 laboratory systems.\u00a0We also provided Computer System Validation support for multiple software systems.\u00a0 This enabled the client to quickly recognize and understand gaps, and begin implementation of mitigation actions, while still addressing the validation needs to incoming computerized systems.<\/p>\n<p>If you need support in FMEA development, gap assessment, or Computer System Validation (CSV) we can help! Reach out to Oxford to learn more.<\/p>\n<div style=\"text-align: center;\">\n<p><a style=\"display: inline-block; padding: 10px 20px; background-color: #ffd300; color: #000; font-weight: bold; text-decoration: none; border-radius: 4px; box-shadow: 0px 3px 5px rgba(0, 0, 0, 0.2); transition: background-color 0.3s ease;\" href=\"https:\/\/www.oxfordcorp.com\/contact\/?utm_source=Insights&amp;utm_medium=CTA_Click&amp;utm_campaign=CTA#i'm-looking-for-talent\">CONNECT WITH OXFORD \u2192<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Find out how we successfully modified the course registration functions of a university system&#8217;s main campus portal, capturing students&#8217; data across campuses.<\/p>\n","protected":false},"author":42,"featured_media":36304,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[181],"tags":[114,113],"category-tag":[],"class_list":["post-36292","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-healthcare","tag-life-sciences"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.1 (Yoast SEO v27.1.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>FMEA and Computer System Validation for 18 Laboratory Systems - Oxford Global Resources<\/title>\n<meta name=\"description\" content=\"Explore how we assisted our client in evaluating, planning, and managing Failure Mode and Effects Analysis. Learn how we identified and addressed potential gaps in existing systems and controls.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FMEA and Computer System Validation for 18 Laboratory Systems\" \/>\n<meta property=\"og:description\" content=\"Explore how we assisted our client in evaluating, planning, and managing Failure Mode and Effects Analysis. Learn how we identified and addressed potential gaps in existing systems and controls.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\" \/>\n<meta property=\"og:site_name\" content=\"Oxford Global Resources\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-10T14:18:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2025\/02\/FMEA-and-Computer-System-Validation-for-18-Laboratory-Systems.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2048\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Megan Hollingsworth\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Megan Hollingsworth\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\"},\"author\":{\"name\":\"Megan Hollingsworth\",\"@id\":\"https:\/\/www.oxfordcorp.com\/de\/#\/schema\/person\/a38a0e553534447de69c457253c40fe9\"},\"headline\":\"FMEA and Computer System Validation for 18 Laboratory Systems\",\"datePublished\":\"2025-03-10T14:18:05+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\"},\"wordCount\":286,\"image\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2025\/02\/FMEA-and-Computer-System-Validation-for-18-Laboratory-Systems.jpg\",\"keywords\":[\"Healthcare\",\"Life Sciences\"],\"articleSection\":[\"Case Study\"],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\",\"url\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/\",\"name\":\"FMEA and Computer System Validation for 18 Laboratory Systems - Oxford Global Resources\",\"isPartOf\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/de\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/fmea-and-computer-system-validation-for-18-laboratory-systems\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2025\/02\/FMEA-and-Computer-System-Validation-for-18-Laboratory-Systems.jpg\",\"datePublished\":\"2025-03-10T14:18:05+00:00\",\"author\":{\"@id\":\"https:\/\/www.oxfordcorp.com\/de\/#\/schema\/person\/a38a0e553534447de69c457253c40fe9\"},\"description\":\"Explore how we assisted our client in evaluating, planning, and managing Failure Mode and Effects Analysis. 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