{"id":26668,"date":"2023-12-14T22:21:15","date_gmt":"2023-12-14T22:21:15","guid":{"rendered":"https:\/\/www.oxfordcorp.com\/?p=26668"},"modified":"2024-01-11T16:54:20","modified_gmt":"2024-01-11T16:54:20","slug":"8000-records-reviewed-within-four-months-for-pharmaceutical-client","status":"publish","type":"post","link":"https:\/\/www.oxfordcorp.com\/es\/insights\/case-study\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\/","title":{"rendered":"8,000 Records Reviewed within Four Months for Medical Device Client"},"content":{"rendered":"

INDUSTRY
\n<\/strong>Life Sciences<\/p>\n

SERVICES<\/strong>
\nMergers & Acquisitions
\nAuditing<\/p>\n

SKILLS
\n<\/strong>Project Management
\nTechnical Reviews
\nNon-Conformance Reporting<\/p>\n

The Challenge
\n<\/strong>During an acquisition, many elements need to be considered. This process becomes even more complex when a multinational medical device organization undergoes an acquisition. Our client had undergone post-acquisition audits from the FDA, and several gaps were identified surrounding field complaints, design control, and risk management. As a result, they had 8,000 records of non-conformances that needed to be reviewed, documented, and appropriately escalated within four months.<\/p>\n

The Solution
\n<\/strong>Because we had an existing relationship with this client, they trusted us to carry out this project promptly yet thoroughly. We provided a Project Manager and 10 Technical Reviewers, Plant Quality Engineers, and Manufacturing Quality Engineers. These individuals divided into groups to review each file and classify it based on severity. From there, the file was escalated and documented correctly. While the Oxford team was working with the client\u2019s internal team, the project manager was also coordinating with the team in Germany to ensure all NCRs were tracked and reported. In addition, we had weekly meetings with the Project Manager to ensure the project was on track.<\/p>\n

The Result
\n<\/strong>With Oxford\u2019s support, the client completed all 8,000 record reviews within the four-month deadline and avoided any consent decrees.<\/p>\n","protected":false},"excerpt":{"rendered":"

INDUSTRY Life Sciences SERVICES Mergers & Acquisitions Auditing SKILLS Project Management Technical Reviews Non-Conformance Reporting The Challenge During an acquisition, […]<\/p>\n","protected":false},"author":9,"featured_media":26678,"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":[113],"category-tag":[],"class_list":["post-26668","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","tag-life-sciences"],"yoast_head":"\n8,000 Records Reviewed within Four Months for Medical Device Client - Oxford Global Resources<\/title>\n<meta name=\"description\" content=\"Hire experienced Project Managers and Technical Reviewers to quickly remediate non-conformance records.\" \/>\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\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"8,000 Records Reviewed within Four Months for Medical Device Client\" \/>\n<meta property=\"og:description\" content=\"Hire experienced Project Managers and Technical Reviewers to quickly remediate non-conformance records.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.oxfordcorp.com\/insights\/case-study\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\/\" \/>\n<meta property=\"og:site_name\" content=\"Oxford Global Resources\" \/>\n<meta property=\"article:published_time\" content=\"2023-12-14T22:21:15+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:54:20+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.oxfordcorp.com\/wp-content\/uploads\/2023\/12\/8000-records-reviewed-within-four-months_resized-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1706\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"caitlin_charles\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"caitlin_charles\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\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\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/\"},\"author\":{\"name\":\"caitlin_charles\",\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/de\\\/#\\\/schema\\\/person\\\/222e7aa67bdcd7a2b204fbde801f56de\"},\"headline\":\"8,000 Records Reviewed within Four Months for Medical Device Client\",\"datePublished\":\"2023-12-14T22:21:15+00:00\",\"dateModified\":\"2024-01-11T16:54:20+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/\"},\"wordCount\":222,\"image\":{\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.oxfordcorp.com\\\/wp-content\\\/uploads\\\/2023\\\/12\\\/8000-records-reviewed-within-four-months_resized-scaled.jpg\",\"keywords\":[\"Life Sciences\"],\"articleSection\":[\"Case Study\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/\",\"url\":\"https:\\\/\\\/www.oxfordcorp.com\\\/insights\\\/case-study\\\/8000-records-reviewed-within-four-months-for-pharmaceutical-client\\\/\",\"name\":\"8,000 Records Reviewed within Four Months for Medical Device Client - 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