{"id":357945,"date":"2024-09-16T21:18:09","date_gmt":"2024-09-17T01:18:09","guid":{"rendered":"https:\/\/caiready.com\/life-sciences\/?post_type=resource&p=357945"},"modified":"2025-06-22T15:50:25","modified_gmt":"2025-06-22T19:50:25","slug":"validation-as-a-service-model","status":"publish","type":"case-study","link":"https:\/\/caiready.com\/life-sciences\/case-study\/validation-as-a-service-model\/","title":{"rendered":"CMO Validation as a Service Model"},"content":{"rendered":"\n
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CMO Validation as a Service Model
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Download the PDF<\/a><\/div>\n<\/div>\n<\/div><\/div><\/div><\/div>\n\n\n\n
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PROJECT OVERVIEW<\/h2>\n\n\n\n

CAI implemented a Validation as a Service model for companies in early-phase clinical trials, addressing the need for speed to patient without requiring a large internal validation department. By leveraging Kneat’s eVLMS platform, CAI established an in-house program with standardized procedures and off-the-shelf content deployable on a project-by-project basis. This approach allowed for rapid project initiation, reduced document development times, and in some cases, eliminated the need for pre-execution review. The model was successfully applied to a small CDMO, resulting in significant cost savings, accelerated timelines, and early identification of equipment issues.<\/p>\n\n\n\n

Topics Covered<\/h2>\n\n\n\n
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  • Standardized validation procedures for clinical trial companies<\/li>\n\n\n\n
  • eVLMS platform implementation for streamlined processes<\/li>\n\n\n\n
  • Pre-approved templates for common validation tasks<\/li>\n\n\n\n
  • Cost reduction in validation projects<\/li>\n\n\n\n
  • Accelerated project timelines in pharmaceutical validation<\/li>\n\n\n\n
  • Early issue identification and resolution in equipment qualification<\/li>\n\n\n\n
  • Compliance with data integrity and electronic signature regulations<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
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    CATEGORY:<\/h3>\n\n\n\n

    Digital Transformation and Harmonization<\/p>\n\n\n\n

    CLIENT:<\/h3>\n\n\n\n

    Wheeler BIO<\/p>\n\n\n\n

    LOCATION:<\/h3>\n\n\n\n

    Oklahoma City, OH<\/p>\n\n\n\n

    Contract Size:<\/h3>\n\n\n\n

    ~$200k USD<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

    CAI works with many companies in early phase clinical trials for whom speed to patient is of the utmost necessity. Often such companies don\u2019t need a large internal validation department, and no especial reason to maintain a robust validation program.<\/p>\n","protected":false},"featured_media":358069,"template":"","meta":{"_acf_changed":true},"categories":[823],"resource-category":[270],"resource-featured-status":[],"resource-type":[268],"class_list":["post-357945","case-study","type-case-study","status-publish","has-post-thumbnail","hentry","category-digital-transformation-harmonization","resource-category-digital-transformation-harmonization","resource-type-case-studies"],"acf":[],"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study\/357945","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/case-study"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/case-study"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media\/358069"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=357945"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=357945"},{"taxonomy":"resource-category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-category?post=357945"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=357945"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=357945"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}