{"id":3979,"date":"2023-07-11T15:24:47","date_gmt":"2023-07-11T15:24:47","guid":{"rendered":"http:\/\/dciinc.s438.sureserver.com\/cps\/?page_id=3979"},"modified":"2024-12-19T22:47:03","modified_gmt":"2024-12-19T22:47:03","slug":"validation-requirements","status":"publish","type":"page","link":"https:\/\/dciinc.com\/cps\/process-fabrication-expertise\/validation-requirements\/","title":{"rendered":"System Validation and Project Testing"},"content":{"rendered":"<div class=\"the_content\"><p><span style=\"font-weight: 400;\">CPS will develop a testing plan that meets your requirements \u2013 from GMP pharma protocols to simple 1 page outlines all with the goal of proving your system works as expected. <\/span><\/p>\n<p><b>For pharmaceutical and biotech projects<\/b><span style=\"font-weight: 400;\">, CPS can provide\u00a0 validation for GMP and GLP systems.\u00a0 We can provide full or partial validation services including protocols, methods, documentation and execution support to suit your project needs.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Work with you to create URS (User Requirement Specifications), FRS (Functional Requirement Specifications, HDS (Hardware Design Specifications, SDS (Software Design Specifications<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">FAT (Factory Acceptance Test), SAT (Site Acceptance Test) that can be leveraged in the IOQ<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">GAMP Compliant<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">21 CFR Part 11\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Traceability Matrix<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Validation Reports<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Sterilization and Clean In Place<\/span><\/li>\n<\/ul>\n<p><b>For other projects that do not require pharmaceutical level testing<\/b><span style=\"font-weight: 400;\">, CPS can help to prepare just the right level of testing and project documentation to verify your system is working properly.<\/span><\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>CPS will develop a testing plan that meets your requirements \u2013 from GMP pharma protocols to simple 1 page outlines all with the goal of proving your system works as expected. For pharmaceutical and biotech projects, CPS can provide\u00a0 validation for GMP and GLP systems.\u00a0 We can provide full or partial validation services including protocols, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":3340,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"content-type":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3979","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>System Validation Requirements for Process Fabrication<\/title>\n<meta name=\"description\" content=\"DCI Inc., CPS &amp; SSWI offer expertise in process fabrication validation requirements. Our nationwide services ensure compliance &amp; operational efficiency.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/dciinc.com\/cps\/process-fabrication-expertise\/validation-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"System Validation Requirements for Process Fabrication\" \/>\n<meta property=\"og:description\" content=\"DCI Inc., CPS &amp; SSWI offer expertise in process fabrication validation requirements. 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