{"id":10155,"date":"2023-07-12T12:50:10","date_gmt":"2023-07-12T10:50:10","guid":{"rendered":"https:\/\/q-finity.de\/?post_type=encyclopedia&#038;p=10155"},"modified":"2024-02-12T15:12:10","modified_gmt":"2024-02-12T14:12:10","slug":"computer-software-assurance-csa","status":"publish","type":"encyclopedia","link":"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/","title":{"rendered":"Computer Software Assurance (CSA)"},"content":{"rendered":"<div class=\"ewa-rteLine\">The CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested. High-Risk functions should be tested more extensively with higher control in a fully scripted test. Low risk functions can be tested more informally with minimal documentation. The basis for the CSA approach is a comprehensive understanding of the <a href=\"https:\/\/q-finity.de\/en\/glossar\/process\/\" target=\"_self\" title=\"Process is a set of interrelated or interacting activities which transform inputs into outputs. If you need more details about process contact us here.\" class=\"encyclopedia\">process<\/a> and function as well as the associated risks for the patient or the product. The CSA approach can be applied during the entire <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a> life cycle, including software development as long as the risk are understood and documented.<\/div>\n<div class=\"ewa-rteLine\">The CSA principles should be applied to all <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer\/\" target=\"_self\" title=\"A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.\" class=\"encyclopedia\">computer<\/a> systems involved in manufacturing a medical device (and medicinal products) or the associated <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> systems (e.g. ERP, LIMS, etc.). Software that is itself a component of a medical device is explicitly excluded.<\/div>\n<div class=\"ewa-rteLine\">The main steps of the CSA approach are:<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">&bull; Define the Intended Use (at a system and\/or function level)<\/div>\n<div class=\"ewa-rteLine\">&bull; Define the risk-based approach for assuring the <a href=\"https:\/\/q-finity.de\/en\/glossar\/quality\/\" target=\"_self\" title='The term quality is derived from the Latin word &ldquo;qualitas&rdquo;, which means characteristic, feature, property or condition. In other words, the term quality defines the degree to which a set of inherent features of an object meets requirements. Inherent means \"intrinsic to a particular unit\". If you want more information about quality contact us here.' class=\"encyclopedia\">quality<\/a> of the software<\/div>\n<div class=\"ewa-rteLine\">&bull; Define the appropriate testing activities<\/div>\n<div><\/div>\n<div class=\"ewa-rteLine\">In all of these steps, the CSA approach emphasizes the need for <a href=\"https:\/\/q-finity.de\/en\/glossar\/critical-thinking\/\" target=\"_self\" title=\"Critical thinking is a systematic, rational, and disciplined process of evaluating information from a variety of perspectives to yield a balanced and well-reasoned answer. Critical thinking promotes informed decision-making and good judgment about where and how to apply and scale quality and compliance activities for computerized systems based on the risks associated with them. A&hellip;\" class=\"encyclopedia\">critical thinking<\/a> when developing the life-cycle strategy of a <a href=\"https:\/\/q-finity.de\/en\/glossar\/computerized-system\/\" target=\"_self\" title=\"A Computerized System is a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, clinical trials data management, vigilance systems, process control and process analytics, manufacturing resource planning, automated manufacturing equipment, manufacturing execution, and document management systems. The computerized system consists of the hardware, software, and network components, together&hellip;\" class=\"encyclopedia\">computerized system<\/a>, especially in terms of the scope and depth of the associated testing and documentation activities.<\/div>\n<div><\/div>\n<div>If you want to have more information about <a href=\"https:\/\/q-finity.de\/en\/glossar\/computer\/\" target=\"_self\" title=\"A Computer is a functional unit that can perform substantial computations, including numerous arithmetic operations and logic operations without human intervention. If you need more information please contact us here.\" class=\"encyclopedia\">Computer<\/a> Software Assurance contact us <a href=\"https:\/\/q-finity.de\/en\/contact\/?swcfpc=1\">here<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested. High-Risk functions should be tested more extensively with higher control in a fully scripted test. Low risk functions can be tested more informally with minimal documentation. The basis for the CSA [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"template":"","encyclopedia-tag":[],"class_list":["post-10155","encyclopedia","type-encyclopedia","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>CSA Computer Software Assurance Glossary<\/title>\n<meta name=\"description\" content=\"CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested\" \/>\n<meta name=\"robots\" content=\"noindex, nofollow\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Computer Software Assurance (CSA)\" \/>\n<meta property=\"og:description\" content=\"CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested\" \/>\n<meta property=\"og:url\" content=\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\" \/>\n<meta property=\"og:site_name\" content=\"QFINITY\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/QFINITY\" \/>\n<meta property=\"article:modified_time\" content=\"2024-02-12T14:12:10+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:site\" content=\"@cQFINITY\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\",\"url\":\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\",\"name\":\"CSA Computer Software Assurance Glossary\",\"isPartOf\":{\"@id\":\"https:\/\/q-finity.de\/en\/#website\"},\"datePublished\":\"2023-07-12T10:50:10+00:00\",\"dateModified\":\"2024-02-12T14:12:10+00:00\",\"description\":\"CSA approach is a method to scale the documentation efforts for test activities according to risk associated with the function to be tested\",\"breadcrumb\":{\"@id\":\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/q-finity.de\/en\/glossar\/computer-software-assurance-csa\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/q-finity.de\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Glossar\",\"item\":\"https:\/\/q-finity.de\/en\/glossar\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Computer Software Assurance (CSA)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/q-finity.de\/en\/#website\",\"url\":\"https:\/\/q-finity.de\/en\/\",\"name\":\"QFINITY\",\"description\":\"Qualit\u00e4tsmanagement &amp; 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