{"id":16895,"date":"2022-04-21T17:51:42","date_gmt":"2022-04-21T12:21:42","guid":{"rendered":"https:\/\/cigniti.com\/blog\/?p=16895"},"modified":"2022-04-21T18:07:45","modified_gmt":"2022-04-21T12:37:45","slug":"validation-healthcare-life-science","status":"publish","type":"post","link":"https:\/\/www.cigniti.com\/blog\/validation-healthcare-life-science\/","title":{"rendered":"Validation and its Approach to Healthcare and Life Science Applications"},"content":{"rendered":"<p><span data-contrast=\"auto\">Validation is the most used and common term to verify the GxP systems, whether they are in systems or in labs. All the required precautions should be followed and maintained every time to keep the system compliant that is used directly or indirectly in the healthcare system.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">GxP and its Function:<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><br \/>\n<span data-contrast=\"auto\">One of the major goals and the most concerning things for any healthcare and pharmaceutical industry, which they always struggle to maintain the balance and try to sort out, is safety.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">GxP is a set of regulations and quality guidelines formulated by the US FDA (United States Food and Drug Administration) in collaboration with ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use)<\/span> <span data-contrast=\"auto\">to ensure the safety of life sciences products while maintaining the quality of processes throughout every stage of manufacturing, control, storage, and distribution. This applies to any organization that generates data submitted electronically in regulatory (e.g., FDA, EMA, TGA) filings. Such software must also include electronic signatures.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">GxP in Validation is \u201cwhen computers or automated data processing systems are used as part of production or the quality system, the (device) manufacturer shall validate computer software for its intended use according to an established protocol.\u201d <\/span><a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-820\/subpart-G\/section-820.70\"><span data-contrast=\"none\">(See 21 CFR \u00a7820.70 (i)).<\/span><\/a><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The relevant GXP system is all or any systems that have an impact on:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Patient Health &amp; Safety<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Product Quality<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"1\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Data Integrity<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><b><span data-contrast=\"auto\">What needs to be validated?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><br \/>\n<span data-contrast=\"auto\">When it comes to what exactly needs to be validated, as per the FDA\u2019s ICH 21 CRF Part 11 requirements, all software in the computer system used in GxP activities must be validated. Validation of computer system software is completely different from validation of device software. Computer system validation is more than testing. System validation performs testing, design control, and configuration management along with testing.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">Is it specific to an application?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><br \/>\n<span data-contrast=\"auto\">Well, this varies between <\/span><b><span data-contrast=\"auto\">non-configurable systems and configurable systems.<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">If it is a <\/span><b><span data-contrast=\"auto\">non-configurable system<\/span><\/b><span data-contrast=\"auto\">, like lab equipment or instruments or medical devices, the testing or validation should basically be performed to prove that the system is meeting all the expectations mentioned in the URS (User Requirement Specifications) Document, which will be filled in by the user for his requirements. The systems tests covered for this kind of testing are<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Installation Qualification (IQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Operational Qualification (OQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Performance Qualification (PQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><span data-contrast=\"auto\">When it is a configurable system or customized system like software used for reporting to regulatory or any software embedded with instruments or medical devices to perform the intended use to meet the business needs as per the URS document, additional tasks and testing will be performed along with the IQ, OQ, and PQ.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">Validation Plans Preparation<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Functional requirements specification\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Design verification<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Installation Qualification (IQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Operational Qualification (OQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Performance Qualification (PQ)<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"6\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Reporting<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><span data-contrast=\"auto\">As per the FDA, validation is \u201c<\/span><i><span data-contrast=\"auto\">confirmation by examination and provision of objective evidence that software specifications conform to user needs and\u202fintended uses in their environment<\/span><\/i><span data-contrast=\"auto\">\u201d.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Validation of the system is the ultimate responsibility of the user. Here, the user is the healthcare or pharmaceutical company that is using the product or process with software to report to regulatory bodies.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The software cannot be completely validated by any vendor on its own. Instead, it must be validated:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">In the user\u2019s environment<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">Within the user\u2019s intended workflow<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"7\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">As specified in the organization\u2019s standard operating procedures (SOPs)<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">All these processes should be documented to ensure that the software specifications conform to the user\u2019s needs.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">The user may also audit the software service provider to confirm that they have a QMS (Quality Management System) and a process.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"auto\">Validation service providers can certainly assist in validation by providing documentation and technical assistance for IQ, OQ, and PQ. They may also offer validation services like consultations, and documentation, or may be involved more actively in other tasks. Still, it is the ultimate responsibility of the user to validate that the system meets their requirements<\/span><span data-contrast=\"none\">.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">How Cigniti can help you with validating your system:<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><br \/>\n<span data-contrast=\"auto\">We at Cigniti can help you by understanding your exact needs and serving you to smoothen your process.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"auto\">What will Cigniti do?<\/span><\/b><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" aria-setsize=\"-1\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"auto\">We understand and mark out the gaps from the current process to exactly what you need. Suggest the necessary changes required in the process after understanding the existing process and finding out the considerable weak areas.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" aria-setsize=\"-1\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"auto\">We build a landscape after a thorough understanding of your process by doing a proper validation assessment and suggesting the areas to improve if required with digitalization and automated processes.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">We drive the training and workshops to take you through the roadmap of what we have planned.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">We prepare a plan with all the GxP compliance requirements documentation for the complete project life cycle, with continuous updates and improvements to the plan by collaborating with all the stakeholders.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"9\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">If required by you, we will also help you to do the continuous support of your validation process by maintaining the validation cycle from time to time as specified by regulatory bodies.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"auto\">Schedule a discussion with our <\/span><a href=\"https:\/\/www.cigniti.com\/industries\/healthcare-software-testing-services\/\"><span data-contrast=\"none\">Healthcare and Life Science domain experts<\/span><\/a><span data-contrast=\"auto\"> to find out more about the validation and its approach to healthcare and life science applications.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Validation is the most used and common term to verify the GxP systems, whether they are in systems or in labs. All the required precautions should be followed and maintained every time to keep the system compliant that is used directly or indirectly in the healthcare system.\u00a0\u00a0 GxP and its Function:\u00a0 One of the major [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":16896,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2710],"tags":[2502,3692,3694,2988,4088,2646,3859,1146,3693,3858,2099,2143,2982,3467,3468,1149,2644,3857,3958,157,3691,3407,1240],"ppma_author":[3985],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Validation and its Approach to Healthcare and Life Science Applications | Healthcare Testing<\/title>\n<meta name=\"description\" content=\"Validation of the system is the ultimate responsibility of the user. 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When it comes to what exactly needs to be validated, as per the FDA\u2019s ICH 21 CRF Part 11 requirements, all software in the computer system used in GxP activities must be validated, says, @Anusha Chowdary, Senior Business Analyst, @Cigniti Technologies. 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