{"id":18,"date":"2024-02-05T18:27:37","date_gmt":"2024-02-05T18:27:37","guid":{"rendered":"http:\/\/localhost\/?page_id=18"},"modified":"2024-07-22T16:48:24","modified_gmt":"2024-07-22T16:48:24","slug":"quality-assurance-compliance","status":"publish","type":"page","link":"https:\/\/www.frontierscience.org\/public\/services-solutions\/quality-assurance-compliance\/","title":{"rendered":"Quality Assurance & Compliance"},"content":{"rendered":"\n
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Quality Assurance & Compliance<\/h2>\n\n

Our integrated quality management systems ensure overall compliance with both domestic and international research regulations. <\/p><\/div><\/div>\n<\/div><\/div>\n\n\n\n

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Overview<\/h2>\n\n\n\n
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Essential Quality Assurance Services<\/h3>\n\n\n\n

Quality assurance is an essential expectation in the research industry. It ensures that studies adhere to relevant domestic and international regulations, while improving functionality and streamlining workflows.<\/p>\n<\/div><\/div>\n\n\n\n

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Regulatory Consultation<\/h3>\n\n\n\n

Whether your study would benefit from a third-party audit to identify compliance gaps, or requires assistance in validating a commercial product, our Quality Assurance department can provide regulatory consultation to help determine which solutions best fit your needs.<\/p>\n<\/div>

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All Phases of the Study Lifecycle<\/h2>\n\n\n\n

Our quality team is familiar with the regulatory aspects of all phases of the study lifecycle including:<\/p>\n\n\n\n

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Conduct Gap Analyses<\/p>\n<\/div>\n<\/div>\n\n\n\n

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Draft Standard Operating Procedures<\/p>\n<\/div>\n<\/div>\n\n\n\n

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Set Up Quality Assurance Workflows<\/p>\n<\/div>\n<\/div>\n\n\n\n

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Track Latest Protocols & Regulations<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n

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Comprehensive Quality Management Plans<\/h2>\n\n\n\n

We assist with audit preparation, vendor selection and management, computer systems validation, trial master file implementation, incident and CAPA management, risk analyses, and any other topics relevant to a comprehensive Quality Management System (QMS).<\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n

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Our Quality Team<\/h2>\n\n\n\n

To develop quality assurance workflows, the Quality Assurance department works closely with other organizational departments, including Software Engineering, Data Management, IT, Biostatistics, Randomization, Database Operations, CDISC, and User Support.<\/p>\n\n\n\n

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We also partner with our highly-talented Technical Writing department to provide tailored documentation, training materials, and full validation suites.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n

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Quality Assurance Process<\/h2>\n\n\n\n
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    Consultation<\/h3>\n\n\n\n

    A regulatory consultation is conducted to discuss the unique aspects of the study and determine the overall goals of the collaborator<\/p>\n\n\n\n

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    Analysis<\/h3>\n\n\n\n

    A detailed gap analysis identifies potential compliance gaps and establishes approaches best suited for project needs<\/p>\n\n\n\n

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    Development<\/h3>\n\n\n\n

    A strategic plan is created based on project requirements, including flexible workflows, tailored documentation and training, and full software validation suites where required<\/p>\n\n\n\n

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    Implementation<\/h3>\n\n\n\n

    Our expert team provides direct assistance to ensure the successful implementation of customized workflows<\/p>\n\n\n\n

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    Our integrated quality management systems ensure overall compliance with both domestic and international research regulations.<\/p>\n","protected":false},"author":1,"featured_media":1083,"parent":354,"menu_order":5,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-18","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/pages\/18"}],"collection":[{"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/comments?post=18"}],"version-history":[{"count":21,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/pages\/18\/revisions"}],"predecessor-version":[{"id":1661,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/pages\/18\/revisions\/1661"}],"up":[{"embeddable":true,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/pages\/354"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/media\/1083"}],"wp:attachment":[{"href":"https:\/\/www.frontierscience.org\/public\/wp-json\/wp\/v2\/media?parent=18"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}