A genomic testing manufacturer uses our regulatory and compliance solution to improve their quality processes, including a CAPA backlog. 


Our client, a leading manufacturer of genomic profiling tests, received audit observations with FDA 21 CFR Part 820 and ISO 13485 as related to CAPA (Corrective and Preventive Action) management. Being relatively new to the regulatory industry and experiencing rapid growth at the same time, internal expertise in Quality and CAPA Management was lacking and related processes were at an early stage of maturity. Client was under increasing pressure from several key pharma partners to improve their quality processes, and had a significant CAPA backlog of various types, including but not limited to Technology, Product Development and Lab Operations. Many of these had been open for over 500 days. With a follow-up FDA audit anticipated, they needed urgent help to reduce the backlog and implement process improvements. 


Our team was engaged to provide Quality and CAPA Management and process expertise. We completed an assessment to catalog gaps with applicable regulations and standards, provided a remediation roadmap and then engaged a CAPA remediation team to complete the effort. Our team consisted of eight (8) experienced resources including an Engagement Manager, Project Manager, CAPA SME and CAPA Specialists that performed the remediation in eight (8) months. A structured communication plan was implemented to maintain transparency and focus on key issues and risks, including daily standup meetings, weekly leadership meetings, weekly status reports and dashboards, financial utilization reports and monthly engagement review meetings. 

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Our team successfully improved the client’s quality process, remediating 50 CAPA.  A subsequent Premarket Approval (PMA) inspection conducted by the FDA, resulted in zero 483 observations.  The FDA also reviewed the CAPA system that was part of the earlier 483 Observation review.  The CAPA system was found to be compliant.  This enabled the client to move its new technology to final PMA approval, which would then be made available to cancer patients on a global basis.   The client extended our contract to continue providing support after the initial terms.