Clear My CAPA Backlog
What You Are Dealing With
Your CAPA backlog is growing, and the deviations are not getting resolved. Your team is managing day-to-day operations while trying to work through a list that keeps getting longer, and the investigations that are closing are not always identifying the real root causes. An aging CAPA backlog is one of the first things FDA investigators look for and repeated citations for ineffective CAPA are among the most damaging findings a company can receive. You need experienced resources who can work through the backlog, identify what is actually driving the deviations, and build a process that keeps going forward.
How We Approach It
We deploy experienced CAPA and deviation management resources to work through your backlog systematically. We conduct root cause analysis, complete impact assessments, implement corrective and preventive actions, and close investigations to a standard the FDA can scrutinize. We also assess your deviation management process and address any systemic gaps that are keeping the backlog from resolving on its own.
What We Have Done
An aseptic combination product manufacturer engaged MEDVACON to investigate deviations and non-conformances in their manufacturing suites. MEDVACON deployed a team of experts, met stringent FDA commitment timelines, resolved a highly technical issue with the combination product mechanical components, and remained on site to support ongoing investigations and closeouts.
A contract manufacturer engaged MEDVACON to address self-reported deviations and CAPAs across multiple operational areas. MEDVACON deployed a dedicated team with a lead assigned to each functional area. Collaboration between MEDVACON and client leadership identified shared root causes across areas of operation, enabling corrective and preventive actions that addressed both immediate impact and future recurrence.