As a result of new product introduction, this medical device industry leader faced regulatory compliance challenges in the evolving marketplace and needed rapid response to various observations to ensure ongoing adherence to applicable regulatory bodies.
Deliver a robust solution to a CAPA concerning Technical Service operation gaps within the FDA regulatory regime.
To address the gaps among Technical Service and Complaint Handling units we conducted an end-to-end process assessment and instituted revisions to integrate disparate operations.
Through the assessment we identified opportunities and implemented process improvements to streamline response time and enhance management reporting capabilities.
Deep quality system and process expertise enabled identification of process gaps with minimum cycles.
Proactive fault testing of to future state solution expedited review and approval for final implementation.
Expertise in the CAPA process and execution enabled the team deliver an effective CAPA outcome.
On time completion of CAPA implementation in accordance with regulatory commitments.
Effective remediation of process gaps.
Process improvement resulting from end-to-end analysis and implementation or enhancements and reporting tools.