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medical device consulting and remediation


The FDA found problems you didn't think were there.

A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.


Focused process improvement and increased bandwidth.

The client committed to an aggressive timeline to address the CAPA issues. R&Q assessed the situation and sourced an experienced team that worked closely with all levels of the operation - from daily meetings with senior management to leading CAPA-specific internal teams. Thorough problem identification and detailed root cause analysis were used to outline a plan to remediate legacy corrective actions and support ongoing corrective actions. Improved sampling plans, more complete root cause analysis, and CAPA management/tracking were identified as keys to future success. Modifications were made to the CAPA process, including CAPA project summary sheets, trace matrices, executive summaries, and process checklists. Additionally, R&Q experts trained and mentored client staff to ensure a sustainable solution.



case study CAPA medical device remediation consultingEfficiency and successful pre-FDA inspection audits.

The majority of the backlog of corrective actions were closed with measurable verifications of effectiveness. The remainder were brought to a manageable time frame for completion. R&Q achieved a time completion percentage of 96.4% for all tasks by the close of the project. This accomplishment was due in part from detailed process management, thorough documentation, and effective review.

Rigorous third party audits resulted in no observations related to the CAPA process.


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