Emergency FDA Audit Support for VoCare

VoCare required RookQS’ expertise to rapidly prepare for the impending FDA inspection. The goal was to ensure compliance, address any existing issues, and minimize the risk of receiving 483s during the audit.

RookQS quickly mobilized to support VoCare , executing a comprehensive plan within the limited 7-day window:

• Internal Audit: Rook conducted a thorough internal audit of VoCare’s processes and documentation. During this audit, the RookQS consultant identified ten critical issues that needed attention. These findings were addressed and documented through Corrective and Preventive Actions (CAPAs), which were opened and managed promptly.
• CAPA Management: The RookQS team not only opened new CAPAs but also worked diligently to close out VoCare’s older, existing CAPAs, ensuring that all corrective actions were up-to-date and effectively documented.
• Management Review: A management review was held to discuss the audit findings, CAPA status, and overall preparedness for the FDA inspection. This review ensured that VoCare’s leadership was fully informed and aligned on the necessary steps.
• Document Preparation: RookQS collaborated with VoCare’s sales personnel to gather additional documentation required for the FDA inspection. This effort ensured that all necessary records were readily available for review.
• QMS Update: The RookQS consultant updated VoCare’s Quality Management System (QMS) to specify that a Rook consultant would act as the active management representative during the inspection. This update streamlined communication and ensured clear leadership during the audit process.
• Pre-Inspection Meeting: To further prepare the VoCare team, the RookQS consultant conducted a pre-inspection meeting. This session focused on explaining the FDA inspection process, advising on how to respond to questions, and setting expectations for the team.
• Leading the FDA Inspection: On the day of the inspection, the RookQS consultant took the lead, guiding the VoCare team through the process. The consultant managed interactions with the FDA, pulled necessary documents, and provided explanations, ensuring a smooth and controlled audit.

Thanks to RookQS’ swift and comprehensive support, VoCare successfully navigated the FDA inspection. The internal audit conducted by RookQS identified ten issues that were resolved prior to the inspection, which helped VoCare avoid multiple 483s.

VoCare’s collaboration with Rook Quality Systems not only minimized the impact of the FDA audit but also reinforced their commitment to maintaining high-quality standards and compliance in the competitive medical device market.