FDA Clinical Audit Tool
Streamline Your Audits with Expertise from Former FDA Investigators
The Clinical Pharmaceutical Audit Tool is a comprehensive and professionally designed resource tailored for companies navigating pre-clinical through Phase 3 pharmaceutical stages. Created with input from former FDA Investigators, this tool provides a strategic framework to ensure audit readiness, identify critical compliance areas, and address common deficiencies found during regulatory inspections. With clear guidance, actionable insights, and practical examples, the audit tool empowers you to confidently manage compliance and focus on what matters most—ensuring quality and regulatory success.
The Clinical Pharmaceutical Audit Tool, created by FD-AID LLC, is a comprehensive resource designed for pharmaceutical companies in pre-clinical through Phase 3 stages. Developed with insights from former FDA Investigators, this tool highlights critical compliance areas, identifies common deficiencies, and provides actionable guidance to streamline audits and enhance regulatory readiness.
Delivered as a locked Word document, the tool is user-friendly, customizable, and integrates links to key FDA, ICH, and USP guidelines for quick reference. Designed for quality and regulatory teams, it helps reduce audit preparation time, ensures focus on critical areas, and builds confidence during inspections.