FDA QSIT Audit Preparation
FDA QSIT Audit Preparation and Training
An FDA audit can be intimidating however, with advanced planning and preparation critical areas of concern can be addressed in advance of the audit. We conduct audits of critical systems using the same techniques an FDA auditor will likely follow.
A.P. Lyon documents findings in the form of a confidential audit report. Our audit reports prioritize any necessary corrective actions. A.P. Lyon also can provide on-site support to ensure corrective actions are implemented in advance of the scheduled audit date. We provide audit preparedness training for all personnel within your facility, develop a facility walkthrough plan, identify the appropriate members of your audit team, and review and organize critical documentation that may be reviewed by the FDA Auditor during the audit. To learn more about how we can help you prepare for your next FDA Audit please contact us at [email protected] |