One of the most common issues identified during FDA inspections is failure to investigate discrepancies and inadequate investigations. We work with clients to install a best-in-class program to minimize the risk of regulatory observations in this area. While there is no “one size fits all” approach, there are many actions companies can take to improve their investigation systems.   Our program recommendations are tailored to each company and can include:

• Investigation workflow improvement and supporting procedures
• Root Cause Analysis and CAPA Training
• Oversight and Governance recommendations
• Investigator Mentoring
• Ways of Working (WOW) Principles