Proactive Strategies to Eliminate Pharmacovigilance Audit Findings
Receiving major Pharmacovigilance Audit Findings during a US FDA or EMA inspection can lead to warning letters, financial penalties, and delays in Regulatory approvals. The key to a “zero-finding” audit is shifting from reactive fixes to a robust system of Quality management.
Common Areas for Major Findings
Inspectors often focus on the “Core Three” where Pharmacovigilance Audit Findings are most frequent:
Late ICSR Reporting: Failure to meet 15-day or 90-day windows.
Incomplete PSMF: A Pharmacovigilance System Master File that does not reflect current operations.
Lack of Oversight: Inadequate monitoring of vendors and partners.
Achieving Audit Readiness
To protect your global clinical trials, your team must adhere to the latest GVP modules. Our advisory services help you conduct mock audits to identify potential Pharmacovigilance Audit Findings before the regulators do.
Contact us for a Consulting & Advisory session to secure your audit readiness.