Pharmacovigilance Audit Success

Client Challenge
A pharmaceutical company was preparing for a pharmacovigilance audit by a regulatory authority. The audit would assess the company’s compliance with global pharmacovigilance regulations, including EU GVP (Good Pharmacovigilance Practices), FDA 21 CFR Part 11, and ICH E2E guidelines. The client was concerned about potential gaps in their pharmacovigilance system and needed expert support to ensure a successful audit outcome.

PVigi’s Solution
PVigi provided comprehensive support to prepare the client for the pharmacovigilance audit. Our approach included:

Pre-Audit Assessment

Gap Remediation

Documentation Preparation

Organized and prepared all necessary documentation for the audit, including:

Pharmacovigilance system master file (PSMF).

Risk management plans (RMPs).

Individual Case Safety Reports (ICSRs) and aggregate reports.

Audit trails and validation records.

Training and Mock Audits

On-Site Audit Support

Outcome
Successful Audit Outcome: The client passed the pharmacovigilance audit with no critical findings, ensuring continued market authorization for their products.

Improved Compliance: The client’s pharmacovigilance system was fully aligned with global regulations, reducing the risk of future non-compliance.

Enhanced Processes: Updated SOPs and workflows improved the efficiency and effectiveness of the client’s pharmacovigilance operations.

Regulatory Trust: The successful audit strengthened the client’s relationship with regulatory authorities, paving the way for smoother future interactions.

Client Confidence: The client gained confidence in their pharmacovigilance system and PVigi’s expertise, leading to a long-term partnership.