Pharmacovigilance Audit


At SJ Pharma Consulting, LLC in Mendham, NJ, we have organized and carried out more than 100 safety audits and assessments since our establishment in 2001. Our team has created a 50-page audit checklist that covers strategy, quality processes, organizational structure, SOPs, and systems and PV risk management.

Within each category of our checklist, multiple audit questions reference the applicable law, guidance, or regulation and the best practices that other companies currently use. With this approach, we see any compliance gaps present within the organization, which will be treated as a priority for remediation.
 
Auditing

Why Are Audits Important?

A drug safety compliance audit verifies if a company's pharmacovigilance operations conform to applicable laws around the world. Apart from providing a comparison to the best practices of similar companies, the audit confirms if your organization is following regulations and guidance.

When you employ our auditing services, you will gain valuable insight that can help you make positive and progressive changes in your organization. Contact us today or read our report, Preparing for a Safety Inspection, to learn more about pharmacovigilance audits and PV risk management.