REMS audits are significantly different than”typical” site audits. Due to the complexity, requirements, and number of parties involved, REMS audits require an agile approach, which Compliance Architects® has shown continued success in delivering.
FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections are prioritized using a risk-based approach.