Regulatory Reporting for Adverse Events

Staff Writer | Business Intelligence Solutions | March 26, 2012

Regulatory reporting allows life science manufacturers to identify adverse events before they become critical issues, facilitating proactive risk avoidance and product regulatory and safety adherence, both now and as regulations continue to evolve.

Regulatory Complaint-handling Requirements

All complaints must be consistently handled in a regulatory compliant manner, according to a written complaint procedure of FDA. Failures to handle complaints in a uniform and timely manner can be cited as a nonconformance. In fact, the FDA often begins inspections this way because these records allow the agency to quickly assess whether a company‟s quality system and CAPA plans are adequate.