Adverse Event Reporting Software for Life Sciences

Comply with FDA Adverse Event Reporting Regulation

As part of the FDA’s adverse event reporting regulation, all manufacturers must send adverse drug reaction reports voluntarily. The FDA also requires that health care professionals and consumers send reports voluntarily through the MedWatch program. Clinical reviewers in the Center for Drug Evaluation Research (CDER) and the Center for Biologics Evaluation and Research (CBER) then evaluate all of these reports to detect safety signals and to monitor drug safety.

The entire adverse event reporting process can seem like a daunting task when manufacturers also must comply with other industry GxP best practices. MasterControl Customer Complaints™ is provides dynamic solutions to help regulated companies effectively and efficiently manage their adverse event reporting processes. MasterControl Customer Complaints features the following: