Adverse Event Reporting

MasterControl provides GxP process management software solutions to help regulated FDA companies comply with adverse event reporting regulation.

Adverse event reporting is based on ICH, FDA and other regulatory standards. Conforming to requirements established by GCP for adverse event reporting is much simpler when document control and process technology enablers are implemented in GCP environments.

The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, including safeguarding of adverse event reporting processes. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better GxP process management.