ADVERSE EVENT REPORTING 3DEXPERIENCE
Is an ENOVIA application of the Dassault Systèmes platform. It automates the adverse event submission process by utilizing decision trees to help drive complaint management investigations and determine regulatory requirements around the world. It creates consistency and full traceability in managing adverse events by providing the ability to submit electronic reports directly to the FDA. All receipt acknowledgements from the FDA are lined up automatically with the corresponding submission and a PDF file will be auto generated.
It provides an AER management system linked to the lifecycle of the product. It manages AER in accordance with ISO13485 norm and FDA part 820 norm.
This application provides the following capabilities:
Govern Adverse Event when a customer reports events that could impact patient safety
Coordinate Activities with Global Stakeholders to evaluate and report event to global regulatory bodies
Connect & Share Information to global stake holders for investigation and resolution
Manage Product Safety Events with complex and varying requirements of global regulatory authorities