PL1819I - Reporting Adverse Events to the FDA Using Windchill & ThingWorx Navigate

Many manufacturers face challenges meeting FDA’s regulatory standards and being able to report on them efficiently. PDSVISION built an easy-to-use ThingWorx App that integrates with Windchill Regulatory Hub and other enterprise applications to do just this. Once a complaint is identified to be reported, the Windchill Reg Hub enables the user to access the eMDR ThingWorx App and pulls all the available information from Windchill. The user fills in the rest. The GUI manages 150 attributes to be shown including patient codes, health codes etc. Once reporting is completed and reviewed, the PDF and HL7 XML file is generated and can be pushed automatically to the FDA. The acknowledgments from the FDA are monitored and the system is automatically updated based on the FDA’s approval/rejection.