Organizations are realizing the benefits of managing their Complaint Handling process within their PLM system.
Complaint Handlers have indicated that having both the detailed complaint information along with the in-depth view of the product record within a single application, significantly improves their ability and efficiency in making decisions on complaints, including if they are reportable to the regulatory bodies.
The electronic Medical Reporting solution from J-Squared Technologies further extends these efficiencies by collecting the necessary reporting details within the PLM solution and then publishing to the Health Level Seven (HL7) Individual Case Safety Report (ICSR). This published HL7 report can then be integrated to the FDA/ESG Gateway, which is an agency wide entry point for all electronic submissions. Once authenticated and validated the submission is routed to the Center for Devices and Radiological Health (CDRH) eMDR database.