A group of pharmaceutical vendor has developed e-government system to report files. The FDA incident reporting system will allow pharmaceutical vendors to file electronics reports on the Food and Drug Administration, which will include loss, theft and other problems related with drug samples.
According to the Director and Government liaison of the PDMA Alliance, Steve Haynes, the industry group has developed this project without any support from FDA and government but FDA will give input to this project. There are two main vendors who developed the system, Synergistix, which makes sales force automation and customer relationship management software and CSSC, a consulting company specializing in regulatory compliance and validation. Vendors are also agreed on the standard elements, which will include incident reports.
