Sparta solutions integrate complaint handling with other QMS processes. As a result, you can centralize complaint intake, efficiently manage site-level investigations, and electronically process CAPAs.
For adverse event reporting, our electronic submission capabilities enable you to track, manage, audit, and directly report on submissions. Use a built-in decision tree to determine whether an Individual Case Safety Report (ICSR) is required or to automatically kick-off the process of collecting data and generating and transmitting the report within the required time frame. You can even relate ICSRs to complaint records, CAPAs, and change requests.