The Product Complaint Management Module is designed to initiate, investigate, review and approve deviation records by completing tasks sequentially tasks such as raising deviations with deviation details, deviation assessment, investigation information, root cause analysis, risk assessment, raising CAPA, final review & approval of the record. Deviation module has built in report queries for generating useful reports which can be saved in pdf format.

The operation of the module is GMP compliant since the designated initiator, investigator, reviewer and approver can complete their tasks and sign off electronically in real time. All saved information needs to be changed under a strict record change management system. The record change activities can be audited through an Audit Trail reporting.