K2ShareHouse module dedicated to CAPA (Corrective and Preventive Action) is designed to meet the regulation requirements defined by ICH (International Conference of Harmonization). More than 50% of FDA observations during inspections are actually related to CAPA system, that is very difficult to be managed without an appropriate software solution.

K2ShareHouse CAPA module facilitates your company compliance, returning at the meantime a lot of benefits in term of process efficiency. Our solution is powerful but simple, avoiding you put any extra effort to manage your CAPA system: your main business scope should be drug production, not CAPA! However, you should manage this.

The CAPA module includes the folllowing main features:

• Identification and communication of a“Quality Issue” (OOS, OOT, Deviation, Complaint etc.)

• Management of documentation associated to the Quality Issue

• Root cause analysis

  Investigation Management and Report

• Risk Assessment tool

• Definition of Preventive/Corrective Actions

• Monitoring and Follow-up of Preventive/Corrective Actions

• Reporting tools

• Management of Communication and alerts/reminder

• Approval workflows

The CAPA module also includes all required features to comply with Electrnic Record and Signature regulation (21 CRF part 11).

Contact us for more information or to request for a demo.