Quality Issues & CAPA Management - K2C Solutions

K2C solution dedicated to Quality Issues and CAPA (Corrective and Preventive Action) is designed to meet the regulation requirements defined by ICH (International Conference of Harmonization) and local regulations. Many observations during FDA or other agency inspections are related to CAPA system, that is very hard to be managed without an appropriate software solution.

K2C CAPA solution 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.

The CAPA module includes the following 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
Management of Investigation and related Report
Risk Assessment
Definition of CAPA Plan as a set of Preventive/Corrective Actions
Monitoring and Follow-up of Preventive/Corrective Actions
Dashboards, charts and statistics
Management of Communication and alerts/reminder
Approval workflows including Electronic Signature compliant with 21 CFR part 11

K2C Deviation and CAPA Management solution also includes all required features to comply with Electronic Record and Signature regulation (21 CRF part 11).