CAPA Manager Features

Corrective and preventive action management CAPA initiation and issue recording CAPA ownership and responsibilities Classification and prioritization Target and completion dates Corrective action assignments CAPA status tracking Follow-up and effectiveness verification Controlled CAPA closure Closure approval options Linked and related CAPA records Complete CAPA history

Customer complaint and product issue recording Investigation categorization and prioritization Structured investigation workflows Product and failure investigation records Root cause analysis and supporting evidence Investigation status, ownership and response tracking Investigation findings and response approval Corrective action and follow-up tracking Complete, traceable investigation history Customer-ready and audit-ready records

5 Whys root cause analysis Fishbone / 6M analysis 5W2H problem definition Is / Is Not analysis Cause and contributing-factor documentation Root cause identification and verification Investigation evidence and supporting records Traceable investigation history

Standard and customer-designed corrective action and investigation workflows Customer-defined workflow stages, tasks and approvals 8D, A3, DMAIC and PDCA workflows Audit Action and HSE workflows Task and action assignments Team leader responsibilities Target completion dates Workflow progression and status Configurable approval controls Up to three named closure approvers Any available approver option Closure requests and approvals Follow-up assignments

Assignment notifications Due-date reminders Overdue action notifications Escalation controls Follow-up reminders Approval notifications Closure requests Personal To-Do lists Status-based notifications

Configurable severity levels Issue classification and categorization Risk-based prioritization Organization-specific categories Functions and departments Configurable labels Fault codes and selection lists Risk and severity reporting

Complete CAPA history Corrective action history Approval and closure records Application audit trail Configuration change history User activity records Supporting evidence and attachments Electronic sign-off Traceable record changes Audit-ready records

Real-time CAPA KPIs Open, closed and overdue CAPA monitoring Mean time to closure Oldest open CAPA monitoring Pareto analysis Trend analysis Interactive charts Corrective action performance analysis Corrective action effectiveness analysis Complaint and investigation analysis Severity and risk analysis Department and function performance Management review reporting Excel data export PDF reports

Advanced CAPA search Multiple simultaneous filters Date-range filtering Pinned common filters Workflow and status filtering Severity and priority filtering Organization and function filtering Ownership and user filtering Configurable field filtering Drill-down from charts and KPIs Data export for further analysis

Customer workflow design and configuration Configurable fields and labels Mandatory field controls Configurable selection lists Fault codes and classifications Severity configuration Functions and departments Workflow availability controls Assignment rules Approval configuration User and role configuration Organization branding

Role-based access and permissions Secure user authentication Two-factor authentication Device recognition and approval Account and session security Restricted-access CAPA records Administrative access controls User access management Single Sign-On (SSO) — optional enterprise module

Secure API access Controlled API authentication Read-only CAPA data access Human-readable API data Configurable API access Integration with external business systems Reporting and BI integration API access controls 30-day API trial Optional subscription module