CAPAs tracked in spreadsheets.
Effectiveness checks forgotten.
Every corrective action tracked from root cause to verified effectiveness.
Every corrective action tracked from root cause to verified effectiveness.
The problem
CAPAs tracked in Excel with no workflow, no reminders, no escalation
Corrective actions sit open for months with no visibility into status
Jump to corrective action without proper investigation or root cause identification
CAPAs closed without verifying the fix actually worked - repeat findings
The solution
Structured steps: identification, investigation, root cause, action plan, verification
Built-in support for 5-Why, fishbone, and risk assessment methodologies
Time-based reminders and escalation when CAPAs age beyond defined thresholds
Scheduled verification tasks to confirm corrective actions resolved the issue
Connects to your quality events - complaints, audit findings, deviations - and drives them to resolution
Log quality events from any source: complaints, audits, deviations, NCRs
Structured root cause analysis with supporting evidence and documentation
Assign corrective and preventive actions with owners and due dates
Scheduled checks confirm the CAPA resolved the root cause
Average CAPA closure time
Overdue CAPAs without escalation
Effectiveness verification rate
CAPA status visibility
Needs structured CAPA processes that satisfy ISO 13485 clause 8.5.2/8.5.3
Need clear tasks, deadlines, and guidance through the investigation process
Need to verify CAPA processes are effective and properly documented
Structured CAPA management with root cause analysis and effectiveness verification - configured in 21 days.