An unresolved CAPA is the most common finding in FDA warning letters. Affinity QMS CAPA Management closes the loop — from event initiation through root cause analysis, action completion, and effectiveness verification — with built-in regulatory linkage for every framework you work under.
Initiate a CAPA From Any Quality Event
CAPA Management connects every quality event to a traceable corrective action — with the root cause analysis tools and effectiveness checks regulators expect.
CAPA Initiation From Any Event
Initiate a CAPA directly from an audit finding, customer complaint, nonconformance, deviation, or management review action item — in one click. The source event is automatically linked to the CAPA record, giving auditors a complete traceability chain from problem to resolution.
Root Cause Analysis Tools
Built-in 5-Why analysis and fishbone (Ishikawa) diagram templates guide investigators through structured root cause analysis. Each tool captures the investigation narrative, contributing factors, and verified root cause — producing the documentation regulators expect to see during CAPA review.
Action Plan Assignment and Due Date Tracking
Define discrete corrective and preventive actions with assigned owners, due dates, and completion criteria. Action items appear in each assignee's dashboard with automated reminders. Overdue actions are escalated to QA leadership — preventing CAPAs from sitting open for months before an audit.
Effectiveness Check Scheduling
Schedule effectiveness checks at defined intervals after action completion — 30, 60, or 90 days, or custom. The system automatically assigns the effectiveness check to the CAPA owner and surfaces it at the right time. CAPAs without verified effectiveness are flagged as open and cannot be formally closed.
CAPA Trending and Metrics Dashboard
Aggregate CAPA data across products, processes, suppliers, and departments to identify systemic quality issues before they become regulatory findings. The trending dashboard tracks open vs. closed CAPAs, average days to closure, recurrence rates, and CAPA sources — exactly the metrics management review requires.
Regulatory Authority Linkage
Tag each CAPA with the specific regulatory requirement that drove it — 21 CFR Part 820.100, ISO 13485 Clause 8.5.2, 21 CFR Part 211.192, or ISO 17025 Clause 8.7. This linkage produces a regulatory traceability matrix that auditors can review instantly — demonstrating a systematic, requirement-driven approach to corrective action.
FDA Audit-Ready CAPA Reports
Generate a complete CAPA report for any individual record or a full CAPA log for FDA inspection — with one click. Reports include initiation date, source event, root cause, action plan, completion dates, effectiveness check results, and closure status. No last-minute data compilation before an audit.
| Regulation / Standard | Clause / Section | CAPA Coverage |
|---|---|---|
| 21 CFR Part 820.100 | Corrective and Preventive Action | Full CAPA procedure: data analysis, investigation, action implementation, effectiveness verification |
| ISO 13485:2016 | Clause 8.5.2 — Corrective Action | Nonconformity identification, root cause analysis, action evaluation, record retention |
| 21 CFR Part 211.192 | Production Record Review | Investigation of batch failures and deviations with CAPA documentation |
| ISO/IEC 17025:2017 | Clause 8.7 — Corrective Actions | Nonconformity identification, root cause, corrective action implementation, effectiveness review |
| 21 CFR Part 111 | Subpart P — Records and Recordkeeping | Investigation records, corrective action documentation, periodic review |
| SQF Code | 2.5.3 — Corrective and Preventive Action | Root cause analysis, corrective action verification, recurrence prevention |
| FDA QMSR (2024) | 820.200 — Complaint Files | Complaint-driven CAPA initiation, investigation, and closure |
Included in Builder — Starting at
$799/mo
CAPA Management is included in the Builder tier ($799/mo) and all tiers above it. It is also included in the Compliance Suite ($1,499/mo) and Full Platform ($2,999/mo).
Book a demo and see how Affinity QMS CAPA Management closes the loop from event to resolution — with the regulatory traceability your auditors require.