CAPA software that closes CAPAs instead of just opening them.
Root-cause analysis (5-whys, fishbone), corrective and preventive actions, effectiveness checks scheduled at closure, and full lineage back to the deviation, audit finding, complaint, or change that opened it. The one CAPA system that an FDA investigator will actually read end-to-end.
You're shopping for CAPA software because half your open CAPAs are over a year old.
Effectiveness checks are 'eventually' and 'we'll get to it'
Root-cause is a sentence in a free-text field
CAPAs don't link back to the deviation or finding that opened them
Closure happens by emailing the QA director a screenshot
Last audit cited CAPA closure rate or effectiveness check rate
There are 47 open CAPAs and nobody knows which are real
CAPA lifecycle, modeled and enforced.
Root-cause workflows
5-whys, fishbone (Ishikawa), Pareto. Structured fields, not free-text — auditors can read the analysis.
Corrective + preventive actions
Action items with owner, due date, and verification. The system won't let you close without them.
Effectiveness checks
Scheduled at closure with a target date. Overdue effectiveness checks are visible to QA leadership. No exceptions.
Closure lineage
Every CAPA links back to the deviation, audit finding, complaint, supplier issue, or change that opened it. One screen, full story.
Hash-chained record
Every event on every CAPA, append-only, exportable as a Part-11-grade audit-trail extract.
Signed closure
QA closure under bound e-signature. No 'I'll close it later' — the record won't accept it.
CAPA software pays back in the next audit.
- Open CAPAs older than 12 months drop to zero in a quarter
- Effectiveness check completion rate hits 100%
- Root-cause quality goes from 'because the operator was tired' to verifiable
- Audit findings on CAPA closure rate stop happening
- QA team capacity opens up — chasing closes is no longer a job
Mapped to every CAPA requirement an auditor cites.
21 CFR Part 820.100
QSR CAPA requirements modeled directly — root-cause, action, effectiveness, communication, documentation.
ICH Q10 / Q9
Pharmaceutical quality system CAPA — risk-based escalation, management notification, change-control linkage.
ISO 13485:2016
Design controls, DHF/DHR/DMR, risk management hooks (14971), CAPA, post-market — same engine, device-grade controls.
CAPA software, answered.
What is CAPA software?
CAPA (corrective and preventive action) software is the system of record for investigating quality events, performing root-cause analysis, taking corrective and preventive actions, verifying effectiveness, and closing the loop. It replaces Excel and the shared mailbox for one of the most-cited audit areas in regulated industry.
How are effectiveness checks enforced?
When a CAPA closes, an effectiveness check is automatically scheduled with a target date (typically 30, 60, or 90 days out). The check has an owner, criteria, and verification fields. Overdue effectiveness checks surface to QA leadership. The CAPA isn't truly closed until the effectiveness check is verified.
Does V5 link CAPAs to deviations, audits, and complaints?
Yes — every CAPA carries its source linkage. Audit finding, deviation, customer complaint, supplier issue, change control — all visible on one screen.
Is the audit trail Part-11 grade?
Yes — hash-chained, append-only, exportable. Inspectors can verify nothing was edited or backdated.
How does this compare to MasterControl CAPA or Veeva Vault CAPA?
Same scope, with documents, audits, training, eBR, and MES on the same platform — and flat platform pricing.
Close every open CAPA by next quarter.
Free trial. Real CAPA module. No sales gate.