CAPA · Corrective Action · Preventive Action
CAPA software that links each action to its cause, owner and evidence.
Root cause, corrective and preventive actions and effectiveness checks sit with the source event, so owners can see what is open and what evidence exists before your team closes it.
Root-Cause Workflows
Corrective + Preventive Actions
Effectiveness Checks
Closure Lineage
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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.
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.
- 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 tied to the serial and DHR — with MDR / EU Vigilance clocks running from complaint intake.
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?
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.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
Close every open CAPA by next quarter.
Free trial. Real CAPA module.