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TRUST SIGNALS
Key highlights of the appMedical device CAPA in Jira: take each nonconformity, deviation or complaint through 5 Whys, a signed plan and effectiveness check

Root causes that pass an audit
Guided five whys and cause categories. A warning appears when the answer reads like human error or training, and similar CAPAs show up while you analyse.
Signed, and bound to the content
Plan approval and closure use electronic signatures with a personal signing password. Change the plan after it was signed and the approval is withdrawn.
Ask Rovo where a CAPA stands
Stage, owner, due date, root cause and action plan, straight from your CAPA register. The Clearlane CAPA agent reads with your own Jira permissions and never changes anything.
Supporting media
More details
CAPA on any Jira work item, no setup: nonconformities (NCR), deviations, complaints, audit findings.
Containment, then guided 5 Whys, with a warning when a root cause reads like human error.
Plan and closure are e-signed, bound to their content. Actions become linked Jira work items; the effectiveness check reminds its owner.
A register of late CAPAs, CSV export, JQL fields, a PDF evidence file. Helps meet ISO 13485, ISO 9001 (10.2) and FDA QMSR (21 CFR 820).
English, French, German. Runs on Atlassian: your data stays in your Atlassian site.
Pairs with Clearlane Controlled Documents and Risk Register. OQ scripts: clearlaneapps.com/validation. Maxime Ragionieri answers in writing within two business days.
Auf Deutsch: CAPA (Korrektur- und Vorbeugungsmaßnahmen) in Jira für Nichtkonformitäten, Abweichungen, Reklamationen und Auditfeststellungen: 5 × Warum, signierter Maßnahmenplan, Wirksamkeitsprüfung, PDF-Nachweisakte; hilft, ISO 13485 und ISO 9001 zu erfüllen.
Resources
App documentation
Comprehensive set of documentation from the partner on how this app works
Privacy and Security
Privacy and security questionnaire has been filled by the partner
Privacy policy
Atlassian's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner.
Partner privacy policySecurity program
This app is not part of the Marketplace Bug Bounty program.
Integration permissions
Clearlane CAPA – Corrective Actions & Nonconformities integrates with your Atlassian app
Version information
Version 3.14.0•for Jira Cloud
- Release date
- Nov 2nd 2026
- Summary
- Signed evidence file kept on the Jira work item; full PDF export
- Details
New and optional: the CAPA evidence PDF can be attached to the Jira work item at each signature (plan approval, closure), by the signer, so the record stays with the work item even without the app. Turned on by a Jira administrator (off by default, on record).
New: attach the evidence file on request, and a full PDF export with every earlier approval and the fingerprints.
Signed records, fingerprints and approval circuits are unchanged.
Enjoying Clearlane CAPA? A short review helps other teams find it.
Validation impact: none- Payment model
- Paid via Atlassian
- License type
- Commercial