No configuration
Any work item can become a CAPA: a customer complaint, an audit finding, a defect, an incident. Open the CAPA panel of that work item, or start one from the CAPA page and the app creates its work item. There are no issue types, workflows or fields to set up.
Six steps, one screen
- Problem: what happened, source, severity, product or process, owner and target date, proposed from the severity.
- Containment: what was done right away, or why nothing was needed.
- Root cause: guided five whys and cause categories. When the answer reads like “human error” or “training”, the app asks you to look once more at what the process allowed.
- Action plan: corrective and preventive actions with owners and due dates, and a measurable effectiveness criterion.
- Implementation: each action becomes a Jira work item linked to the CAPA. Its status comes back on its own.
- Effectiveness: the CAPA waits for its check date, then reminds the owner. Not effective? It goes back to the root cause, and the failed check stays on record.
Signatures bound to the content
A coordinator approves the plan and closes the CAPA with an electronic signature: name, date, meaning, a statement shown before signing, a personal signing password and a SHA-256 fingerprint of what was signed. Change the problem, the root cause or the plan after approval and the approval is withdrawn. The owner of a CAPA cannot approve or close it, unless you allow it.
Similar problems, before they come back
While you analyse the root cause, CAPAs on the same product or process, or with the same kind of cause, are listed so you can check whether similar nonconformities exist or could occur.
The register and the evidence file
- One register for the site: open, late, plans to approve, checks due, median age and the share of CAPAs effective the first time.
- Filters, search and CSV export for Excel, in English or French format.
- A PDF evidence file per CAPA: every step, the actions, the signatures, the work item’s attachments and the full audit trail.
- Searchable in Jira: capaStage, capaSeverity, capaDue, capaOverdue and capaNumber work in JQL and filters.
Clearlane CAPA helps teams meet the CAPA requirements of ISO 9001 §10.2, ISO 13485 §8.5.2–8.5.3 and 21 CFR 820. Your own validation still applies.
Permissions and data
The app runs on Atlassian Forge (Runs on Atlassian). You see a CAPA only if you can see its work item. Work items for new CAPAs and their actions are created with the permissions of the person who asks. CAPA records, the audit trail, settings, Atlassian account IDs and the names shown at signing are kept in Atlassian’s storage for your site; signing passwords only as a salted hash. Reminders are posted as comments on the CAPA’s work item. Nothing is sent to our servers or to anyone else.
- Where do I find it?
- In Jira’s apps menu for the register, and in the CAPA panel of any work item.
- Who can approve and close?
- Coordinators: the people and groups a Jira administrator names in the settings, usually the quality team. Jira administrators are always coordinators.
- Does it work in French?
- Yes. The app follows each person’s Jira language, in English or French, in light and dark themes.
Validation support: ISO 13485 8.5.2 mapping and OQ test script →