Your QMS records in Jira and Confluence, in one place for your auditor.
Medical device, pharma and biotech teams already write their procedures in Confluence and track their work in Jira. Then the audit comes, and the evidence sits in spreadsheets, inboxes and exported PDFs. Clearlane for Quality keeps it where the work happens: signed SOPs, training records for each version, CAPA closed with proof, IEC 62304 test evidence and a risk register, in five apps that share one supplier file.
Runs on Atlassian Your data stays in your Atlassian site.
The evidence exists. It is just scattered.
Most quality teams on Atlassian are not missing records. They are missing the link between the record, the version and the signature.
SOPs approved by email
An approval in an inbox does not show who signed which version, or whether the page was edited afterwards.
Training in a spreadsheet
The list says people read the SOP. It does not say which version, or that they read it again after the last change.
CAPA and tests outside Jira
The fix is a Jira work item, but the root cause, the effectiveness check and the test evidence live somewhere else, and the link breaks at audit time.
Five apps, one quality system inside Atlassian.
Each app works on its own, on your existing pages and work items. Start with the record your next audit will check, then add the next one: same rules, same signatures, same supplier file.
- Clearlane Controlled Documents
Approve and review SOPs
Named approvers sign with their signing password, the document becomes effective and gets its next review date. Any later edit is flagged against the approved version.
- Clearlane Read & Understood
Train on the current version
People confirm the exact version they read, can answer comprehension questions and sign. A new version asks them to confirm again.
- Clearlane CAPA
Close CAPA with proof
Any Jira work item becomes a CAPA: guided root cause analysis that looks beyond “human error”, signed plan, actions as Jira work items, dated effectiveness check, signed closure.
- Clearlane Tests
Show what is really tested
Test cases and step-by-step runs in Jira, requirement coverage, a bug in one click, signed campaigns and a PDF report for IEC 62304 evidence.
- Clearlane Risk Register
Review risks regularly
A risk register per project: 5 × 5 risk map before and after treatment, actions as linked work items, signed periodic reviews and an ISO 14971 template.
Every app starts with a free trial on the Marketplace.
Everything your validation file needs from the supplier.
Ready before you ask. One assessment covers every app, because every app is built, hosted and released the same way.
Supplier assessment, filled in
Company, hosting, security, release process, support and validation materials, on two pages.
OQ test scripts
Ready-to-run operational qualification scripts, step by step, with expected results.
Requirement mappings
21 CFR Part 11, ISO 13485 and IEC 62304: what each app does, and what stays your part.
Security questionnaire answers
Hosting, data residency, access, signatures, vulnerabilities and incidents. Every app is built natively on Atlassian Forge (Runs on Atlassian), with no Connect components. At least 30 days’ notice in the release notes before any functional change that affects signed records, signatures or approval workflows; security fixes ship without delay and are noted in the release notes afterwards.
Useful on their own, even if you never install anything.
Written for the people who will run the process. Share them freely.
21 CFR Part 11 checklist
The key requirements for electronic records and signatures in Confluence: what to check, what the app provides and what stays your part, with a box to tick.
CAPA, a written walkthrough
One nonconformity followed from detection to signed closure, step by step, with screenshots of the real app.
Ask Rovo, get the app’s own answer.
Each of the five apps adds a Rovo agent: ask in plain words which CAPAs are overdue, where a document stands, who has not read a page yet, which tests failed or which risks are overdue for review. It answers from the app’s records, only with what you are allowed to see, and it only reads: it never changes anything.
It works where Rovo is turned on for your Atlassian site; Clearlane adds no AI model of its own.
One person reads and answers, in writing.
Maxime Ragionieri, founder of Clearlane, answers quality and validation teams himself: [email protected].
Send your supplier questionnaire, your intended use or the process you want to see. You get a written answer within two business days and, if it helps, a written walkthrough of that process, screen by screen, before you install anything.
Everything stays in writing, so your quality and purchasing files keep a trace of every answer.
Questions, answered.
- Are the apps validated or certified?
- No software arrives validated for your use: you validate it for your intended use. We give you the starting point: requirement mappings, OQ test scripts and a filled-in supplier assessment.
- Where are our quality records stored?
- In your Atlassian site, in Atlassian’s Forge storage, following your site’s data residency. Clearlane runs no servers, and the apps never send your content to Clearlane. See our trust center.
- Can we start with one app?
- Yes. Each app is its own Marketplace app with a free trial, and the others are covered by the same supplier assessment. Controlled Documents, Read & Understood, Tests and Risk Register are free for up to 10 users.
- How is it billed?
- By Atlassian, on your usual Atlassian invoice, monthly or yearly. The Pricing tab of each Marketplace listing shows the price for your team size.
- Can we see a process before installing?
- Yes. Each app page has a short demo video, and we can send you a written walkthrough of your own process, screen by screen.
Start with the record your next audit will check.
Free trial on the Atlassian Marketplace. Nothing to install outside your Atlassian site.