GxP procedures, training and CAPA in Confluence and Jira.
SOPs approved with electronic signatures bound to the content, read-and-understood training records for each version, deviations and CAPA in Jira, and a PDF evidence file for every record. Built on Atlassian Forge: your GxP records stay in your Atlassian site.
One app for each GxP record.
Each app works on its own, on your existing pages and work items. Start with the record your next inspection will look at.
- Clearlane Controlled Documents
Approve and review SOPs
Named approvers sign with their signing password; the SOP becomes effective and receives its next review date. Any later edit is flagged against the approved version.
- Clearlane Read & Understood
Train on the current version
Readers confirm the exact version they read, optionally answer comprehension questions and sign. A new version asks them again.
- Clearlane CAPA
Handle deviations and CAPA
Any Jira work item becomes a CAPA: root cause guided past “human error”, signed plan, actions in Jira, dated effectiveness check.
- Clearlane Tests
Execute validation protocols
Write IQ, OQ or PQ steps as test cases, run them in campaigns with step results and evidence, sign each run and the closure, export a PDF report.
Requirement, what the app does, your part.
The detail for each regulation, with OQ scripts, is on our validation support page.
| Requirement | What Clearlane does | Your part |
|---|---|---|
| Approved written procedures (EU GMP Chapter 4; 21 CFR 211.100) | Controlled Documents: approval by named approvers with e-signatures, effective date, periodic review, edits after approval flagged, obsolete documents kept with their history. | Write the SOPs, choose the approvers and the review period. |
| Training on current procedures (EU GMP Chapter 2; 21 CFR 211.25) | Read & Understood: confirmation per person and page version, optional questions and signature, new confirmation after each new version, PDF and CSV records. | Define who must read what, and keep evidence of practical training. |
| Deviations and CAPA (ICH Q10; 21 CFR 211.192) | CAPA: problem, containment, root cause, signed action plan, actions as Jira work items, effectiveness check, signed closure, PDF evidence file. | Investigate, decide the actions and judge their effectiveness. |
| Electronic signatures (21 CFR 11.50, 11.70, 11.200; Annex 11 §14) | Atlassian sign-in plus a personal signing password at each signature; name, date and time and meaning shown; SHA-256 fingerprint of what was signed; lock after repeated failures. | Write the signature policy and send the certification letter to the FDA. |
| Audit trail (21 CFR 11.10(e); Annex 11 §9) | Time-stamped entries with the person for every step, signature and confirmation. The apps offer no way to edit or delete them. | Review the audit trail as your procedures require. |
| Copies and printouts (21 CFR 11.10(b); Annex 11 §8) | A PDF evidence file per document, read request, CAPA and test campaign; CSV exports of registers. | Decide which file is the official copy and archive it. |
| Security and access (21 CFR 11.10(d), (g); Annex 11 §12) | Atlassian sign-in and permissions; each app checks the person’s rights on the server; nothing leaves your Atlassian site. | Manage accounts, groups and permissions; remove leavers promptly. |
| Suppliers and validation (Annex 11 §3, §4) | Supplier assessment form, OQ test scripts and requirement mappings on our validation support page. | Validate for your intended use, based on your risk assessment. |
| Change management (Annex 11 §10) | Release notes on the Atlassian Marketplace. Updates are installed automatically by Atlassian; those that need new permissions wait for your administrator’s approval. | Assess each release and revalidate what it touches. |
| Storage and archiving (Annex 11 §7, §17) | Records kept in Atlassian’s Forge storage for your site, following your site’s data residency. | Set retention periods and archive the PDF evidence files, also before uninstalling an app. |
References to EU GMP Annex 11 are to the 2011 version (a revision is under consultation). References are given to help you find the relevant requirement, not as a claim of compliance.
A PDF for every record your inspector asks for.
SOP evidence file
Signatures with name, date, meaning and fingerprint, revisions, read confirmations and the audit trail.
Training record
Who confirmed which version, when, how many tries, signature IDs and the audit trail.
CAPA evidence file
The six steps, signatures, attachments and the audit trail. Nothing is deleted.
Protocol report
Each step result and comment, signatures with fingerprints, and requirement coverage.
Questions, answered.
- Can we use Clearlane apps in a GxP environment?
- They are built for it: signatures bound to the content, audit trails, PDF evidence files and validation support. Like any computerised system, you validate them for your intended use; our OQ test scripts and requirement mappings are a starting point.
- Do the apps replace an eQMS?
- For teams that already work in Confluence and Jira, they cover SOPs, training records, deviations and CAPA, and protocol execution. They do not cover batch records, laboratory data or supplier management.
- Where are our GxP records stored?
- In your Atlassian site, in Atlassian’s Forge storage, following your site’s data residency. Clearlane has no servers and never receives your content. See our trust center.
- Can we start with one department?
- Yes. Controlled Documents and Read & Understood are free for up to 10 users: a quality team can start with SOP approvals and training records, then extend to more people. CAPA starts at $10 a month.
Start with your SOPs.
Controlled Documents is free for up to 10 users. No setup, nothing to install outside your Atlassian site.