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* All init qms templates to be effective Signed-off-by: Anna Khismatullina <[email protected]> * Fix tracex files Signed-off-by: Anna Khismatullina <[email protected]> * Remove readme Signed-off-by: Anna Khismatullina <[email protected]> * Disable RBAC for tracex sandboxes Signed-off-by: Anna Khismatullina <[email protected]> --------- Signed-off-by: Anna Khismatullina <[email protected]>
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class, title, status, assignee
| class | title | status | assignee |
|---|---|---|---|
| tracker:class:Issue | Step 4 – Review and approve your document ✅ | Todo | New User |
TraceX includes electronic signatures that comply with all regulatory requirements, including 21 CFR Part 11 (FDA). These signatures ensure every step of the review and approval process is fully traceable and audit-ready.
Signatures are timestamped and will appear in the final exported PDF in the correct order:
Author → Reviewer → Approver
This guarantees traceability and regulatory compliance.
🔁 Review Phase
- Click “Send for review”
- Select reviewers (pre-filled from the team you assigned in Step 2 — you can adjust this list if needed).
If you’re the only user in this TraceX workspace for now, simply assign yourself to test the review phase. - Confirm submission by entering your electronic signature
- Click Send
Reviewers can add comments or suggestions and sign electronically to confirm review.
✅ Approval Phase
- Once reviewed, click “Send for approval”
- Select the approvers
- Confirm by signing
⚠️ Important Notes:
- All comments must be resolved before approval. If not, the “Send for approval” button will be disabled.
- If the document was edited by the author after the first review completion, it must be reviewed again before approval.
- Approvers can then sign, approve, or reject the document.
🎉 Congratulations! You’ve now completed Step 4 ✅
