Audit
Audit due date defaults to 30 days from Audit end date.
| Workflow Task | Due Date |
|---|---|
| Prepare Audit Report | 3 days before External Audit due date |
| Approve Audit Report | External Audit due date |
| Issue Audit Report (External Audits only) | 3 days after task is sent |
Audit Program
| Workflow Task | Due Date |
|---|---|
| Approve Audit Program | 3 days after task is sent |
CAPA Action
| Workflow Task | Due Date |
|---|---|
| Complete CAPA Implementation | 3 days before CAPA Action due date |
| Approve CAPA Implementation | CAPA Action due date |
Change Action
| Workflow Task | Due Date |
|---|---|
| Complete Change Action Implementation | 3 days before Change Action due date |
| Approve Change Action Implementation | Change Action due date |
Change Controls
| Workflow Task | Due Date |
|---|---|
| Complete Change Plan | 10 days after task is sent |
| Approve Change Plan | 3 days after task is sent |
| QA Approve Change Plan | 3 days after task is sent |
| QA Final Approval | 3 days after task is sent |
Deviations
Deviation due date defaults to 30 days after awareness date for internal deviations and 45 days for external deviations.
| Workflow Task | Due Date |
|---|---|
| Complete Assessment | 5 days after task is sent |
| Quality Approval | 3 days after task is sent |
| Complete Investigation & CAPA Plan | 3 days before Deviation due date |
| Complete Final Approval | Deviation due date |
Effectiveness Check
| Workflow Task | Due Date |
|---|---|
| Complete Effectiveness Check | 3 days before Effectiveness Check due date |
| Approve Effectiveness Check | Effectiveness Check due date |
Finding
Finding due date defaults to 30 days from the Audit Report issuance.
| Workflow Task | Due Date |
|---|---|
| Complete Response | 3 days before External Finding due date |
| Complete Response Approval | External Finding due date |
Impact Assessments
| Workflow Task | Due Date |
|---|---|
| Complete Impact Assessment | 5 days after task is sent |
Investigation
| Workflow Task | Due Date |
|---|---|
| Complete Investigation | Investigation due date |
Standalone CAPA
| Workflow Task | Due Date |
|---|---|
| Complete CAPA Plan | 10 days after task is sent |
| QA Approve CAPA Plan | 3 days after task is sent |