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 Control
Note
The due dates shown here are for the tasks to build & approve the change plan, and then approve the final execution. The overall due date that the change execution (inculding approval) must be completed is set manually and can be edited until the inital plan is approved, after which an extension request is required.
| 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 |
Deviation
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 Assessment
| Workflow Task | Due Date |
|---|---|
| Complete Impact Assessment | 5 days after task is sent |
Investigation
| Workflow Task | Due Date |
|---|---|
| Complete Investigation | Investigation due date |
Qualification
| Workflow Task | Due Date |
|---|---|
| Complete Qualification | 3 days before Qualification due date |
| Complete Qualification Review | Qualification 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 |