CAPA pod
Corrective and preventive action: problem statement, root cause, action plan and effectiveness check.
Draftv1.0av1.0 effective
Pod
- Process area
- CAPA
- Owner
- Priya N.
- Version & status
- v1.0a · draft
- Effective date
- — not effective —
- Steps
- 3
- Paths
- 2
Corrective and preventive action: problem statement, root cause, action plan and effectiveness check.
Source SOPs
- SOP-DEV-002 Deviation Managementcited v1.0 v6.0 effective in vaultVault
Clause traceability & gap report
| Clause | Requirement | Satisfied by |
|---|---|---|
| SOP-DEV-002 §3.1 | Problem statement | CAPA intake & problem statement |
| SOP-DEV-002 §4.2 | Root cause determination | Root cause analysis |
| SOP-DEV-002 §6.1 | Effectiveness verification | Effectiveness check |
Stats
Steps
3
Agents
2
Paths
2
Estimated effort
6 h
Auto gates
2
Notify gates
2
Review gates
1
E-sign gates
1
Readiness: 0 blocking · 0 advisory.
Agents used
- SOP Decomposer v1.2approved
1 step · CAPA intake & problem statement
- Compliance Checker v1.0approved
1 step · Effectiveness check
Governance defaults
- Draft versions are the only editable ones.
- Author ≠ approver — the Process Owner approves.
- Part 11 e-signature required to make a version effective.
- Effective versions are immutable; new work opens a new draft.
- Agent version propagation is verified, never re-approved.
- Every version entry is hash-chained into the audit trail.
Pod conditions
Entry conditions are checked before a run may start. Exit conditions are checked before a run may be marked complete. Mandatory conditions stop the action; advisory ones warn and may be switched off per product.
Entry conditions (0)
No entry conditions — a run of this pod is never held at entry.
Exit conditions (0)
No exit conditions — a run of this pod is never held at exit.