Periodic audit pod
Annual periodic review of validated systems: scope, evidence sampling and the continued-validation statement.
In Reviewv1.4v1.3 effective
Pod
- Process area
- Periodic review
- Owner
- Dr. Elena V.
- Version & status
- v1.4 · in-review
- Effective date
- — not effective —
- Steps
- 3
- Paths
- 2
Annual periodic review of validated systems: scope, evidence sampling and the continued-validation statement.
Source SOPs
- SOP-VAL-001 Computer System Validationcited v6.0 v6.3 effective in vaultVault
Clause traceability & gap report
| Clause | Requirement | Satisfied by |
|---|---|---|
| SOP-VAL-001 §11.1 | Periodic review scope and frequency | Periodic review scope |
| SOP-VAL-001 §11.3 | Evidence sampling | Evidence sampling |
| SOP-VAL-001 §11.6 | Periodic review report and conclusion | Periodic review report |
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 · 2 advisory.
Agents used
- SOP Decomposer v1.2approved
1 step · Periodic review scope
- Evidence Collector v1.1approved
1 step · Evidence sampling
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. Effective versions are read-only — open a draft to edit.
Entry conditions (2)
- A completed release-validation run exists for this product.
mandatory · a completed run of pod-release exists
- The Process Owner confirms the review window is the correct one.
advisory · attested by Process Owner
Exit conditions (1)
- The Quality Head signs the continued-validation statement.
mandatory · attested by Quality Head