Release pod — change control + CSA
Composes change control, computer software assurance and pre-deployment verification into one governed pod, resolved by GAMP category and risk class.
Pod
- Process area
- Change control
- Owner
- Priya N.
- Version & status
- v2.2 · draft
- Effective date
- — not effective —
- Steps
- 13
- Paths
- 4
Composes change control, computer software assurance and pre-deployment verification into one governed pod, resolved by GAMP category and risk class.
Source SOPs
Clause traceability & gap report
| Clause | Requirement | Satisfied by |
|---|---|---|
| SOP-CC-003 §4.1 | Change request raising and classification | Change request intake & classification |
| SOP-CC-003 §4.3 | Impact analysis on requirements and validated state | Requirements delta analysis |
| SOP-CC-003 §6.5 | Pre-deployment verification | Pre-deployment verification |
| SOP-CC-003 §7.1 | Change closure and release authorisation | Change closure & release authorisation |
| SOP-QA-011 §5.2 | ALCOA+ control verification | Data integrity controls verification |
| SOP-QA-014 §5.3 | Periodic trend review | Periodic trend review |
| SOP-SUP-004 §3.2 | Leveraging supplier documentation | Supplier assessment leverage |
| SOP-VAL-001 §5.4 | Risk assessment and control mapping | Risk assessment (GxP & data integrity) |
| SOP-VAL-001 §5.4newer version | Data-integrity impact scored separately and mapped to an ALCOA+ control | Risk assessment (GxP & data integrity) |
| SOP-VAL-001 §6.1 | Configuration and design specification | Design specification review |
| SOP-VAL-001 §7.2 | Risk-based CSA test strategy | Validation test plan (CSA) |
| SOP-VAL-001 §8.1 | Unscripted assurance activities | Reduced UAT · A·B |
| SOP-VAL-001 §8.4 | Scripted qualification execution | Full IQ/OQ/PQ execution · C·D |
| SOP-VAL-001 §9.3 | Validation summary and evidence index | Evidence package assembly |
| SOP-VAL-001 §9.6newer version | Evidence retention statement in the validation summary | Not yet reflected in this pod |
Stats
Readiness: 17 blocking · 6 advisory.
Agents used
- SOP Decomposer v1.2approved
2 steps · Change request intake & classification, Design specification review
- Change Impact Analyzer v0.3in-review
1 step · Requirements delta analysis
- Compliance Checker v1.0approved
3 steps · Supplier assessment leverage, Data integrity controls verification, Periodic trend review
- Risk Classifier v2.0approved
1 step · Risk assessment (GxP & data integrity)
SOP-VAL-001 v6.0 → v6.3, §5.4 new — see Review SOP changes below.
- Test Case Generator v1.4approved
2 steps · Validation test plan (CSA), Full IQ/OQ/PQ execution · C·D
- Evidence Collector v1.1approved
1 step · Evidence package assembly
- • §5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to.
- • §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
§5.4 is new: risk assessment must score data-integrity impact separately from GxP impact and cite the ALCOA+ control it maps to. §7.2 (amended) — traceability rows must cite the requirement source document version.
Dispositioning these items and approving the draft clears this pod's SOP-change flag.
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 (4)
mandatory · profile.risk_class is set
advisory · vault "URS-001" is effective
mandatory · attested by Validation Lead
advisory · attested by System Owner
Exit conditions (3)
mandatory · attested by QA Approver
mandatory · release status = in-validation
advisory · attested by Validation Lead