VAL
e-sign: active
Pods

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.

Draftv2.2v2.1 effective

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.

  • SOP-CC-003 Change Controlcited v4.2Vault
  • SOP-VAL-001 Computer System Validationcited v6.0 v6.3 effective in vaultVault
  • SOP-QA-011 Data Integrity & ALCOA+cited v2.1 v3.0 effective in vaultVault
  • SOP-SUP-004 Supplier Assessment & Qualificationcited v1.0Vault
ClauseRequirementSatisfied by
SOP-CC-003 §4.1Change request raising and classificationChange request intake & classification
SOP-CC-003 §4.3Impact analysis on requirements and validated stateRequirements delta analysis
SOP-CC-003 §6.5Pre-deployment verificationPre-deployment verification
SOP-CC-003 §7.1Change closure and release authorisationChange closure & release authorisation
SOP-QA-011 §5.2ALCOA+ control verificationData integrity controls verification
SOP-QA-014 §5.3Periodic trend reviewPeriodic trend review
SOP-SUP-004 §3.2Leveraging supplier documentationSupplier assessment leverage
SOP-VAL-001 §5.4Risk assessment and control mappingRisk assessment (GxP & data integrity)
SOP-VAL-001 §5.4newer versionData-integrity impact scored separately and mapped to an ALCOA+ controlRisk assessment (GxP & data integrity)
SOP-VAL-001 §6.1Configuration and design specificationDesign specification review
SOP-VAL-001 §7.2Risk-based CSA test strategyValidation test plan (CSA)
SOP-VAL-001 §8.1Unscripted assurance activitiesReduced UAT · A·B
SOP-VAL-001 §8.4Scripted qualification executionFull IQ/OQ/PQ execution · C·D
SOP-VAL-001 §9.3Validation summary and evidence indexEvidence package assembly
SOP-VAL-001 §9.6newer versionEvidence retention statement in the validation summaryNot yet reflected in this pod

Stats

Steps
13
Agents
6
Paths
4
Estimated effort
70 h
Auto gates
9
Notify gates
4
Review gates
10
E-sign gates
3

Readiness: 17 blocking · 6 advisory.

  • 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.
Design specification review
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §6.1→SOP-VAL-001 §6.1 · SOP-VAL-001 v6.3 delta reviewed

§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.

Risk assessment (GxP & data integrity)
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §5.4→SOP-VAL-001 §5.4 · SOP-VAL-001 v6.3 delta reviewed

§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.

Validation test plan (CSA)
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §7.2→SOP-VAL-001 §7.2 · SOP-VAL-001 v6.3 delta reviewed

§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.

Reduced UAT · A·B
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §8.1→SOP-VAL-001 §8.1 · SOP-VAL-001 v6.3 delta reviewed

§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.

Full IQ/OQ/PQ execution · C·D
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §8.4→SOP-VAL-001 §8.4 · SOP-VAL-001 v6.3 delta reviewed

§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.

Evidence package assembly
AI-proposed · from SOP deltaawaiting dispositionGovernance · SOP clauses
SOP-VAL-001 §9.3→SOP-VAL-001 §9.3 · SOP-VAL-001 v6.3 delta reviewed

§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.