Demo state
V0.2 · plant-command prototype

Seeded cross-application scenarios and session-local decisions only.

Native workflows
0 production workflows
Core enforcement
Preview only
Compliant signatures
Not available

Investigation dossier

Investigations & CAPA

Evidence, uncertainty and action lineage remain visible from detection through QA closure.

Lead investigationINV-DEMO-011

Calibration out-of-tolerance impact assessment

Potential product impact has not been assessed. This dossier organizes the seeded evidence without selecting a cause or closing the investigation.
OverdueHigh
Owner
QA Investigations
Due
20 Jul 2026
Stage
Evidence gathering
QA posture
Escalation required

Investigation selected · workflow state current.

Date
18 Jul 2026
Owner
QA Investigations
Evidence
Incomplete
Attention
Product-impact evidence missing
Dated record

Chronology

Event time is preserved independently from record-entry time; no separate entry timestamp is represented in this seeded scenario.

  1. Calibration exception referred

    Stage state: complete

    A demonstration Veritas signal was referred for quality assessment.
    Owner
    Quality Systems
    Evidence
    Seeded Veritas referral

  2. Potentially affected use held

    Stage state: complete

    The seeded scenario marks related use for review; no live hold was applied.
    Owner
    QA Operations
    Evidence
    Demonstration containment state

  3. Initial evidence scope opened

    Stage state: complete

    Equipment history and candidate affected records were requested.
    Owner
    QA Investigations
    Evidence
    Partial · source record unavailable

  4. Evidence gathering started

    Stage state: current

    Calibration history is represented while batch-impact evidence remains incomplete.
    Owner
    QA Investigations
    Evidence
    Incomplete

  5. Hypotheses remain open

    Stage state: blocked

    Evidence for and against remains explicit without selecting a cause.
    Owner
    Lead Investigator
    Evidence
    Conflicting and incomplete

  6. Action chain not established

    Stage state: blocked

    Corrective and preventive action records are not connected.
    Owner
    Not assigned
    Evidence
    CAPA-DEMO-005 unavailable

  7. Effectiveness review unavailable

    Stage state: upcoming

    No effectiveness workflow is implemented.
    Owner
    Not assigned
    Evidence
    Not applicable until CAPA exists

  8. Decision not available

    Stage state: upcoming

    No authoritative approval or closure can occur in this demonstration shell.
    Owner
    QA
    Evidence
    Decision basis incomplete

  9. Closure unavailable

    Stage state: upcoming

    Authoritative investigation closure is outside this demonstration shell.
    Owner
    QA
    Evidence
    Not ready
Evidence board

What is known, missing and unverified

Evidence readiness

Investigation decision evidence

Initiating context is represented, but manufacturing, analytical, procedural and interview evidence remain incomplete or unavailable.Incomplete
VeritasCalibration and validated-state evidenceSource record not connectedAwaiting source
INV-DEMO-011Seeded
Calibration out-of-tolerance referral and candidate affected-use scope.
Freshness / timestamp
Referred 16 Jul 2026
Integrity / provenance
Seeded Sentinel investigation · original Veritas record unavailable
Decision relevance
Defines the initiating condition and candidate impact interval.
Missing expected evidence
Original calibration record, equipment-use history and restriction assessment
PrismLaboratory impact evidenceAnalytical review remains incompleteIncomplete
QEV-DEMO-014Seeded
Assay-review quality event linked to the calibration concern.
Freshness / timestamp
Current to seeded state · 19 Jul 2026
Integrity / provenance
Read-only demonstration projection · provenance incomplete
Decision relevance
Required to assess whether reported analytical results may be affected.
Missing expected evidence
Reviewed source results, specification conclusion and laboratory approval context
FoundryManufacturing impact evidenceAffected batches and executed records unavailableNot connected
MFG-EVIDENCE-UNAVAILABLEUnavailable
Candidate manufacturing records and equipment-use relationships.
Freshness / timestamp
Not synchronized
Integrity / provenance
Expected Foundry source · no adapter connected
Decision relevance
Needed to bound product and process impact.
Missing expected evidence
Affected batch list, executed-record context and equipment-use confirmation

Inspection unavailable in this shell · unavailable

ImprintControlled proceduresRendered controlled source unavailableNot connected
DOC-DEMO-017Seeded
Environmental monitoring and calibration procedure relationship.
Freshness / timestamp
Not synchronized
Integrity / provenance
Seeded Imprint relationship · Core identity expected
Decision relevance
Needed to assess procedural requirements and potential procedural cause.
Missing expected evidence
Rendered effective revision, historical revision and Core relationship state
PersonnelInterview and role contextReviewer interview unavailableIncomplete
INT-DEMO-011-ASeeded
Instrument-owner interview represented in the seeded scenario.
Freshness / timestamp
18 Jul 2026 · event time only
Integrity / provenance
Seeded interview note · no authoritative record
Decision relevance
Supports equipment-use reconstruction.
Missing expected evidence
Reviewer interview, role assignment and source-backed interview record

Inspection unavailable in this shell · seeded

Root-cause governance

Open hypotheses

Evidence for and against remains explicit. No root cause is selected in this shell.
H1

Calibration drift affected reported results

Open hypothesis · demonstration

Evidence for

  • Out-of-tolerance condition is represented in the seeded event
  • Use during the candidate interval requires review

Evidence against or limiting

  • No connected source confirms affected measurements
  • Reviewed laboratory impact evidence is unavailable
H2

Administrative calibration-record error

Unresolved alternative · demonstration

Evidence for

  • Source record is not connected
  • Provenance fields remain incomplete

Evidence against or limiting

  • No verified correction or source audit trail is available
H3

Isolated equipment issue without product impact

Cannot conclude · demonstration

Evidence for

  • No product impact has been established in the shell

Evidence against or limiting

  • Candidate records and batches have not been fully assessed
Action lineage

CAPA chain

1Cause not selected
2Corrective action unavailable
3Preventive action unavailable
4Owner unassigned
5Due date not set
6Verification not started
7Effectiveness not available
Module scope and controlled ownership

Defined module areas

  • Investigations
  • Root-Cause Analysis
  • Immediate Corrections
  • Corrective Actions
  • Preventive Actions
  • CAPA Programmes
  • Effectiveness Checks
  • Commitments
  • Investigation Register
  • CAPA Register

Sentinel ownership

  • Investigation planning
  • Root-cause governance
  • CAPA approval
  • Effectiveness and QA closure

Authority boundary

Lifecycle controls are represented here as a defined shell. Approval, effectiveness verification and closure engines are not implemented.

Implementation stateDefined shell · non-authoritative
  • Workflow, persistence, electronic signatures and compliant audit trails are not implemented.