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Hybrid GraphRAG Wiki & Architecture

Physical Asset & Metrology Management

Overview (/assets)

The Physical Asset Management module governs 202 analytical instruments, manufacturing skids, cleanroom utilities, and facility hardware units. It enforces strict separation between regulated GxP assets and Good Engineering Practice (GEP) non-regulated assets.

Physical Asset Management Interface

Master Asset Registry Architecture

The 202 seeded assets are divided into two distinct regulatory tiers:

1. GxP Regulated Assets (101 Units)

  • Governed under 21 CFR Part 11, EU Annex 11, and ISO 13485:2016.
  • Encompasses:
    • Analytical Laboratory Instruments: HPLC/UPLC, GC-MS, ICP-MS, TOC Analyzers, UV-Vis Spectrophotometers.
    • Upstream/Downstream Bioprocessing: 50L to 2000L Single-Use Bioreactors, Tangential Flow Filtration (TFF) Skids, Chromatography Skids.
    • Critical Utilities: GMP Steam Autoclaves, Depyrogenation Ovens, Grade A/B Cleanroom Air Handling Units, -80°C Ultra-Low Freezers.
  • Mandatory NIST-traceable calibration schedules, grace period enforcement (+/- 10%), and automated Out-of-Tolerance (OOT) deviation creation.

2. Non-GxP Enterprise & Facility Assets (101 Units)

  • Governed under ISO 9001 and Good Engineering Practice (GEP).
  • Encompasses:
    • Commercial Office Facilities: Rooftop HVAC units, cafeteria chillers, data center in-row CRAC units.
    • General IT Hardware: Developer laptops, meeting room AV consoles, office printers.
    • Warehouse Logistics: Electric forklifts, pallet stretch wrappers, loading dock levelers.
  • Maintains standard maintenance work orders without triggering Part 11 electronic signature requirements.

Key Capabilities

Users can filter the 202 assets by:

  • Criticality: Direct GxP Impact, Indirect Impact, Non-GxP.
  • Operational Status: In Service, Under Maintenance, Calibration Overdue, Decommissioned.
  • Facility Location: Quality Control Lab, Biologics Pilot Plant, Cleanroom Suite 3, Central Utility Plant.
  • Software Linkages: Filter by computerized systems controlling the hardware (for example, find all instruments attached to Empower CDS).

2. NIST Calibration Governance

  • Displays last calibration date, certificate number, calibration interval, and next due date.
  • Highlights overdue calibrations in high-contrast status badges.
  • Overdue calibrations on GxP assets automatically trigger lockouts and alert the AssetManagementAgent and CmmsMaintenanceAgent.

3. Hardware-to-Software Graph Linkages

In the Memgraph knowledge graph, physical assets are explicitly mapped to computerized systems:

(:Asset {tag: "EQ-HPLC-001"})-[:CONTROLLED_BY_SOFTWARE]->(:System {code: "CDS"})
(:Asset {tag: "EQ-BIO-002"})-[:CONTROLLED_BY_SOFTWARE]->(:System {code: "MES"})

When a software change control is initiated in the QMS, the system automatically traverses these edges to identify all impacted physical instruments requiring re-qualification.

Operational Use Case Scenario Workflows

Physical Asset Management enforces strict segregation between regulated manufacturing/laboratory equipment and standard facility hardware.

Scenario 1: Analytical HPLC Calibration Drift Out-of-Tolerance (OOT) Triage

sequenceDiagram
    autonumber
    actor Met as QC Metrologist
    participant UI as Physical Assets Console (/assets)
    participant AssetAgent as AssetManagementAgent
    participant CmmsAgent as CmmsMaintenanceAgent
    participant PG as PostgreSQL System of Record
    participant CDS as Empower CDS Interface


    Met->>UI: Filters by "Calibration Overdue" & selects EQ-HPLC-001
    UI->>AssetAgent: Audits calibration interval and tolerance limits
    AssetAgent->>PG: Sets asset status to "Under Maintenance / Lockout"
    AssetAgent->>CDS: Emits instrument lock signal preventing sample injection
    AssetAgent->>CmmsAgent: Issues urgent work order WO-CAL-2026-11
    CmmsAgent-->>UI: Dispatches NIST-traceable recalibration protocol
    Met-->>UI: Uploads calibration certificate and restores "In Service" state

1. Context & Operational Pre-conditions

  • Regulated Asset: Waters Alliance HPLC System EQ-HPLC-001.
  • Governing Standards: 21 CFR § 211.68, 21 CFR § 211.160(b)(4), and ISO 17025.
  • Condition: The instrument calibration interval elapsed without a certified re-calibration record on file.

2. Detection & Immediate Automated Containment

  1. The QC Metrologist opens /assets and observes EQ-HPLC-001 flagged with a high-contrast status badge: Calibration Overdue.
  2. The AssetManagementAgent triggers automated containment:
    • Updates asset operational state in PostgreSQL to Under Maintenance / Lockout.
    • Sends an active lockout signal to the Empower Chromatography Data System (CDS), preventing laboratory analysts from launching analytical sample sequences on the uncalibrated instrument.
    • Logs an Out-of-Tolerance (OOT) event in the QMS.

3. Maintenance Work Order & NIST Calibration Execution

  1. The CmmsMaintenanceAgent automatically generates Work Order WO-CAL-2026-11.
  2. Certified external metrology technicians perform multipoint flow rate, wavelength accuracy, and pressure transducer calibration using NIST-traceable reference standards.
  3. The Metrologist uploads Calibration Certificate NIST-CAL-99421 directly through the asset modal dialog.

4. Re-Qualification & Return to Service

  1. The Metrologist executes standard system suitability testing (SST) per SOP-QC-022.
  2. The asset status transitions to In Service.
  3. The system clears the Empower CDS software lockout, and logs a 21 CFR Part 11 audit trail event confirming return to commercial testing status.

Scenario 2: New Bioreactor Skid Registration & MES Knowledge Graph Binding

1. Context & Operational Pre-conditions

  • Facility Expansion: Installation of a new 500L Single-Use Bioreactor EQ-BIO-005 in Biologics Pilot Suite 2.
  • Automation Dependency: The skid will be controlled by Emerson DeltaV Manufacturing Execution System (MES).

2. Asset Registration Workflow

  1. Automation Engineer navigates to /assets and clicks Register Asset.
  2. Fills out the registration form:
    • Asset Tag: EQ-BIO-005
    • Classification: Direct GxP Impact (Biopharmaceutical production skid)
    • Governing Standard: 21 CFR § 211.65, 21 CFR § 211.67, and ISO 13485:7.5.1
    • Location: Biologics Pilot Plant - Suite 2
    • Calibration Interval: 180 Days
    • Controlling Software: Selects MES (DeltaV)

3. Knowledge Graph Topology Synthesis

Upon registration, the backend updates the Memgraph database:

MERGE (a:Asset {tag: "EQ-BIO-005", name: "500L Single-Use Bioreactor", criticality: "Direct GxP"})
MERGE (s:System {code: "MES"})
MERGE (a)-[:CONTROLLED_BY_SOFTWARE]->(s)
MERGE (a)-[:LOCATED_IN]->(loc:Location {name: "Biologics Pilot Plant Suite 2"})

The asset is immediately linked to the system-level validation requirements of DeltaV MES.

4. Qualification Protocol Dispatch

  1. The /validation module automatically receives a notification of the newly registered GxP asset.
  2. The RequirementsTraceabilityAgent drafts an Installation Qualification protocol (IQ-BIO-005) verifying electrical utility connections, sanitary clamp fittings, and DeltaV OPC-UA communication addresses.

Scenario 3: Non-GxP Facility Chiller Preventative Maintenance Workflow

1. Context & Operational Pre-conditions

  • Equipment: Commercial Rooftop Chiller EQ-CHILL-012 servicing administrative office spaces.
  • Classification: Non-GxP Enterprise / Facility Asset.
  • Governing Standard: ISO 9001 and Good Engineering Practice (GEP).

2. Maintenance Execution

  1. Facilities Technician accesses /assets, filtering by Criticality: Non-GxP Enterprise.
  2. Selects EQ-CHILL-012 to review scheduled semi-annual maintenance checklist:
    • Compressor refrigerant pressure check
    • Intake fan belt tension inspection
    • Air filter matrix replacement
  3. The technician checks off completed tasks and enters technician employee ID.

3. Regulatory Segregation & Governance

  • Because the asset is flagged Non-GxP, the system bypasses 21 CFR Part 11 electronic signature mandates and QA secondary verification.
  • Work order completion updates the CMMS ledger and schedules the next service interval for 180 days out without generating compliance deviations.