Pharmaceutical Manufacturing Line

Hazard & Risk Analysis (HRA) — ISO/IEC/IEEE 15289 — Report | IEC 61508 Phase 3
Generated 2026-03-27 — UHT Journal / universalhex.org

Hazard Register

SIL-Allocated Requirements

Safety Case Structure (GSN)

Goal Structuring Notation per GSN Community Standard v3. Top goal decomposes into hazard mitigation sub-goals, each supported by SIL-allocated requirements and verification evidence.

flowchart TD
  G0["<b>G0: Top Goal</b><br/>Pharmaceutical Manufacturing Line is acceptably safe"]
  S0{"<b>S0: Strategy</b><br/>Argument by hazard<br/>mitigation per IEC 61508"}
  G0 --> S0
  G1["<b>G1: H-001</b><br/>Airborne potent compound exposure from containment breach du...<br/>SIL 2"]
  S0 --> G1
  Sn0_0(["<b>IFC-022</b>"])
  G1 --> Sn0_0
  Sn0_1(["<b>SUB-REQ-040</b>"])
  G1 --> Sn0_1
  Sn0_2(["<b>SUB-REQ-042</b>"])
  G1 --> Sn0_2
  G2["<b>G2: H-002</b><br/>Cross-contamination of drug product with residual API from p...<br/>SIL 3"]
  S0 --> G2
  Sn1_0(["<b>SUB-REQ-050</b>"])
  G2 --> Sn1_0
  Sn1_1(["<b>SUB-REQ-051</b>"])
  G2 --> Sn1_1
  Sn1_2(["<b>SYS-REQ-020</b>"])
  G2 --> Sn1_2
  G3["<b>G3: H-003</b><br/>Dust explosion from fine pharmaceutical powder exceeding LEL...<br/>SIL 2"]
  S0 --> G3
  Sn2_0(["<b>SUB-REQ-040</b>"])
  G3 --> Sn2_0
  Sn2_1(["<b>SUB-REQ-053</b>"])
  G3 --> Sn2_1
  Sn2_2(["<b>SYS-REQ-029</b>"])
  G3 --> Sn2_2
  G4["<b>G4: H-004</b><br/>Out-of-specification product released due to PAT system fail...<br/>SIL 3"]
  S0 --> G4
  Sn3_0(["<b>IFC-REQ-001</b>"])
  G4 --> Sn3_0
  Sn3_1(["<b>IFC-REQ-003</b>"])
  G4 --> Sn3_1
  Sn3_2(["<b>SUB-REQ-003</b>"])
  G4 --> Sn3_2
  G5["<b>G5: H-005</b><br/>Loss of cleanroom environmental control (pressure cascade, t...<br/>SIL 1"]
  S0 --> G5
  Sn4_0(["<b>VER-REQ-045</b>"])
  G5 --> Sn4_0
  G6["<b>G6: H-006</b><br/>Electronic batch record data integrity failure — corrupted, ...<br/>SIL 2"]
  S0 --> G6
  Sn5_0(["<b>SUB-REQ-008</b>"])
  G6 --> Sn5_0
  Sn5_1(["<b>SUB-REQ-009</b>"])
  G6 --> Sn5_1
  Sn5_2(["<b>SUB-REQ-010</b>"])
  G6 --> Sn5_2
  G7["<b>G7: H-007</b><br/>Operator mechanical entrapment in tablet press turret, compr...<br/>SIL 2"]
  S0 --> G7
  Sn6_0(["<b>SUB-REQ-011</b>"])
  G7 --> Sn6_0
  Sn6_1(["<b>SUB-REQ-039</b>"])
  G7 --> Sn6_1
  Sn6_2(["<b>SUB-REQ-046</b>"])
  G7 --> Sn6_2

GSN Export (YAML)

Machine-readable safety case structure. Import into GSN tools (Astah GSN, ASCE, NOR-STA).

# GSN Safety Case — Pharmaceutical Manufacturing Line
# Generated 2026-03-27
# Goal Structuring Notation (GSN) per GSN Community Standard v3

goals:
  G0:
    text: "Pharmaceutical Manufacturing Line is acceptably safe"
    type: top-goal
    supported_by: [S0]

strategies:
  S0:
    text: "Argument by hazard mitigation per IEC 61508"
    supported_by: [G1, G2, G3, G4, G5, G6, G7]

  G1:
    text: "H-001: Airborne potent compound exposure from containment breach during tablet compression, material transfer, or cleaning"
    sil: 2
    safe_state: "all material transfer stopped, containment isolators sealed, HVAC switched to full exhaust with HEPA filtration, operators evacuate to clean zone"
    supported_by: [IFC-022, SUB-REQ-040, SUB-REQ-042, SUB-REQ-048, SUB-REQ-065, VER-REQ-044, VER-REQ-054, VER-REQ-056, VER-REQ-065, VER-REQ-071, VER-REQ-075, VER-REQ-091, VER-REQ-101]
    evidence: [VER-111, VER-REQ-069, VER-REQ-071, VER-REQ-075, VER-109, REQ-SEPHARMAMANUFACTURING-018, SUB-REQ-023, SYS-REQ-013, SUB-REQ-045, SUB-REQ-042, SUB-REQ-048, REQ-SEPHARMAMANUFACTURING-017, SUB-REQ-061]
  G2:
    text: "H-002: Cross-contamination of drug product with residual API from previous campaign"
    sil: 3
    safe_state: "batch quarantined, line locked out pending full cleaning validation with HPLC confirmation below acceptance limit"
    supported_by: [SUB-REQ-050, SUB-REQ-051, SYS-REQ-020, VER-REQ-046, VER-REQ-077, VER-REQ-078, VER-REQ-086, VER-REQ-099]
    evidence: [VER-REQ-077, VER-REQ-078, VER-REQ-086, REQ-SEPHARMAMANUFACTURING-021, SUB-REQ-050, SUB-REQ-051, SYS-REQ-020, SUB-REQ-059]
  G3:
    text: "H-003: Dust explosion from fine pharmaceutical powder exceeding LEL in enclosed equipment with ignition source present"
    sil: 2
    safe_state: "equipment de-energised, nitrogen inerting activated, explosion vents open, dust extraction at maximum flow"
    supported_by: [SUB-REQ-040, SUB-REQ-053, SYS-REQ-029, VER-REQ-044, VER-REQ-080]
    evidence: [VER-REQ-069, VER-REQ-080, REQ-SEPHARMAMANUFACTURING-018, SUB-REQ-053]
  G4:
    text: "H-004: Out-of-specification product released due to PAT system failure or calibration drift"
    sil: 3
    safe_state: "batch quarantined for offline laboratory testing, real-time release suspended, production continues only with traditional QC release until PAT recalibrated and verified"
    supported_by: [IFC-REQ-001, IFC-REQ-003, SUB-REQ-003, SUB-REQ-004, SUB-REQ-005, SUB-REQ-058, SYS-REQ-018, VER-REQ-040, VER-REQ-041, VER-REQ-047, VER-REQ-061, VER-REQ-062, VER-REQ-067, VER-REQ-084, VER-REQ-090, VER-REQ-098]
    evidence: [VER-REQ-004, VER-REQ-009, VER-REQ-004, VER-REQ-005, VER-REQ-005, VER-REQ-001, VER-REQ-001, VER-REQ-002, VER-REQ-002, VER-REQ-003, VER-REQ-003, VER-REQ-098, VER-REQ-061, SUB-REQ-022, SUB-REQ-025, SUB-REQ-031, SYS-REQ-018, SUB-REQ-036, SUB-REQ-047, SUB-REQ-057, REQ-SEPHARMAMANUFACTURING-016, SUB-REQ-058]
  G5:
    text: "H-005: Loss of cleanroom environmental control (pressure cascade, temperature, humidity) causing microbial contamination or product degradation"
    sil: 1
    safe_state: "product exposure points sealed, HVAC alarm initiates automatic damper closure, exposed product quarantined, production halted until environmental conditions restored and verified"
    supported_by: [VER-REQ-045]
    evidence: [REQ-SEPHARMAMANUFACTURING-019]
  G6:
    text: "H-006: Electronic batch record data integrity failure — corrupted, incomplete, or falsified manufacturing records"
    sil: 2
    safe_state: "system switches to verified paper backup records, electronic system locked for forensic investigation, affected batches quarantined pending data integrity review"
    supported_by: [SUB-REQ-008, SUB-REQ-009, SUB-REQ-010, SUB-REQ-014, SUB-REQ-015, VER-REQ-038, VER-REQ-094]
    evidence: [VER-REQ-006, VER-REQ-006, VER-REQ-019, VER-REQ-019, VER-REQ-008, VER-REQ-008, VER-REQ-012, VER-REQ-038, VER-REQ-012, VER-REQ-012, SUB-REQ-014, REQ-SEPHARMAMANUFACTURING-015, REQ-SEPHARMAMANUFACTURING-015]
  G7:
    text: "H-007: Operator mechanical entrapment in tablet press turret, compression rollers, or granulator impeller"
    sil: 2
    safe_state: "all rotating equipment de-energised and mechanically braked, safety interlocks prevent restart until guards closed and confirmed, LOTO applied for maintenance access"
    supported_by: [SUB-REQ-011, SUB-REQ-039, SUB-REQ-046, VER-REQ-037, VER-REQ-044, VER-REQ-065, VER-REQ-066, VER-REQ-092]
    evidence: [VER-REQ-007, VER-REQ-007, VER-REQ-068, VER-REQ-066, SUB-REQ-012, REQ-SEPHARMAMANUFACTURING-018, SUB-REQ-045, SUB-REQ-046, REQ-SEPHARMAMANUFACTURING-024]

solutions:
  IFC-022:
    text: "The interface between the Containment Safety PLC and the HVAC Air Handling Unit SHALL use a hardwired 24 VDC discrete si"
    verification: Test
    sil: 2
  IFC-REQ-001:
    text: "The interface between the Process Analytical Technology Subsystem and the Manufacturing Execution System SHALL transmit "
    verification: Test
    sil: 3
  IFC-REQ-003:
    text: "The Manufacturing Execution System SHALL transmit diversion acknowledgment and operating mode commands to the Process An"
    verification: Test
    sil: 3
  SUB-REQ-001:
    text: "The PAT Subsystem NIR spectrometer SHALL acquire diffuse reflectance spectra (900-1700 nm, minimum 256 wavelength channe"
    verification: Test
    sil: 3
  SUB-REQ-002:
    text: "The PAT Subsystem Raman spectrometer SHALL acquire spectra (200-3200 cm-1, spectral resolution 4 cm-1) at 30-second inte"
    verification: Test
    sil: 3
  SUB-REQ-003:
    text: "The PAT Subsystem SHALL evaluate all CQA chemometric models (content uniformity PLS, blend homogeneity PCA, particle siz"
    verification: Test
    sil: 3
  SUB-REQ-004:
    text: "When a CQA limit exceedance is detected, the PAT Subsystem SHALL actuate the batch diversion valve to the reject positio"
    verification: Test
    sil: 3
  SUB-REQ-005:
    text: "The PAT Subsystem SHALL perform continuous sensor self-diagnostics evaluating signal-to-noise ratio, wavelength calibrat"
    verification: Test
    sil: 3
  SUB-REQ-008:
    text: "The Manufacturing Execution System SHALL enforce 21 CFR Part 11 compliant electronic signatures on all EBR critical entr"
    verification: Test
    sil: 2
  SUB-REQ-009:
    text: "The Manufacturing Execution System SHALL maintain a tamper-evident audit trail recording every EBR creation, modificatio"
    verification: Test
    sil: 2
  SUB-REQ-010:
    text: "The Manufacturing Execution System SHALL compute and store a SHA-256 cryptographic hash on every EBR write operation, ma"
    verification: Test
    sil: 2
  SUB-REQ-011:
    text: "The Manufacturing Execution System SHALL maintain a real-time lockout registry mapping each equipment unit to its lockou"
    verification: Test
    sil: 2
  SUB-REQ-014:
    text: "The Manufacturing Execution System SHALL perform automated EBR database backups at intervals not exceeding 15 minutes, w"
    verification: Test
    sil: 2
  SUB-REQ-015:
    text: "When a data integrity failure is detected (hash chain discontinuity or backup verification failure), the Manufacturing E"
    verification: Demonstration
    sil: 2
  SUB-REQ-016:
    text: "When the High Shear Granulator wet mass torque profile or integrated NIR wet-mass spectrum reaches the validated endpoin"
    verification: Test
    sil: 2
  SUB-REQ-017:
    text: "The Fluid Bed Dryer SHALL reduce granule loss-on-drying (LOD) to the target value (product-specific, typically 1.0-3.0% "
    verification: Test
    sil: 2
  SUB-REQ-018:
    text: "The Fluid Bed Dryer SHALL maintain inlet air temperature within plus or minus 2 degrees Celsius of the MES recipe setpoi"
    verification: Test
    sil: 2
  SUB-REQ-019:
    text: "The Granule Sizing Mill SHALL reduce post-drying granule agglomerates such that the resulting sized granule D90 is less "
    verification: Test
    sil: 2
  SUB-REQ-020:
    text: "The IBC Blender SHALL achieve a blend uniformity of API content RSD less than or equal to 5.0% across the blend mass, as"
    verification: Test
    sil: 2
  SUB-REQ-021:
    text: "The Granulation and Blending Subsystem SHALL record the mass of each material charge and transfer at each process step, "
    verification: Test
    sil: 2
  SUB-REQ-022:
    text: "When the PAT NIR blend-endpoint monitoring is unavailable (sensor fault or communication loss), the Granulation and Blen"
    verification: Test
    sil: 2
  SUB-REQ-023:
    text: "While processing OEB 3 or higher potency compounds (OEL less than 10 micrograms per cubic metre), the Granulation and Bl"
    verification: Test
    sil: 2
  SUB-REQ-025:
    text: "The Rotary Tablet Press SHALL monitor upper punch compression force at each station on every rotation and reject tablets"
    verification: Test
    sil: 2
  SUB-REQ-031:
    text: "The PAT Subsystem CQA model evaluation and diversion actuation function SHALL be implemented on a hardware architecture "
    verification: Test
    sil: 3
  SUB-REQ-036:
    text: "The Process Analytical Technology Subsystem SHALL operate from a dedicated 230V AC 50Hz UPS-backed power supply providin"
    verification: Test
    sil: 3
  SUB-REQ-037:
    text: "The PAT Subsystem SHALL provide a manual CQA override interface accessible to the QC Analyst role, enabling a qualified "
    verification: Test
    sil: 3
  SUB-REQ-038:
    text: "The Manufacturing Execution System SHALL implement a watchdog timer that monitors core EBR processing heartbeat at 30-se"
    verification: Test
    sil: 2
  SUB-REQ-039:
    text: "The Tablet Compression Subsystem SHALL operate from a dedicated 400V AC 50Hz 3-phase power supply with a soft-starter pr"
    verification: Test
    sil: 2
  SUB-REQ-040:
    text: "The Granulation and Blending Subsystem SHALL operate from 400V AC 50Hz 3-phase power supply for the High Shear Granulato"
    verification: Test
    sil: 2
  SUB-REQ-042:
    text: "The Containment and Environmental Control Subsystem SHALL operate from a UPS-backed 230V AC power supply providing minim"
    verification: Test
    sil: 2
  SUB-REQ-046:
    text: "While in Maintenance mode, the system SHALL prevent equipment power-on by any means (HMI, PLC, remote command) for any e"
    verification: Test
    sil: 2
  SUB-REQ-047:
    text: "While in Degraded Production mode, the system SHALL quarantine all completed batches in MES quarantine status within 60 "
    verification: Test
    sil: 3
  SUB-REQ-048:
    text: "The Containment and Environmental Control Subsystem SHALL detect airborne API concentration above the OEL action limit ("
    verification: Test
    sil: 2
  SUB-REQ-049:
    text: "The Containment and Environmental Control Subsystem SHALL perform continuous air monitoring at each sampling point at a "
    verification: Test
    sil: 2
  SUB-REQ-050:
    text: "When the Cleaning Validation results for any swab location exceed the acceptance limit, the Manufacturing Execution Syst"
    verification: Test
    sil: 3
  SUB-REQ-051:
    text: "The Material Handling and Dispensing Subsystem SHALL enforce a two-person independent check for all API dispensing opera"
    verification: Test
    sil: 3
  SUB-REQ-052:
    text: "The Tablet Compression Subsystem SHALL perform a real-time metal detection check on the tablet stream at the press outpu"
    verification: Test
    sil: 2
  SUB-REQ-053:
    text: "The Granulation and Blending Subsystem SHALL monitor for dust explosion risk by measuring dust concentration at the FBD "
    verification: Test
    sil: 2
  SUB-REQ-054:
    text: "The Packaging and Serialisation Subsystem SHALL perform 100 percent vision inspection of each blister cavity for correct"
    verification: Test
    sil: 2
  SUB-REQ-057:
    text: "The Process Analytical Technology Subsystem SHALL maintain a rolling 30-day archive of all CQA model inputs, model outpu"
    verification: Test
    sil: 3
  SUB-REQ-058:
    text: "The Process Analytical Technology Subsystem SHALL provide a qualified user override mechanism that enables a QC Analyst "
    verification: Test
    sil: 3
  SUB-REQ-061:
    text: "The Manufacturing Execution System SHALL implement a hardware watchdog timer with a 30-second timeout that triggers a co"
    verification: Test
    sil: 2
  SUB-REQ-062:
    text: "The Containment and Environmental Control Subsystem SHALL install differential pressure transmitters at each controlled "
    verification: Inspection
    sil: 1
  SUB-REQ-063:
    text: "The HVAC Air Handling Unit SHALL maintain cleanroom supply air conditions within the range 20±2°C (temperature), 45±5% R"
    verification: Test
    sil: 2
  SUB-REQ-064:
    text: "The HVAC Air Handling Unit SHALL maintain a minimum differential pressure of +10 Pa between adjacent cleanroom grades an"
    verification: Test
    sil: 2
  SUB-REQ-065:
    text: "When the Containment Safety PLC detects a containment integrity failure (isolator pressure above -5 Pa for more than 5 s"
    verification: Test
    sil: 2
  SYS-REQ-002:
    text: "The system SHALL generate, execute, and archive electronic batch records (EBRs) with electronic signatures, access contr"
    verification: Test
    sil: 2
  SYS-REQ-016:
    text: "The system SHALL implement machine safety controls compliant with EN ISO 13849-1 (Safety of machinery — Safety-related p"
    verification: Test
    sil: 2
  SYS-REQ-018:
    text: "The system SHALL enforce PAT qualification procedures per FDA Process Analytical Technology Guidance (2004) and ICH Q8, "
    verification: Test
    sil: 3
  SYS-REQ-019:
    text: "The system SHALL generate an automatic deviation record in the EBR whenever any critical process parameter exceeds its v"
    verification: Test
    sil: 2
  SYS-REQ-020:
    text: "The system SHALL maintain a cleaning status registry for every product-contact equipment item, updated in real-time as c"
    verification: Test
    sil: 3
  SYS-REQ-027:
    text: "The Process Control System SHALL provide a hardware-enforced manual override capability at each equipment control panel "
    verification: Test
    sil: 2
  SYS-REQ-029:
    text: "The system SHALL implement dust explosion prevention measures compliant with ATEX Directive 2014/34/EU (Equipment and pr"
    verification: Test
    sil: 2
  VER-109:
    text: "Verify SUB-REQ-065: In a qualified test environment, simulate containment integrity failure by reducing isolator pressur"
    verification: Test
    sil: 2
  VER-111:
    text: "Verify IFC-022: Interrupt the 24 VDC hardwired signal bus between the Containment Safety PLC and the HVAC Air Handling U"
    verification: Test
    sil: 2
  VER-112:
    text: "Verify end-to-end containment response chain: introduce a simulated OEB 4 API dust release at the Potent Compound Isolat"
    verification: Test
    sil: 2
  VER-114:
    text: "Verify SUB-REQ-064: Disturb cleanroom pressure by propping a pass-through door open for 10 seconds during operational co"
    verification: Test
    sil: 2
  VER-REQ-037:
    text: "The verification activity for SUB-REQ-012 SHALL apply a maintenance lock to a designated piece of equipment via the MES "
    verification: Test
    sil: 2
  VER-REQ-038:
    text: "The verification activity for SUB-REQ-014 SHALL run the MES EBR database for a simulated 4-hour production period, confi"
    verification: Test
    sil: 2
  VER-REQ-039:
    text: "The verification activity for SUB-REQ-016 SHALL execute three consecutive High Shear Granulator runs using a validated p"
    verification: Test
    sil: 2
  VER-REQ-040:
    text: "The verification activity for SUB-REQ-022 SHALL disable the PAT NIR blend-endpoint monitor (simulate sensor fault) mid-b"
    verification: Test
    sil: 2
  VER-REQ-041:
    text: "The verification activity for SUB-REQ-025 SHALL run the Rotary Tablet Press at nominal speed with instrumented punches a"
    verification: Test
    sil: 2
  VER-REQ-044:
    text: "The verification activity for SYS-REQ-005 SHALL actuate the emergency stop function via operator E-stop button, automati"
    verification: Test
    sil: 2
  VER-REQ-045:
    text: "The verification activity for SYS-REQ-006 SHALL inject simulated parameter exceedances (differential pressure exceedance"
    verification: Test
    sil: 1
  VER-REQ-046:
    text: "The verification activity for SYS-REQ-008 SHALL execute one complete product changeover sequence (cytotoxic to standard "
    verification: Test
    sil: 3
  VER-REQ-047:
    text: "The verification activity for SUB-REQ-031 SHALL deploy a primary DAC Workstation and a configured hot-standby instance i"
    verification: Test
    sil: 3
  VER-REQ-050:
    text: "The verification activity for SUB-REQ-017 SHALL execute three drying cycles with placebo granules at the product-specifi"
    verification: Test
    sil: 2
  VER-REQ-051:
    text: "The verification activity for SUB-REQ-018 SHALL install calibrated thermocouples at FBD inlet air duct and product chamb"
    verification: Test
    sil: 2
  VER-REQ-052:
    text: "The verification activity for SUB-REQ-019 SHALL run a post-drying milling cycle on a representative placebo granule batc"
    verification: Test
    sil: 2
  VER-REQ-053:
    text: "The verification activity for SUB-REQ-021 SHALL execute a complete granulation and blending campaign in the MES test env"
    verification: Test
    sil: 2
  VER-REQ-054:
    text: "The verification activity for SUB-REQ-023 SHALL activate OEB 3 compound handling mode in the test environment, execute a"
    verification: Test
    sil: 2
  VER-REQ-056:
    text: "The verification activity for the OEL/OEB containment system requirement (SYS-REQ-013) SHALL operate a production run wi"
    verification: Test
    sil: 2
  VER-REQ-061:
    text: "The verification activity for the PAT qualification enforcement requirement (SYS-REQ-018) SHALL set one PAT instrument's"
    verification: Test
    sil: 3
  VER-REQ-062:
    text: "The verification activity for the PAT power supply requirement SHALL simulate a mains power failure by switching off the"
    verification: Test
    sil: 3
  VER-REQ-063:
    text: "The verification activity for the PAT manual override requirement SHALL log in as QC Analyst role in the MES test enviro"
    verification: Test
    sil: 3
  VER-REQ-064:
    text: "The verification activity for the MES watchdog timer requirement SHALL stop the EBR processing heartbeat in the test env"
    verification: Test
    sil: 2
  VER-REQ-065:
    text: "The verification activity for the Emergency Stop recovery requirement SHALL trigger a simulated containment breach alarm"
    verification: Test
    sil: 2
  VER-REQ-066:
    text: "The verification activity for the Maintenance LOTO display requirement SHALL apply a LOTO lock to the rotary tablet pres"
    verification: Test
    sil: 2
  VER-REQ-067:
    text: "The verification activity for the Degraded Production mode real-time release block requirement SHALL activate degraded p"
    verification: Test
    sil: 3
  VER-REQ-071:
    text: "The verification activity for the Containment and Environmental Control Subsystem UPS requirement SHALL disconnect mains"
    verification: Test
    sil: 2
  VER-REQ-075:
    text: "The verification activity for SUB-REQ-048 SHALL inject a simulated airborne concentration at 85 percent of OEL into the "
    verification: Test
    sil: 2
  VER-REQ-077:
    text: "The verification activity for SUB-REQ-050 SHALL inject a cleaning validation failure result (location 7 swab result exce"
    verification: Test
    sil: 3
  VER-REQ-078:
    text: "The verification activity for SUB-REQ-051 SHALL attempt to advance an API dispensing step in the MES test environment wi"
    verification: Test
    sil: 3
  VER-REQ-080:
    text: "The verification activity for SUB-REQ-053 SHALL connect a calibrated dust concentration monitor to the FBD exhaust duct,"
    verification: Test
    sil: 2
  VER-REQ-084:
    text: "The verification activity for SUB-REQ-057 SHALL operate the PAT subsystem for 31 days in the test environment, query the"
    verification: Test
    sil: 3
  VER-REQ-086:
    text: "The verification activity for the cleaning status registry requirement (SYS-REQ-020) SHALL set equipment item A's cleani"
    verification: Test
    sil: 3
  VER-REQ-090:
    text: "The verification activity for SYS-REQ-003 SHALL inject 50 pre-characterised CQA test spectra spanning 10 nominal, 10 OOS"
    verification: Test
    sil: 3
  VER-REQ-091:
    text: "The verification activity for SYS-REQ-004 SHALL install calibrated airflow velocity probes at all access point openings "
    verification: Test
    sil: 2
  VER-REQ-092:
    text: "The verification activity for SYS-REQ-011 SHALL register an active LOTO lockout device in the MES for three separate equ"
    verification: Test
    sil: 2
  VER-REQ-094:
    text: "The verification activity for SYS-REQ-002 SHALL execute a complete batch lifecycle in the MES test environment: create a"
    verification: Test
    sil: 2
  VER-REQ-098:
    text: "The verification activity for SUB-REQ-058 SHALL log in as QC Analyst in the MES test environment, trigger a CQA limit vi"
    verification: Test
    sil: 3
  VER-REQ-099:
    text: "The verification activity for SUB-REQ-059 SHALL conduct a physical inspection of the Granulation and Blending Subsystem "
    verification: Test
    sil: 2
  VER-REQ-101:
    text: "The verification activity for SUB-REQ-061 SHALL: (a) Watchdog test — suspend the MES heartbeat signal in a test environm"
    verification: Test
    sil: 2
  VER-REQ-104:
    text: "The verification activity for SYS-REQ-027 SHALL confirm: (a) with PLC in RUN mode, pressing the manual override pushbutt"
    verification: Test
    sil: 2