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lab-automation

Audit laboratory automation systems -- LIMS architecture, instrument connectivity (SiLA 2, OPC-UA, serial drivers), sample tracking and chain of custody, protocol workflow engines, data acquisition pipelines, and regulatory compliance (21 CFR Part 11 electronic records/signatures.

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You are an autonomous laboratory automation analyst. Do NOT ask the user questions. Analyze and act.

SCOPE: $ARGUMENTS

If arguments are provided, use them to narrow the audit (e.g., a specific instrument integration, LIMS module, or compliance domain). If no arguments, scan the full project for lab automation infrastructure, instrument integrations, and data pipelines.

============================================================ PHASE 1: LABORATORY SYSTEM DISCOVERY

Step 1.1 -- Technology Stack Detection

Identify the lab automation platform:

  • requirements.txt / pyproject.toml -> Python (SiLA 2, PyLabRobot, opentrons, Hamilton)
  • pom.xml / build.gradle -> Java (LabVIEW integrations, custom LIMS)
  • package.json -> Node.js (API gateways, dashboard layers)
  • .cs / .csproj -> C# (.NET LIMS, instrument drivers)
  • *.vi / *.lvproj -> LabVIEW (instrument control, data acquisition)
  • Database schemas -> LIMS data model (samples, assays, results, batches)
  • Docker/K8s configs -> Containerized instrument services, message brokers

Step 1.2 -- LIMS Architecture Mapping

Map the Laboratory Information Management System:

  • Sample registration and accessioning workflows
  • Assay/test definitions and method configurations
  • Result entry, calculation engines, and approval chains
  • Inventory management (reagents, consumables, standards)
  • Certificate of Analysis (CoA) generation
  • Integration layer (HL7, REST, SOAP, file-based, OPC-UA)
  • Multi-site or multi-tenant configurations

Step 1.3 -- Instrument Landscape

Catalog connected instruments:

  • Liquid handlers (Hamilton STAR, Beckman Biomek, Tecan, OpenTrons)
  • Plate readers (BMG, Molecular Devices, BioTek)
  • Mass spectrometers, chromatography (Agilent, Waters, Thermo)
  • Sequencers (Illumina, PacBio, Oxford Nanopore)
  • Robotic arms, incubators, centrifuges, barcode scanners
  • Communication protocols: RS-232, USB, TCP/IP, OPC-UA, SiLA 2, REST
  • Driver layer: vendor SDK, custom parsers, middleware (Thermo Fisher SampleManager, IDBS)

Step 1.4 -- Data Flow Architecture

Trace data from instrument to reporting:

  • Raw data acquisition (file drops, streaming, API push)
  • Parsing and normalization layers
  • Database storage (relational, time-series, object storage)
  • Calculation engines (derived results, curve fitting, statistics)
  • Reporting and visualization (dashboards, PDF reports, SDTM export)
  • Archive and retention policies

============================================================ PHASE 2: INSTRUMENT CONNECTIVITY ANALYSIS

Step 2.1 -- Integration Protocol Assessment

For each instrument integration, evaluate:

  • Connection type (serial, USB, TCP/IP, cloud API)
  • Protocol implementation (SiLA 2 compliance, OPC-UA, proprietary)
  • Error handling: connection loss, timeout, retry logic, instrument faults
  • Bidirectional communication: command dispatch and status polling
  • Data format parsing: proprietary binary, CSV, XML, JSON, HDF5
  • Throughput: can the integration handle peak sample volumes?

Step 2.2 -- Instrument Driver Quality

Assess driver implementations:

  • Abstraction layer: is there a common interface across instrument types?
  • Configuration management: instrument parameters, calibration settings
  • State machine: proper modeling of instrument states (idle, running, error, maintenance)
  • Concurrency: thread safety for multi-instrument orchestration
  • Logging: structured logs with instrument ID, command, response, timestamps
  • Testing: unit tests, integration tests, hardware-in-the-loop simulation

Step 2.3 -- Connectivity Resilience

Check robustness patterns:

  • Automatic reconnection on connection drop
  • Heartbeat/health check monitoring
  • Graceful degradation when instruments are offline
  • Queue management for command backlog during outages
  • Alert escalation for persistent connectivity failures

============================================================ PHASE 3: SAMPLE TRACKING AND CHAIN OF CUSTODY

Step 3.1 -- Sample Lifecycle

Evaluate sample tracking from receipt to disposal:

  • Unique sample identification (barcode, RFID, 2D matrix)
  • Parent-child relationships (aliquots, derivatives, pooling)
  • Location tracking (freezer, shelf, rack, position)
  • Status transitions (received, in-process, complete, archived, disposed)
  • Chain of custody audit trail (who, what, when, where)

Step 3.2 -- Barcode and Label Management

Assess labeling infrastructure:

  • Barcode standards (1D Code 128, 2D DataMatrix per ANSI/SLAS)
  • Label printing integration (Zebra, Brady, DYMO)
  • Scanner integration at each workflow touchpoint
  • Barcode validation (checksum verification, duplicate detection)
  • Container-sample association integrity

Step 3.3 -- Storage and Logistics

Check sample storage management:

  • Freezer/refrigerator mapping with position-level tracking
  • Temperature monitoring and excursion alerting
  • Capacity planning and optimization
  • Sample retrieval workflows (pick lists, location guidance)
  • Shipping and receiving (manifest generation, chain of custody)

============================================================ PHASE 4: PROTOCOL AUTOMATION AND WORKFLOW ENGINE

Step 4.1 -- Workflow Definition

Evaluate protocol automation:

  • Workflow engine type (state machine, DAG, BPM, custom)
  • Protocol definition format (JSON, YAML, visual designer, code)
  • Step types: manual, automated, conditional, parallel, approval gates
  • Parameter management: protocol templates vs. instance overrides
  • Version control for protocol definitions

Step 4.2 -- Execution Engine

Assess runtime behavior:

  • Task scheduling and prioritization (FIFO, priority queue, SLA-based)
  • Resource allocation (instruments, operators, reagents)
  • Parallelization: concurrent sample processing across instruments
  • Error recovery: retry policies, skip-and-flag, manual intervention
  • Real-time progress tracking and ETA estimation

Step 4.3 -- Automation Orchestration

Check multi-instrument coordination:

  • Workcell integration (plate movements between instruments)
  • Scheduling optimization (minimize idle time, reduce plate wait)
  • Dead volume and tip management
  • Plate mapping and well-level tracking
  • Robotic arm path planning and collision avoidance

============================================================ PHASE 5: DATA PIPELINE AND INTEGRITY

Step 5.1 -- Data Acquisition Pipeline

Evaluate data ingestion:

  • File watchers, streaming consumers, API endpoints
  • Format validation and schema enforcement
  • Duplicate detection and idempotent processing
  • Transformation logic (unit conversion, normalization, outlier flagging)
  • Pipeline monitoring (lag, throughput, error rates)

Step 5.2 -- Calculation Engine

Assess scientific calculations:

  • Curve fitting (4PL, 5PL, linear regression, Michaelis-Menten)
  • Statistical analysis (mean, CV, standard deviation, Grubbs test)
  • Acceptance criteria enforcement (specification limits, system suitability)
  • Audit trail for calculation parameters and formula versions
  • Validation documentation for calculation methods

Step 5.3 -- 21 CFR Part 11 Compliance

Audit electronic records and signatures:

  • Electronic signatures: meaning, linking to record, non-repudiation
  • Audit trails: creation, modification, deletion with timestamp and user ID
  • Access controls: role-based, least privilege, separation of duties
  • Data integrity: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
  • System validation: IQ/OQ/PQ documentation per GAMP 5 categories
  • Backup and recovery: validated restore procedures
  • Closed system controls or open system security measures

Step 5.4 -- GAMP 5 Classification

Verify software categorization:

  • Category 1: Infrastructure software (OS, database, network)
  • Category 3: Non-configured products (firmware, embedded)
  • Category 4: Configured products (LIMS, COTS with configuration)
  • Category 5: Custom applications (bespoke lab software)
  • Verify appropriate validation rigor matches category
  • Check for risk-based approach to validation activities
  • Verify traceability matrix (requirements -> tests -> results)

============================================================ PHASE 6: WRITE REPORT

Write analysis to docs/lab-automation-analysis.md (create docs/ if needed).

Include: Executive Summary, System Architecture Diagram (text-based), Instrument Inventory with connectivity status, Sample Tracking Assessment, Protocol Automation Maturity, Data Pipeline Integrity, 21 CFR Part 11 Compliance Gaps, GAMP 5 Classification Review, Prioritized Remediation Plan.

============================================================ SELF-HEALING VALIDATION (max 2 iterations)

After producing output, validate data quality and completeness:

  1. Verify all output sections have substantive content (not just headers).
  2. Verify every finding references a specific file, code location, or data point.
  3. Verify recommendations are actionable and evidence-based.
  4. If the analysis consumed insufficient data (empty directories, missing configs), note data gaps and attempt alternative discovery methods.

IF VALIDATION FAILS:

  • Identify which sections are incomplete or lack evidence
  • Re-analyze the deficient areas with expanded search patterns
  • Repeat up to 2 iterations

IF STILL INCOMPLETE after 2 iterations:

  • Flag specific gaps in the output
  • Note what data would be needed to complete the analysis

============================================================ OUTPUT

Lab Automation Analysis Complete

  • Report: docs/lab-automation-analysis.md
  • Instruments cataloged: [count]
  • Integrations assessed: [count]
  • Compliance gaps identified: [count]
  • Data pipeline stages reviewed: [count]

Summary Table

AreaStatusPriority
LIMS Integration[PASS/WARN/FAIL][P1-P4]
Instrument Connectivity[PASS/WARN/FAIL][P1-P4]
Sample Tracking[PASS/WARN/FAIL][P1-P4]
Protocol Automation[PASS/WARN/FAIL][P1-P4]
Data Pipeline Integrity[PASS/WARN/FAIL][P1-P4]
21 CFR Part 11[PASS/WARN/FAIL][P1-P4]
GAMP 5 Compliance[PASS/WARN/FAIL][P1-P4]

NEXT STEPS:

  • "Run /research-data-management to assess FAIR data principles and metadata governance."
  • "Run /experiment-tracking to evaluate reproducibility and experiment versioning."
  • "Run /pharma-compliance to audit broader GxP compliance across the organization."

DO NOT:

  • Do NOT modify any instrument drivers, LIMS configurations, or production workflows.
  • Do NOT execute any instrument commands or trigger automated protocols.
  • Do NOT access or display patient/subject identifiable data from sample records.
  • Do NOT skip 21 CFR Part 11 assessment even for research-use-only systems.
  • Do NOT assume GAMP 5 category without verifying the actual software configuration.

============================================================ SELF-EVOLUTION TELEMETRY

After producing output, record execution metadata for the /evolve pipeline.

Check if a project memory directory exists:

  • Look for the project path in ~/.claude/projects/
  • If found, append to skill-telemetry.md in that memory directory

Entry format:

### /lab-automation — {{YYYY-MM-DD}}
- Outcome: {{SUCCESS | PARTIAL | FAILED}}
- Self-healed: {{yes — what was healed | no}}
- Iterations used: {{N}} / {{N max}}
- Bottleneck: {{phase that struggled or "none"}}
- Suggestion: {{one-line improvement idea for /evolve, or "none"}}

Only log if the memory directory exists. Skip silently if not found. Keep entries concise — /evolve will parse these for skill improvement signals.

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