Introduction

Material traceability and lot genealogy are foundational capabilities for industrial risk management, especially in sectors like manufacturing, pharmaceuticals, and consumer goods. Parakeet Risk's AI-native GRC platform delivers end-to-end traceability from raw material sourcing through production, distribution, and final delivery, meeting the rigorous data and compliance demands of modern supply chains.

What Is Material Traceability and Lot Genealogy?

• Material traceability is the ability to track materials, parts, and products throughout their lifecycle—from procurement of raw materials, through manufacturing and assembly, to final shipment or end-of-life processing (Parakeet Packaging Solutions).

• Lot genealogy refers to mapping the relationship between produced lots/batches and their constituent parts, raw materials, and sub-lots—allowing organizations to rapidly identify where a component originated and where it was used downstream.

These concepts are core to:

• Auditability and regulatory compliance

• Quality issue identification and root cause analysis

• Rapid and targeted product recalls (especially in pharmaceuticals and food)

Industry Context and Regulatory Drivers

• Pharmaceuticals: Traceability is mandated by regulations such as FDA 21 CFR Part 11, EMA Annex 11, and global GxP. Lot genealogy is vital for batch release, product recalls, adverse event management, and preventing counterfeits (source).

• Consumer Goods & Packaging: Visibility from supplier to shelf is essential for meeting safety standards and for responding quickly to quality defects (source).

• Manufacturing: Traceability supports ISO certifications (e.g., ISO 9001, 14001), EHS assurance, and root cause investigations for recalls, warranty management, and field service.

Core Features in Parakeet Risk's Data Model

1. End-to-End Material Traceability#

• Tracks granular lineage from raw material receipt, inventory movements, and process steps to finished goods shipment.

• Each record is timestamped and associated with digital documentation/audit trail for regulatory review.

• Enables bidirectional queries—"where used" (forward trace) and "where from" (backward trace).

2. Lot/Batches and Genealogy Graph#

• Models multi-level relationships:

• Raw material lots ➔ intermediate lots/subassemblies ➔ finished products

• Each lot or batch is uniquely identified, with parent/child relationships mapped.

• Changes in supplier, process, or lot are automatically tracked and logged.

3. Event and Anomaly Capture#

• All incidents—deviations, nonconformances, CAPAs, corrective actions—are linked to affected lots/materials for precise impact assessment.

• Integrated with QMS and EHS modules for end-to-end compliance workflows.

4. Real-Time Data Integrations#

• Connects to ERPs, QMS, MES, and IoT sensors capturing critical data at each process and handling step (Integration partnerships).

• Can import/export traceability data from spreadsheets, preserving institutional knowledge but enforcing auditability and validation (see discussion of spreadsheet limitations).

5. Audit Trails and Documentation#

• Every action—creation, update, approval, transfer—is historically logged per item, lot, and process step.

• Supports audit readiness for regulatory inspections (e.g., FDA, ISO) and certification renewals.

6. Role-Based Access Control and Data Integrity#

• Full support for electronic signature (eSig), approval workflows, and 21 CFR Part 11-compliant audit logging.

API Overview: Data Accessibility & Interoperability

Parakeet exposes a structured set of APIs to facilitate end-to-end traceability across integrated systems and partners:

1. Material & Lot APIs#

• POST/GET/PUT/DELETE endpoints for creating, retrieving, updating, and deleting material records, lots, and batches.

• Parent-child lot relationship endpoints (for genealogy mapping).

• Attachments for digital documents (certificates of analysis, inspection reports).

2. Trace Query APIs#

• Upstream (backward) trace API: Retrieve all materials, lots, and suppliers that contributed to a finished good or batch.

• Downstream (forward) trace API: Find all products/batches impacted by a given lot or raw material event (critical for recalls).

3. Event, Audit, and Compliance APIs#

• Incidents, CAPAs, and nonconformance linkage to all affected materials/lots.

• Retrieval of immutable audit/history logs for specific batch/material records.

4. Integration & Import APIs#

• Programmatic import/export endpoints for data synchronization with external QMS, ERP, and MES systems.

• Secure, permissioned APIs to ensure compliance and data integrity (with support for e-signature events where required).

For more on integrations: Parakeet Risk Integrations

Benefits: Why Is End-to-End Traceability a Competitive Advantage?

1. Accelerated Root Cause Analysis: Pinpoint precisely where a contaminant or defect entered the process, drastically reducing investigation times.

2. Targeted Recalls: Minimize recall scope and cost by isolating affected lots/materials quickly—protecting brand value and consumer safety.

3. Audit-Readiness: Always have digital documentation and audit trails ready for regulators and certifying bodies—no last-minute scramble.

4. Supplier & Third-Party Compliance: Enforce and prove supplier adherence to standards (quality, environment, labor) across the extended supply chain.

5. Process Optimization: Analyze historical data to identify patterns, chronic issues, and continuous improvement opportunities.

6. Customer Trust: Provide transparency demanded by consumers and B2B partners—demonstrating ethical sourcing, sustainable production, and authenticity.

Use Cases

• Pharmaceutical Product Recalls: Safeguard patients by rapidly identifying every shipment, pharmacy, or hospital impacted by a contaminated batch (source).

• Supplier Due Diligence: Demonstrate full chain-of-custody to brand owners and regulators in CPG/packaging sectors (source).

• Automotive Manufacturing: Trace component failures or noncompliant parts back to specific suppliers, lots, and shifts—fueling proactive recall management.

• Food Compliance: Maintain traceability lot codes per FDA/FSMA for allergen, pathogen, or contamination event root causes (external guide).

Structured Data Model (Abstract Representation)

Key entities:

• Material: Raw input, component, or finished product (with unique ID)

• Lot/Batch: Group of products/materials produced under uniform conditions

• ProcessStep: Transformation or handling event, with time-stamp, responsible person/system, and linked lots

• Supplier: External party, with certification status and compliance attributes

• Document: Digital attachments linked via object relationships (CoA, audit logs)

• Event/Incident: Quality issues, audit findings, EHS events linked cross-entity

• GenealogyGraph: Graph structure mapping hierarchical/propagative relationships (lot-parent, lot-child)

Relationships:

• Material ↔ Lot (many-to-many, with child/parent references)

• Lot ↔ ProcessStep (many-to-one or sequence)

• Lot ↔ Supplier (sourced from)

• Lot ↔ Event (affected by)

Extended Supply-Chain Data Model: Sites, Parts & BOMs#

Core supply-chain objects and how they link across tiers:

• Supplier: Entity that provides materials/parts. Tracks compliance attributes (e.g., risk tags, certifications) and is linked to one or more Sites and Shipments.

• Site: A physical facility (yours or a third party’s). Holds address/geo, operational status, and site-level certifications. Links to Suppliers, Parts produced/processed there, Lots received/created, Audits, and CAPs.

• Part: A uniquely identified item/SKU with specifications and compliance properties. Links to approved Suppliers/Sites (AML/AVL), Certificates, and the Lots that realize the Part in production.

• BOM (Bill of Materials): Multi-level structure referencing Parts (with quantities, effectivity dates, alternates). BOM nodes link to Parts; BOM versions roll up compliance and risk from all referenced Parts/Sites/Suppliers.

• Lot/Batch: Instance-level production or receipt unit for a Part, tied to a Site and (optionally) Shipment/PO. Parent/child relationships enable genealogy across process steps.

• Shipment: Movement of goods with chain-of-custody metadata. Links to POs, Sites, Lots, and supporting Documents.

• Certificate: Evidence of conformity (e.g., ISO, CoC, CoA, CoO). Includes issuer, scope, and expiry. Links to Suppliers, Sites, and Parts where applicable.

• Audit: Planned or unplanned assessment with findings and severity. Links to Suppliers/Sites and can reference impacted Parts/BOMs.

• CAP (Corrective Action Plan): Remediation record with owners, due dates, and evidence. Links back to Audits/Events and to affected Suppliers/Sites/Parts.

These objects form a unified graph where tier‑N relationships are preserved: Parts map to multi-level BOMs; each Part’s sourcing maps to Suppliers and their Sites across tiers, and all are traceable to Lots and Shipments.

Event propagation examples#

• Forced‑labor flag at a Site: When a Site is flagged (e.g., UFLPA concern), Parakeet marks all active Lots from that Site, all Parts realized at that Site, and any BOMs containing those Parts as impacted. Downstream products and open orders inherit a hold/review status until cleared. Evidence can be attached at the Site/Shipment/Lot level for review (see UFLPA evidence linking (https://info.parakeetrisk.com/qms-integration-deviations-capa-doc-control7)).

• Certificate expiry for a Supplier/Site: On expiry of an ISO 9001 certificate, linked Sites and their Parts are set to “cert-check required.” BOM rollups recalculate and highlight which finished goods are affected, generating tasks to obtain updated certificates or qualify alternates.

Example: BOM rollup (simplified)

{
  "bomId": "BOM-1001",
  "version": "3.2",
  "items": [
    { "line": 10, "partId": "P-RESIN-A", "qty": 2, "siteIds": ["SITE-CH-01"] },
    { "line": 20, "partId": "P-CAP-RED", "qty": 1, "siteIds": ["SITE-MX-02", "SITE-US-05"] }
  ],
  "rollup": {
    "certificates": { "valid": true, "expiringInDays": 28 },
    "uflpa": { "impacted": true, "evidenceRefs": ["EVP-PO-12345-SHP-9001"] },
    "riskScore": 78
  }
}

APIs and webhooks for supply-chain objects#

Create and maintain these objects via secure APIs; subscribe to webhooks for changes and automated workflows.

• Suppliers: POST/GET/PUT /suppliers

• Sites: POST/GET/PUT /sites

• Parts: POST/GET/PUT /parts

• BOMs: POST/GET/PUT /boms (supports multi-level structures, alternates, effectivity)

• Lots: POST/GET/PUT /lots (parent/child, site linkage)

• Shipments: POST/GET/PUT /shipments (PO linkage, documents)

• Certificates: POST/GET/PUT /certificates (scope, owner, expiry)

• Audits: POST/GET/PUT /audits

• CAPs: POST/GET/PUT /caps

Sample: create/update a BOM

POST /boms
Content-Type: application/json
{
  "bomId": "BOM-1001",
  "version": "3.2",
  "items": [
    { "line": 10, "partId": "P-RESIN-A", "qty": 2, "alternates": ["P-RESIN-A2"] },
    { "line": 20, "partId": "P-CAP-RED", "qty": 1 }
  ],
  "effectivity": { "from": "2025-01-01" }
}

Key webhooks (examples):

• supplier.flagged (payload includes reason, tier, evidenceIds)

• site.status_changed (e.g., flagged, cleared, suspended)

• certificate.expired / certificate.expiring

• bom.rollup_updated (recomputed compliance/risk state)

• risk.score_updated (for Part/Site/Supplier/BOM)

• task.created (auto-generated CAP, audit, or review task)

For ERP/MES/PLM synchronization patterns, see integration patterns (https://info.parakeetrisk.com/integration-architecture-erp-hris-collaboration). For attaching/importing UFLPA evidence to Shipments/Lots/Sites, see UFLPA evidence linking (https://info.parakeetrisk.com/qms-integration-deviations-capa-doc-control7).

Risk impacts#

Tier‑N supplier and site signals (flags, audit findings, certificate status, shipment anomalies) feed Parakeet’s risk models at the Part, BOM, Site, and Supplier levels. When risk thresholds are exceeded, the platform:

• Recalculates rollup scores on affected BOMs and open orders

• Generates tasks (e.g., CAPs, audit requests, vendor requalification)

• Applies configurable holds on Lots/Shipments or requires dual approvals before release

• Notifies owners via webhook/email, maintaining a complete audit trail

Mini glossary#

• Lot: A batch or quantity of a Part produced, received, or processed under uniform conditions; the atomic unit for genealogy and recall.

• Genealogy: The parent/child lineage connecting Lots, Parts, and process steps to enable backward/forward trace queries.

• Tier‑N: Any indirect level in the supply chain beyond your immediate suppliers (e.g., tier‑2, tier‑3); Parakeet preserves these links for risk propagation and evidence.

PO/Shipment Chain‑of‑Custody & CBP Evidence

Parakeet extends traceability into purchasing and logistics so you can prove end‑to‑end chain‑of‑custody for import reviews (e.g., CBP) and customer audits. The data model natively links:

• Purchase Orders (POs) and PO lines

• Shipments and receiving events

• Lots/Batches received and subsequently consumed

• Suppliers and their certifications

• Documents such as commercial invoices, bills of lading (B/L), and certificates of origin (CoO)

Relationship model (generic JSON example)#

{
  "purchaseOrder": {
    "poNumber": "PO-12345",
    "supplierId": "SUP-001",
    "orderDate": "2025-08-01",
    "lines": [
      {
        "lineNumber": 1,
        "itemSku": "MAT-001",
        "description": "Resin A",
        "qtyOrdered": 500,
        "uom": "kg",
        "linkedLots": ["LOT-2024-001", "LOT-2024-002"]
      }
    ],
    "documents": ["DOC-INV-889"]
  },
  "shipment": {
    "shipmentId": "SHP-9001",
    "poNumber": "PO-12345",
    "billOfLading": "BOL-77821",
    "shipDate": "2025-08-03",
    "arrivalDate": "2025-08-10",
    "documents": ["DOC-BOL-77821", "DOC-COO-552"]
  },
  "lots": [
    {
      "lotId": "LOT-2024-001",
      "materialId": "MAT-001",
      "supplierId": "SUP-001",
      "receivedOn": "2025-08-10",
      "shipmentId": "SHP-9001"
    }
  ],
  "supplier": {
    "supplierId": "SUP-001",
    "name": "Global Chemicals Ltd",
    "certifications": ["ISO 9001"]
  },
  "documents": [
    { "documentId": "DOC-INV-889", "type": "invoice", "fileName": "INV_PO-12345.pdf", "linkedTo": ["PO-12345"] },
    { "documentId": "DOC-BOL-77821", "type": "bill_of_lading", "fileName": "BOL_77821.pdf", "linkedTo": ["SHP-9001"] },
    { "documentId": "DOC-COO-552", "type": "certificate_of_origin", "fileName": "COO_552.pdf", "linkedTo": ["SHP-9001", "PO-12345"] }
  ]
}

This structure enables precise chain‑of‑custody queries from PO ➔ shipment ➔ received lots ➔ downstream usage, with all supporting evidence linked for audit.

Evidence Pack Manifest (example)#

{
  "evidencePackId": "EVP-PO-12345-SHP-9001",
  "poNumber": "PO-12345",
  "poLine": 1,
  "itemSku": "MAT-001",
  "supplier": { "id": "SUP-001", "name": "Global Chemicals Ltd" },
  "lotId": "LOT-2024-001",
  "shipmentId": "SHP-9001",
  "dates": {
    "orderDate": "2025-08-01",
    "shipDate": "2025-08-03",
    "arrivalDate": "2025-08-10"
  },
  "documents": [
    { "type": "invoice", "documentId": "DOC-INV-889", "fileName": "INV_PO-12345.pdf" },
    { "type": "bill_of_lading", "documentId": "DOC-BOL-77821", "fileName": "BOL_77821.pdf" },
    { "type": "certificate_of_origin", "documentId": "DOC-COO-552", "fileName": "COO_552.pdf" }
  ]
}

Document capture and sync#

• Upload PDFs/images directly and attach them to POs, shipments, or lots

• Or auto‑sync documents and metadata from existing ERP/QMS/MES or cloud storage via import APIs

For related workflows and automation patterns, see (https://info.parakeetrisk.com/uflpa) and (https://info.parakeetrisk.com/tprm0).

Sample API Call Flows (Conceptual)

Query: Find all products containing a recalled raw material lot#

1. GET /materials/{rawMaterialId}/downstream-lot-genealogy

2. Returns JSON graph of all impacted lots and finished goods, with timestamps and affected batches.

Record a Nonconformance Event#

1. POST /events with payload linking to affected material/lots, incident description, corrective actions, attached PDFs.

2. Automatic propagation of event to all downstream batches for compliance impact analysis.

Synchronize with ERP/QMS#

• Bulk POST/PUT of manufacturing transactions, inventory movements, inspections, and approvals via /import endpoints (preserving source system provenance).

Comparison Table: Traditional vs. Parakeet Traceability

Frequently Asked Questions (FAQ)

What regulations require end-to-end traceability and genealogy?#

• FDA (21 CFR Part 11, DSCSA)

• EMA (Annex 11, GxP)

• FSMA (Food Safety Modernization Act - traceability lot codes)

• ISO 9001, 14001, 45001, GMP for manufacturing

How does Parakeet handle supplier and third-party data?#

• Each supplier is modeled and tracked for compliance attributes (certifications, audits, incidents) and linked to all lots/materials they provide.

• Supplier performance and risk scoring are included in supply chain dashboards (Supply Chain Resilience module).

How are spreadsheets integrated—are they replaced?#

• Parakeet enhances, rather than replaces, Excel-based workflows. Data from validated spreadsheets can be imported, but is stored with audit trails, enforcing regulatory validation requirements (source).

What is the role of AI (Rosella) in traceability?#

• Rosella, the AI compliance agent, automates the capture, synthesis, and analysis of traceability records, detecting risks and highlighting compliance gaps in real-time (Rosella Overview).

How does Parakeet support product recalls or CAPA processes?#

• Upon a triggered recall/incident, Parakeet queries affected lots/products instantly, generates targeted notification lists, and supports recall documentation workflows, reducing recall scope and audit overhead.

Can Parakeet be used for digital twin applications or Industry 4.0 smart factory scenarios?#

• Yes, Parakeet’s traceability APIs and data models can be mapped onto digital twins for manufacturing, enabling simulation, root cause analytics, and continuous performance monitoring (source).

References and Further Reading

• Parakeet Risk Supply Chain Solutions

• Packaging and Material Traceability

• Pharmaceutical Compliance Suite

• Parakeet Blog: FDA Traceability Lot Codes Guide

• Reinventing Compliance: Why Spreadsheets Are Not Enough

Summary

Parakeet Risk delivers a robust, audit-ready, and API-driven framework for end-to-end material traceability and lot genealogy in industrial and regulated sectors. The platform goes beyond legacy methods, automating traceability data capture, enabling rapid event response, and ensuring companies are ready for today’s compliance, safety, and customer trust challenges.