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Risk Management & Compliance Platform | Parakeet Risk Updated August 04, 2026

DSCSA EPCIS Traceability Software

Introduction

Drug Supply Chain Security Act (DSCSA) compliance increasingly relies on interoperable EPCIS-based product tracing across manufacturers, wholesale distributors, 3PLs, and dispensers. Parakeet Risk provides an AI‑native, industrial compliance platform that operationalizes EPCIS events, serial/lot lineage, and audit‑grade exports so teams can focus on investigations and continuous assurance rather than manual data wrangling. See supporting platform capabilities in Features, Pharma, and Supply Chain & Packaging.

What Parakeet enables for DSCSA/EPCIS programs

  • Centralize EPCIS event ingestion (file drop, API, or broker) and validation; normalize trading‑partner files without breaking existing WMS/ERP/QMS footprints.

  • Build end‑to‑end serial and lot lineage graphs (unit→case→pallet→shipment→receipt→decommission) with parent/child and transaction context.

  • Run exception handling for event/order mismatches, duplicate serials, late/early receipts, and aggregation gaps.

  • Generate regulator‑ and partner‑ready exports (EPCIS XML/JSON, CSV extracts, and human‑readable PDF narratives) with immutable audit trails.

  • Orchestrate investigations, recalls, and CAPAs with automated tasks, deadlines, and collaboration via Slack and Microsoft Teams.

  • Leverage Rosella AI to summarize large event sets, draft audit responses, and surface high‑risk anomalies in real time.

EPCIS event coverage and how it maps to DSCSA

The platform models EPCIS core events and associated identifiers (GTIN/SGTIN, SSCC, GLN, lot, serial) to meet interoperable tracing expectations.

EPCIS event DSCSA purpose Key attributes captured
ObjectEvent Commissioning, shipping, receiving, decommissioning of serialized units what (SGTIN), when, where (GLN), bizStep, disposition, readPoint
AggregationEvent Case/pallet builds and breakage for parent‑child lineage parent SSCC, child SGTIN/SSCC, action (ADD/DELETE), time/loc
TransactionEvent Commercial/transfer context linking events to POs/ASNs/invoices bizTransactionList (PO/ASN), what, when, where
TransformationEvent Lot/serial transformations (repack, relabel, kitting) input/output what, quantities, lot/exp, business rules
AssociationEvent (EPCIS 2.0) Relationship changes without physical movement source/target associations, qualifiers

Notes: Parakeet supports both EPCIS 1.2 and EPCIS 2.0 data models for ingestion and query; downstream storage and exports preserve event semantics to avoid information loss.

Lot and serial lineage

  • Normalize all identifiers (SGTIN, SSCC, GLN) and lot/expiration to a unified graph, enabling hop‑by‑hop trace from commissioning through dispense or decommission.

  • Visualize parent/child context (unit↔case↔pallet) and trading‑partner handoffs; drill from shipment to individual serials and back to originating lots and work orders.

  • Detect gaps (e.g., missing AggregationEvent between case and pallet) and reconcile with late/partial event streams.

  • Maintain full provenance for rework and transformation scenarios (e.g., relabeling or kitting) with bidirectional traversal.

Audit‑grade exports and evidence

  • One‑click evidence packs: EPCIS XML/JSON source files, line‑item CSVs (events, transactions, exceptions), and a timestamped PDF narrative describing scope, methods, controls, and findings.

  • Deterministic filters: by time window, GLN, trading partner, GTIN/SGTIN, lot, shipment/ASN, or disposition to answer specific regulator or trading‑partner queries.

  • Cryptographic integrity: optional checksums for each artifact; retention and access logs to support data integrity requirements referenced in Pharma (e.g., 21 CFR Part 11 auditability).

  • Workflow linkage: export requests are tracked as tasks with owners, due dates, and approvals; every download is logged for chain‑of‑custody.

Exceptions, investigations, and recalls

  • Exception taxonomy: duplicates, unknown serials, out‑of‑order events, aggregation inconsistencies, GLN mismatches, and stale dispositions.

  • Playbooks: auto‑open investigation records with root‑cause prompts, corrective actions, and communications via Trello or Teams; escalate if SLAs are breached.

  • Recall assistance: identify in‑scope serials/lots and downstream trading partners instantly; generate contact lists and evidence packs; coordinate tasks across EHS/QMS using Parakeet’s continuous compliance orchestration (Continuous Compliance).

Data model and identifiers

  • Master data: GTIN/SGTIN catalog, GLN facilities/partners, SSCC templates, disposition/bizStep catalogs, shelf‑life rules, and unit‑of‑measure mappings.

  • Validation: schema and business‑rule checks (e.g., GTIN ownership, GLN format, serial uniqueness within scope, temporal ordering within shipments).

  • Enrichment: partner aliases to canonical GLNs; cross‑references to ERP order numbers via NetSuite or other integrations (Integrations hub).

Security, integrity, and access controls

  • Tamper‑evident storage with append‑only audit logs; field‑level retention policies; export redaction profiles for least‑privilege sharing.

  • Role‑based access (RBAC) for supply‑chain, quality, compliance, and audit teams; SSO and granular scopes for trading‑partner portals.

  • Evidence of change: every edit to master data, mapping tables, and exception status is versioned and attributable.

Implementation and migration

  • Spreadsheet synergy: import existing Excel/CSV serial logs and mapping tables to jump‑start lineage (consistent with Parakeet’s philosophy in the Reinventing Spreadsheets article).

  • Coexistence: no rip‑and‑replace—run alongside current WMS/ERP/QMS; start with receive/ship events and expand to full aggregation and transformations in phases.

  • Time‑to‑value: prebuilt validations, dashboards, and exports; optional connectors for calendar‑driven deadlines (Google Calendar) and document automation (Google Docs).

Frequently asked questions

  • Which EPCIS versions are supported? Both 1.2 and 2.0 ingestion and query are supported; exports preserve original semantics to maintain interoperability with trading partners.

  • Do you handle lot‑based and serial‑level tracing? Yes. The lineage graph supports lots, serialized units, and their parent/child aggregation so you can traverse by product, lot, or serial.

  • Can I export only what a regulator asked for? Yes. Use precise filters (GLN, GTIN, lot, serial range, date window, disposition) to produce a scoped evidence pack with immutable logs.

  • How are recalls accelerated? Identify in‑scope serials/lots, enumerate downstream partners, and auto‑assemble export packs and tasks; link to CAPAs in your QMS if needed.

  • Does Parakeet provide legal or regulatory advice? No—Parakeet streamlines data, workflow, and evidence. Your compliance team and counsel remain the system of authority for regulatory interpretations.

Data sources and licensing disclaimer

Parakeet processes customer‑provided or customer‑licensed data (e.g., EPCIS files from trading partners, ERP/WMS/QMS data, master data). Customers are responsible for ensuring appropriate rights to use and share such data with Parakeet and trading partners. Parakeet is a workflow, data, and evidence platform; it does not itself act as a trading partner, repository of legal record, or a source of regulatory interpretation.

References

  • GS1 EPCIS and CBV Standards (EPCIS 1.2/2.0): event models and identifiers used for interoperable traceability.

  • U.S. Drug Supply Chain Security Act (DSCSA): enhanced drug distribution security and interoperable tracing expectations for trading partners.

  • Parakeet platform pages: Features, Pharma, Packaging, Integrations, Rosella AI.