A technical knowledge base for pharmaceutical serialization and DSCSA track-and-trace compliance.
🌐 Live site: www.serializationautomation.org
Serialization Automation is a free, in-depth engineering resource for the people who build and operate Drug Supply Chain Security Act (DSCSA) compliance systems: supply-chain operations teams, serialization specialists, compliance officers, and the Python automation engineers who turn regulatory mandates into production pipelines. Every guide pairs the regulatory “why” with runnable Python you can lift straight into a track-and-trace pipeline — GS1 identifiers, EPCIS 2.0 events, verification routing, aggregation hierarchies, and audit-ready data retention.
DSCSA compliance is not a feature you bolt onto a packaging line — it is a distributed system that has to stay correct under high throughput, partial failure, and adversarial inspection. Most material online stops at the regulatory summary. This site goes all the way to the code: typed data contracts, idempotent ingestion, EPCIS event synthesis, exception handling, and immutable audit trails. It is written to serve two readers at once — the compliance officer who needs every design decision traced back to a rule, and the engineer who needs a snippet that actually runs on Python 3.10+.
The library is organized into three deeply interlinked areas:
- DSCSA Compliance Architecture & Standards Mapping — mapping internal ERP/WMS data to GS1 identifiers, generating EPCIS 2.0 events, verification router service (VRS) design, trading-partner verification and onboarding, suspect-product investigation, encryption boundaries, and 21 CFR Part 11 audit trails.
- Serialization Data Ingestion & EPCIS Event Sync — production pipelines for API polling and webhooks, schema validation and error handling, real-time stream processing, async batch pipelines, live monitoring and alerting, and EPCIS repository storage and retention.
- Aggregation Hierarchy & Validation Workflows — case-and-pallet aggregation logic, parent-child serial mapping, decommission and reaggregation rules, and threshold tuning for high-speed packaging lines.
Across these areas you’ll find 50+ pages spanning architectural overviews, focused topic guides, and step-by-step, code-first walkthroughs — each with hand-authored diagrams, GS1/EPCIS data contracts, and practical gotchas (leading-zero NDC mismatches, UTC vs. local EPCIS timestamps, idempotency-key collisions, and more).
- Runnable Python throughout — Pydantic v2 validators,
asynciopipelines,lxmlEPCIS parsing, circuit breakers, dead-letter-queue drains, and hash-chained audit logs. - Standards-accurate — GS1 Application Identifiers
(01)(21)(17)(10), SGTIN/SSCC/GLN handling, and the four EPCIS event types (ObjectEvent,AggregationEvent,TransactionEvent,TransformationEvent). - Original inline SVG diagrams — every architectural concept is illustrated with a custom, accessible, theme-aware diagram; no stock imagery.
- Structured data — every page ships Article, Breadcrumb, HowTo, and FAQ JSON-LD for rich search results.
- Eleventy (11ty) static site generator
- Hand-authored inline SVG diagrams and a lightweight, dependency-free design system
- Installable, offline-capable Progressive Web App (service worker + app-shell precache)
- Deployed on Cloudflare Workers
npm install
npm run build # build the static site into _site/
npm start # local dev server with live reloadCorrections, suggestions, and new-topic requests are welcome — please open an issue. The goal is to keep this the most accurate, practical, code-first reference for DSCSA serialization engineering on the web.
© serializationautomation.org. Content and code are provided as an educational reference for the pharmaceutical serialization community.