Aligning ERP Design to Drug Supply Chain Security Act (DSCSA) Serialization and Traceability

If you are a life sciences start up building your first operational backbone, or a growing manufacturer, repackager, or distributor moving off spreadsheets and legacy tools, the Drug Supply Chain Security Act (DSCSA) is pushing the industry toward an interoperable, electronic way to identify and trace certain prescription drugs at the package level as they move through the supply chain.

That outcome lives or dies on two things

1. Your ability to manage serialized product data correctly, and your ability to exchange that data reliably with your trading partners.

2. This is where ERP design decisions matter. Not because ERP must do everything, but because ERP must connect to the right things, enforce the right controls, and avoid becoming the bottleneck.

Serialization and traceability, the part most teams underestimate

Serialization is the assignment and use of a unique identifier at the package level, so each saleable unit can be referenced unambiguously as it changes ownership and moves through the supply chain. DSCSA’s vision relies on that package level identity plus electronic exchange of related transaction data.

Traceability is what you do with that identity, capturing and linking serialized events, storing them as trusted records, and exchanging the right data with the right trading partner at the right time. Most teams do not get stuck on the barcode itself, they get stuck on the operating model behind it, who owns the data, where it lives across ERP and other systems, and how exceptions are handled without breaking the chain of evidence.

Common friction points

• You do not know where serialization lives in your application landscape

• You cannot keep product identity aligned across ERP, warehouse, and shipping

• You do not have clean master data required for partner exchange

• You have no clear exception process for rejects, holds, returns, rework, and quarantines

• You are relying on manual file handling for partner connections

  
  

Where ERP fits in DSCSA Compliance, and where it should not

ERP should be your operational system of record for products, locations, inventory states, orders, shipments, and financial traceability. ERP should enforce controls around who can transact what, and it should anchor the business process. ERP is rarely the best place to be your serialization event repository or your partner connectivity engine.

A practical pattern that scales:

• A serialization and traceability platform manages serial number commissioning, aggregation, event capture, EPCIS exchange, and partner connectivity

• ERP manages item and site master data, inventory ownership, order to cash, and the operational steps that trigger events

• WMS and packaging line systems execute scanning and aggregation where work happens

• Integrations keep product identity and event status aligned across systems

FDA has published guidance on standards for interoperable exchange, and EPCIS is commonly referenced as an industry standard approach in that context.

ERP requirements that matter most for DSCSA readiness

If you are selecting a new ERP or redesigning processes, focus requirements on the workflows that create or consume serialized truth.

Product and master data readiness

• Clean item identity management aligned to how you label and trade, including Global Trade Item Number (GTIN) strategy and packaging hierarchies

• Stable location, license plate, and inventory status design so holds and quarantines are unambiguous

• Controlled change management for item, packaging, and labeling attributes

Inventory and execution controls

• Scan driven receiving, picking, packing, and ship confirmation where serialization is in scope

• Inventory states that support quality disposition and prevent unauthorized movements

• Support for aggregation and de aggregation behaviors based on how your operations actually work

Partner exchange and evidence

• Integration capability that supports secure, reliable data exchange with trading partners

• Clear data ownership model so you can answer who is the source of truth for which elements

• Audit friendly records, retention, and access controls that align to regulated operations

Exception handling that will show up on day one

• Product holds, suspect product workflows, and disposition outcomes

• Returns, rework, relabel, and repack scenarios

• Short shipments, substitutions, and split case behavior

Implementation pitfalls we see in ERP programs

• Treating serialization as a reporting feature rather than an execution design

• Assuming the implementation partner understands DSCSA details without proving it

• Leaving integrations to late stage, then discovering master data misalignment

• Under designing exception handling, then building manual workarounds that become permanent

• Letting vendors define requirements, instead of documenting them in your language

Turn DSCSA requirements into implementation design

John Hannan LLC helps you turn DSCSA requirements into implementation design by translating serialization and traceability expectations into clear, testable requirements, fit for purpose workflows, and an application architecture that holds up under real receiving, picking, shipping, and exception handling. For startups preparing for commercialization and growing firms replacing ERP, we pressure test what must be true across ERP, WMS, and traceability platforms, tighten scope and data ownership, and guide vendor and partner decisions so the solution is defensible, implementable, and adopted in day-to-day operations.

Contact John Hannan LLC to discuss ERP Advisory support that is tailored to your needs, team capacity, and budget, so you can make confident decisions and keep delivery on track.