DSCSA Interoperability Software for Serialization and EPCIS
Package-level tracing under the DSCSA means serial numbers, aggregation links and EPCIS events exchanged with every trading partner, and one wrong link breaks inference for everything below it. Agnotic Technologies builds the traceability software to your requirements.
Last reviewed by the Agnotic Technologies engineering team
What does DSCSA interoperability software need to do?
DSCSA interoperability software has to commission serial numbers for units, cases and pallets, record aggregation links, exchange EPCIS events with every trading partner and answer verification requests for saleable returns. Agnotic Technologies builds these systems for manufacturers, repackagers and distributors, shaped to each client's packaging lines, partners and existing ERP.
Which DSCSA problems does this solve?
Package-level tracing turns every shipment into data that has to be right at both ends of the exchange.
Serial numbers at every level
Every saleable unit, case and pallet needs its own identifier, so the serial number pool grows with each packaging level. The pool has to be generated or requested per product and replenished before a line runs short.
Aggregation errors break inference
A receiver scans one case or pallet label and infers what is inside. One wrong parent to child link breaks inference for every unit below it.
EPCIS exchange with many partners
Commissioning, packing, shipping and receiving events have to reach each trading partner in a form they can process. A failed exchange with one partner can go unnoticed until product is held at receiving.
Saleable return verification
A wholesale distributor must verify the product identifier before it distributes a saleable return again. Returns arrive unevenly, so verification requests have to be sent, answered and logged without a backlog.
Partial cases and repackaging
Opening a case, building a mixed pallet or repackaging product changes the packaging hierarchy. Each change needs disaggregation and new aggregation events, or the data stops matching the stock.
Exceptions and suspect product
Data mismatches, missing events and suspect product investigations sit outside the normal flow. Without a workflow they end up in email threads and spreadsheets with no audit trail.
What do we build for DSCSA traceability?
Agnotic Technologies builds DSCSA software to your requirements: your packaging lines, your trading partners and the ERP or warehouse system you already run. We build new components or extend the ones you have.
Serialization and aggregation records
Serial number pools per product, commissioning at unit, case and pallet level, and parent to child aggregation records that stay correct when a case is opened or a pallet is rebuilt.
EPCIS event exchange with trading partners
An EPCIS 2.0 repository and partner connections that send and receive commissioning, packing, shipping and receiving events, with monitoring per partner so a failed exchange shows up quickly.
Verification request handling
A service that sends, answers and logs verification requests for saleable returns and suspect product, checking each product identifier against your serialization records.
Exception and quarantine workflows
Queues for data mismatches, missing events and suspect product, with quarantine status on the affected stock and a record of who resolved each case and how.
Product tracing responses
Lookups that assemble the transaction history for a product or lot from the events your system already holds, when a regulator or trading partner asks for it.
Audit trail
An append-only log of every commissioning, aggregation change, exchange and verification, so you can show what happened to a package and when.
ERP and warehouse integration
Connections between the traceability system, packaging line equipment, ERP and warehouse management, so shipments and serial data stay in step.
Which EPCIS events does DSCSA tracing produce?
Most package-level tracing comes down to five activities. A system may batch several containers into one event; the number of identifiers inside the events stays the same.
| Activity | EPCIS event type | CBV business step | What the event records |
|---|---|---|---|
| Serializing units, cases and pallets | ObjectEvent | commissioning | New identifiers for units, cases and pallets |
| Packing units into a case | AggregationEvent | packing | The units inside one case |
| Building a pallet from cases | AggregationEvent | packing | The cases on one pallet |
| Sending a shipment | ObjectEvent | shipping | One shipment leaving for a trading partner |
| Taking a shipment into inventory | ObjectEvent | receiving | One shipment received, written by the trading partner |
How does the packaging hierarchy set the serial count?
Every saleable unit gets its own serial number, then every case and every pallet gets an identifier of its own. The number of cases is units divided by units per case, rounded up, and pallets follow the same way from cases.
Under the DSCSA, the serial on a package or homogeneous case is part of a standardized numerical identifier that pairs the National Drug Code with a serial number of up to 20 characters. A pallet is one more identifier to generate and track; which identifier it carries is agreed with your trading partners.
Aggregation is what lets a receiver scan one case or pallet label and infer what is inside. Each parent to child link has to be right, because one wrong link breaks inference for every unit below it.
Which parts of the system carry the load?
Each part of the DSCSA data load lands on a different component of the traceability system.
Serial number pool
Identifiers per year set the size of the serial number pool you generate or request per product, and how often it is replenished.
Aggregation database
Aggregation links set database growth and the disaggregation work when a case is opened or a pallet is rebuilt.
EPCIS repository throughput
EPCIS events per day set the throughput your repository and the exchange with each partner must sustain.
Message size
Units per shipment set the size of each EPCIS document a partner receives and processes.
Partner connections
Shipments per partner per day show how many connections need monitoring, and how fast a failed exchange with one partner shows up.
Verification service
Saleable return verifications set the volume of verification requests your system sends, answers and logs.
Should you size for the average day or the peak?
Size for the peak. Annual volume divided by shipping days gives an average day, and shipping is rarely even across the year.
Your busiest month shows the load the repository and partner connections must carry on a heavy day. Returns arrive unevenly too, so size the verification service for the busiest weeks as well.
DSCSA work that is easy to underestimate
- Partial cases, mixed pallets and repackaging, which add aggregation and disaggregation events.
- The exchange of transaction information and transaction statements beyond the shipping event.
- Exception volume, such as suspect product investigations, data mismatches or corrections. How we build exception handling is covered on our pharmaceutical software development page.
- Returns that come back in a sealed homogeneous case, which can be verified once per case rather than once per package.
- Compliance dates and exemption status, which depend on your trading partner type. Confirm those against FDA guidance.
Which rules and standards set the DSCSA data load?
Short facts we build traceability systems around, each linked to its primary source.
Under the DSCSA, a standardized numerical identifier combines the National Drug Code for the product with a unique alphanumeric serial number of up to 20 characters, and identifies each package or homogeneous case.
Source: 21 U.S.C. 360eee(20) (govinfo)Before further distributing a saleable returned product, a wholesale distributor must verify the product identifier for each sealed homogeneous case or, if the product is not in a sealed homogeneous case, on each package.
Source: 21 U.S.C. 360eee-1(c)(4)(D) (govinfo)The DSCSA's enhanced drug distribution security requirements call for systems and processes to verify product at the package level, which may include the use of aggregation and inference as necessary.
Source: 21 U.S.C. 360eee-1(g) (govinfo)GS1 EPCIS 2.0 defines an AggregationEvent for objects that are physically aggregated together, as when cases are aggregated to a pallet, alongside ObjectEvent, TransactionEvent, TransformationEvent and AssociationEvent.
Source: GS1 EPCIS Standard 2.0The GS1 Core Business Vocabulary 2.0 defines business steps such as commissioning, which associates an identifier with an object, packing, where aggregation typically occurs, shipping and receiving.
Source: GS1 Core Business Vocabulary (CBV) Standard 2.0
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Which standards does Agnotic build healthcare software against?
HIPAA
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, strict access controls, and traceable audit logs.
GDPR
General Data Protection Regulation
Implement lawful consent flows, data minimization, retention controls, and secure processing for sensitive health data.
FHIR
Fast Healthcare Interoperability Resources
Enable standardized health data exchange across apps, care teams, and systems through standards-based FHIR APIs.
HL7
Health Level Seven International
Support enterprise-grade interoperability with HL7-based integrations for records, events, and clinical messaging workflows.
HITRUST
Health Information Trust Alliance
Align security programs to healthcare-specific control and risk management practices trusted by providers and ecosystem partners.
HITECH
Health Information Technology for Economic and Clinical Health Act
Design with breach notification readiness, digital record safeguards, and operational controls that support regulated care programs.
SaMD
FDA Software as a Medical Device
Plan software quality, traceability, and documentation pathways for products that may require SaMD review and submission.
MDR (EU)
Medical Device Regulation (European Union)
Prepare EU market-ready processes for risk classification, evidence tracking, and lifecycle governance under MDR expectations.
SAMHSA
Substance Abuse and Mental Health Services Administration
Apply confidentiality controls and consent-aware sharing models for behavioral and mental health data experiences.
Where should you go next?
- Pharmaceutical software developmentGxP-aligned systems, including DSCSA traceability and exception handling.
- Pharmacy management softwareDispensing, inventory and receiving workflows at the pharmacy.
- Healthcare system integration servicesConnecting serialization, ERP and partner systems.
- Healthcare interoperability engineeringStandards-based data exchange between organizations.
- Supply chain EDI volumeX12 transactions and acknowledgments exchanged with trading partners.