EPCIS and DSCSA: How Serialization Software Supports Compliance

Overview: Pharmaceutical serialization software is what makes EPCIS data exchange and DSCSA compliance work in practice. By managing serialized identifiers, capturing event data, and automating communication between trading partners, serialization systems transform regulatory requirements into reliable, verifiable traceability. The result is a connected pharmaceutical supply chain built on accuracy, transparency, and compliance readiness.

How DSCSA Compliance Has Entered Its Most Demanding Phase

The Drug Supply Chain Security Act (DSCSA) has reshaped how pharmaceutical products are tracked and verified in the United States. For years, manufacturers, repackagers, wholesalers, and dispensers focused on:

• Applying unique serial numbers to each product package
• Maintaining transaction histories and verification records

Now, the DSCSA’s final interoperability phase—originally due in November 2023 and under enforcement discretion through November 2025—requires those stakeholders to:

• Exchange serialized data electronically in a standardized format
• Use systems that support interoperable data sharing across the supply chain

To meet these requirements, companies rely on the EPCIS standard developed by GS1, which defines how event data—such as packaging, shipping, and receiving—is captured and shared across systems. Serialization software makes those exchanges possible, turning regulatory mandates into verifiable, auditable digital records across the pharmaceutical ecosystem.

Connecting DSCSA Requirements with EPCIS Standards

The DSCSA sets the rules for traceability; EPCIS provides the common language to carry them out. Together, they create the framework that serialization software must support.
Key DSCSA requirements addressed through EPCIS include:

• Serialization at the package level: Each saleable unit must have a unique product identifier (NDC, serial number, lot number, expiration date).
• Transaction data exchange: Trading partners must electronically share standardized transaction information (TI), transaction history (TH), and transaction statements (TS).
• Verification requests and responses: Systems must verify product identifiers at the package level to detect illegitimate or suspect products.
• Data retention and retrieval: Serialized data must be stored securely and retrievable for audits or FDA inspections.

Under these requirements, EPCIS provides the structure for that information—defining how serialized “events” are recorded and shared. Serialization software translates physical movements into digital EPCIS event records that can be exchanged seamlessly between supply chain partners.

How Serialization Software Enables DSCSA Compliance

Serialization platforms like Covectra’s manage every stage of data handling required for compliance—from serial-number assignment to EPCIS file generation and data exchange across trading partners.

1. EPCIS Event Capture and Management

Serialization software collects every event tied to a product’s lifecycle—commissioning, aggregation, shipping, and receiving—and stores it in EPCIS format. These structured records create a complete product genealogy, enabling instant verification of origin, movement, and ownership.

2. Interoperable Data Exchange

EPCIS 1.2 and 2.0 standards allow different systems to “speak” the same data language. Modern serialization software automates this communication, ensuring files conform to GS1 standards and reducing the risk of data rejection or rework.

For companies exchanging thousands of EPCIS files daily, that interoperability minimizes compliance risk and delays.

3. Audit-Ready Traceability

Every DSCSA participant must be prepared to demonstrate traceability during inspections. Serialization software centralizes event data, creating auditable records that regulators can review without manual compilation.

By maintaining a consistent EPCIS data trail, companies can confirm shipment integrity and identify anomalies such as diverted or counterfeit products.

EPCIS 2.0: Preparing for the Next Stage of Traceability

The introduction of EPCIS 2.0 marks a significant evolution in data sharing. It uses JSON and RESTful APIs rather than XML, simplifying integration with cloud-based systems. According to GS1, EPCIS 2.0 improves real-time data visibility and enables richer event detail across global supply chains.

Serialization software that supports EPCIS 2.0 prepares pharmaceutical companies for:

• Faster onboarding of new trading partners
• Streamlined data validation and error reporting
• Enhanced visibility across packaging, warehousing, and logistics operations

By adopting EPCIS 2.0-ready systems, organizations can future-proof compliance while aligning with industry-wide modernization efforts.

Common Challenges in EPCIS and DSCSA Integration

Even experienced compliance teams face obstacles when implementing EPCIS-based data exchange.

Key challenges include:

• Legacy system compatibility: Older serialization systems may not support EPCIS 1.2 or 2.0, requiring upgrades or middleware solutions.
• Data quality management: Inconsistent product identifiers or incomplete aggregation hierarchies can cause EPCIS file rejections.
• Partner readiness: Not all supply chain partners have transitioned to interoperable EPCIS systems, creating temporary data gaps.
• Security and authentication: EPCIS messages must be transmitted securely, often via AS2 or other encrypted channels, to meet DSCSA’s data integrity standards.

Serialization software mitigates these issues by validating data before exchange, supporting multiple EPCIS versions, and enforcing secure transmission protocols.

Best Practices for EPCIS Data Exchange and Serialization Management

Pharmaceutical companies can strengthen DSCSA compliance by adopting practical serialization management practices that align with EPCIS requirements.

Recommended approaches include:

• Use standardized identifiers: Follow GS1 GTIN and GLN standards across all packaging levels.
• Validate EPCIS data before transmission: Ensure event completeness, parent-child relationships, and schema conformance.
• Automate error handling: Configure alerts for data mismatches or missing events to avoid downstream compliance issues.
• Maintain synchronization with partners: Regularly test data exchange with trading partners to confirm interoperability.
• Store EPCIS events securely: Use encrypted, access-controlled repositories for all serialized event data.

These practices help companies maintain reliable, regulator-ready traceability under DSCSA mandates.

How Covectra Supports EPCIS and DSCSA Compliance

Covectra’s serialization software enables manufacturers and distributors to capture, exchange, and verify serialized data across global supply chains. Built around EPCIS and GS1 standards, the platform supports:

• Generation and management of serialized identifiers for product packaging and aggregation
• Automated creation and exchange of EPCIS event files for DSCSA compliance
• Integration with warehouse, ERP, and logistics systems through flexible APIs
• Secure data storage and audit reporting for full traceability and verification

With a proven track record in serialization, traceability, and authentication, Covectra helps pharmaceutical companies maintain compliance while improving operational transparency.

Serialization Software and the Future of Supply Chain Security

The DSCSA’s interoperability phase redefines pharmaceutical traceability. With EPCIS now serving as the primary structure for standardized communication, serialization software must evolve to manage larger data volumes, cross-partner collaboration, and real-time verification. Platforms that unify EPCIS event capture, data exchange, and compliance reporting will shape how the industry ensures supply chain integrity and patient safety in the years ahead.

As DSCSA enforcement moves closer, many pharmaceutical teams are refining their serialization and EPCIS strategies. The answers below address some of the most common questions about data exchange, compliance, and software readiness.

FAQs: EPCIS, DSCSA, and Serialization Software

What does EPCIS mean in pharmaceutical serialization?

EPCIS (Electronic Product Code Information Services) is a GS1 data standard that defines how companies record and share product-movement events such as packaging, shipping, and receiving. In pharmaceutical serialization, EPCIS enables trading partners to exchange data in a consistent format required under DSCSA.

How does serialization software help companies meet DSCSA requirements?

Serialization software manages product identifiers, creates EPCIS event files, and securely exchanges data with trading partners. It ensures every serialized package can be traced from manufacture to dispensing, meeting DSCSA mandates for traceability, verification, and interoperability.

What is the difference between EPCIS 1.2 and EPCIS 2.0?

EPCIS 1.2 uses XML for data exchange, while EPCIS 2.0 supports JSON and modern APIs for faster, more flexible integration. EPCIS 2.0 also improves event visibility and scalability for large-volume serialization programs.

Why do pharmaceutical companies need interoperable serialization systems?

Interoperability allows every DSCSA trading partner—manufacturers, repackagers, distributors, and dispensers—to exchange serialized data without format conflicts. It reduces manual rework, ensures audit readiness, and maintains supply-chain security.

How does Covectra support EPCIS and DSCSA compliance?

Covectra’s serialization software generates EPCIS event data, manages secure partner communication, and maintains verifiable audit trails. The platform aligns with DSCSA requirements and GS1 standards, helping organizations stay compliant through 2025 and beyond.

Build a Compliant and Connected Pharmaceutical Supply Chain

Covectra’s serialization software supports every stage of DSCSA and EPCIS implementation, from serial number generation to partner data exchange. Ensure accuracy, security, and full traceability across your operations. Contact Covectra to explore compliance solutions.

Read More:
What Is Pharmaceutical Serialization and Why Is It Critical Today?
DSCSA Compliance 2025: What Pharma Companies Need to Know
Assessing Your DSCSA Pharma Serialization Provider