Serialization has been a reality in pharma for years. The difference in 2026 is that more teams are being judged by what happens after the serial numbers are applied: partner data exchange, troubleshooting, verification workflows, and how quickly problems get resolved without slowing operations.
If you’re comparing pharma serialization software, focus on tools that reduce EPCIS headaches, scale across sites and partners, and help teams stay ready for DSCSA requirements without turning every change into a project.
Here are the capabilities that matter most when evaluating platforms in 2026:
1) EPCIS support that works in the real world (plus EPCIS 2.0 readiness)
EPCIS is where serialization programs succeed or stall. In 2026, pharma serialization software has to support real partner needs, not just generate events on paper.
What to look for:
2) Trading partner onboarding that doesn’t restart from scratch every time
Many teams can serialize product—but onboarding partners can still feel like repeated custom work. A platform should support repeatable onboarding and reduce long email chains and slow rollouts.
What to look for:
3) Partner testing and EPCIS file validation before launch
Failed EPCIS exchanges create delays, escalations, and rework. Testing and validation tools help teams catch problems earlier, when fixes are cheaper.
What to look for:
4) Exception management designed for high-volume serialization operations
In pharma serialization, exceptions show up in daily work: aggregation breaks, missing scans, packaging line changes, partner rejections, or corrections after shipping.
What to look for:
5) Saleable returns verification support (and workflows teams can run every day)
Returns verification is a real comparison point between serialization software platforms. Teams need workflows that support returns without turning verification into a bottleneck.
What to look for:
6) Aggregation support that matches DSCSA requirements (and stays flexible)
DSCSA traceability is commonly discussed at the saleable unit level (the package sold to the pharmacy). Some products or risk profiles may require deeper serialization levels, but DSCSA evaluation shouldn’t be framed around “unit dose” as a baseline requirement.
What to look for:
7) Integrations that don’t require constant custom work
Serialization software is part of a larger tech stack. Most teams need stable integrations across systems and sites.
What to look for:
Practical integration support for systems like:
8) Performance and scalability that fits modern volumes
Serialization can generate huge volumes of serial numbers, events, and partner transactions. In 2026, performance expectations are higher than “it eventually processes.”
What to look for:
9) Reporting that supports audits, investigations, and daily monitoring
Reporting needs to support daily operations, investigations, and audits. Operations, quality, and IT teams need fast answers when issues come up.
What to look for:
10) Security, audit logs, and access controls buyers expect in 2026
Most teams don’t buy serialization software for its security features, but security gaps create procurement delays and ongoing risk.
What to look for:
When you narrow down vendors, the best questions are the ones that force specifics—especially around EPCIS exchange and operational support.
Here are practical questions teams use during evaluation:
Many problems only appear at scale—during onboarding, production volume, and troubleshooting.
Watch for red flags like these:
Integrations require heavy custom development with limited documentation
The platform should support standard enterprise integration expectations.
Pharma serialization software decisions involve more than compliance checkboxes. In 2026, teams need a platform that supports high-volume operations, reliable EPCIS exchange, faster partner onboarding, and practical tools for verification and exception handling.
The best evaluations stay focused on outcomes: fewer partner failures, faster issue resolution, cleaner reporting, and a path to scale without repeated custom effort.
If you’re evaluating pharma serialization software for 2026 DSCSA readiness and partner interoperability, Covectra can help you review requirements, compare options, and plan next steps.
Contact us to talk with a Covectra team member.
Start with interoperability and operations. Look closely at EPCIS support, trading partner onboarding, exception handling, returns verification workflows, and reporting that helps teams respond quickly.
Ask for documentation and a clear roadmap. A strong vendor should support EPCIS 1.2 today and explain how EPCIS 2.0 fits their interoperability approach and partner exchange capabilities.
Ask what onboarding steps are standardized, what requires custom services, and what tools help validate EPCIS before go-live. Fast onboarding depends on repeatable configuration and strong testing workflows.
Ask to see how the platform surfaces EPCIS failures, aggregation problems, and missing events. Strong exception handling includes clear logs, resolution workflows, and traceability across serial numbers and shipments.
Ask how the platform supports expanding from one line or site to many. Look for proven performance at volume, repeatable integration patterns, and reporting tools that work across sites and partners.
Read More
Product Serialization Explained: How Serialized Data Connects Products, Systems, and Supply Chains
Serialization in Pharma: Driving Compliance, Safety, and Traceability
What Is Pharmaceutical Serialization and Why Is It Critical Today