---
title: "Serialized Traceability: Gaps Between Pharma Partners"
description: Serialized traceability is vulnerable at handoffs between partners. Pharma manufacturers can close the gaps with CMOs, trading partners, and IT/OT teams.
---

[Blog](https://info.covectra.com/blog)

# [Serialized Traceability: Gaps Between Pharma Partners](https://info.covectra.com/blog/serialized-traceability-gaps-between-pharma-partners)

 Written by [Covectra](https://info.covectra.com/blog/author/covectra) | Oct 14, 2026, 12:00:00 PM

In the pharma supply chain, serialized traceability is vulnerable at handoffs. Whether it’s between contract manufacturers and brand owners, trading partners exchanging data, or IT and packaging line systems, a gap at any of them can leave product stuck on the receiving dock. 

In a 2025 survey of pharmaceutical manufacturing and distribution executives, 55% reported receiving data without the corresponding product at least sometimes.

Closing these gaps starts before go-live, with an engineering study of real operations, and continues after it, with a clear owner for exception handling.

## **Key Takeaways**

- **Aggregation errors reach the next partner.** In the same survey, 44% said product arrives with inaccurate aggregation data sometimes or often.
- **CMO handoffs need standard processes.** Accommodating each contract manufacturer's existing processes introduces room for human error.
- **Exception response times matter.** HDA reports that some manufacturers are slow to respond to data exception reports, and some don't respond at all.
- **IT rules can disrupt line systems.** Applying IT policies, such as password changes, to machine accounts on line systems can cause problems.
- **Prevention starts with an engineering study.** Understanding processes upfront minimizes unknowns during implementation.

## **Where Serialized Traceability Gaps Appear Between Pharma Supply Chain Partners**

In October and November 2025, Informa TechTarget surveyed 100 director-level and senior executives in pharmaceutical manufacturing and distribution about their DSCSA implementations. Most were confident in their systems, with 76% rating themselves extremely or very confident in their serialization accuracy.

They also reported regular exceptions on inbound deliveries. At least some of the time:

- 55% receive data without the corresponding product
- 49% receive product with incorrect data
- 44% receive product with inaccurate aggregation data
- 18% receive product with missing data

The survey counted these exceptions on inbound deliveries, but their causes can start earlier in the chain. FDA's guidance notes that aggregation errors may happen during the aggregation or packing process, before the product ships. 

### **At the CMO Handoff: Different Processes, One Record**

Virtual brand owners that manage product through several CMOs need a serialization platform that works with each CMO's systems. The CMOs' own processes add complexity:

- **Different operating models.** CMOs often run their business differently than the brand owners they serve, and the brand owner may not fully understand how complex those differences are.
- **Site-by-site accommodations.** With multiple CMO locations, accommodating each site's existing processes and resistance to change introduces room for human error.
- **Line-to-line differences.** Aggregation flows can differ from one packaging line to the next.
- **Custom in-house systems.** These take the most time to integrate, and project timelines need to account for it.

### **At Receiving: Aggregation Data the Next Partner Relies On**

Aggregation links each unit's serial number to its case, and each case to its pallet. Downstream partners use these parent-child records to infer what a case contains without opening it.

The DSCSA doesn't define aggregation, but FDA guidance supports it and calls it essential to trading partners' daily operations. The same guidance says the selling trading partner should reconcile its transaction information with the product it physically ships.

In the survey, 76% of respondents receive product by scanning the outermost serial number and rely on the DSCSA repository to validate the full inference. The report notes that when physical product doesn't match the repository data, the mismatch may not be identified during warehouse scanning. Line-level causes are covered in our post on[traceability software failures in pharma production](https://info.covectra.com/blog/traceability-software-failures-in-pharma-production).

#### **Examples of Aggregation Errors**

FDA's guidance gives four examples of aggregation errors a receiving partner may encounter:

- Missing product
- Extra product
- Duplicate data
- Missing case identifier

FDA recommends resolving these discrepancies within 10 business days and not selling the product to the next trading partner until they're resolved.

### **Between Trading Partners: Data Exceptions**

Data exchange between manufacturers and wholesale distributors has improved. In an[HDA member survey](https://www.hda.org/newsroom/2025/august/hda-statement-on-dscsa-implementation-milestone-for-distributors/), the median level of accurate data exchange between trading partners at the pieces level was 98.5% as of early June 2025.

[HDA's exception handling guidelines](https://hda.org/publications/exceptions-handling-guidelines-for-the-dscsa/) sort mismatches between data and product into five categories:

- Data issue
- Product, no data
- Data, no product
- Packaging and labeling
- Unavailable for distribution

Response time is part of the problem. In a[June 2025 column](https://www.oemmagazine.org/home/article/22943042/healthcare-distribution-alliance-hda-improving-dscsa-data-exchange-accuracy-during-the-fdas-phased-exemption-periods), HDA reported that some manufacturers are slow to respond to data exception reports or send corrections, and some don't respond at all.

Among surveyed executives, 93% list rejecting the product among their exception responses.

### **At the IT/OT Boundary: Office Rules on Line Systems**

Serialization systems on the packaging line are operational technology (OT). IT security teams sometimes apply standard IT rules to these systems, such as password changes on machine accounts, which can cause problems on the line.

Operations teams, in turn, are not always aware of the IT rules that affect data exchange inside the company. Firewalls, network paths, and security groups on domain servers can all cause data exchange failures.

## **How Manufacturers Close Serialized Traceability Gaps**

Addressing these gaps starts during engineering and planning, before a line goes live. Successful pharmaceutical traceability projects align people, processes, data, and technology.

- **Run an engineering study first.** On paper, the requirements look simple: generate serial numbers, print codes, exchange EPCIS data. Real operations are more complex, and an engineering study maps those processes before the design is set.
- **Bring packaging and warehouse teams in early.** Involving them late, and training them insufficiently before operations begin, are repeated mistakes.
- **Standardize CMO processes.** Engage contract manufacturers early, identify their systems at the start, and share the case for standardized processes, which also helps with validation and quality control.
- **Plan for IT and OT together.** Respect company IT rules, and work with IT to understand why some settings need to differ for OT systems.
- **Decide who handles exceptions after go-live.** Exception management, issue resolution, and trading partner support continue after implementation. Confirm whether your vendor takes on that work or whether it falls to your team.
- **Name one point of contact.** Assign one management contact instead of spreading responsibility between department heads.
- **Set realistic timelines.** Schedules need time to engage every department involved and to integrate any custom systems.

## **Serialized Traceability FAQs for Pharma Manufacturers**

### **How do we keep serialization consistent between several CMOs?**

Engage each CMO early, identify their systems and partners at the start of the project, and agree on standardized processes. Accommodating each site's existing processes introduces room for human error, while standardization helps with validation and quality control.

### **What should we do when a trading partner flags a data exception?**

FDA's guidance recommends notifying the trading partner involved, determining the reason for the error, and working together to resolve it promptly. The resolution should be documented, including the nature of the error, how it was resolved, the people involved, and the date.

### **How long do we have to resolve an aggregation error?**

FDA's guidance recommends that the purchasing trading partner resolve aggregation errors and other discrepancies within 10 business days and not sell the product onward until then. If the discrepancy can't be resolved and the product is determined to be suspect or illegitimate, verification requirements apply, including quarantine and investigation where applicable.

### **Does the DSCSA require us to aggregate our product?**

The DSCSA doesn't define aggregation, but FDA supports its use and considers it an essential part of trading partners' daily operations. FDA's guidance also recommends using aggregated data to infer case contents only when the case's security seal is intact.

## **How Covectra Supports Serialized Traceability**

Covectra provides the platform, engineering, implementation, and support for[pharmaceutical manufacturers and brand owners](https://www.covectra.com/pharma/) as a single source.[AuthentiTrack](https://www.covectra.com/products/authentitrack/), its EPCIS-certified track and trace platform, connects contract manufacturers with brand owners' traceability systems through a secure data gateway. Exception management, issue resolution, and trading partner support are included in the engagement. Covectra's[serialization engineering and integration services](https://www.covectra.com/pharmaceutical-serialization-services/) include systems integration, implementation support, and consulting.

[Request a serialization review](https://www.covectra.com/contact-us/) to find and close the gaps in your serialized traceability.

## **Related Posts**

- [Pharma Track and Trace Software: What to Look For When Switching Providers](https://info.covectra.com/blog/pharma-track-and-trace-software-switching-guide)
- [Pharma Serialization Software: What to Evaluate in 2026](https://info.covectra.com/blog/pharma-serialization-software-10-features-buyers-compare)
- [Serialization in Pharma: Driving Compliance, Safety, and Traceability](https://info.covectra.com/blog/serialization-in-pharma-driving-compliance-safety-and-traceability)

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