Who Should Be Involved When Evaluating Pharmaceutical Serialization Software Vendors
By Covectra | Posted on September 24, 2026
Choosing among pharmaceutical serialization software vendors affects packaging lines, warehouse operations, IT security, DSCSA compliance, budgets, and contract manufacturing relationships. The selection team needs a representative from each of those areas:
- An executive sponsor
- Operations
- Packaging and warehouse staff
- IT and IT security
- Regulatory affairs and quality
- Finance
- Contract manufacturers that handle your product
A single point of contact coordinates the group and owns the final decision. Each function brings knowledge that the others lack, and leaving one out narrows what the team can evaluate.
Key Takeaways
- Serialization decisions involve many departments. A serialization vendor affects packaging, IT, compliance, finance, and contract manufacturing partners.
- Executive sponsorship shapes the outcome. Without senior management involved, serialization gets evaluated only as a cost of goods sold.
- The people closest to the line know the operation. Packaging and warehouse staff offer a firsthand account of daily operations.
- IT and OT perspectives need to meet early. IT security rules can conflict with the needs of packaging line systems.
- Bring CMOs in at selection. Contract manufacturers run their businesses differently, and those differences shape what a vendor needs to support.
- One owner keeps the decision moving. A single point of contact prevents responsibility from being split among department heads.
Why Pharmaceutical Serialization Vendor Selection Needs a Cross-Functional Team
A pharmaceutical serialization vendor decision reaches further into the organization than its name suggests. The system runs on packaging lines, exchanges data with trading partners, operates within IT security policies, and carries DSCSA obligations. Each of those areas has an owner, and each owner sees a different set of risks.
How Business Buying Groups Work
Industry data shows both the number of parties involved and the challenges that can bring.
- 13 people take part in the average B2B buying decision (Forrester, 2024).
- 89% of purchases involve two or more departments (Forrester, 2024).
- 74% of buyer teams show unhealthy conflict, such as conflicting objectives or disagreement on the best course of action (Gartner, 2025).
- Buying groups that reach consensus are 2.5 times more likely to report a high-quality deal (Gartner, 2025).
More people at the table means more expertise but also more potential for friction. The goal is a team that covers every affected function and can still reach agreement.
What Alignment Looks Like
Selection teams that work well include engaged representatives from every organization the system affects. They treat the decision like a four-legged stool: people, processes, data, and technology all need to be aligned before the vendor choice can be made.
The Functions That Need a Seat at the Table
Here is what each function brings to serialization vendor selection, and what the team loses when that seat is empty.
Executive Sponsor
An executive sponsor connects the vendor decision to the organization's strategic goals. The sponsor is positioned to ask how serialization could increase the likelihood of organizational success, a question that falls outside any single department's scope. The sponsor also has the authority to bring every affected function into the process.
What Goes Wrong Without Them
Without senior management involvement, serialization gets evaluated as a cost of goods sold. The team chooses a pharmaceutical serialization vendor to meet a compliance requirement and doesn't explore what the serialization data could do for the business.
Operations
Operations knows how the organization's processes run. Selection teams that work well understand those processes up front and communicate requirements clearly, which minimizes unknowns once the project begins.
What Goes Wrong Without Them
Vendors can only design for what they are told. Line details that aren't shared during selection can turn into surprises during installation.
Packaging and Warehouse
Packaging and warehouse staff work with the processes that a serialization system touches every day. Bringing them into discussions early gives the selection team a firsthand account of daily operations from the people who will use the system.
What Goes Wrong Without Them
When packaging and warehouse staff join the conversation late, the people closest to the work have had no input on the choice.
IT and IT Security
Serialization systems run on the operational technology (OT) side of the business, including packaging line equipment and the machine accounts that support it. IT security rules don't always fit OT systems. A routine policy like periodic password changes can cause problems when applied to machine accounts on a packaging line.
The reverse holds as well. Operations teams may not know the IT rules that govern data exchange, such as firewall settings, network paths, and security groups on domain servers.
What Goes Wrong Without Them
Conflicts between IT policy and OT requirements can cause data exchange failures. Selection teams that work well respect company IT rules while listening to why an OT solution may need adjustments. Having IT security involved during selection means those adjustments can be discussed with prospective serialization software companies before a commitment is made.
Regulatory Affairs and Quality
Regulatory affairs knows the compliance obligations the system has to meet. Quality brings validation into the conversation. Every serialization system has to be validated, and validation is a cost consideration in any vendor decision.
What Goes Wrong Without Them
When regulatory timelines aren't part of the selection plan, compliance work can be pushed to the last possible minute. That leads to compressed schedules and suboptimal launches.
Finance
Serialization is a cost of goods sold, so the vendor decision affects the cost of every product the system serializes. For manufacturers considering a change of serialization provider, finance also weighs switching costs, including revalidation. Finance should also be part of reviewing the pricing questions in a vendor evaluation checklist, such as whether support and exception management are included or billed separately.
What Goes Wrong Without Them
When finance joins only at the approval stage, the team may have shortlisted vendors without a clear view of how costs, including switching costs, would be structured over time.
Contract Manufacturing Partners
Contract manufacturers run their businesses differently from the brand owners they serve, and the complexity of those differences is not always understood by the brand owner. For companies working with multiple CMOs or locations, standardized processes are the goal, and CMOs need to help shape the decision for standardization to work.
What Goes Wrong Without Them
Trying to accommodate each CMO location's existing processes, along with resistance to change, introduces room for human error. Custom in-house systems also take the longest to integrate. When CMO systems and partners aren't identified at the start, timelines don't account for that work.
Give Every Seat at the Table the Same Starting Point
A cross-functional selection team works best when everyone evaluates vendors against the same questions. Covectra's executive brief, Serialization Doesn't Have to Be a Cost of Doing Business, examines why underperforming vendor relationships persist and what they cost the business. It also includes vendor questions organized by service model, platform, pricing, and implementation, giving operations, IT, finance, and regulatory affairs a shared framework to work from.
How to Structure the Serialization Vendor Selection Team
Getting the right functions involved is the first step. How the team is organized determines whether it can reach a decision.
Name One Point of Contact
Successful organizations give management one point of contact for the decision instead of splitting responsibility among department heads. The executive sponsor provides authority. The point of contact keeps the process moving, gathers input from each function, and serves as the main contact for prospective vendors.
Agree on Objectives Before Vendor Conversations
Clearly articulated objectives give every function a shared definition of success. When operations, IT, finance, and regulatory affairs agree on what the system needs to accomplish, vendor conversations stay focused, and disagreements get worked out internally before they reach the vendor.
Give Every Department Time in the Schedule
A timeline that leaves out the time needed to engage every department is unrealistic from the start. A workable selection schedule includes time for each function to review requirements and weigh in.
How Covectra Works With Serialization Selection Teams
Covectra is a serialization and brand protection company headquartered in Westborough, Massachusetts, with over four billion serial numbers issued worldwide.
One Provider for the Full Program
The platform, the implementation, the engineering, and the ongoing support all come from a single source. For a selection team, that means fewer vendor relationships to evaluate and manage.
Support for the Selection Process
Engineering and consulting services include support for the vendor decision itself:
- Serialization vendor assessment and selection
- Serialization technology assessment
- Serialization requirements and compliance planning
Built for Teams Without Serialization Specialists
The service model is designed for mid-size manufacturers and virtual brand owners. These pharmaceutical serialization services are included as part of the engagement:
- Exception management and issue resolution
- System maintenance
- Trading partner support
The platform is built for teams without dedicated internal serialization specialists.
Support for Multiple CMO Relationships
AuthentiTrack is EPCIS certified and enables interoperability between contract manufacturers' and brand owners' traceability systems through a secure data gateway. That makes it well suited for brand owners managing product data from multiple CMOs.
Questions About Selecting Pharmaceutical Serialization Software Vendors
Who should own the decision when we select a serialization vendor?
One point of contact should own the process, backed by an executive sponsor with the authority to bring every affected department in. Splitting responsibility among department heads makes it harder to reach a decision and harder for vendors to know whose requirements take priority.
When should we bring our contract manufacturers into the serialization vendor selection?
At the start. CMOs run their businesses differently from brand owners, and custom in-house systems take the longest to integrate. Identifying CMO systems and partners early helps the team set a realistic timeline and build toward standardized processes.
What happens if a department is left out of the serialization vendor selection?
It depends on the seat. Without an executive sponsor, the decision stays tied to compliance. Without IT security, policy conflicts can cause data exchange failures. Without regulatory input on timing, schedules can become compressed. Without CMOs, integration work goes unplanned.
Give Your Selection Team a Shared Starting Point
A serialization vendor decision belongs to more than one department, and every function at the table needs the same information to weigh in. Covectra's executive brief, Serialization Doesn't Have to Be a Cost of Doing Business, gives that team a common set of vendor questions and a clear picture of what serialization looks like when it is working the way it should.
You can also contact us at Covectra by calling (508) 614-5843 or filling out this form. Let’s discuss your serialization needs.
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