Most pharmaceutical manufacturers chose their serialization vendor under pressure. The DSCSA compliance deadlines were firm, the vendor options were limited, and getting the system running took priority over getting it right. A decade later, many of those same relationships are still in place — not because they're working well, but because switching feels harder than staying.
That calculus is worth revisiting. The serialization vendor market looks different today than it did when most contracts were signed. And the questions that didn't get asked the first time around deserve answers before the next renewal arrives.
This post walks through a serialization vendor evaluation checklist: the criteria that matter most when assessing a current provider or evaluating a new one for the first time.
When the FDA established the DSCSA compliance timeline, a handful of vendors were positioned to provide serialization services at scale. Most pharmaceutical manufacturers — mid-size companies, virtual brand owners, contract manufacturers — made vendor decisions under time pressure, with limited basis for comparison.
Those vendors scaled up aggressively to meet compliance demand. They are now rationalizing that infrastructure. Employee reviews on Glassdoor from 2024 and 2025 document repeated rounds of restructuring at major serialization providers, with technical and service teams bearing a disproportionate share of the cuts.
The companies that built market presence on early positioning are delivering a different level of service than the one their customers signed up for. Many of those original contracts are now coming up for renewal. Most will be renewed without serious evaluation — not because the service is good, but because switching feels harder than staying.
The costs of poor serialization vendor performance tend to get distributed among departments, attributed to different causes, and never add up to a number that points back to the vendor. Staff hours spent on exception management get charged to operations. Inventory delays get attributed to distribution. Rework gets absorbed by quality. The vendor relationship stays off the ledger.
In practice, the impact shows up across several functions:
That accounting makes it easy to avoid two questions that deserve a direct answer: what is the current arrangement actually costing, and what would a better vendor relationship be worth?
Serialization Doesn't Have to Be a Cost of Doing Business — Covectra's executive brief examines why underperforming vendor relationships persist, what they cost the business, and what serialization looks like when it is working the way it should. Download the Executive Brief.
Whether you are assessing a current provider or evaluating one for the first time, these are the questions that matter.
A useful benchmark: the platform your team uses every day should not require outside expertise to operate. In some cases, platform complexity is a byproduct of building for enterprise scale. In others, it functions as a switching cost — a system so difficult to untangle that leaving becomes harder than staying. Either way, the cost is carried by the client.
Vendors that offer serialization implementation and support as part of their engagement — rather than handing off at go-live — significantly reduce the risk of disruption during a transition.
The reluctance to switch serialization vendors in a regulated environment is understandable. The original implementation was a significant undertaking, and the idea of repeating any version of it is enough to end the conversation before it starts.
The validated system concern carries more weight for packaging line hardware, where a switch involves physical installation, revalidation, and line disruption. For cloud-based serialization platforms, the process is more contained. Migrating to a new provider involves data migration, trading partner connectivity, and user training — a defined scope with a measurable timeline.
One mid-size pharmaceutical manufacturer that migrated its serialization system to Covectra saw line throughput improve by 40% following the transition. The improvement came not from the migration itself but from what followed: a vendor relationship structured around owning operational complexity rather than passing it to the client.
For virtual brand owners managing product through multiple CMO relationships, the vendor question looks slightly different, but the stakes are comparable. Rather than switching a system they operate themselves, they are choosing a cloud platform that needs to work reliably across the different systems their CMOs use. That interoperability requirement is where many standard pharmaceutical serialization software platforms fall short, and it deserves specific attention when evaluating a prospective vendor.
When the vendor owns the operational complexity — exception management, issue resolution, system maintenance, trading partner support — the client's relationship with serialization changes. The function stops consuming internal resources and starts generating information the business can use.
A 2026 analysis in Pharmaceutical Technology makes a broader argument that the industry has been slow to address: serialization data, when properly managed, is a source of operational intelligence. Organizations making use of it are finding value in three areas:
Serialization handled this way stops being overhead. It becomes a function the business can rely on and, over time, build on.
Timeline varies depending on the complexity of your trading partner network and existing system configuration. Cloud platform migrations are significantly more contained than standing up a new serialization program from scratch — data migration, trading partner connectivity, and user training are the primary workstreams. A realistic timeline depends on the scope of your current setup and the vendor's implementation support model.
The costs tend to be distributed rather than visible in one place. Staff hours spent on exception management, time lost to investigations and rework, manual workarounds that become embedded in daily operations, and slow vendor response times all carry a cost that rarely gets attributed to the vendor relationship directly. The question is whether those costs, calculated honestly, exceed what a switch would involve.
Not necessarily a different type, but a platform that handles interoperability well is a specific requirement for virtual brand owners managing product through multiple CMOs. When brand owners and contract manufacturers are running different systems, the serialization platform needs to manage the messaging format differences that creates — otherwise that complexity falls to the brand owner to manage manually.
The most important criteria are service model, platform usability, pricing structure, and transition support. Specifically: does the vendor take ownership of exception management and support, or does that work fall to your team? Is the platform operable without dedicated internal specialists? Does the pricing model include support or bill separately for incidents? And what does the vendor's implementation and transition support look like in practice?
Yes — with proper planning and a vendor experienced in managing transitions. The key is understanding the scope of what a migration involves for your specific situation: data migration, trading partner connectivity, any revalidation requirements, and the timeline for each. Working with a vendor that has managed transitions from major incumbent providers reduces the risk of disruption significantly.
Covectra's executive brief — Serialization Doesn't Have to Be a Cost of Doing Business — walks through the full vendor evaluation framework and what a better-structured vendor relationship looks like in practice. Download the Executive Brief.
Have questions about your current serialization setup? Contact our Covectra team directly.
Keep Learning