What a DSCSA exception really costs you

By Joe Lipari, Director of Global Traceability, Systech

Imagine the receiving dock at a wholesaler with your product on the truck. When the receiver scans a pallet and the data doesn’t match, or only partially matches due to a late file or missing serial numbers, the product is halted. It’s placed in quarantine, and a resolution clock begins.

At that point, Drug Supply Chain Security Act (DSCSA) transitions from a policy framework to an operational challenge.

Over the past 20+ years at Systech, I have observed these situations firsthand. My experience began with vision inspection and packaging automation, prior to the widespread adoption of serialization. My perspective on exceptions is grounded in direct operational experience.

In most cases, exceptions result from human error: an incorrect scan or a delayed file transmission. While the objective of DSCSA—preventing such mistakes before they impact patient safety—is straightforward in theory, it remains challenging in practice.

The clock, the freight and the report card

One exception sets a chain of consequences in motion:

• Product that can’t be verified stops moving. It sits.
• The service-level agreement (SLA) clock. Depending on your contract you may have as little as 24 hours to resolve. Miss the window, and the wholesaler puts return freight on the shipment and sends it back to you. You pay for that.
• The weekly scorecard. Wholesalers grade the industry, and they hand out report cards. Every week: the POs you should have processed, the data they got and where you fell short. You were either 100%, or you weren’t.

Cumulatively, these issues result in recurring freight expenses, lost operational uptime and diminished standing with partners.

Why do exceptions happen at all?

Most exceptions originate from human involvement, so the critical consideration is how many errors your system can prevent before they occur. If a system lacks the intelligence to intercept these mistakes, operational challenges will inevitably arise.

It is important to acknowledge that no vendor can guarantee the prevention of all exceptions. Human involvement inherently introduces the possibility of error. An effective system minimizes preventable exceptions and expedites the resolution of those that do occur.

What 40 years on the line actually buys you

Most exceptions are born long before they show up as a quarantine event at a wholesaler’s dock. They start upstream: during a line changeover, in a late file or in a messy handoff between partners. Catching them early takes more than visibility at one point in the process. It takes a system built on an understanding of how product, data and operations connect from the line to the supply chain.

That’s what four decades of operating on the pharmaceutical line gives us. We’ve worked where packaging, serialization, inspection and downstream traceability all come together, so we understand how small issues start and how to stop them before they become costly exceptions. A platform built on that line-up experience can recognize risk earlier, surface the right signals faster and help teams prevent problems before they start.

The speed of information becomes the speed of resolution

When an exception fires, what decides your day is how quickly the right person can see the record and act on it. The data is usually already there, just buried where no one can quickly reach it.

We built Systech TraceIQ to close that gap:

• Records come to the people who need them. Supply, quality and partner coordination teams get the data without digging through reports or waiting on a power user.
• The TraceIQ virtual assistant finds the record fast. An investigation that used to take an afternoon takes minutes.
• You resolve before the clock runs out. Find it, understand it, close it, before the product sits long enough to trigger return freight.

That’s the difference between clearing exceptions in hours and chasing the same one three weeks later.

How we help

Exceptions affect your margin, uptime and partner relationships every week, so the goal is a system that prevents what it can and helps clear the rest before the damage spreads.

At Systech, we’ve spent 40 years where serialization becomes real—on the line, in the plant, in the supply chain—and we built Systech TraceIQ on what that taught us. It brings serialized data to the people who manage exceptions, surfaces the right record quickly and turns exception handling into something your team can run in hours instead of weeks.

If exceptions are eating your team’s week, let’s talk. Talk to a DSCSA traceability expert today.

FAQs

What counts as a DSCSA exception?

An exception is anything that breaks the clean flow of product and data: a missing or late file, a partial scan, a serial number off by a digit or a product that arrives without matching transaction data. Six different categories of errors are listed below:

• Data issues
• Damaged product
• Product, no data
• Data, no product
• Packaging
• Product hold

Most come down to human error. Left unresolved, they trigger quarantine and start your SLA clock.

How long do we have to resolve an exception?

Usually 24 to 72 hours, depending on the SLA you’ve signed with your wholesaler or 3PL. Miss that window, and the product can be sent back with return freight on your bill. The exact terms live in your trading-partner contracts, so start there.

Can any system stop every exception?

No, and you should be wary of any vendor who claims it can. People run packaging lines, and people make mistakes. The goal is a system that prevents as many exceptions as possible at the source and helps you clear the rest fast.

Why do wholesaler scorecards matter so much?

Wholesalers grade trading partners, often weekly, on how cleanly your data and product arrive. Low scores strain the relationship and can put your shelf access at risk. Clean, consistent scorecards are a good sign that your exception handling is working.

Where does Systech TraceIQ fit in exception handling?

We built TraceIQ to bring serialization data to the operations, quality and supply teams who resolve exceptions, instead of leaving it buried in a system only a power user can navigate. Its virtual assistant surfaces the right records quickly, so issues get found and closed before they disrupt product movement.