DSCSA exception handling and verification, with six agents tracing every mismatch
Every trade-data exception fixed with the partner, and held stock released the same day.
See one case, screen by screen ↓When a wholesaler scans a pallet and cannot match it to your EPCIS data, the pallet is quarantined at receiving. The product is right; the data is not. An aggregation that was never updated after re-work at a pack station, a shipping event that hit a partner gateway that was down, a packaging line set up with the wrong GTIN — and millions of dollars of product sit on a dock waiting for you.
Fixing it means reading the partner’s exception email, pulling our aggregation and shipping events, the serial repository and the ERP delivery, matching them case by case against what they scanned, digging through pack-station and dock logs for why they differ, then writing the corrected events and a reply in the fields the partner expects. Meanwhile verification requests keep coming — saleable returns, suspect product checks — each with a 24-hour answer the law sets.
Estimated split, in hours, for a held pallet — by hand and with the solution.
Six specialist agents catch, sort, trace and fix every exception and answer serial checks inside 24 hours; the serialization lead signs.
Crestline Health Supply’s Columbus dock cannot match one case on a pallet of Veltrimab pens to our data, and at 09:12 its exception email arrives. Here is what happens next, screen by screen, in the working solution.
Dana opens the desk and sees the lanes from Plant 5 in Raleigh through the Memphis DC to five wholesaler docks. $5.26 M is held at receiving across 5 pallets, 8 exceptions are open, 1,284 verification requests came in today, and 98.6% of cases matched on arrival this month against a 99.5% target.
Latest from the exchange, 09:12: “Crestline Columbus holds pallet …4217 — product, no data.”
EX-1041 opens with everything about the shipment: PO 4500088213, delivery 80041377, pallet SSCC, GTIN, lot VP26-0711, 12 cases, 720 pens, $2.09 M. Marcus Bell’s email from Crestline’s receiving exceptions team sits underneath: one case on the pallet is not in our aggregation data, so the full pallet is in quarantine.
“11 of 12 cases matched. Case (00) 003712345000006171 is on the pallet but is not in your aggregation data.”
The Exchange watcher links the email to Crestline’s “unmatched” receipt status for pallet …4217. The Exception classifier files it as Product, no data — aggregation error, at 96% confidence. The Shipment reconciler lines up 12 cases sent against 12 scanned: 11 match, and case …0617 is not in our data. Each record opens in the evidence panel as it is read.
Case by case, the reconciliation shows our data lists …0598, which is not on the pallet, and Crestline scanned …0617, which is not in our data. The pack-station re-work log RW-2291 explains it: on Oct 5 case …0598 was crushed at the Memphis pack station and its 60 pens moved into new case …0617. The repository update timed out and was never retried. The pens, lot and quantity are right.
From the re-work log: “Aggregation update queued to repository — sync status: FAILED (timeout), not retried.”
Four EPCIS changes, drafted and marked “Draft · needs a signature”: an aggregation DELETE taking …0598 off pallet …4217, an aggregation ADD putting …0617 on it, a destroying event for the empty case …0598, and the shipping event re-sent to Crestline Columbus. The reply to Marcus Bell is drafted in the fields Crestline expects, with Sam Patel copied.
Nothing leaves the company without a signature.
The signing screen lists exactly what will go to Crestline Health Supply. Dana picks the meaning of her signature — “I approve this correction and its release to the trading partner” — and enters her password. The signature is recorded on the audit trail and kept 6 years. At $2.09 M the release is under the $3 M threshold, so one signature is enough.
Four EPCIS events go to Crestline and are acknowledged in 0.4 s, and Dana’s reply follows. Crestline re-scans the pallet: 12 of 12 cases match. The watcher records the release of $2.09 M from quarantine and closes EX-1041. Every step — agents and people — is on the activity record.
“Crestline released $2.09 M from quarantine · EX-1041 closed.”
VR-77310: Bayfield Drug Distribution asks to verify a Veltrimab pen returned as saleable in Sacramento, with 22 hours left. The Verification responder parses the identifier and finds 6 events for the serial — commissioned at Plant 5, shipped to Bayfield Dallas, reported damaged under credit CM-5512, destroyed on Sep 30, and now back as a saleable return. The history conflicts, so it stops for a person.
“This pen should not exist.”
The identifier is genuine, so the pack may have been diverted instead of destroyed — a possible suspect product. The recommended answer is not verified, with the requestor asked to quarantine the pen and a suspect product investigation opened. Lena decides, and the 24-hour clock stops when she sends the answer.
If the product is illegitimate, FDA and partners are told within 24 hours.
The same desk, seen by the four people who run it — what their day looked like, and what it looks like now.
Six specialist agents catch, sort, trace and fix every exception and answer serial checks inside 24 hours; the serialization lead signs.
Watches EPCIS acknowledgements and rejections, the exceptions mailbox and partner receiving status; raises an exception and re-sends late data under the rule.
Puts each exception in the industry categories — product no data, data issue, data no product, packaging and labeling, unavailable for distribution — and the sub-type.
Lines up what we sent — pallet, cases, packs from our aggregation and shipping events — against what the partner scanned, and pulls the ERP delivery.
Finds why the data and the product differ — re-work at a pack station, a failed message, master data, a short pick — from warehouse and system logs, and says whether the cause is on our side or the partner’s.
Drafts the smallest set of corrected EPCIS events that makes our data match the physical shipment, and the reply to the wholesaler with GLN, GTIN, serial, lot, PO and tracking.
Answers verification requests from the serial repository inside 24 hours; answers “verified” on its own only when the serial is active, lot and expiry match and its history allows it.
Signs every correction. The agents propose; a named person decides.
Anyone on the desk can ask in plain words — or tell it what to change. Answers cite the records they come from.
Why is the Crestline Columbus pallet held?
Crestline is holding pallet …4217 — 720 Veltrimab pens, $2.09 M — because case …0617 is on the pallet but not in our data. Case …0598 was crushed at the Memphis pack station on Oct 5 and its pens moved into …0617; the aggregation update failed, so our data still lists …0598. The fix is two aggregation events and a re-sent shipping event.
Answer the routine verification requests now
Done. Two routine requests were waiting from the phone line and email, both answered verified: the serials are active and the lot and expiry match. The three requests with a conflict stay with a person — the most urgent is VR-77310, a pen recorded destroyed on Sep 30.
Add a rule: re-aggregate every re-worked case before it ships
Done. A pallet with a re-worked case now cannot ship until the repository shows the new case on it. This is the cause behind 31% of our exceptions in the last 30 days, including EX-1041. The rule is on in Settings, Priya Raman is told, and it is on the audit trail.
Which partner sends us the most exceptions?
Bayfield: 83 exceptions in 30 days, 98.2% matched on arrival and an 11.6 h median to release, the slowest of the three. 58% of its exceptions start on our side, mostly master data.
13 screens from the working solution, on its sample data. Pick one to see it large.
Who signs, what runs by itself and the clocks the desk keeps are settings.
| Setting | Default | Choose from |
|---|---|---|
| Signs corrected EPCIS events | Dana Okafor | Dana Okafor · Omar Haddad |
| Sends the reply that releases a held shipment | Sam Patel | Sam Patel · Dana Okafor |
| Decides suspect or illegitimate product | Lena Ortiz | Lena Ortiz · Omar Haddad |
| Second signature above | $3 M | $1 M to $10 M |
| Warn the owner of a verification answer | 6 h left | 2 to 12 h left |
| Release target for a held shipment | 24 h | 8 to 72 h |
| Re-send late data on its own | On | On · Off |
| Record retention | 6 years | Locked |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample trade data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published requirement (21 U.S.C. 360eee-1: verification within 24 hours, records kept 6 years; FDA DSCSA exemptions for missing or incorrect trade data, 2024–2025). People and companies named on this page are characters in the working solution.
A mismatch between the EPCIS data a manufacturer sends and the product a trading partner receives. The industry groups them as product with no data, data issue, data with no product, packaging and labeling, and unavailable for distribution. Until it is fixed, the partner usually holds the affected product at receiving.
The Shipment reconciler builds both views of the pallet — from our aggregation and shipping events and the serial repository, and from the partner’s scan — and matches them case by case and pack by pack. The Root-cause analyst then searches pack-station re-work, dock scan, gateway and master data logs, states the cause with citations and says whether it started on our side or the partner’s.
No. The Correction & reply writer drafts the corrected events and the partner reply; nothing leaves the company until a named person signs, with a second signature above the threshold you set. The one thing it does on its own is re-send late data when the product arrived before the data and our events already exist — a rule that is on in the working solution and can be turned off.
Requests arriving through the verification router, email or phone are checked against the serial repository. Routine ones — serial active, lot and expiry matching, history allowing it — are answered automatically. Destroyed, recalled, shipped-elsewhere or never-assigned serials stop for a person with the serial’s life story and a recommended answer, and the owner is warned before the 24 hours run out.
It always goes to distribution quality. The recommended answer is “not verified”, the requestor is asked to quarantine the product and a suspect product investigation is opened. If the product is found illegitimate, the notification to FDA and every immediate trading partner is drafted for signature, inside the 24 hours the law allows.
Yes. Each partner has a scorecard: the share of cases matched on arrival, exceptions by type, where the cause started and the median time to release. It can be shared with the partner, and a weekly send can be switched on in Settings.
Yes. The agents investigate and draft; people sign every correction and reply, decide every conflicting verification and every suspect product, and can send a draft back to the agents with a note. Every step by an agent or a person is on the record and kept for 6 years.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your partner connections, the exception guideline you follow and a sample of past exceptions — and it goes live once every quality gate has passed. We will walk you through it on your own exceptions first.
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1-min filmWe’ll run the DSCSA Exception and Verification Desk on a sample of your own partner exceptions.