DSCSA exception management that finds the broken link and gets held stock released the same day
Trade-data exceptions fixed with partners and held stock released same day
See one case, screen by screen ↓It is the work of resolving the mismatches a trading partner raises when the product on its dock does not match the EPCIS data it received — product with no data, data with no product, data issues, packaging and labeling, and product unavailable for distribution. DSCSA Exception Management adds six agents that classify each exception, trace it along its event chain to the broken link and draft the corrected events and the partner message, for the serialization lead to sign.
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Since FDA's DSCSA exemptions for manufacturers and wholesale distributors ended in 2025, the product on a wholesaler's dock has to match the EPCIS data the manufacturer sent. When one case serial is wrong in the aggregation data, the wholesaler quarantines the whole pallet and emails an exception. The serialization team then traces the cause by hand: the commissioning, aggregation and shipping events in the serial repository, the ERP delivery, the pack-station re-work log and the dock scan log, compared serial by serial.
Meanwhile the clocks keep running. Every verification request — a saleable return, a status check from a pharmacy — must be answered within 24 hours, and a serial whose history conflicts, a pen recorded destroyed that comes back as a saleable return, is a possible suspect product, not a routine answer. Held stock waits for the investigation, and the transaction information has to be kept for at least six years.
Estimated split for a typical product-no-data exception, from the partner's email to released stock, by hand and with the solution.
Six agents trace each exception along its event chain, draft the fix and the partner message, and keep every request on a 24-hour clock; the serialization lead signs.
7 October, 05:31: Crestline Health Supply's receiving dock in Columbus, OH scans a pallet from Northwind Bio: 12 cases, 720 Veltrimab 40 mg pens, lot VP26-0711, PO 4500088213. Here is what happens next, screen by screen, in the working solution.
Marcus Bell in Crestline's receiving exceptions sends CR-COL-26-0917: 11 of 12 cases matched, and case …0617 is on the pallet but not in Northwind's aggregation data. Crestline quarantines the whole pallet — $2.09 M held at receiving. The Exchange watcher reads the email and the receipt status, raises EX-1041 and starts its 24-hour clock.
Header: “$2.09 M held at receiving · 19 h 01 m left to answer Crestline.”
The Exception classifier files it under the industry category Product, no data, sub-type aggregation error, at 96% confidence. The Shipment reconciler builds both hierarchies — our aggregation and shipping events against Crestline's dock scan — and matches case by case: 12 cases sent, 12 scanned, 11 match, case …0617 not in our data. Every step shows its time and the record behind it.
The Shipment reconciler is read-only on the serial repository; every difference cites both records.
Case …0598 was crushed at Memphis pack station PS-2 on 5 October and its 60 pens were moved into a new case, …0617 (re-work RW-2291). The repository update that should have swapped the case on pallet …4217 timed out and was never retried, so the ship data still lists …0598. On the event chain the shipping event is marked as the broken link, and the two records sit side by side underneath.
“Broken link · Ship data says case …0598 · the dock scanned case …0617.” A cause without a cited record is reported as unknown.
Four events are drafted: an aggregation DELETE that removes case …0598 from pallet …4217, an aggregation ADD for case …0617 with its 60 pens, a destruction event for the empty …0598, and the shipping event for PO 4500088213 re-sent to Crestline Columbus. The draft is marked “needs a signature”.
The reply names the pallet's SSCC, the replacement case, the PO, lot VP26-0711 and expiry 2028-06-30, explains the re-work, and asks Crestline to release the pallet from quarantine. Sam Patel in trade customer service is copied. It can be edited before it goes.
“Please release the pallet from quarantine and let us know if anything still does not match.”
Dana reads what will be sent to Crestline Health Supply — the four steps — and signs: “I approve this correction and its release to the trading partner.” Sent now, the correction answers Crestline with 19 h 01 m left on its 24-hour clock. Above $3 M a second signature from Omar Haddad would be required; this pallet is below it.
“Signed electronically by Dana Okafor · Oct 7, 2026 10:30 · recorded on the audit trail and kept 6 years.”
Crestline accepts the corrected data and re-scans at 10:34: 12 of 12 cases match. At 10:35 the pallet is released to stock and the 720 pens are back in the channel. On the chain, the corrected events turn green and the header reads “19 h 01 m to spare · answered inside 24 hours”.
“Chain whole again · Crestline matched.”
Bayfield Drug Distribution's Sacramento returns desk asks whether a Veltrimab pen is ours (VR-77310). Its life story says it was shipped to Bayfield Dallas, reported damaged under credit CM-5512 and witnessed destroyed on 30 September. The responder stops for a person and recommends “not verified” — a possible suspect product. Lena Ortiz in distribution quality decides.
Conflicts are never answered automatically. The routine ones — 1,279 today — are, at a median of 0.31 s.
Over the last 30 days, 205 of 212 exceptions were resolved, $38.6 M of held product went back into the channel and 38,940 verification requests were answered — 100% within 24 hours, none late. The top cause is aggregation not updated after re-work, the same cause as EX-1041.
“Answered within 24 h · 100% · none late · 6-year record kept.”
The same exception, seen by the five people who carry it — what their day looked like, and what it looks like now.
Six agents trace each exception along its event chain, draft the fix and the partner message, and keep every request on a 24-hour clock; the serialization lead signs.
Watches EPCIS acknowledgements and rejections, the exceptions mailbox and partner receiving status; raises one exception per pallet and partner reference, starts its clock, 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 — with a sub-type such as aggregation error, late data, wrong GTIN, short ship or duplicate serial.
Lines up what we sent — pallet, cases and packs from our aggregation and shipping events — against what the partner scanned, case by case and pack by pack, 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 pack-station, dock scan and gateway logs and master-data changes, and says whether the cause is on our side or the partner's.
Drafts the smallest set of EPCIS events that makes our data match the physical shipment — aggregation DELETE and ADD, destruction for destroyed items, a re-sent shipping event — and the partner reply with GLN, GTIN, serial, lot, PO and tracking.
Answers verification requests from the serial repository inside 24 hours — “verified” automatically 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.
Ask in plain words why a pallet is held, what is still on the clock or which partner sends the most exceptions — or tell it what to do. Every answer points to its records.
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. 2 routine requests were waiting from the phone line and email — VR-77318 from Pinecrest Hospital Pharmacy and VR-77319 from Riverbend Specialty Pharmacy — both answered verified. Both 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 has the most and the slowest release — 83 exceptions in 30 days, 98.2% of cases matched, release in 11.6 h — and 58% of its exceptions start on our side, mostly master data. Crestline has 74 at 7.8 h, Summit Rx 55 at 9.1 h.
12 screens from the working solution, on its sample data. Pick one to see it large.
Who decides, what runs by itself and the clocks every request runs on are settings — every change is on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Signs corrected EPCIS events | Dana Okafor | Dana Okafor · Omar Haddad |
| Sends partner replies | Sam Patel | Sam Patel · Dana Okafor |
| Suspect product decisions | Lena Ortiz | Lena Ortiz · Omar Haddad |
| Second signature above | $3 M | Step from $1 M to $10 M, $1 M at a time |
| What runs by itself | Answer routine verification requests · re-send late data · draft the partner reply with every correction | Each rule on or off · weekly scorecard to each partner, Monday 07:00 (off) · stopping for a person on a history conflict is locked on |
| Verification answer warning | 6 h left | Step from 2 h to 12 h left |
| Release target for a held shipment | 24 h | Step from 8 h to 72 h, 4 h at a time |
| 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 data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (21 U.S.C. 360eee-1 — 24 hours to answer a verification request, transaction records kept not less than 6 years; FDA DSCSA exemptions for missing or incorrect trade data, 2024–2025). The five exception categories are those of HDA's Exceptions Handling Guidelines for the DSCSA. People, companies and products named on this page — Northwind Bio, Crestline Health Supply, Bayfield Drug Distribution, Summit Rx Wholesale, Lakeview Logistics, Veltrimab — are fictional: characters and sample data in the working solution.
It is the work of resolving the mismatches a trading partner raises when the product on its dock does not match the EPCIS data it received — product with no data, data with no product, data issues, packaging and labeling, and product unavailable for distribution. DSCSA Exception Management adds six agents that classify each exception, trace it along its event chain to the broken link and draft the corrected events and the partner message, for the serialization lead to sign.
The Shipment reconciler matches our aggregation and shipping events against the partner's scan, case by case. The Root-cause analyst then searches pack-station re-work logs, dock scan logs, gateway logs and master-data changes, and states the cause with a citation for every statement — or reports it as unknown when no record supports it.
Routine ones, yes: the Verification responder answers from the serial repository when the serial is active, the lot and expiry match and its history allows it. In the working solution that was 1,279 requests in one day at a median of 0.31 s. A destroyed, recalled, shipped-elsewhere or never-assigned serial stops for a person with its life story and a recommended answer.
The Exception classifier and Verification responder route any duplicate, conflicting or never-assigned serial to distribution quality. The requestor can be asked to quarantine the product, and if it is determined illegitimate, the notification to FDA and the immediate trading partners is drafted and goes out only when distribution quality signs the decision.
No. The agents never alter an existing event and are read-only on the serial repository. They draft new corrective events — aggregation DELETE and ADD, destruction, a re-sent shipping event — and nothing is sent to a partner until a person signs.
Yes. The serialization lead signs every correction with the meaning of the signature, a second person signs above $3 M, trade customer service sends partner replies, and distribution quality decides suspect product. Every signature and agent step is on the audit trail and kept 6 years.
Yes. Who signs corrections, replies and suspect-product decisions, the second-signature threshold, which rules run by themselves, the verification warning and the release target are all settings. Record retention is fixed at 6 years.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your partner connections, exception handling guideline, signers and a sample of past exceptions and verification requests — 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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