Recall Traceability for Med-Surg & Lab Distributors

A recall answered in hours: every customer, every lot, every ship date

A recall lands, and 21 CFR 821.30 gives you five working days to produce every lot, serial, expiration, ship date and destination from three systems.

A data warehouse built specifically for medical and lab distributors answering a recall. Connect Prophet 21, your WMS, your shipping system, and the GUDID. Live in about 48 hours.

Med-surg distributorsLab products & diagnosticsSpecialty surgicalIndependent medical distributorsPhysician-office supplyLong-term care & post-acuteHome medical equipmentGPO-contracted distribution
SOC 2 Type II Your data stays in your warehouse Sits on the systems you run

The join, made visible

Every system you run — and the answers you can't get today.

Prophet 21ERP orders & invoicesInfios WMSLots & palletsShipStationShipments & trackingAccessGUDIDUDI attributesSalesforceShip-to contactsFDA & mfr portalsRecall noticesRecall lists in hoursHolds on open ordersQuarantine reconciliationWhatever you ask next

One shared key across every system. No exports, no VLOOKUP — the tools you already run, finally answering the questions that matter.

Good morning, Morgan.

What do you want to know?
Q3 Revenue
$14.2M
+11% vs Q2
Revenue by Month, Q2–Q3
AprMayJunJulAugSep
Q3 Revenue by Region
West
Southeast
Midwest
EMEA
Top Accounts
Account Region Q3 Revenue QoQ
Helix Manufacturing West $2.10M +18%
Northwind Retail Southeast $1.64M +12%
Cedar & Co. Midwest $0.98M +9%
Atlas Logistics EMEA $0.87M +0%
Published
Helix Manufacturing Manufacturing · West At risk $2.10M Aug 14 KP
Summary

Renewal due in 71 days. Usage down 12% QoQ and two support escalations open — flagged at risk by the renewal model.

Health
62/100
Atlas Logistics Logistics · EMEA At risk $0.87M Sep 09 DM
Northwind Retail Retail · Southeast In progress $1.64M Aug 22 RS
Cedar & Co. SaaS · Midwest In progress $0.98M Sep 03 KP
Vertex Health Healthcare · West Renewed $1.32M Jul 30 DM
Sable Foods CPG · Southeast Renewed $0.74M Jul 18 RS
Trigger
New Invoice When a new invoice arrives
Extract Line Items AI reads the invoice
Match to Vendor Query the vendor table
Duplicate? Branch on vendor match
true false
Flag for Review Hold the duplicate
Alert Finance Post to #finance
Approve & Post Send to the ledger
End Posted & done
Ready to run
DATA SCIENCE & ML

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Synopsis is a data warehouse for med-surg and lab distributors under 21 CFR 821.30 device tracking and FDA UDI recordkeeping, live on your own systems in about 48 hours. Prophet 21 order and invoice history, Infios WMS lot receipts, ShipStation shipment records, AccessGUDID device identifiers, and Salesforce accounts land in one warehouse keyed to the same lot. A recall becomes one query returning every customer, every lot, and every ship date, in hours instead of five working days of document pulls. Updated August 2026.

Popular pairings

The pairings that turn a recall into a query.

A trace only works if the lot, the shipment, and the customer are the same key. These pairings make them so.

Prophet 21 + Infios WMS

Synopsis integrates Prophet 21 order history with Infios WMS lot receipts and picks, so every unit shipped carries the lot it came from.

Infios WMS + ShipStation

Synopsis connects Infios WMS pick and pack records to ShipStation shipments, so a lot maps to a tracking number and a delivery date.

Prophet 21 + AccessGUDID

Synopsis joins Prophet 21 item records to AccessGUDID device identifiers, so a UDI in a recall notice resolves to your own SKUs immediately.

ShipStation + Salesforce

Synopsis syncs ShipStation shipment destinations to the Salesforce account and contact, so the notification list is built rather than assembled.

Infios WMS + Prophet 21

Synopsis integrates Infios WMS on-hand lot positions with open Prophet 21 orders, so remaining stock is quarantined before it ships.

Körber + ShipStation

Synopsis joins Körber warehouse lot movements to ShipStation outbound shipments, so a distributor on a different WMS gets the same unbroken trace.

Questions

Answers before you ask.

Can it trace a recalled lot to every customer, ship date, and unit still on hand?

Yes. WMS lot receipts, ERP orders and invoices, and carrier ship confirmations land in one warehouse keyed to the same lot, SKU, and customer, so the trace runs both directions: from a recalled lot out to every customer and ship date, or from a complaint back to the receipt and the purchase order. What is still on hand reconciles against the quarantine daily until close-out. Synopsis brings the records together for analysis; it doesn't replace your systems of record.

Does this cover 21 CFR 821.30 device tracking records?

21 CFR 821.30 asks a distributor of a tracked device to hold the lot number, the serial number, the expiration date, the ship date and the destination, and to produce them within five working days of a manufacturer request or ten working days of an FDA request. Synopsis puts those records in one queryable place: your WMS supplies the lot, serial and expiration, your ERP and carrier files supply the ship date and the destination, and AccessGUDID resolves a device identifier to your SKU. GUDID itself carries the device identifier only, never the lot, which is why the WMS side of the join does the work. Synopsis makes the data queryable; it doesn't certify FDA compliance, and your quality system stays the system of record.

Our lot numbers only live in the WMS, and the ERP has none of them. Is that a problem?

No. That split is the usual one. The WMS supplies the lot, serial, and expiration, the ERP supplies the order, the customer, and the invoice, and the carrier files supply the ship date and the delivery scan. We key all three to the same lot and customer, and that is the join the trace runs on.

Does Synopsis integrate Prophet 21 with a WMS for lot traceability?

Yes. Prophet 21 order and invoice history and WMS lot receipts land in one warehouse keyed to the same lot, so every customer, ship date, and remaining unit for a recalled lot is one query. The same holds for Infios, Körber, Blue Yonder, Epicor WMS, ShipStation, and the rest of a distributor's systems.

We run a system that isn't listed here. Can you connect it?

Usually, yes. The AI builds the connector from an export or an API, and a new system is typically flowing in days. If it can produce a file, it is a candidate.

How long until we can start asking questions?

Your first connected systems are answering questions in about 48 hours, and a full rollout lands in days, not a multi-quarter data project.

Do we need a data team or anyone who knows SQL?

No. We configure your warehouse with you and connect the systems you already run; your team just asks questions in plain English. Nobody has to write SQL or babysit pipelines unless they want to.

Does Synopsis replace the software we already use?

No. Your systems of record — ERP, CRM, accounting, and the rest — stay exactly where they are. Synopsis sits on top and joins them into one place you can query, so you report across everything instead of exporting from each tool.

Where does our data live, and is it secure?

Your data stays in your own warehouse — we don't keep a copy. Access is governed per user and every query is audit-logged. Synopsis is SOC 2 Type II, and you can review our live security posture in the Trust Center.

How is this different from a BI tool or a stack of dashboards?

BI tools chart data that something else already had to clean and join. Synopsis does that upstream work — connecting your systems, resolving entities, and enforcing your metric definitions — then answers in plain English, builds the dashboards, and traces every number back to its source.

Get started

See it on your own data.

Most demos take about 30 minutes. Bring a question you've been waiting months to answer — we'll reply within 24 hours.

Book a 30-minute demo

See Synopsis run against medical & lab distributor recall traceability data.

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