Lot and serial traceability
Every component lot and every finished serial traced from receipt through production to the customer, for UDI, recalls and field actions.
Medical device ERP that keeps lot and serial traceability, device history records and quality workflows in the same system as production, inventory, purchasing and financials.
Why device makers call us
Most medical device companies come to us at the same point: the device history record is assembled from paper travelers, lot and serial numbers live in a spreadsheet beside the ERP, and an FDA inspection or a customer audit means days of reconstruction.
SAP Business One for medical device manufacturing replaces that patchwork with one validated system of record for purchasing, supplier qualification, production, lot and serial control, quality, inventory, sales and financials, with the audit trail built in rather than bolted on.
Requirements
Eight areas where medical device ERP software earns its keep, and the ones we configure first.
Every component lot and every finished serial traced from receipt through production to the customer, for UDI, recalls and field actions.
The DHR assembled from the production order as it runs: components issued, operations completed, inspections passed, signatures captured.
Who changed what and when on every controlled record, with electronic signatures where the procedure requires them.
Incoming, in-process and final inspections against the lot, non-conformances raised from them, and CAPAs tracked to closure.
Approved supplier lists by part, certificates on file, and receiving that blocks unapproved sources.
Configuration documented for IQ, OQ and PQ, with change control on the system itself.
Shelf life on every lot, quarantine until release, and first-expired-first-out picking.
Complaints tied to the serial, service history and returns in the same record the device was built in.
FDA compliance
SAP Business One supports compliance; validation stays with the manufacturer. The system holds the controlled records, enforces the workflow you define, keeps the audit trail and produces the reports an inspector asks for. Your quality team owns the procedures and the validation package, and we document the configuration so that package is straightforward.
Zeus Scientific, a medical diagnostics manufacturer regulated by FDA, automated its data entry and moved production tracking onto Versago on the floor, so its staff now spend more time analyzing data than entering it.
The Third Wave build
SAP Business One already covers purchasing, production, inventory, quality, sales and financials. What makes it a medical device ERP is the configuration and the add-ons around it. A typical Third Wave device build includes:
Every build starts with your quality procedures, your item master and your lot and serial rules, not a template.
Sub-sectors
Different device classes, the same operating problems: records that have to trace, documents that have to match, and inspections that do not wait.
Zeus Scientific makes diagnostic test products under FDA oversight and runs production tracking and shipping on SAP Business One.
TMJ Medical, a Class III device manufacturer in the Crocker Ventures portfolio, tracks device sales, lot and serial numbers and raw materials in one SAP platform.
Customer-owned designs, device history records per customer, and job costing that shows what each run earned.
Lot and expiry tracking, quality holds and traceability aligned with FDA, ISO and cGMP requirements for distributors.
Serialized units, service contracts and preventive maintenance tied to the original sale.
GMP batch records and lot genealogy for makers on the pharma side of the line.
Client results
Two FDA-regulated manufacturers, one system.
Success StoryZeus Scientific
Medical diagnostic testing manufacturers like Zeus Scientific are highly regulated by the Food and Drug Administration. This means they need to keep track of a lot of data, and if it isn’t automated, the headcount—and headaches—go way up.
Case StudyCrocker Ventures
Crocker Ventures is a family owned venture capital firm. Crocker Ventures operates and has the majority stake in a handful of small operating companies and R&D startups.
Client reviews
They provided automated programs that have greatly reduced manual labor time, reduced errors, and simply provided data we otherwise would not have had access to easily.
They are responsive, consistent, and thorough; they are able and willing to examine the underlying business process to best understand which technological options will address the true need.
Third Wave Business Systems has been a highly valued partner, consistently helping us solve complex business challenges. They streamline operations, adapt solutions to our specific needs, and provide timely support that minimizes downtime and maximizes efficiency.
How to choose
Most lists of the best ERP for medical device companies rank vendors. The better test is whether the system can build the device history record as production runs and trace a serial in minutes. Five questions settle it.
Ask for a mock recall in the demo, on your own part numbers.
From the production order as it runs, or from a binder someone assembles afterwards. Only one of those survives an inspection.
Who, what and when on item, lot, order and quality records, and electronic signatures where your procedure needs them.
Licenses, implementation, add-ons and hosting. Our SAP Business One pricing guide lays out the ranges for a device manufacturer and what moves them.
Validation and data migration move the date more than company size. Our implementation timeline guide covers the phases, and Zeus Scientific and TMJ Medical above show the manufacturers we have taken live.
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