Serialization, UDI, device history records, and quality holds on an ERP built to pass an FDA inspection.
A medical device manufacturer has to show, for any unit in the field, what components went into it, who built it, which procedures were followed, what was tested, and when it shipped. Add UDI labeling, complaint handling, and a quality system that has to hold product until release, and a generic manufacturing setup falls short. NetSuite, configured by Consule for serialized, traceable production, holds the device history record in the system and the quality gates in the workflow.
Serial and lot capture at every step. Component lots and serials recorded on the work order as they are consumed, and the finished device serialized at completion, so genealogy is captured while the device is built rather than reconstructed later.
The DHR in NetSuite. Work instructions, operator sign-offs, test results, and label records attached to the work order and the serial, retrievable for any unit in seconds.
Quality gates in the workflow. Inspection and release steps that hold inventory until quality signs off, with nonconformance and CAPA records linked to the lot or serial.
Scheduling with rework built in. FactorySync plans builds against capacity and accommodates rework loops without losing the serial history.
Engineer-to-order and custom devices. For configured or custom devices, Project2Prod ties the build to the customer project and its cost.
Device history for any serial produced from the system, not assembled from folders.
Trace forward from a component lot to every device and customer affected.
Product cannot ship until quality releases it, by system rule rather than by memory.
Actual components, labor, and rework rolled up to the serial and the batch.
Configured for regulated device production
Consule configures NetSuite for serialized, lot-controlled manufacturing with quality gates, and extends it with FactorySync and Project2Prod where scheduling or project-based builds demand it. If your device history records live outside your ERP, we will walk through one product line and one inspection with you.
Yes. Serial and lot data, work instructions, sign-offs, test results, and label records are captured on the work order and linked to the finished device serial, so the DHR is retrievable from the system for any unit.
Device identifiers and production identifiers are held on the item and the lot or serial, and flow to labels produced from NetSuite or a connected labeling system.
Inspection and release are steps in the workflow. Inventory sits in a quarantine status until quality releases it, and nonconformance and CAPA records link to the affected lot or serial.
NetSuite is used by many FDA-regulated manufacturers. Validation is performed on the configured system; Consule produces the validation documentation as part of the implementation.
Consule delivers this as a NetSuite implementation, a NetSuite optimization of a system you already run, or an integration project, with ongoing support under the CARE program.
