Traceability as a property of the record
Lot and serial tracking is configured through receipt, production and shipment, so tracing a unit is a query rather than an investigation.
Medical devices
A device business can be run well for years and still be one untraceable lot away from a very bad quarter.
In short
Medical device manufacturers need traceability that holds up under audit across a supply chain they only partly control. TechCloudPro implements Oracle NetSuite for lot and serial tracking, bill of materials and multi entity consolidation, with privileged access controls over the systems holding that record.
What an audit tends to find
- Lot and serial traceability has to survive an audit, and parts of the chain sit with suppliers.
- A recall simulation takes days when it should take minutes, because the record spans several systems.
- Quality documentation lives apart from the transactional record it describes.
- Contract manufacturing means owning inventory that the business cannot physically see.
- The systems holding the regulated record have privileged accounts nobody has reviewed recently.
How we work with device companies
Bill of materials that matches the built product
Assembly and revision structures are set up so the documented product and the shipped product are the same thing.
Visibility into outsourced production
Owned inventory held at a contract manufacturer is tracked as inventory, which is what keeps the traceability chain unbroken across the handover.
Control over the systems holding the record
Privileged access to the systems of record is managed deliberately, because the integrity of the regulated record depends on who can change it.
This sector in depth
- NetSuite for Medical Device CompaniesTechCloudPro implements NetSuite for medical device manufacturers: serial and lot traceability, controlled change, supplier qualification and audit evidence that holds up.
The practices that apply
- Oracle NetSuite and ERPCloud ERP end to end, from OneWorld multi subsidiary consolidation to SuiteCloud development against your own processes.
- CybersecurityPrivileged access and machine identity, including the AI agents quietly becoming your most privileged users.
- AI and automationPrivate AI deployment, enterprise retrieval, and agentic workflows built inside the systems your business already runs on.
Related reading
- QMS and ERP Integration for Medical Device CompaniesQMS and ERP integration for device companies. The trouble lives in the overlap between the two. How to set the boundary so every record has exactly one owner.
- Third Party Access Management in a Device BusinessThird party access management for device businesses. Engineers, contract manufacturers and vendors need access. How to grant it without standing privilege.
- Medical Device Traceability from Component to RecipientMedical device traceability from component to recipient. Where serialisation beats lot control, where chains break, and what a device history record needs.
Where we work from
- United StatesDelivery and commercial teams working United States business hours, across ERP, AI, identity security and specialist hiring.
- IndiaThe engineering and delivery base, running the build and support side of implementations across both time zones.
Questions device companies ask
- Does NetSuite support lot and serial traceability
- Yes, through receipt, production and shipment. The implementation work is in making sure the chain is unbroken where production is outsourced.
- How fast should a recall simulation be
- It should be a query rather than a project. When it takes days, the usual cause is that the record spans several systems that were never joined.
- Can contract manufacturing stay inside the traceability chain
- Yes, provided owned inventory at the third party is tracked as inventory rather than treated as a purchase that appears on receipt.
Start with your situation
Describe what is not working. We will tell you which practice it belongs to.
Book a consultationOther ways to reach us