SAP Business One for Medical & Healthcare
SAP Business One for medical and healthcare manufacturers secures serial/lot traceability, quality control, and MDR/ISO regulatory compliance in one system. End-to-end lot tracking keeps you audit-ready at all times and lets you identify and manage affected products fast and precisely. With inventory and service processes unified in one dashboard, error risk drops.
Secure serial/lot traceability, quality, and regulatory compliance for medical and healthcare manufacturers with SAP Business One — build audit-ready operations.
Safe, audit-ready operations in the medical sector
Serial / Lot Traceability
End-to-end traceability and recall management.
Quality Control
Digitize quality control and certification processes.
Regulatory Compliance
Secure MDR/ISO and regulatory compliance.
Inventory & Service
Bring inventory, service, and conformity processes into one dashboard.
Supply Chain
An end-to-end visible, secure supply chain.
Reporting
Audit-ready record-keeping and reporting infrastructure.
A typical transformation for a medical device supplier
Before: UDI/lot tracking and audit files were maintained manually.
After: Serial/lot traceability, quality control, and the certificate archive were built into SAP workflows.
Audit compliance
Ready at all times
Lot tracking
End to end
Error risk
Reduced
Capabilities that stand out for Medical & Healthcare
Serial/Lot Traceability
Full traceability, including UDI, and audit readiness.
Quality & Regulatory Compliance
Processes aligned with regulatory and quality standards.
Recall Management
Identify and manage affected products fast.
Cold Chain & Inventory
Stock and shipment control for temperature-sensitive products.
This solution is built on the SAP Business One platform; you can explore the implementation and integration process in our consulting services.
Common questions in medical and healthcare
01Is serial and lot traceability enough for medical products?
Serial and batch (lot) tracking are standard inventory features, so every product is traced in one chain from goods receipt to delivery. Regulation-specific code structures such as UDI do not come in standard fields; they are built with user-defined fields and configuration, and the scope is agreed during the initial analysis.
02How fast can we produce the records an audit asks for?
Traceability reports come out in minutes: a single report lists where a lot came from, which quality control it passed and which customers received it. When certificates and analysis documents are attached to the related records, the audit file does not have to be assembled separately.
03Can cold-chain temperature be monitored?
SAP Business One does not measure temperature itself; readings from measurement devices can be fed in through an integration and linked to batch records. What the standard system does handle is separating storage by warehouse and bin and using quality control steps to block non-conforming product from shipping.
04Does the system cover MDR and ISO requirements on its own?
It does not. The system carries the record-keeping, traceability and documentation side of those requirements, while the procedures of your quality management system stay with you. SAP Business One produces the data that proves those procedures were followed; which record maps to which requirement is worked out together during scoping.
Let's talk about a solution tailored to your industry
We'll adapt SAP Business One to fit your business. Schedule a discovery call.