Manufacturing Traceability Software — Lots, Serials, Recall
Manufacturing traceability software ties every finished unit back to the supplier lot, operator, machine and shift that produced it — and forward to the exact customer who received it. When a defect surfaces or a recall hits, you isolate affected quantities in minutes, not days, with an audit trail that withstands FDA and EU scrutiny.
What the system covers
Inbound lots and ingredients
Receiving captures supplier lot, production date, expiry, certificate of analysis and incoming-QC links in a single scan.
Outbound serial numbers
Every finished unit gets a unique serial or partition lot generated by a configurable scheme, carrying its full genealogy.
Forward and backward traceability
Forward: from raw lot to every customer who received product. Backward: from customer complaint to the supplier lots and operators involved.
Recall workflow
A recall instantly produces the list of affected customers, quantities, invoices and partners — with email templates, notice printing and return tracking.
GS1 and UDI label printing
GS1-128, DataMatrix, QR and UDI labels for medical devices printed straight to Zebra and Honeywell hardware — no separate label software.
Audit trail and compliance
Tamper-evident log of actions, timestamps, operators and reasons. Built-in reports for FDA 21 CFR Part 11, EU 178/2002, FSSC 22000 and MDR 2017/745.
Who it fits
Food and beverage
EU Regulation 178/2002 demands one-step-forward, one-step-back traceability. Our lot traceability system answers in under 15 minutes — allergen, contamination or mis-labeling alike.
Pharmaceuticals
GMP, serialization and EMVS reporting under the Falsified Medicines Directive. Aggregation and commissioning messages flow to the national HUB automatically.
Automotive parts
IATF 16949 requires traceability by lot, supplier, machine and certificate. OEM warranty claims are answered in under an hour with hard evidence attached.
Medical devices
UDI-DI and UDI-PI generation, EUDAMED registration and DHF/DMR linkage. Serials underpin post-market surveillance and vigilance reporting.
How we build it
We do not resell someone else's SaaS. We build your own manufacturing traceability software on a proven stack: PostgreSQL with temporal rows and event sourcing for full history, .NET or Node.js for business logic, React/Next.js on the web, React Native on industrial terminals. REST APIs and webhooks plug into your ERP, warehouse and regulatory portals.
We start with one to two days on site, mapping how lots actually move, who scans when, where the chain breaks. From that map we lock the MVP scope — receiving with supplier lots, shop-floor production reporting, outbound serial numbers and a recall report. GS1 printing, EMVS connectors and EUDAMED export ship in later sprints. See how we approach custom ERP development and custom software development.
The system works in real time with your quality control system and order management system, so QC results automatically hold or release lots for shipment. Go-live happens in stages, support runs on an SLA — no surprises in year one.
Why Saitami for your traceability project
Recall investigation time
From 3-5 days of digging through notebooks and spreadsheets to under 30 minutes of automated reporting — averaged across food and pharma deployments.
Audit pass rate
Every client passes BRCGS, FSSC 22000 and IATF 16949 traceability audits on the first attempt after go-live.
Starting investment
Fixed price for the MVP phase. No per-user licensing, no hidden subscription. You own the system outright.
Frequently Asked Questions
How long does manufacturing traceability software take to implement?
Manufacturing traceability software typically goes live in 6 to 12 weeks for the first productive phase. A small plant with one line reaches production use in 6-8 weeks. A mid-size plant with multiple lines, warehouse and regulatory connectors lands closer to 10-12 weeks. We never do big-bang go-lives — we deploy in stages, starting with inbound receiving and supplier lots.
Does the system cover FDA and EU traceability requirements?
The system covers FDA 21 CFR Part 11 for electronic records, EU Regulation 178/2002 for food traceability, FSSC 22000 for food safety, MDR 2017/745 with UDI for medical devices and IATF 16949 for automotive parts. For pharma we ship an EMVS connector to the national HUB. The audit trail is tamper-evident with cryptographic signing on every event.
Can it integrate with existing ERP or warehouse software?
It integrates with existing ERP or warehouse software in nearly every project. We connect to Microinvest, Plus Minus, Ajour, SAP Business One and Microsoft Dynamics via API or direct database hand-off. Lots and serials sync both ways, so warehouse and accounting see the same lots production sees. You keep your ERP — we add the traceability layer on top.
How much does manufacturing traceability software cost?
Manufacturing traceability software starts from €6,800 for an MVP rollout in a small plant and typically lands between €14,000 and €32,000 for a mid-size operation with multiple lines, GS1 label printing, recall workflow and regulatory connectors. Pricing is fixed against the agreed scope, paid in milestones, and never includes per-user fees. Post-go-live support runs on a separate SLA.
Ready for end-to-end traceability?
Book a 45-minute free consultation. We walk through your lots and recall scenarios, demo our manufacturing traceability software live, and leave you with a concrete phase-one plan at a fixed price and timeline.
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