Digitise every batch. End-to-end transparency.
OneSC is a batch orchestration and automation platform that digitises the full lifecycle across your operations including execution, quality, documentation and release. Acting as a control layer over ERP, MES, QMS and LIMS, it enables audit-ready data, governed workflows and real-time visibility without disrupting validated systems. Built for one connected supply chain across Germany, Austria and Switzerland — and beyond.
- ERPBatch BX-2041 released to packaging
- LIMSSample S-9981 — within spec
- Partner3PL ETA Frankfurt updated to 14:20
- QMSSOP-217 acknowledged by 12 operators
Batch processes still run on paper, email and spreadsheets.
Across life-sciences and chemicals, from raw materials to finished product, the batch is the unit of work AND the unit of risk. Paper records, fragmented systems and disconnected partners turn every batch into a constant chase for evidence and sign-off → resulting in out-of-stock issues, delayed batch release, QP bottlenecks, late deviation detection and incomplete audit trails across CMOs.
Detect earlier. Act faster. Release with confidence.
OneSC helps regulated organisations move from reactive investigations to proactive operational control—enabling quality, supply chain and manufacturing teams to identify risks earlier, intervene faster and maintain confidence in every released batch.
The objective isn't simply managing issues. It's preventing them.
From Recall Response to Recall Prevention
Packaging Verification
Controlled workflows, evidence capture, and electronic sign-off help ensure the right product, packaging, and documentation stay aligned throughout the batch lifecycle.
Partner Visibility
A shared operational view across CMOs, packaging providers, logistics partners, and quality teams reduces risk from manual handovers, siloed systems, and miscommunication.
Real-Time Exception Detection
Surface deviations, missing evidence, and process exceptions before release—enabling intervention before issues become complaints, investigations, or recalls.
Audit-Ready Traceability
Every action, decision, and approval is recorded in a complete digital audit trail, accelerating investigations and driving continuous quality improvement.
Measured across global pharma deployments — one of many flagship outcomes from OneSC implementations.
Audit-ready by design, not by exception.
Every action signed, time-stamped and traceable. OneSC is delivered with a full validation pack and maps to the frameworks your auditors already use.
Six capabilities. One platform.
Switch the sector to see how OneSC adapts to your operating model.
Batch execution & e-records
Electronic batch records & e-signatures replace paper end-to-end.
Real-time batch visibility
Live status of every batch, order and shipment across the network.
AI-assisted quality insights
Pattern detection across batches surfaces deviations before release. Full human oversight, audit trails and controlled deployment aligned to GxP expectations
Decentralised orchestration
One workflow language across internal sites and external CMOs.
Compliance — when you need it
GxP, GAMP 5, Annex 11 and 21 CFR Part 11 ready out of the box.
Tracing & logistics
Continuous temperature, GPS and condition tracing per shipment.
Batch orchestration. One platform.
OneSC is the control layer that digitises the full batch lifecycle across ERP, MES, QMS, LIMS, and validated systems. Built to run globally, governed locally, and audit-ready everywhere.
From workshop to production in weeks, not quarters.
Configuration delivered with validation documentation aligned to GAMP 5 and Annex 11, including traceability and audit evidence.
Discover
Workshops, partner mapping, document model agreed against your SOPs aligned with GAMP 5 lifecycle.
Design
Workflows, roles and integrations designed against your existing tech estate.
Build
Configuration, validation pack and audit-ready evidence delivered.
Operationalise
Platform in production, partners onboarded, OneSC support live.
“Sharing information and collaborating with our supply-chain partners is seamless through OneSC — enabling the rapid decision-making necessary for a robust service.”
Bringing OneSC to regulated industry across Germany, Austria and Switzerland.
Supporting YOU under EMA, EU GMP and German quality requirements. If you run regulated operations and want to see what a control tower over your tech estate looks like across your sites and partners — let’s talk.