Pharmaceuticals & Biotech
Paper batch records slow release and hide errors.
Electronic batch records, weigh-and-dispense control and review by exception.
21 CFR Part 11 · EU Annex 11 · GAMP 5
MES has to fit the regulation and the rhythm of the plant. These are the environments we configure for.
Every manufacturing environment has different requirements for traceability, quality, process control and production execution.
Paper batch records slow release and hide errors.
Electronic batch records, weigh-and-dispense control and review by exception.
21 CFR Part 11 · EU Annex 11 · GAMP 5
Every device needs a history you can hand an auditor.
Device history records, serial and lot genealogy, and enforced process steps.
ISO 13485 · UDI · 21 CFR Part 820
A recall is a race to find every affected lot.
Lot genealogy, allergen and changeover control, and traceability records ready on demand.
HACCP · BRCGS · food traceability rules
Customers audit your process control, not just your parts.
Process-parameter capture, serial genealogy, andon escalation and first-pass yield tracking.
IATF 16949 · AS9100
High-mix lines change over all day.
Line and feeder material verification, board-level traceability and machine data collection.
IPC-CFX · IPC-Hermes
Batch-to-batch consistency is the product.
Recipe management, equipment allocation and batch tracking modelled on the ISA-88 batch standard.
ISA-88 · IEC 61512
The same execution disciplines apply across manufacturing. Describe your process and we will say honestly whether an MES fits.