From the bioreactor to the batch record, one validated stack.
GMP control systems and validated software for pharmaceutical and biotech manufacturers. ISA-88 batch logic, MES integration, and IQ/OQ/PQ execution designed for 21 CFR Part 11, EU Annex 11, and GAMP 5 from day one.
Three places GMP work grinds to a halt.
Validated silos
Quality, MES, LIMS, historians, and the control system all live in their own validated boxes. Data moves between them on spreadsheets and email. Every handoff is a chance for a deviation, and every change request stalls in re-validation.
Batch review bottleneck
Reviewers spend hours per batch checking electronic records against master batch records, verifying calculations, and chasing missing signatures. Release cycle time stretches from days into weeks. Production sits on inventory it cannot ship.
Migration paralysis
Legacy PLCs and unsupported SCADA platforms keep running because nobody wants to re-validate a process area. Risk grows quietly until a controller fails or a vendor drops support, and then the migration has to happen on the worst possible timeline.
Three systems we build for life sciences manufacturers.
Built for validated systems,
and measurable throughput.
Aggregate impact across recent batch automation, MES integration, and validated migration deployments. Specific projects scoped on request.
Got a GMP system that should be one validated stack?
Straight answers.
Yes. Our automation team designs and deploys GMP-compliant control systems for pharmaceutical and biotech manufacturing — PLC programming, SCADA, environmental monitoring, and process equipment integration. Our software team builds validated platforms, data pipelines, and AI applications that manage quality, regulatory, and operational data across the drug manufacturing lifecycle. Both sides are engineered for validation from day one.
Every system we build that touches GxP data is designed for 21 CFR Part 11 and EU Annex 11 from the first design decision — electronic records, electronic signatures, audit trails, access controls, and operational checks built into the architecture rather than bolted on. Risk-based validation methodology per GAMP 5 with documentation that satisfies regulatory expectations without over-engineering the effort.
Yes. We execute phased migrations in validated manufacturing environments — Allen-Bradley PLC-5 to ControlLogix, Siemens S5 to S7, and proprietary OEM controller replacements — with re-validation strategies that leverage risk-based approaches per GAMP 5. Each phase maintains validated state through the transition, with IQ/OQ documentation that minimizes validation effort without compromising compliance.
Yes, with the right validation framework. We build explainable, auditable models with the documentation, validation evidence, and change control frameworks required for GxP environments — predictive quality, process optimization, adverse event signal detection, and clinical trial analytics. Designed to support human decision-making rather than replace it, with a clear regulatory path.
Control Systems: Allen-Bradley ControlLogix & CompactLogix, Siemens S7-1500 & S7-1200, Beckhoff TwinCAT. SCADA & HMI: Ignition, FactoryTalk SE & Optix, AVEVA System Platform, GE iFIX, Siemens WinCC. MES & Batch: Ignition MES, PharmaSuite, AVEVA Batch Management, custom ISA-88 implementations. Safety: Allen-Bradley GuardLogix, Siemens F-PLCs.
Yes. We've built batch record review systems that compare electronic batch records against master batch records, verify calculations, and generate discrepancy reports — reducing review time by roughly 38% in production deployments. Deviation and CAPA workflow automation with structured investigation routing, root cause analysis tools, effectiveness checks, and trending — all within a validated framework.
Ready to talk about your project?
Whether it's a cGMP controller migration, a pharmaceutical quality management system, electronic batch records, or AI that works in a validated GxP environment — tell us what you're trying to solve.