We specialise in advanced process control and Manufacturing Execution System (MES) solutions built for the life sciences industry — with a deep focus on biotechnology and regulated manufacturing environments.
Validation asks whether the system does what you said. Release asks whether you recorded what you did, and did it under control. We built one model that answers both.
makeHistori brings a blend of domain expertise, platform knowledge and innovative thinking to every engagement. We work end-to-end — from initial user requirements through to validated functional specifications — in accordance with GAMP 5 and ISPE best practice, so regulatory compliance and audit-readiness are built in at every stage rather than assembled at the end.
We work across platforms and vendors, and we also build our own. Where a client's operational reality is best served by an established DCS or MES product, that is what we specify and deliver. Where it is better served by a modern, namespace-first architecture, we have built one — VData. The choice stays the client's; the standards work is the same either way.
End-to-end project delivery across process automation and MES landscapes — user requirements, functional and design specification, configuration, and qualification — to GAMP 5 and ISPE best practice.
Platform experience
Bridging traditional automation and cloud-native architecture, with depth on the AWS platform stack:
The aim is to unlock insight, improve visibility and enable rapid iteration — inside validated, GxP-compliant environments, not alongside them.
Designing and implementing robust data flows across the old and the new, so brownfield systems reach modern cloud or on-premises platforms without discarding the investment already made.
Legacy OT
Modern IIoT
Assessing, planning and implementing an architecture that matches your compliance, scalability and digital maturity — without compromising data integrity or operational reliability. That means being honest about the trade-offs between:
Most real plants need a considered path between the two, not a wholesale conversion to either.
Alongside the consulting work we build VData — a family of manufacturing applications that share a single modelled namespace, so the data that runs the plant is the same data that releases the batch.
It rests on one idea: bring the plant's irregular sources into a fixed, modelled Unified Namespace, and build every application on the assumption that the model is there. Signals are mapped and given meaning once — an ISA-95-shaped hierarchy of enterprise, site, area, line and unit, with versioned equipment profiles beneath — and after that, orders, operations, logbooks, review and release all read the same picture of the same plant.
The suite runs today as a working platform used for demonstration and pilot work.
We combine industrial-grade engineering with modern digital tools to drive efficiency, traceability and innovation in life sciences manufacturing. Whether you are upgrading legacy systems, designing a new facility, or implementing a cloud-based MES architecture — we can help.
info@makehistori.com