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.
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