Pharma software development, in production in weeks

Move digital and AI initiatives out of pilot and into regulated production. Dreamix is a pharma software development company building validated workflow automation and integration for pharma, biopharma, CDMOs and manufacturing sites, connected to the MES, LIMS, ERP and QMS systems you already run.

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They trust us

They take pride in the development of the platform and are extremely technically proficient!

Alexander Tsiaras

CEO, StoryMD

Pilots are easy & abundant. Validated production is where programmes stall.

Most pharma organisations have no shortage of digital and AI pilots. What is scarce is the route from a working prototype to a system that runs in a GMP environment, with validation evidence, audit trails and a named owner behind it.

Programmes rarely fail in the lab. They stall at the point where the work has to be handed to QA and defended.

Scientist examining a sample at a laboratory workstation

Move AI and digital initiatives into regulated production

Putting a model or a new workflow into production in a regulated environment is an engineering and documentation problem before it is a data science one. We build for that from the first session.

Validation-ready architecture

Audit trails, access control and data lineage designed at the start, rather than reconstructed in the weeks before an inspection.

AI steps that show their work

Every input the model saw and produced, as well as every human approval, is recorded. The system supports the decision and documents it. It does not make the decision quietly.

Evidence produced as you go

Traceability matrices linking requirements to tests, and validation documentation delivered as part of the engagement rather than assembled in a rush at the end.

Have a pilot waiting for production?

Tell us where it stands today.

Automate the enterprise workflows that sit between your validated systems

MES, LIMS, ELN, ERP and QMS are usually bought separately, at different times, often by different sites. Then employees have to spend time connecting them: re-keying batch data, chasing deviation approvals by email, reconciling spreadsheets before a review, filing the same document into three systems.

This usually takes up a lot of qualified people’s time.

We build the integration and orchestration layer that closes those gaps and lets staff focus on more critical tasks.

MES

LIMS & ELN

ERP

QMS

Data historians

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Dreamix integration and orchestration layer

Production integrations with Veeva, built and running.
The same approach applies to MES, LIMS and ERP platforms with exposed APIs, plus standard exports and, where necessary, file-based interfaces.
Orchestration that propagates a completed step automatically instead of creating a manual copy task for somebody.
A single operational view assembled from the systems you already run, rather than another system to maintain.

We work alongside your existing platforms. Replacing a validated MES or QMS is a much larger programme with a much longer path to production, and it is rarely what the friction actually requires.

Ask us what it takes to connect your stack →

Quality approval checkmark over a tablet, surrounded by process icons

Release faster without sacrificing quality

In a validated environment every release carries a testing burden, and manual user acceptance testing is where the timeline goes. Automated functional and regression testing, built against your own platform configuration, shortens that cycle and catches defects while they are still cheap to fix.

Quality automation for a Top 10 Pharmaceutical Company

The client’s custom-configured Veeva Quality Management platform needed rigorous user acceptance testing, and defects traced back to unclear or outdated requirements were threatening a major module release. They had already calculated that a bug found early costs roughly ten times less to fix than one found late.

We extended their behaviour-driven development framework with generic, reusable test steps that work across the whole Veeva platform, so new modules could be covered with minimal additional effort and onboarding time came down with them.

75%

of defects identified during early development, shorter regression cycles, and a user acceptance test that users could spend on usability and business value rather than on finding bugs.

Case study →

Time from project start to a working solution in production

12 to 24 weeks

Build a focused solution from scratch and deploy the first production release.

Phased for larger programmes

Useful functionality goes live early rather than waiting for the full scope.

Both assume your integration environments and a named business or quality owner are available from week one.

Built to be validated, audited and defended

We design to GAMP 5, EU GMP Annex 11 and 21 CFR Part 11, and we work to ALCOA+ data integrity principles. Audit trails, access control and data lineage sit in the architecture from the first session rather than being added before an inspection.

Traceability matrices link requirements to tests, and validation documentation, including IQ, OQ and PQ evidence and the final report, is produced as part of the engagement. Your QA team gets what it needs to place the system in a GMP environment.

FAQs

MES, LIMS, ELN, ERP, QMS and data historians, plus the site systems around them. We have production integrations with Veeva. Others connect through vendor APIs, standard exports, OPC UA and ISA-95 patterns on the plant side and, where necessary, file-based interfaces. We start by mapping what you run and what each system is allowed to do, because that determines the shape of everything else.

Yes, and that is the usual case. We build the workflow and integration layer around your validated core systems. Replacing an MES or a QMS is a much larger programme with a much longer path to production, and it is rarely what the friction actually requires.

All three, with different starting points. Pharma and biopharma usually arrive with a pilot that cannot get into production, or a workflow spread across systems that do not talk to each other. CDMOs arrive with client-facing visibility and onboarding, where a faster and cleaner handover is a commercial advantage. Manufacturing sites arrive with the gap between the shop floor and the enterprise.

We design to GAMP 5, Annex 11 and 21 CFR Part 11, and we deliver the traceability and validation documentation with the system. Your QA team owns the validation decision. Our job is to hand them a system and an evidence pack they can defend.

60 to 90 days where an accelerator fits, from project start to production. A bespoke build reaches its first production release in 12 to 24 weeks. Both assume your integration environments and a named owner are available from week one.

A business or operations owner who can make workflow decisions, access to a test environment for the systems we are integrating with, and someone from IT and someone from QA for the integration and validation questions. We handle the rest, from discovery through production and support.

You do, entirely, including the customisations to the accelerator.