AI Governancefor pharma.
Flownium deploys on-premise, connects to your QMS, ERP and LIMS without replacing them, and structures traceable, auditable, compliant AI workflows. Your data never leaves your environment.
A platform designed to accelerate critical processes
Flownium structures workflows, orchestrates data from your systems and ensures traceable, governed execution.
Structure workflows
Visual & intuitive workflow design. Configurable business rules.
Orchestrate data from your systems
QMS, ERP, LIMS, EDMS… No system replacement.
Ensure traceability & auditability
Complete workflow history. AI interaction logs. Decision justification. Audit-ready export.
AI only operates within a workflow-validated framework
Roles, validations & governed decisions. Workflow versioning and governance. Every decision is demonstrable.
On-premise deployment
Your data never leaves your infrastructure. No cloud dependency. Full compliance with your security policies.
Why is Flownium different?
Processes become executable
In critical processes (non-conformances, Change Control, Validation), decisions can vary between individuals. Flownium structures the decision-making logic to ensure consistency, reproducibility and control.
AI is governed, not left unchecked
Most AI tools generate analyses or suggestions. Flownium executes AI only within configured and approved workflows.
Auditability is native
Flownium is designed to operate in audited environments. Every action is: traced, versioned, justified.
A new orchestration layer
Quality systems store data. Flownium structures their use by orchestrating workflows on top of existing tools.
Your data stays sovereign
Flownium deploys on your infrastructure. No data passes through third-party servers. A non-negotiable requirement in regulated environments.
What Flownium concretely transforms
Non-conformances
Today
Scattered data. Experience-dependent analyses. Variable justifications. Frequent reopenings.
With Flownium
Structured analysis workflow. Consolidated data, guided investigations, governed action plan.
Impact
25–40% reduction in analysis time. Up to 50% fewer reopenings. Auditable justifications.
Change Control
Today
Scattered data and history. Variable change analysis. Multiple back-and-forths. Inconsistent justifications across files.
With Flownium
Automatically consolidated data. Complete workflow for scoping, impact, risk and action. Smoother, more consistent validation.
Impact
20–35% reduction in processing time. More consistent decisions. Less risk of underestimating an impact.
Qualification & Validation
Today
Manual protocol drafting. Variable document structures. Long formalization times.
With Flownium
Automated structured generation of protocols and reports, integrated with internal data.
Impact
30–50% reduction in drafting time. Document harmonization. Inspection-ready files.
Measurable return on investment from the first year
Conservative optimization
hours saved per year
in annual savings
Example from an industrial site
4 to 6 hours per non-conformance
10 to 15 hours per change control
10 to 15 hours per Qualification file
500 non-conformances / year
150 Change Controls / year
50 Qualification / Validation files
Based on an average loaded cost of €70/h
Beyond the financial gain
- ✓Fewer reopenings
- ✓Less inter-department back-and-forth
- ✓More consistent decisions
- ✓Better knowledge capitalization
- ✓Reduced audit gap risk
A transparent model
Gains are based on conservative assumptions: • Partial optimization of processing times • Without radical organizational transformation • Based on real field data • Applicable from the first quarter of deployment Each estimate is verifiable and tailored to your operational context.
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Our vision, our approach
A conviction
Critical processes are not slow due to a lack of skills. They are slow because information is scattered and decisions are not sufficiently structured.
A different approach to AI
We don't seek to make AI more spectacular. We make it usable, traceable and controllable in environments where every decision must be justifiable.
A clear ambition
Transform complex decisions into executable and auditable processes. To enable organizations to gain speed, reliability, and control.
The founders
A biotechnology engineer, Michael has spent over 10 years in highly regulated industrial environments (pharma and medical devices). He has led Quality and MSAT departments, managed complex investigations and driven operational transformation programs. In direct contact with operations, one reality stands out: systems document processes. They don't structure decision-making. Flownium was born from this field reality: turning decisions into the engine of critical process execution.
A CentraleSupélec engineering graduate, Victor has over 10 years of experience in engineering and technology platform development. He has designed architectures capable of supporting distributed, complex and highly scalable systems. At Flownium, he designs the infrastructure that allows AI to be integrated directly into operational workflows. An architecture designed to: • connect existing systems • structure process execution • ensure traceability, governance and robustness