About
About the company
Bruni Manufacturing Systems supports pharmaceutical manufacturers in designing, integrating and validating the digital systems that run regulated production.
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Engineering-led
We work at the intersection of automation, IT and quality — turning operational requirements into GMP-compliant digital systems.
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Compliance by design
Every system is built to hold up under inspection, with documentation and validation support aligned to the client’s quality framework.
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Scoped to fit
Engagements range from single-site MES engineering to multi-vendor, multi-site program coordination.

We help manufacturers move from paper-based processes to connected, standards-based digital manufacturing — designing MES recipes, integrating shop-floor systems with ERP and LIMS, and coordinating the vendors and system integrators involved along the way.
Our focus is Drug Substance and Drug Product manufacturing environments, where system changes have to satisfy both operational and regulatory requirements at once. That means documentation, validation and change control are built into the engineering work, not added afterward.
Bruni Manufacturing Systems is built to bring senior, hands-on expertise to organizations that need it — for a single project or an ongoing program.
Let's talk about your manufacturing systems.
Whether it’s a single MES recipe, an OT/IT integration, or program leadership across multiple sites — get in touch to discuss scope.
Services
Manufacturing Systems
Technology & standards
Platforms and frameworks we work with across MES, automation, historian, ERP and warehouse projects.
Standards & frameworks
Standards and regulatory frameworks supporting manufacturing, quality, validation, clinical practice and logistics projects.
| Standard / Framework | Application / Description |
|---|---|
| ISA-95 | Manufacturing data standardization and harmonization of data models across sites |
| ISA-88 | Batch control and recipe standardization, coupled with ISA-95 |
| ISA-18.2 | Alarm management, including alarm rationalization and design |
| GxP | General regulatory quality framework |
| GAMP 5 | GAMP 5-aligned validation practices |
| ICH E6(R2) | Good Clinical Practice (GCP) Guidelines (certification) |
| IATA DGR | Dangerous Goods Regulations for the air transport of dangerous goods |
Basel, Switzerland — MES & automation engineering
Manufacturing systems built to hold up under GMP scrutiny.
Bruni Manufacturing Systems designs, integrates and validates the MES, automation and OT/IT systems that run regulated pharmaceutical production — from single recipe changes to multi-site digital rollouts.

